Using Education to Improve Medication Adherence in ...

Using Education to Improve Medication Adherence in Hypertension

Submitted by

Chinyere Oghide

A Direct Practice Improvement Project Presented in Partial Fulfillment

of the Requirements for the Degree

Doctor of Nursing Practice

Grand Canyon University

Phoenix, Arizona

February 18, 2021

GRAND CANYON UNIVERSITY

Using Education to Improve Medication Adherence in Hypertension

by

Chinyere Oghide

has been approved

February 18, 2021

APPROVED:

JoAnna Cartwright, PhD, APRN, NNP-BC, DPI Project Chairperson

Maurene Schneider, MSN, RN, DPI Project Committee Member

ACCEPTED AND SIGNED:

__________

Lisa G. Smith, PhD, RN, CNE

Dean and Professor, College of Nursing and Health Care Professions

_________________________________________

Date

2/19/2021

Abstract

Antihypertensive medication non-adherence is a common problem in healthcare.

Currently, the project site has no program to increase medication adherence (MA) in their

hypertensive patients. Therefore, the purpose of this quantitative, quasi-experimental

quality improvement project was to determine if the implementation of the Million Hearts

program impacted the adherence to antihypertensive medication among adult patients,

with known hypertension (HTN) in a primary care clinic setting in New York, over a four

week period. Orem’s self-care theory and Ajzen’s theory of planned behavior were the

project’s theoretical foundation. Data on MA was measured using the Hill-Bone

Medication Adherence Scale HB-MAS scale in hypertensive adults aged 18 years and

older (n = 15) at baseline and at four weeks. A two-tailed paired sample t-test showed

that there was a clinical and statistically significant improvement in patients MA (M =

35.6; SD = 1.55; p = 0.00). The results of the Million Hearts program may increase MA

adherence in this population of patients. Based on the results, it is recommended that the

project is sustained at the site, blood pressure measurements are trended over a year to

determine if the increased MA improves the blood pressure measurements.

Keywords: HTN, medication adherence, Hill-Bone Medication Adherence Scale,

theory of planned behavior, Ajzen, Orem, self-care theory, American Heart Association,

Million Hearts.

Dedication

This project is dedicated to my parents, Eze Omeudo Peter and Lolo Beatrice

Oduoza, of happy memory, who believed in education as the best route to success. My

father’s statement of encouragement was always “Forward ever, backward never.” and

believed in my successful capabilities. Both of you have gone ahead of me to God, but

are evergreen on earth and your influence has made possible my DNP educational

journey.

Acknowledgments

First and foremost, my gratitude goes to my Almighty God who, in his infinite

mercy and goodness, inspired me to begin and to complete this project. Though the DNP

journey initially appeared distant, I am exceptionally grateful to all those who contributed

to making it a pleasant journey.

My wholehearted gratitude goes to my committee chairperson, Dr. JoAnna

Cartwright who consistently guided and encouraged me during my project. I extend my

sincere gratitude to my content expert, Maurene Schneider, who was always there for me

and very supportive at my project site. I would like to thank Dr. Stephanie Hills for her

encouragement from the foundation to the end of my DNP journey. I also like to thank all

my instructors for their dedication.

Very many thanks to my project site primary care nurses, Mary, Felicia, and

Lena, for their contribution to my project. I extend my profound gratitude to Anne

Wilburn for constant encouragement and forever being pleasant throughout the journey.

Finally, I thank my family – my dear husband, Godwin, my darling daughter,

Esosa, and my darling son, Nosa, for keeping me company during my sleepless nights,

and helping my computer illiteracy. I extend my gratitude to my six brothers and three

sisters for their daily prayers. To my parents, I say ‘Adieu’ as they rest in perfect peace

with God.

Table of Contents

Chapter 1: Introduction to the Project ..................................................................................1

Background of the Project ...............................................................................................2

Problem Statement ...........................................................................................................4

Purpose of the Project ......................................................................................................5

Clinical Question .............................................................................................................6

Advancing Scientific Knowledge ....................................................................................7

Significance of the Project ...............................................................................................9

Rationale for Methodology ............................................................................................10

Nature of the Project Design ..........................................................................................11

Definition of Terms .......................................................................................................13

Assumptions, Limitations, Delimitations ......................................................................14

Summary and Organization of the Remainder of the Project ........................................16

Chapter 2: Literature Review .............................................................................................18

Theoretical Framework ..................................................................................................22

The theory of planned behavior (TPB) ......................................................................22

Orem’s self-care theory. .............................................................................................24

Review of the Literature ................................................................................................25

Medication non-adherence .........................................................................................26

Uncontrolled HTN .....................................................................................................37

Strategies for medication adherence (MA) ................................................................48

Summary ........................................................................................................................58

Chapter 3: Methodology ....................................................................................................61

Statement of the Problem ...............................................................................................62

Clinical Question ...........................................................................................................63

Project Methodology ......................................................................................................65

Project Design ................................................................................................................66

Population and Sample Selection ..................................................................................67

Instrumentation and Sources of Data .............................................................................69

Hill-Bone Medication Adherence Scale (HB-MAS) .................................................69

Self-Measured Blood Pressure (SMBP) ....................................................................70

Electronic Health Records (EHRs) ............................................................................70

Validity ..........................................................................................................................71

Reliability .......................................................................................................................72

Data Collection Procedures ...........................................................................................73

Data Analysis Procedures ..............................................................................................74

Potential Bias and Mitigation ........................................................................................76

Ethical Consideration .....................................................................................................77

Limitations .....................................................................................................................78

Summary ........................................................................................................................79

Chapter 4: Data Analysis and Results ................................................................................81

Descriptive Data ............................................................................................................82

Data Analysis Procedures ..............................................................................................85

Results ............................................................................................................................86

Summary ........................................................................................................................90

Chapter 5: Summary, Conclusions, and Recommendations ..............................................92

Summary of the Project .................................................................................................93

Summary of Findings and Conclusion...........................................................................94

Implications ...................................................................................................................96

Theoretical implication ..............................................................................................96

Practical implications .................................................................................................97

Future implications ....................................................................................................97

Recommendations ..........................................................................................................98

Recommendations for future projects ........................................................................98

Recommendations for future practice ........................................................................99

References ........................................................................................................................101

Appendix A ......................................................................................................................126

Grand Canyon University Institutional Review Board Outcome Letter ......................126

Appendix B ......................................................................................................................127

Hill-Bone Medication Adherence Scale (HB-MAS) ...................................................127

Appendix C ......................................................................................................................128

Permission to Use Hill Bone Scale (HB-MAS) ...........................................................128

Appendix D ......................................................................................................................129

Center for Disease Control and Prevention Million Hearts Tools ...............................129

Appendix E ......................................................................................................................132

Permission to Use Center of Disease Control and Prevention Million Hearts Tools ..132

List of Tables

Table 1. Demographics of Project Sample ....................................................................... 83

Table 2. Total scores of MA Data as measured with HB-MAS Tool ............................... 84

Table 3. Blood Pressure Comparison................................................................................ 85

Table 4. Pre/Post-Intervention Comparison ...................................................................... 89

List of Figures

Figure 1. Bar Graph displaying the mean scores as measured by HB-MAS. ................... 88

Figure 2. Pre and post blood pressure comparison using the mean BPs........................... 89

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Chapter 1: Introduction to the Project

Medication non-adherence is not taking medications as ordered by their primary

care provider (Galozy, Nowaczyk, Sant, Ohlsson, & Lingman, 2020). Non-adherence to

medicines is a significant health problem, especially for patients with chronic diseases

requiring multiple medications (Smith et al., 2017).

Currently, the project site has over 50% of their patients that are noncompliant

with their hypertensive treatment. Nurses at the project site identified the obstacles of

adherence to antihypertensive medications as a public health problem, which led to this

project's development. The complexity of hypertensive medication adherence is directly

related to the patients' knowledge, perception, and refills from the pharmacy (Galozy et

al., 2020). Patients' medication non-adherence in hypertension (HTN) can decrease but

requires thorough assessment and cooperation between the care provider and patients

(Nafradi, Galimbertti, Nakamoto, & Schultz, 2016). Non-adherence to antihypertensive

medications is a significant public health problem, causing annual deaths of about 9.4

million worldwide (Nielsen, Shrestha, Neupane, & Kallestrup, 2017). Effective treatment

for non-adherence depends on the patient's willingness to assess and understand the

conditions that prevent adherence.

Hypertension is a significant precursor of heart and kidney diseases, causing

about two-thirds of the world's mortalities and claiming about 7.1 million deaths annually

(Nikparvar et al., 2019). Hence, hypertensive patients need to understand their disease

process and agree to the definition of medication adherence. Patients need to take their

medications as recommended by health care professionals and take an active part in their

treatment plan for HTN and their providers (Turcu-Stiolica, Subtirelu, Meca, & Bogdan,

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2019). Non-adherence to antihypertensive medication is a general problem among adults,

but it is more prevalent among elderly patients (Al-Ruthia et al., 2017). This age group is

more likely to have comorbidities and be on multiple medications, which predispose

them to medication non-adherence.

Chapter 1 will present the background of the project, describing the problem,

purpose, and clinical questions which directed it. Then, how the project advanced

scientific knowledge and its significance will be described. The rationale for the

methodology and design will be discussed. The chapter will end with a discussion of key

terms, assumptions, limitations, and delimitations.

Background of the Project

The primary care clinic for the quality improvement project is an adult care clinic.

Seventy-five percent of the clinic patients have a diagnosis of HTN, and most of them are

non-adherent to their HTN medications. HTN is a public health disease worldwide

(Nielsen et al., 2017). According to the guidelines of the American Heart Association

([AHA] 2017), HTN is any blood pressure (BP) that is equal to or greater than 130/80.

The estimate was that by the year 2025, 29.2% of adults in the world would have HTN

(Veisani, Jenabi, Nematollahi, Delpisheh, & Khazaei, 2019). Eghbali-Babadi, Khosravi,

Feizi, and Sarrafzadegan (2017) predict that there will be 1.56 billion people with HTN in

2025. HTN is a chronic disease, but can be controlled to prevent cardiovascular disease

and death's adverse effects, which is crucial, considering the 10.4 million deaths globally

in 2017 (Wang et al., 2020). Though antihypertensive medication can control HTN, poor

adherence to the drug has a negative outcome and could pose an economic burden to

society (Abbas et al., 2020). Non-adherence or poor adherence to hypertension

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medication is a global problem and varied in prevalence. For instance, as noted in the

literature, a non-adherence of 86.7% and 12.7%, respectively, were discovered in two

outpatient clinics in Brazil. (Magnabosco et al., 2015). The statistics show that non-

adherence to antihypertensive medication can vary in different parts of New York, such

as urban areas. In the study of Li et al. (2019) about prevalence in New York City, the

researchers found non-adherence of 36% among 18 to 44 years of age, 11.8% among 45

to 64 years of age, 4.7% among 65 years old and above. The project site calculation

estimates that about 68% of the population with HTN have non-adherence to their

antihypertensive medication.

The estimated prevalence of medication non-adherence in older adults worldwide

is about 50% of hypertensive patients (Mahmoodi et al., 2019). Studies have shown that

there is an increase in mortality with uncontrolled HTN when there is non-adherence

(Bansal, Rajput & Mathur, 2019). This is exemplified by Carvalho and Santos (2020)

who found that 50% of hypertensive patients had controlled BP secondary to adherence

to their medications and influence from other non-pharmacological factors.

The DPI project attempts to improve medication adherence among hypertensive

primary care patients. Healthcare professionals are available to help the patients maintain

normal BPs by prescribing appropriate medications and scheduling office visits, but

many of the patients do not keep their appointments. Factors affecting their non-

adherence include forgetfulness, which may or may not be intentional, background

knowledge of HTN, other complications, costs, medication side effects, and general

attitude towards treatments (Abbas et al., 2020).

4

The project site facility makes reasonable accommodation for all patients to

maintain health, such as home-based primary care (HBPC), a community-based outreach

center (CBOC), and home telehealth. The primary care providers (PCP) can evaluate the

BP readings from electronic health records (EHRs) and adjust the BP medications

accordingly. However, gaps in knowledge still exist despite these opportunities. Hence

this evidence-based DPI project attempts to close the gap with education on the

relationship between HTN and medication adherence.

Problem Statement

It was unknown if or to what degree the implementation of the Million Hearts

education program impacted adherence to antihypertensive medication as measured by

the Hill-Bone Medication Adherence Scale (HB-MAS) when compared to current

practice among adult patients 18 years and older with known hypertension in rural New

York state. Medication non-adherence occurs at any age, but it is more prevalent in the

elderly population due to mental status and other age-related factors (Mahmoodi et al.,

2019). Though the exact cause of antihypertensive medication non-adherence is

unknown, research has identified knowledge deficit and forgetfulness as the leading

proponents (Abbas et al., 2020). The current clinic practice of mentioning taking all

medications as prescribed during an office visit has not improved adherence. In this

project, nurses target non-adherence to antihypertensive medication, using the Million

Hearts educational intervention to address the knowledge gap. The goal is for the patients

to know the adverse effects and the resultant associated comorbidities and take their BP

medications, subsequently preventing cardiovascular diseases (CVD) complications such

as stroke, heart failure, and renal insufficiency.

5

Hypertensive patients are selected from the population as they come for their

routine clinic appointments with the PCPs. Though the population's age criterion was 18

years and above, the project patients were older adults between 46 and 97. The principal

investigator (PI) supplied the education tool from the Million Hearts program (see

Appendix D), instructed the nurses, and the nurses taught the patients using the teaching

tool. The HB-MAS questionnaire measured the project's evidence by pre- and post-

interventions and was used once every week, for four weeks, to evaluate the patients'

medication adherence.

Purpose of the Project

The purpose of this quantitative, quasi-experimental project was to determine if or

to what degree the implementation of the Million Hearts education program could impact

the adherence to antihypertensive medication as measured by HB-MAS, when compared

to current practice among adult patients 18 years and older with known hypertension, in a

primary care clinic setting in New York over four weeks. This DPI project aimed to

determine if education could impact medication adherence to hypertensive patients. The

strategies were to empower patients to proper self-care; check their BP; help them

understand that HTN is the most significant risk factor for CVD, that adverse effects

could be prevented if patients' HTN was controlled; and be aware that prescribed

antihypertensive medications could control HTN if the patients took them as prescribed.

This evidence-based project was expected to improve patients' medication adherence

(MA).

The project's independent variable was the Million Hearts education, and the

dependent variable included the patient outcome of the medication adherence as

6

measured by the HB-MAS. This instrument measured weekly MA by self-report of the

patients. The second dependent variable was the patients' self-measured BP at home

using their BP kit. The nurse also took the patients' BPs at the office at pre-intervention,

and post-intervention. Although the length of the project would not show a substantial

change in blood pressure, the primary investigator (PI) included the blood pressure

measurements to look at the trends and relationship to medication adherence as

additional, but not primary, data. The BP readings were not for measuring medication

adherence. The clinic nurses for the project were instructed on using the tools and were

comfortable monitoring the patients every week. Each patient would receive a weekly

telephone call from the nurses to assess their MA's progress using the patients' responses

from the HB-HBP questionnaire.

The project contributed to evidence-based practice (EBP) in nursing because

nurses are very involved in their healthcare. When new policies and procedures are

written, the implementation is carried out by the bedside nurses. According to Karaman

and Akyolcu (2019), nurses spend more time with patients and their relatives who are

incredibly, if not critically, ill. In this DPI project, the PI instructed the nurses about the

Million Hearts education using a power-point presentation, and the nurses taught the

same information to the patients. The EBP could become a policy at the facility after this

project. Consequently, it will be applied to solve other healthcare problems.

Clinical Question

The following clinical question guided the DPI project:

Q. To what degree does the implementation of the Million Hearts education

impact the adherence to antihypertensive medication as measured by HB-MAS,

7

when compared to current practice among adult patients 18 years and older with

known hypertension in a primary care clinic setting in upstate New York over

four weeks?

This DPI was a quantitative project with a quasi-experimental design, using the

HB-MAS questionnaire to evaluate the outcome. The goal of the development was to

improve antihypertensive medication adherence using an education program. Hence, the

fulfillment of the project outcome expectation is that the patients, after receiving the

intervention, would benefit from taking their medications as prescribed compared to

before the intervention. The data from the baseline questionnaire for each person would

be compared to the post-intervention questionnaires' data at the end of the four weeks of

intervention to evaluate adherence. The outcome was expected to be positive to support

the problem statement of impacting adherence to BP medication. The pre- and post-BP

would also be checked. The PI included blood pressure measurement only as an

additional, not a primary data, to look at the trends and relationship to medication

adherence. The length of the project would not show a substantial change in blood

pressure.

Advancing Scientific Knowledge

Nursing science is vital to patient care, since its focus is on individualized care

through patient and family-centered care to achieve a maximum quality outcome (Grady,

2017). According to the National Institute of Health (NIH, 2017), individualized care is a

better approach to the patient's general welfare, because care delivery is planned between

the providers and the patient. Adherence to antihypertensive medications is significant in

health care and to the patient's general interest, which, if untreated in this case, can result

8

in uncontrolled HTN. This public health problem can be prevented or reduced with

adherence to BP prescribed medications. Following nursing science, the clinic nurses in

this project will actively engage the patients in their care plan to understand the

importance of controlled BP. The DPI project can fill the gap created by antihypertensive

non-adherence with a resultant malignant HTN.

Applying nurses' scientific knowledge, holistic care comprising all aspects of life

such as social, educational, biological, and environmental, and how these factors affect

health, will be considered in the project. Education to the patients, using the Million

Hearts program as in this DPI project, will make the patients informed in their self-care.

The provision of technological equipment, such as a blood pressure monitoring kit, also

fosters patient and family-centered care by applying nursing science (Grady, 2017).

According to Grady (2017), nursing science's goal is to improve quality of life by

individualizing patients' care needs. Future interventions that could improve the patients'

MA and subsequent BP control would be a referral to a home telehealth program. These

technologies, such as smartphone apps and computers, are linked to the health care

providers for ease of BP monitoring and medication adherence (McKoy et al., 2015).

The theory used to provide the foundation for this DPI project is the theory of

planned behavior (TPB) developed by Icek Ajzen in 1985, from a descriptive qualitative

study. This theory explains the relevance of the intentions of doing things and the

consideration of how important things are to a person (Hartley, Hoch, & Cramer, 2018).

In the case of medication adherence, frequent, friendly monitoring would eventually

foster the relevance of doing it without monitoring or further education.

9

Another theory that was applied to the foundation of this DPI project was Orem's

self-care theory, which described the association between a person and the environment

(Orem, 2001). Blood pressure is one of the chronic diseases and can be monitored and

controlled by health care providers with the patients' cooperation. In this project, the

nurses used the Million Hearts program to educate the patients and HB-MAS to monitor

their medication adherence.

Registered professional nurses were conscious of their capabilities and

management of non-adherence to antihypertensive medication and the effects of blood

pressure. Nurses applied their expertise to effectively manage such chronic conditions as

summarized by Orem’s self-care theory. Hence, the reasoning of improving medication

adherence with telephone calls is supported with the scientific knowledge background.

Significance of the Project

Using the implementation of Million Hearts education program to improve blood

pressure medication adherence fits into current health maintenance technologies. HTN

has no warning signs and can be silent, unrecognized, and untreated for many years until

it becomes an emergency (Achhab, Nazek, Maalej, Alami, & Nejjari, 2019). Considering

non-adherence to antihypertensive medication is one of the significant causes of strokes,

heart attacks, kidney failure, and death, as described by Pawloski et al. (2016). An

aggressive regimen, team based-approach to improve MA, is required in the control of

HTN.

This DPI project was important because the patients would benefit from the

intervention as evidenced by the HB-MAS data. Yazdanpanah, Saleh Moghadam,

Mazlom, Ali Beigloo, and Mohajer (2019) strongly recommended medication adherence

10

to prevent uncontrolled HTN. The potential practical application from this project was

the patients would take an active part in their care by monitoring their BP and taking their

medications as prescribed. The PI included blood pressure measurement only as an



pressure.

Rationale for Methodology

The methodology for the project was quantitative. The quantitative method was

the best for the project because the data collection was measurable and quantifiable. It

had to be numerically measurable for statistical analysis of data (Ali & Bhaskar, 2016).

The significant measurable variable for this project was the number of times the patient

took the BP medication as prescribed during the four weeks of the intervention to

improve medication adherence. The HB-MAS was the pre- and post-questionnaire to

evaluate the patients' medication adherence. Weekly data of the patients' medication

adherence was obtained over the phone using the same HB-MAS questionnaire. Logs of

the patients' data were compared to evaluate adherence to their antihypertensive

medication. There was also a comparison between the pre- and post-BP. Although the

project's length would not show a substantial change in blood pressure, the blood

pressure measurements were included to look at the trends and relationship to medication

adherence as additional, but not primary, data.

The quantitative methodology was the best approach to this project because the

dependent and independent variables needed quantifying accurate comparison. The use of

numbers, tables, and ratios were significant in the accuracy of the interpretations of an

11

EBP project's findings. The research identified quantitative methodology as a stable, in-

depth analysis in confirming a study (Bolondi, Branchetti, & Giberti, 2018). A qualitative

method is not appropriate for this evidence-based DPI project because qualitative

methods explore occurrences more. They use structured interviews or reviews of case

records. According to Van den Berg and Struwig (2017), a qualitative approach is

appropriate for explaining theories' events and development. The theories for this project,

Orem's self-care theory, and the theory of Planned Behavior, have already been

developed.

Nature of the Project Design

This DPI project applied a quasi-experimental design which required a pre-

intervention questionnaire and a post-intervention questionnaire using the HB-MAS.

Blood pressure was checked before the intervention and post-intervention. Blood

pressure measurements were included only as an additional, not primary data, to look at

the trends and relationship to medication adherence. The length of the project would not

show a substantial change in blood pressure. Nurses at the project site were instructed

using a PowerPoint presentation based on the Million Hearts education tool. Then the

nurses taught the patients using the same Million Hearts education as the intervention.

The pre-intervention screening of the patients using HB-MAS was done to

evaluate their baseline medication adherence. The intervention required individualized

teaching at the PCP's office. The teaching information was consistent with the Million

Hearts education program on HTN and the importance of medication adherence. Pre-

intervention BP was also checked for the purpose of monitoring the trends. The nurses'

weekly telephone calls to the patients were to obtain data regarding their medication

12

adherence for the week. Each patient would respond numerically to each of the nine

questions following the HB-MAS questionnaire. After four weeks of the intervention, the

post-intervention questionnaire provides numerical data for comparison with the baseline

medication adherence. The patients' BP checked at post-intervention was included by the

PI only as an additional, not a primary data, to look at the trends and relationship to

medication adherence. The length of the project (four weeks) would not show a

substantial change in blood pressure.

A quasi-experimental design was the best design for this DPI project because it

would address the PICOT question more appropriately than any other method. The

system is consistent with the quasi-experimental design described by Bloomfield and

Fisher (2019), because there could be a causal-comparative relationship between the

dependent and independent variables. It addressed the extent that implementing the

Million Hearts education program would impact the adherence to antihypertensive

medication. The HB-MAS questionnaire was used to obtain data for the patients'

medication adherence. A cross-sectional study design is not appropriate for this DPI

project because this design is more of an observational study of outcomes (Bangdiwala,

2018). Though a questionnaire can be used in collecting the data like a quasi-

experimental design, the analysis of a cross-sectional design does not establish a causal

relationship for comparison.

The steps taken for the data collection were as follows: (a) recruit the sample of

hypertensive patients who were non-adherent to antihypertensive medication as

determined by the HB-MAS, (b) obtain baseline numerical data from the samples, (c)

have the nurses teach the patients using the Million Hearts education materials, (d) check

13

baseline blood pressures, (e) establish weekly phone calls from the nurse, and (f) obtain

post-intervention medication adherence data, and post-intervention BP check. Although

the project's length is too short for showing a substantial change in blood pressure, the PI

included the blood pressure measurements to look at the trends and relationship to

medication adherence as additional, but not primary data.

Definition of Terms

The following terms were used in this project:

Cardiovascular disease (CVD). Cardiovascular disease is the general name for

heart diseases such as stroke and heart attack. Their main cause is uncontrolled high

blood pressure (high BP), but this can be prevented or controlled by taking any

medication ordered by the provider (Pioli et al., 2018).

Hypertension (HTN). Hypertension is a condition when blood pressure (BP) is

higher than the set normal limits of 130/80, where 130 is the systolic blood pressure

(SBP), and 80 is the diastolic blood pressure (DBP). Any SBP greater than 130 or DBP

greater than 80, is referred to as HTN (Ihm et al., 2019). It is a silent killer and has no

warning signs until it becomes a medical emergency (Achhab et al., 2019).

Medication adherence (MA). Medication adherence in HTN is a public health

problem that affects all ages but especially the elderly population. MA is taking

medications as prescribed by the clinician (Galozy et al., 2020).

Million Hearts. Million Hearts is an extensive advertisement that the American

Heart Association (AHA) uses to teach and encourage people to prevent heart diseases.

The aim is to prevent one million heart attacks, kidney diseases, strokes, and death within

five years. The aim is medication adherence (CDC, 2015).

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Hills-Bone medication adherence scale (HB-MAS). HB-MAS is a scale with

nine questions used in testing the medication taking of the patients concerning the

patients' MA. It has one to four numerical responses designed by The Hill Bone Scales

Team (Kim, Hill, Bone, & Levine, 2000). According to Johns Hopkins University School

of Nursing (2020), Hill-Bone Medication Adherence Scale (HB-MAS), a nine-item scale,

is specifically designed originally for measuring compliance with the treatment of HTN.

The scale can measure medication adherence in other chronic conditions, such as diabetes

and chronic obstructive pulmonary disease. The university recommends the use of the

Hill-Bone scale at every health care visit for improved patients' outcomes.

Non-adherence in HTN. Non-adherence in HTN is not doing what is supposed

to be done to prevent hypertension. Non-adherence to antihypertensive medication can

predispose to CVD, stroke, heart failure, and kidney failure, and these have increased

mortality due to uncontrolled HTN. Non-adherence to BP medication is a significant

cause of uncontrolled HTN (Abbas et al., 2020).

Assumptions, Limitations, Delimitations

It was assumed the patients would present to the outpatient clinic whenever they

were scheduled to come. It was also assumed the patients would show up at their

appointments and be interested in taking their medications as prescribed, but tend not to

take, probably because they forget or do not know the importance. If so, there would be

no HTN medication non-adherence, which is currently a significant medical problem

(Smith et al., 2017). It was assumed all the patients would remember to check their BP as

needed. However, forgetfulness and not knowing the importance of BP treatment are

among the significant reasons for patients' medication non-adherence (Abbas et al.,

15

2020). There was an assumption that after receiving education every adult is aware of the

complications of uncontrolled HTN, and prescribed pharmacological management is not

the only regimen for the control of HTN and prevention of CVD (Mahmoodi et al.,

2019).

The project was designed for adult patients from 18 years of age and above, but

HTN is more prevalent among older adults (Al-Ruthia et al., 2017). Hence, this project's

general population was 46 to 97 years old, though the proposed age group was 18 years

and above. Another limitation was the small sample size of 15 patients. This population

was too small to show statistical significance or reach generalizable findings. Though

there were many uncontrolled hypertensive patients among the population, only 15

consented to participate in the project. Being a DPI project, every uncontrolled

hypertensive patient should be accepted to participate. Large samples produce more

accuracy with a low margin of error, because a large data reveals every detail with high

statistical significance (Khalilzadeh & Tasci, 2017).

Though HTN has no warning sign, CVD's warning sign, such as stroke, is HTN

(Barua et al., 2019). The project facility provided extensive care for the patients'

convenience and obtained the maximum quality outcome of care. The patients could

utilize the resources closest to their homes, such as community-based outreach centers

(CBOC), for frequent checks of their BPs. They could also be enrolled in home-based

primary care (HBPC) if unable to go to the CBOC or be registered in-home telehealth to

monitor the BP closely. The DPI project aimed to close the existing gap using education.

Hence, having care locations at proximity makes it easier to check BPs and adjust

antihypertensive medications.

16

Empowerment could enable patients' self-care and to monitor their BP. Not all

patients want to monitor their BP, despite being provided with a BP kit. However, the

nurses provided individualized teaching of appropriate BP testing for accurate results.

This activity might have made the patients feel more responsible for their care, with

subsequent adherence to antihypertensive medication.

Summary and Organization of the Remainder of the Project

Research defined medication adherence in various ways, but the definitions

explain that medication should be taken as prescribed by a health care professional

(Galozy et al., 2020). The researchers reported that HTN, a chronic disease, requires

pharmacological intervention for older adults' control with other associated health

problems. Medication non-adherence has been found in all age groups, but research

determined it was more prevalent with older adults (Smith et al., 2017). Hypertension

was found to be the most significant risk factor for CVD and death from its complications

(Wang et al., 2020). Antihypertensive medications have been shown to control HTN, but

non-adherence to the medications, as reported by Bansal, Rajput, and Mathur (2019), was

found to be a significant cause for uncontrolled HTN.

This evidence-based project attempted to improve MA by enabling the control of

HTN and preventing CVD and its associated public health costs and death. The patients

were taught about HTN, related factors, and the importance of taking antihypertensive

medications using the Million Hearts education program. The period of the intervention

was four weeks. The pre- and post-interventions were numerically measured with be the

HB-MAS questionnaire. The HB-MAS was the tool used for obtaining the MA data. The

17

evaluation of the data from the HB-MAS for pre- and post-intervention, and weekly

during the intervention period of four weeks; were compared to give the MA outcome.

Nursing science is vital in obtaining a maximum quality outcome of care (Grady,

2017), and it was applied in this project. The theory of planned behavior (Ajzen, 1985)

and Orem's self-care theory (2001) were also applicable because, after completing the

DPI project, the patients are expected to continue taking their BP medications as

prescribed without any further intervention after the project period. The methodology and

design for this DPI project was a quantitative, quasi-experimental design from which

numerical data were obtained and compared for accuracy of the project interpretations

(Bolondi et al., 2018).

The next section is Chapter 2 of the project, which provides a literature review of

about 50 related articles. The chapter will involve analyzing and synthesizing the articles,

identifying the themes, subthemes, and identifying at least one quantitative methodology.

In Chapter 3, the project's methodology, which builds off the literature, will be described

in detail. Chapter 4 will provide the results of data collection and analysis. Chapter 5 will

provide and interpretation of the results.

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Chapter 2: Literature Review

As defined by Pan, Lei, Hu, and Li (2020), medication adherence (MA) is the

taking of medications as prescribed. Furthermore, if taken as prescribed, antihypertensive

medication produces positive BP control (Pan et al., 2020). Medication non-adherence is

defined as a situation where medication is not taken as prescribed even if the reason is

that it is forgotten (Malek, Heath & Green, 2017). Typically, clinicians provide advice

and information regarding prescribed medications, and patients are expected to follow

accordingly. Medication non-adherence is a significant public health problem, especially

for hypertensive patients, affecting 20% to 50% of the patients (Nafradi, Galimberti,

Nakamoto, & Schultz, 2016).

Hypertension is the precursor of heart and kidney diseases and causes about two-

thirds of the world's mortalities and 7.1 million deaths annually (Nikparvar et al., 2019).

The Centers for Disease Control and Prevention (CDC) in 2017 reported an estimated

death of 472,000 people from HTN in the US, and this approximates 1,300 deaths per

day. Approximately 108 million people in the United States have HTN, and only 24% of

them have controlled BP (CDC, 2017).

The lists of the items to improve medication adherence (MA) among the patients

(who will be further discussed in the literature review) are divided into three themes and

nine subthemes. The themes are medication non-adherence, uncontrolled HTN, and

strategies for medication adherence. The subthemes are (a) patients-providers

communication of non-adherence, (b) barriers to MA, (c) factors affecting MA, (d)

factors associated with uncontrolled HTN, (e) patient-clinician communications about

19

HTN, (f) disparities in HTN, (g) patient education, (h) facilitators, and (i) outpatient

monitoring.

Many factors determine non-adherence to medication, such as patients, provider

relationships, and medications (Acosta et al., 2015). Patients' involvement and

communication with health care professionals are significant aspects of medication

adherence, including behavioral factors and knowledge (Nafradi et al., 2016). Costa et al.

(2015) recommended improvement methods to reduce risk factors to the patients and

described them as behavioral, self-management, educational, and reminder interventions.

The literature review to improve adherence to antihypertensive medications requires an

outline approach that focuses on the patients' role, the healthcare providers, and

medicines.

Multiple studies linked uncontrolled HTN to medication non-adherence and

describe the relationship as a significant public health problem that affects all aspects of

health (Ruppar et al., 2015). Ruppar et al.'s systematic review of the clinical practice

guidelines (2015) includes the declaration of the World Health Organization (WHO) in

its 2003 report on non-adherence to medications as affecting mainly people with chronic

conditions, leading to higher risks for treatment failure and increased healthcare

utilization and associated hospitalization (Ruppar et al., 2015; WHO, 2003).

As described by the US Institute of Medicine, clinical practice guidelines enable

maximum outcome patient care as cited by Ruppar et al. (2015), which are developed

from the existing knowledge to improve medication adherence. The purpose of this

quantitative, quasi-experimental project was to determine if or to what degree the

implementation of the Million Hearts education program could impact the adherence to

20

antihypertensive medication as measured by HB-MAS, when compared with current

practice among adult patients 18 years and older with known hypertension, in a primary

care clinic setting in New York over four weeks.

The existing gap in the literature of medication non-adherence could be filled by

the DPI project using education as an intervention. The clinic nurses always check the

patients' vital signs whenever the patients go for their clinicians' appointments, and the

patients are notified of the status of their BP, which is a way of monitoring their BP. This

evidence-based project added to the current knowledge level to improve medication

adherence. The gap of non-adherence to antihypertensive medication was determined for

multiple reasons, including the patients' knowledge deficit, and the project's educational

interventions can fill it. Nafradi et al. (2017) promoted treatment adherence and positive

outcome of care, considering the patient takes an active part in their prescribed

treatments. The DPI filled the gap by teaching the patients the importance of taking their

BP medications as prescribed and included behavior and lifestyle modifications. The

endpoint was the patients' positive health outcome, as measured by the HB-MAS.

According to the American College of Cardiology (ACC) and American Heart

Association (AHA) guidelines for HTN in 2017, HTN is any BP equal to or above 130/80

where 130 mmHg is the systolic BP, and 80 mmHg is the diastolic BP (CDC, 2020).

Antihypertensive medications control HTN, but non-adherence to HTN medication is a

significant cause of uncontrolled HTN (Pan et al., 2020). According to Barua, Faruque,

Banik, and Ali (2019), HTN is the most common and significant cause of cardiovascular

disease (CVD) in the world. Being non-infectious and silent, HTN can remain dormant

for many years until it causes harm (Achhab et al., 2019).

21

Environmental and genetic factors predispose an individual to HTN as discovered

by Zilbermint, Hannah-Shmouni, and Stratakis (2019). The researchers found HTN to be

more prevalent among African Americans than any other ethnic group, and it is

significant due to genetics, which explains the familial relationship. Other indicators that

predict the existence of HTN include socioeconomic status (SES), gender, age, obesity,

and lifestyle (Neufcourt, Deguen, Bayat, Zins, & Grimaud, 2020). Historically, people

with low SES have poor control of HTN due to knowledge deficit, low level of

education, and low income. Neufcourt et al. (2020) further explained HTN as being more

prevalent among men than women.

Non-adherence to hypertension medication has many associated factors, but

according to Etebari, Pezeshki, and Fakour (2019), non-adherence has no prior history.

The event is created by the patients who did not take their medications as prescribed, and

they end up with uncontrolled HTN. One factor determining non-adherence to HTN

medication is the patient's low treatment motivation, which explains the patients' lack of

interest in their health condition. Bansal et al. (2019) ascribed this low motivation to a

lack of education about HTN. SES of the patients, their attitudes towards treatment, and

beliefs about medications are contributory determinants to HTN medication non-

adherence (Abbas et al., 2020). Mahmoodi et al. (2019) discussed the high economic

costs affecting the affordability of the long-term use of HTN medications. Etebari et al.

(2019) reported therapeutic control of HTN as the adherence to the medicines and all

other recommendations from the clinician. HTN is a chronic disease, so it requires long-

term treatment to sustain HTN control. The DPI project will be designed to enable the

patients suffering from HTN to take an active part in the management of their HTN. The

22

care will involve the education of the patients, including knowledge about behavior and

lifestyle modifications.

The rest of this chapter will present the results of the literature review. It will

begin with a discussion of the theoretical framework. Then, the literature will be

discussed according to themes and subthemes. The themes were medication non-

adherence, uncontrolled hypertension, and medication adherence strategies. The

subthemes were: patient and provider communication, barriers to medication adherence,

the factors affecting medication adherence, associated factors, patient-clinician

communication, disparity in hypertension, patient education, facilitators, and outpatient

monitoring for sustainability.

Theoretical Framework

The theoretical framework explains the model from which the evidence based

project is constructed. Two theories were applied in this project. The selected theories

were: the theory of planned behavior and Orem’s self-care theory. The theories supply a

background explanation to the transmission of the project by the participating nurses.

The theory of planned behavior (TPB). The theory used to provide the

foundation for this practice project is the theory of planned behavior (TPB). Theory of

planned behavior was developed through a descriptive qualitative study to analyze five

physical education teachers' beliefs about their students with disabilities (Ajzen, 1985).

The disabled students were Japanese and were integrated into a class with regular

students. Demographic data were collected by questionnaires and used open-ended

questions. The teachers applied structured face-to-face interviews after validation and

translation of the tool from English to Japanese. The data were statistically analyzed. The

23

students' disabilities influenced the teachers' beliefs, and their views were higher with

severe disabilities, though it was a difficult task (Sato & Hodge, 2009). Overall, the study

had a positive outcome.

The literature discussed various modes of behavior and found a specific aspect of

an individual's behavior could be predicted correctly (Ajzen, 1985); thus, TPB resulted.

TPB explained the relevance of the intentions of doing things and how important it is to

the person (Hartley et al., 2018). In medication adherence, frequent friendly reminders to

take medications as prescribed will eventually foster patients' relevance of taking their

antihypertensive medications without being reminded. Blood pressure (BP), one of the

chronic diseases, can be monitored and controlled by the health care providers with the

cooperation of the patients. HTN is a chronic condition without a complete cure. In this

case, self-care provides an opportunity for monitoring the patients' association. People's

appropriate treatment, if applied as prescribed, yields the expected results.

The theory of planned behavior is related to the DPI project in many ways,

starting from the theory's purpose, which evaluated the teachers' beliefs about teaching

disabled students. There was a concern for them since they were in the same class with

regular students without disabilities. They should have equal opportunity in education

without discrimination. The teachers modified their beliefs even though it was not easy to

accommodate the students with their chronic disabilities to reduce disparity. Similarly,

the DPI project has identified medication non-adherence in HTN and will address it to

enable the patients to achieve a positive outcome of care.

The theory of planned behavior applied in the teaching tool was to help

hypertensive patients to understand their chronic disease and was the best way to achieve

24

a quality patient outcome. Being knowledgeable about the predictive factor of HTN and

how to keep it controlled was significant, and TPB predicted the factors. Emphasis was

placed on the use of medications and, more significantly, on medication adherence

(Etebari et al., 2019). Other non-pharmacological therapies, such as exercise and lifestyle

modifications, diet, and weight reduction, are adjunct therapy to medications. Gao et al.

(2020) applied the TPB in predicting exercise for diabetic patients (a chronic disease, like

HTN), and it was successful. Since the treatment outcome was predicted using TPB (Gao

et al., 2020), the DPI project's education intervention outcome predicted a positive result.

The researchers applied TPB in the evaluation of clinical errors in a hospital, and

225 nurses were involved in the study about reporting clinical errors. Findings were

consistent with the positive behavioral effect on the nurses' clinical errors with a p-value

of less than 0.05 (Seyedin, Ravaghi & Nikmaram, 2016). Jeong and Kim (2016) studied

knowledge and belief about hand hygiene among 208 nursing students and found 68.1%

correct response. The evaluation's focus was based on the TPB; the study concluded with

positive behavioral beliefs influenced by hand hygiene compliance (Jeong & Kim, 2016).

Orem’s self-care theory. Orem's self-care theory (2001) is another theory which

relates the patient and its environment, especially the nursing care. According to Whelan

(1984), this nursing intervention was crucial in supporting the patients' health. Analyzing

Orem's self-care model, the patient needs the nurses' intervention to sustain life and

maintain health (Whelan, 1984). Orem's self-care theory applies to the DPI project

because patients try to take care of themselves, and nurses were expected to intervene in

the patients' area of deficits.

25

Applying Orem's self-care theory, the nurses would determine the patients'

deficiencies in adherence to antihypertensive medication using the HB-MAS. Then the

nurses applied the intervention with Million Hearts education to remove the patients'

deficits. The nurses followed-up with the patients, using weekly telephone calls to obtain

the data on the number of times the patients took, or did not take, the antihypertensive

medications. Following Orem's theory, the nurses would continue helping the patients

until they arrive at their highest medication adherence level. Hosseinzadeh et al. (2019)

studied the dietary salt consumption of 250 hypertensive patients and applied Orem's

self-care theory. The study was based on the patients' capability and deficiency of self-

care, while the nurses used education for the intervention, with a resultant patients'

reduction of dietary salt consumption (Hosseinzadeh et al., 2019).

Review of the Literature

The literature review was divided into three major themes: medication non-

adherence, uncontrolled hypertension, and medication adherence (MA) strategies. Each

theme was further divided into subthemes, and they were discussed in the review of the

literature. Search engines used in collecting the literature were the Cumulative Index of

Nursing and Allied Health Literature (CINAHL), Cochrane, and Google Scholar. Search

terms used were HTN, medication adherence, heart health education, HB-MAS, and

peer-reviewed articles. More than 85% of the literature sources were published in the last

five years. MA will be examined in line with HTN. The aim is to synthesize HTN, what

constitutes uncontrolled HTN, and how medication non-adherence is related to

uncontrolled HTN. The next part examines the strategies, including the interventions and

pharmacological methods, to control HTN and sustain adherence to antihypertensive

26

medications. This DPI project used Million Hearts education to teach the patients about

their disease and its relationship with MA.

Medication non-adherence. The first theme of the DPI project is medication

non-adherence. The literature will define and review MA with particular reference to

HTN medications. Non-adherence to medications is prevalent in people with chronic

diseases, especially cardiovascular disease, and is associated with an increased risk of

hospitalization and mortality (Mekonnen & Gelayee, 2020). In chronic conditions,

patients tend to be on many medications for their symptoms, which also affects MA

(Walsh, Bennett, Wallace, & Cahir, 2020). Patients might not have full knowledge of all

the medicines prescribed to them. Meckonnen and Gelayee (2020) found the patients'

understanding of their medications, such as the purpose, dosage, and side effects, can

influence their MA.

First Kilic and Dag (2020) presented descriptive cross-sectional research on the

relationship between health literacy and medication adherence among patients with HTN

and related this to chronic diseases. HTN is a chronic disease, and low health literacy

affects the control of HTN (Firat Kilic & Dag, 2020). HTN is the leading cause of

cardiovascular disease, and older adults are more likely to experience medication non-

adherence (Etebari, Pezeshki, & Fakour, 2019). Besides, Firat Kilic and Dag (2020)

described other effects to prevent MA, especially the health knowledge deficit of the

clinician's medications. The question was whether there is a relationship between health

literacy and MA in HTN. A descriptive cross-sectional study comprised of 101 adult

people suffering from HTN who attended outpatient clinics were studied using Adult

Health Literacy Scale (AHLS) with 23 items (First et al., 2020). These authors found that

27

patients with low numbers of years for their diseases had higher AHLS, and poor AHLS

was associated with HTN and subsequent medication non-adherence. In this study, 57.4%

of the population had HTN for about ten years. The study identified the use of one center

for the research as a limitation. For future studies, the researchers recommended a more

prominent center for a larger population.

Khayyat et al. (2019) presented their research of the association between MA and

quality of life (QOL) among patients with HTN and diabetes (DM). Chronic conditions,

such as HTN and DM, are health conditions and can challenge QOL and subsequent MA

(Khayyat et al., 2019). The researchers studied 300 adult patients with chronic conditions

of HTN and DM. A cross-sectional study from five primary care clinics was selected, and

Morisky Medication Adherence Scale (MMAS-8) and World Health Organization

Quality of Life -BREF (WHOQOL-BREF) questionnaires were applied for data

collection. The study was conducted in line with this DPI project because it would also

use a questionnaire. Khayyat et al. (2019) concluded that females had lower QOL and

poor MA than males, and patients with low education experienced poor MA, considering

their covariates of physical, psychological, social, and environmental factors. There was

no mention of the actual numbers of males or females. The study's limitation was the

questionnaires were self-reported, which could have reduced the survey's accuracy.

Wahyuni et al. (2019) studied adherence to antihypertensive medication among

80 patients in primary care located in Medan city. These researchers defined HTN as a

significant health problem for senior citizens. Antihypertensive medication is the

treatment of choice for controlling HTN in this age group, but it is ineffective without

adherence to the prescribed medications (Wahyuni et al., 2019). The study's purpose was

28

to show the relationship between the knowledge of HTN, attitude towards treatment, and

effective communication of medication adherence by the clinicians. Wahyuni et al.

(2019) used a cross-sectional analytic methodology and studied 80 randomly selected

hypertensive patients on antihypertensive medication. Data collection was by

questionnaire. The research findings showed 76.3% had insufficient knowledge of MA,

73.8% had negative attitudes toward MA, while 56.3% were adherent to antihypertensive

medication due to good communication with clinicians (Wahyuni et al., 2019).

Non-adherence to antihypertensive medication was studied by Nielsen, Shrestha,

Neupane, and Kallestrip (2017), and the aim was to review the relationship between

medication adherence, antihypertensive drugs, and income status. The methodology was

a review of articles using the Meta-analysis of Observational Studies in Epidemiology

Guideline (MOOSE). The research covered 22 low- and middle- income countries such

as South Asia, Arab, and sub-Saharan countries (Nielsen et al., 2017). The researchers

found that non-adherence was worse in low-income countries, which Nielsen et al. (2017)

attributed the non-adherence to lack of health care resources and affordability, which led

to poor quality of life in the population. The researchers also identified the limitation of

the search process, which did not cover non-English speaking countries. There was

minimum selection bias by including the population from a structured community setting

with MA. Another limitation is the varying sample sizes, two of which were large, which

impacted the result (Nielsen et al., 2017).

In synthesis for medication non-adherence, the literature reviewed showed

medication non-adherence is a public health problem, especially in HTN. The adverse

effects of non-adherence to antihypertensive medications led to stroke and other

29

cardiovascular diseases. Hence, patients need to be very involved in their care. While

Nielsen et al. (2017) attributed low income and affordability to the cause of non-

adherence to antihypertensive medication, knowledge deficit of the patients and poor

knowledge of the dosage, side effects, and purpose of their medications also influence

their medication adherence (Wahyuni et al., 2019; Meckonnen & Gelayee, 2020). Only

about 158 (39.3%) of the population were adherent to antihypertensive medications, had

good knowledge of medications, and were associated with higher adherence (Meckonnen

& Gelayee, 2020).

Patient and provider communication of non-adherence. The first subtheme for

medication non-adherence is patient and provider communication. HTN is a chronic

disease, requiring interaction between the patient and the health provider to incorporate

diet and lifestyle modifications such as physical activity and stress control (Ruiz-

Fernandez, Marcos-Jorquera, Gilart-Iglesias, Vives-Boix, & Ramirez-Navarro, 2017).

Patients' attitudes towards the disease and understanding the relationship with the

medications play a significant role in MA. Ruiz-Fernandez et al. (2017) presented their

research on the empowerment of patients with HTN. The researchers described that many

patients tend to forget to take their BP medication, and some deny their diagnosis of

HTN. Patients' poor understanding of HTN leads to ineffective treatment and subsequent

health care costs (Ruiz-Fernandez et al., 2017).

The study of Zullig et al. (2015) described the patient's communication with the

provider regarding questions during office visits and explored medication adherence

status in terms of the patient's race. A cross-sectional analysis of the patients was

conducted. The study's purpose included the improvement of post-myocardial infarction

30

management of risk factors of cardiovascular disease (Zullig et al., 2015). The

researchers found that of the 298 (74%) patients who had all their questions answered by

their provider, 183 were adherent to their medications, while 115 patients were non-

adherent to their medications. Both groups admitted that their provider answered all their

questions. Results on racial communication were not completely clarified based on some

differences in adherence and would require further evaluation (Zullig et al., 2015).

Nafradi et al. (2016), in their quantitative study on intentional and unintentional

medication non-adherence in HTN, provided an example of the importance of effective

communication between patients and their healthcare providers to improve medication

adherence in HTN. Non-adherence to antihypertensive medication, whether intentional or

unintentional, is a significant public health problem and predisposes patients to

uncontrolled HTN (Nafradi et al., 2016). This study aimed to determine the patients'

motives for their non-adherence to antihypertensive medication. The researchers studied

109 patients who were on one or more medicines for their HTN. A cross-sectional design

and quantitative method were used in analyzing the patients' characteristics for 13

months, such as their concept of medication adherence and following their providers'

advice. A face-to-face questionnaire was used to obtain demographic data. The research

applied functional health literacy measurement and statistical analysis. The researchers

found medication non-adherence among patients who had less belief in their providers

and concluded that health care providers' communication of patients' concerns regarding

their medication is significant in their patients' adherence to antihypertensive medication

(Nafradi et al., 2016).

31

The study of Schoenthaler et al. (2016) explored MA in Blacks with HTN and

addressed the prediction variables, such as patient-provider communication. Historically,

complications of HTN arising from uncontrolled HTN, which mainly results from non-

adherence to treatment, is significantly higher among blacks than whites (Nguyen-Huynh,

Young, Alexeeff, Hatfield, & Sidney, 2019). The researchers studied the MA of 815

black patients with uncontrolled HTN over 12 months with HTN education interventions,

home BP monitoring, and monthly counseling on lifestyle (Schoenthaler et al., 2016).

The purpose of the counseling was to evaluate the multilevel intervention to improve

HTN among blacks by involving the patient-provider interactions. As perceived by the

patients and the providers' encouragement to the patients, the providers' communication

quality was assessed at baseline, at six months, and at 12 months using the Likert-type

scale. The study's findings showed that self-efficacy is associated with the quality of

patient-provider communication and improvement in MA (Schoenthaler et al., 2016).

In synthesis, while MA has many foci, patients' role of active involvement can

reduce non-adherence. With a poor understanding of HTN, patients will not pay much

attention to remembering to take their antihypertensive medication. Effective

communication between the patients and their healthcare providers can enhance the

patients' understanding and enable them to take responsibility for their care. This led to

183 patients' adherence to antihypertensive medications when all their questions were

addressed, and they had a better rapport with their PCPs (Zullig et al., 2015). Nafradi et

al. (2016) agreed with the importance of effective communication between the patients

and their healthcare providers to improve medication adherence in HTN.

32

Barriers to MA. The second subtheme to medication non-adherence is the MA

barrier that focuses on anything or condition preventing effective treatment to HTN to

achieve MA, including pregnancy (Webster et al., 2018). Lack of financial support for

the patient is a barrier to medication adherence because the patient might not be able to

afford their medication (Mamaghani, Hasanpoor, Maghsoodi, & Soleimani, 2020).

Mamghani et al. (2020) also reported that living in rural areas can be a barrier, since the

patients cannot quickly get their medications, considering accessibility to their PCPs and

their nearest pharmacy. Data were expressed in percentages only. Using a cross-sectional

design, Mamaghani et al. (2020) studied 238 hypertensive patients in five different areas.

Data analysis with SPSS, showing 18% of the patients had low MA, 43.6% had medium

MA, and 38.2% had good MA.

Najimi, Mostafavi, Sharifirad, and Golshiri (2018) studied the barriers to MA in

patients with HTN using a qualitative method to identify the obstacles. Considering that

pharmacotherapy is one of the best and most common means of controlling HTN to

prevent its risks of coronary artery disease (CAD) (by 20% to 30%, and stroke by 35% to

40%), this study aimed to identify and prevent any barriers to MA (Najimi et al., 2018).

Semi-structured interviews were used to collect the purposive sampling of 60

hypertensive patients from the clinic. Najimi et al. (2018) concluded that the patients'

lifestyle, forgetting to take their antihypertensive medications, and lack of advice from

the healthcare professionals were significant barriers to non-adherence to drugs. The

results were put into codes, not numbers. The researchers identified the patients' low

socioeconomic status and the method of selection of the participants as limitations to the

study, and the identified barriers as prospective research materials to improve MA.

33

Another study for identifying a barrier to MA was the qualitative exploration of

perception towards antihypertensive medication. Tan, Hassali, Neoh, and Saleem (2017)

purposively recruited and studied 17 hypertensive patients and their perception of

medication quality using semi-structured interviews with a phenomenological approach.

Realizing the poor adherence to antihypertensive medications, which would lead to poor

quality outcomes of care and increased costs with associated products and increased

utilization of resources, the study evolved in order to remove the barriers (Tan et al.,

2017). The study resulted in the development of positive investigations to overcome

barriers to antihypertensive medication adherence. The researchers concluded that poor

antihypertensive medication adherence was a misconception of the medication side

effects and lack of knowledge. A structured questionnaire was identified as a limitation to

the method of data collection. Multiple languages were involved, and the researchers also

classified the participants' low socioeconomic status as limitations (Tan et al., 2017).

In a study of adherence to treatment among hypertensive patients,

Balasubramanian, Nair, Rakesh, and Leelamoni (2018) recruited 189 rural area

hypertensive patients. According to Balasubramanian et al. (2018), poor or non-

adherence to antihypertensive medication is a significant barrier to HTN control. The

study's purpose was to assess barriers by evaluating the adherence in India's rural area. A

cross-sectional study with a semi-structured questionnaire data collection was used to

study 189 hypertensive patients in Kerala. MA was assessed with MMAS-4 with 46% of

high MA, 41.3% of medium MA, and 12.7% of low MA. The findings from the study

showed poor MA to their antihypertensive medication. This is a barrier to HTN control,

and poor knowledge increases the risks of HTN; further, associated medication non-

34

adherence is a result of uncontrolled HTN (Balasubramanian et al., 2018). The

recommendation for the poor MA in the study is a comprehensive strategy for improving

antihypertensive medication. The only limitation reported by the researchers is the use of

the MMAS-4 scale with an un-validated language.

In synthesis, the articles discussed the identification and prevention of barriers to

MA. Identifying those usual ways of life is one aspect, but seeing them as barriers and

preventing or changing them could be challenging to patients because the patients may

not recognize them as barriers. Though identifying the barriers was from the patients'

perspectives, Tan et al. (2017) considered developing positive strategies as better options

to focus on the obstacles. Poor or non-adherence to antihypertensive medications is a

barrier to HTN control (Balasubramanian et al., 2018). Barriers to MA present in

different forms, but the endpoint is uncontrolled HTN. With barriers removed,

medication would be taken as prescribed, and HTN would be controlled.

Factors affecting medication adherence. The third subtheme for medication non-

adherence is the factors affecting MA. In a prior study, researchers identified HTN as a

public health problem that could be controlled with antihypertensive medication, and

non-adherence to the drugs led to uncontrolled HTN (Gebremichael, Berhe, &

Zemichael, 2019). Age and lack of awareness can contribute to MA, and older adults are

more affected by medication non-adherence (Jin, Kim, & Rhie, 2020). This is due to their

age-related conditions, such as the number of medications they are prescribed, dosing

frequency, understanding of the pharmacy's instructions, and the patients' satisfaction (Jin

et al., 2020).

35

Zhang et al. (2020) studied 1,916 community-managed randomly selected patients

with known HTN. A self-designed questionnaire was applied for a period of four months

for face-to-face demographic data collection. The findings of the research showed

comorbidities were associated with non-adherence to antihypertensive medications. In

contrast, the community-managed patients had reduced non-adherence, and the non-

adherence was directly related to uncontrolled HTN (Zhang et al., 2020). The researchers

reported the limitations of not having a control group for better comparison and identified

this as an opportunity for future study.

Another study links non-adherence to HTN by Mugwano et al. (2016). The

sample of the study drawn from stroke patients with HTN was evaluated. A cross-

sectional study was used in 112 patients who were over 60 years of age. Stroke, which is

a result of uncontrolled HTN, was noted to have claimed the lives of approximately 5.5

million people worldwide in 2001, out of about 15 million people had a stroke (Mugwano

et al., 2016). The research concluded that poor adherence to antihypertensive medication

is a significant problem, and lack of adequate knowledge has worsened the situation. Out

of the 112 participants, 78 (70%) had ischemic stroke secondary to lack of knowledge

(Mugwano et al., 2016).

Another factor related to non-adherence in antihypertensive medication is the

patients' knowledge towards medication, such as forgetfulness, socioeconomic status, and

general attitude towards drugs (Chetoui et al., 2016). Chetoui et al. (2016) studied CVD

patients. The purpose was to evaluate adherence to antihypertensive medications and

identify the cause of non-adherence among those patients aged 65 years old and above. In

a prior study, only 24% of the patients reached BP goal; but other findings of their study

36

revealed 93% of the sample had non-adherence to their antihypertensive medications, out

of which 44% was secondary to forgetting to take their medications, some stopped taking

the antihypertensive altogether, 15% found the medications too expensive (Chetoui et al.,

2016). These researchers concluded that adherence to antihypertensive drugs was poor

and identified the need for patient-healthcare provider communication to enhance

medication adherence (Chetoui et al., 2016). This was the gap which the DPI project was

aiming to close.

Pawloski et al. (2016) tried to identify patients' reasons for non-adherence to their

antihypertensive medications. Knowing of non-adherence in HTN is the precursor to

uncontrolled HTN, which predisposes to stroke, CVD, and renal failure. The researchers

studied the medication adherence of 240 patients in Minneapolis who were on home BP

telemonitoring. The study aimed to determine if home BP telemonitoring and HTN

medication management by pharmacists could improve medication adherence. The

pharmacy interventions consisted of the patients' medication inventories and prescription

refill history. Medication adherence was calculated at the beginning of the study and after

the twelve months of the intervention. The research findings did not show significant

improvement in antihypertensive medication adherence; there was maintenance of high

MA including at pre-intervention, and the researchers had no numerical data because

there was no significant difference between the pre-intervention and the post-intervention

(Pawloski et al. (2016).

In the synthesis of factors affecting MA, the article on community-managed

patients identified comorbidities as significant for non-adherence to antihypertensive

medication (Zhang et al., 2020). It is also noted that not every patient with a co-morbid

37

condition is non-adherent to their medications, but the literature did not signify the actual

number. One factor with comorbidity is that multiple medications are required to control

the other symptoms for other diseases. While these present as barriers to MA, there is a

correlation between non-adherence and medication affecting factors, but community

management of the patients improved MA (Zhang et al., 2020).

In summary, the researchers' commonality in this theme is the effect of non-

adherence to antihypertensive medications. While Carvalho and Santo (2020) considered

non-adherence to antihypertensive medications as being more prevalent in

underprivileged countries, Firat Kilic and Dag (2020) agreed and attributed it to their low

health literacy. All of the articles linked uncontrolled HTN to non-adherence to their

antihypertensive medications. Many patients, especially the older population, have

increased medication non-adherence (Khayyat et al. 2019). The researchers agree that

older people are on multiple medications due to their chronic conditions and poor life

quality. These, in addition to inadequate knowledge, influence medication non-

adherence.

Uncontrolled HTN. The second theme for this DPI project is uncontrolled

hypertension. HTN is a major risk factor for CVD, and the literature identified CVD

causes one in four deaths annually among all races in the United States and has claimed

about 200 billion dollars each year (Napiekowski & Prado, 2020). According to the ACC

and AHA guidelines, normal BP is a systolic BP (SBP) of equal to or less 120 mmHg and

diastolic BP (DBP) equal to or less than 80 mmHg. It is elevated if the SBP is up to 129

mmHg or DBP of 80 mmHg (Napiekowski & Prado, 2020). Any SBP of 130 mmHg or

greater or DBP of 80 or greater is regarded as HTN as amended parameters from 2017 by

38

ACC and AHA, to institute early treatment for HTN to prevent the complications of a

stroke, CVD, renal disease, and mortality (Napiekowski & Prado, 2020; ACC & AHA,

2017). SBP, which is greater than 180 mmHg or DBP greater than 120 mmHg, is

hypertensive urgency because target organ damage is eminent, thus meaning it is now

uncontrolled HTN and should be prevented (Napiekowski & Prado, 2020).

Associated factors. The first subtheme of uncontrolled HTN is the associated

factors. A challenging aspect of BP's treatment is uncontrolled HTN, considering the

related risks to CVD and target organs (Ghazali et al., 2020). Poorly controlled HTN still

exists despite many preventive measures, and lack of control is worse in the presence of

other comorbidities such as diabetes (Almalki et al., 2020). Obesity, behavioral factors

such as diet, physical activity, and other health conditions are associated with

uncontrolled HTN (Masilela, Pearce, Ongole, Adeniyi, & Benjeddou, 2020).

Ghazali et al. (2020) studied one of the factors to understand HTN and determine

the prevalence of uncontrolled HTN among patients who attended three primary care

clinics in a district in Malaysia. The study was comprised of 460 patients. A cross-

sectional method and structured modified questionnaires were used for data collection.

The patients' BP was based on the AHA definition of equal to or greater than 130/80

mmHg for HTN. In the study of 460 hypertensive patients, 249 of them, representing

54.1%, had controlled BP, while 211 patients, which represented 45.9% of the

population, showed a significantly high prevalence of uncontrolled HTN (Ghazali et al.,

2020). The researchers concluded other factors, such as diabetes, obesity, and the male

gender, were in combination with non-adherence to antihypertensive medications and

worsened the uncontrolled HTN.

39

In cross-sectional research by Tesfaye et al. (2020) at a teaching hospital, the

researchers studied 345 hypertensive patients for about four weeks, using a systematic

sampling technique. Data were collected with a face-to-face structured questionnaire and

chart review. The study aimed to determine the prevalence of uncontrolled HTN.

Analysis of the course was through the Statistical Package for the Social Sciences

(SPSS). Uncontrolled HTN was found in 52.7% of the patients, and these had significant

associated factors of knowledge deficit, cigarette smoking habit, alcohol consumption,

and obesity. The most significant predictor of uncontrolled HTN was the lack of

knowledge of hypertensive related complications (Tesfaye et al., 2020). There is a gap

created by these conditions, which fits into the DPI project. The limitation identified by

the researchers was concerning the self-reporting of the participants' lifestyle.

Nguyen-Huynh et al. (2019) did a pragmatic randomized controlled trial to

improve blood pressure control among blacks with persistent HTN. It was referred to as

the Shake Rattle and Roll (SRR) method. The purpose of the study was to determine

whether diet and lifestyle change, including enhanced monitoring, could improve HTN

among blacks over a 12-month period. The research sample was divided into three

groups: the control group who received the usual care (UC) from their primary care

provider (PCP), the enhanced monitoring patients who received their usual HTN

medication plus BP check visits, and the third group who received the enhanced

monitoring including telephone calls. The population comprised 31 to 34 PCPs, and three

groups of patients. One group consisted of 1,129, patients, the second group was 349

people, and the third group was 286 patients. The researchers reported positive results

among the patients who participated in blood pressure monitoring, but the other patients

40

remained in uncontrolled HTN because they did not partake in routine BP monitoring. In

this study, the researchers identified a possible bias in selecting the sample, and related it

to no consent required from the control group (Nguyen-Huynh et al., 2019).

Saradamma, Kottarath, Saleem, Jaya, and Thaj (2019) conducted a cross-sectional

study of 300 patients aged 18 years and above. The researchers were concerned about

persistent uncontrolled HTN despite the patients' intake of their antihypertensive

medications. The aim of the study was to determine the prevalence of uncontrolled HTN

and identify any associated contributory risk factors. The literature reviewed that HTN is

a non-communicable disease with high morbidity and mortality, and such diseases are

responsible for 60% of all deaths (Saradamma et al., 2019). Data were obtained by a

structured questionnaire on lifestyle, diet, and stress levels. Findings from the research

showed 68.3% uncontrolled HTN despite antihypertensive treatments. The findings were

associated with a sedentary lifestyle, alcoholism, psychological stress, comorbidities such

as diabetes, and family history of HTN (Saradamma et al., 2019). The researchers did not

specifically mention their study limitations but had recommendations of lifestyle

modifications and close monitoring of BP by healthcare providers.

Woodhama, Taneepanichskul, Somrongthong, and Auamkul (2018) identified

another associated factor in medication adherence among elderly hypertensive patients.

The objective was to assess antihypertensive medication adherence. The researchers

studied 408 hypertensive patients, aged 60 to 79 years old, selected by random sampling.

Data collection was by structured questionnaire, and the medication adherence was by

pill count. The research findings showed 86.8% of the patients had poor adherence to

their antihypertensive medications. With the addition of a family member as a caretaker,

41

which is also the associated factor, adherence to their antihypertensive medication

improved about eight times higher than their normal rate (Woodhama et al., 2018).

Hence, family involvement in elderly patients' care is significant in adherence to their

antihypertensive medications.

While lack of understanding of HTN is a factor in uncontrolled HTN, it is

supported by the study, which showed only 249 (54.1%) of controlled BP, while 211

(45.9%) had uncontrolled HTN (Ghazali et al., 2020). In another study, uncontrolled BP

is a little more than 50% of the population; 52.7% of the patients in the article have

uncontrolled HTN, including associated factors (Tesfaye et al., 2020). HTN was

uncontrolled for personal reasons, but they were all similar, such as lifestyle, lack of

knowledge, and other risk factors (Saradamma et al., 2019; Nguyen-Huynh et al., 2019).

Patient-clinician communication. The second subtheme for uncontrolled HTN is

the patient and clinician communication, which focused on improving HTN control and

fostering MA. Provider-patient communication intervention includes any factor which

prevents patients from adhering to their medications and other BP control regimen. By so

doing, the patients can discuss any problem that could hinder medication adherence.

Many strategies can improve adherence to antihypertensive medications when the

provider engages a face-to-face discussion about the medicines (Millions Hearts/CDC,

2016).

Robbins, Butler, and Schoenthaler (2019) addressed patient education and

counseling, especially in HTN care. The researchers identified some signs of burnout,

such as low job satisfaction, depressive look, and stress among participants. They

remarked that 25% to 65% of healthcare workers experience burnout (Robbins et al.,

42

2019). This research aimed to examine the relationship between provider burnout and

patient-provider communication and outcome of care in HTN. A cross-sectional method

was used, and the participants were 26 primary care providers (PCPs) and 80

hypertensive patients, about 61 years old. Care visits were recorded, followed by the

providers' surveys. The research findings supported the objective that provider burnout

could impact HTN with the decreased quality outcome (Robbins et al., 2018). The

limitation is the method of sampling of the participants, as reported by the researchers.

In a study by Tavakoly Sany et al. (2018), a randomized controlled method to

study the effect on HTN outcome was used. Hypertension is a worldwide public health

problem with an increased risk of stroke, heart disease, mortality, and morbidity

(Tavakoly Sany et al., 2018). The aim of the research was to improve HTN outcomes

using educational communications skills training among patients and their healthcare

providers. The study consisted of 35 healthcare providers and 240 hypertensive patients

for 12 months. The pre/post-intervention analysis showed a significant improvement in

their communication skills, antihypertensive medication adherence, and subsequent HTN

outcomes. Poor communication skills predispose the patients to uncontrolled HTN

because of a lack of trust and understanding of their health care providers. The

researchers concluded that the health care providers' communication skills training

improved patient-provider communication skills (Tavakoly Sany et al., 2018).

Another patient-clinician communication affecting the control of HTN is the

approach to understanding the medication dialogue in patients and provider relationships

(Schoenthaler, Basile, West, & Kalet, 2018). The study aimed to describe the

communication between the PCPs and their hypertensive patients regarding their

43

medications. Effective communication between the patient and the PCP is significant in

the accurate understanding of the patient's health condition and appropriate rapport,

supporting the quality outcome of care (Schoenthaler et al., 2018). The research by these

authors was a qualitative observational study from three ambulatory care settings. The

samples were 29 providers and 94 hypertensive patients, and their conversations were

audiotaped. The study result provided a clearer understanding of the patients' other

concerns, such as non-adherence to medications and interactive communication between

them and the provider. Similarly, non-effective patient-provider contact could produce an

adverse patient outcome, which results in uncontrolled HTN secondary to medication

non-adherence (Schoenthaler et al., 2018). The limitations were the use of low-income

patients, one-time patient-provider communication, and audiotapes for data collection.

Ibe and colleagues (2017) discussed their qualitative analysis, examined

community health workers' (CHW) intervention on 140 low-socioeconomic hypertensive

patients. This study aimed to investigate the effect of CHW communication on low-

income HTN patients. The randomized controlled method used coaching times by the

CHWs during the patients' office visit communication. The study's findings sought a

positive answer to the CHWs' communication activation intervention (Ibe et al., 2017).

The researchers recommended more research on CHWs intervention.

Another study on patient-clinician communication was by Brenk-Franz et al.

(2017). The aim of the study was to determine the relationship between adult attachment

and self-management and evaluate the effect of the patient-provider relationship. From

the literature review, self-management is vital in patients with chronic diseases, of which

HTN is one (Brenk-Franz et al., 2017). This study sampled 209 patients aged 50 years to

44

85 years with chronic diseases of HTN, diabetes, and other chronic diseases. The adult

attachment was measured with a self-rating questionnaire, while the resources and self-

management were measured with a self-management questionnaire. The Patient Reaction

Assessment (PRA) was used in calculating the patient-provider relationship as perceived

by the patient, and a seven-point Likert scale was applied for the data. Following

statistical analysis, the research findings showed high communication of the patients with

their healthcare providers about their illness and treatment, a developed rapport between

physicians and patients, physicians receiving patients' questions, and better self-

management for the quality outcome of care (Brenk-Franz et al., 2017). This is consistent

with the care of HTN, which is a chronic disease and can be controlled with effective

communication with the PCP when they explain medication side effects and self-

management, which, if unattended, will predispose to uncontrolled HTN.

In synthesizing the patient-clinician communication subtheme, it was noted that in

communicating necessary educational materials and counseling patients, the healthcare

provider attempts to encourage the patients to normal HTN. However, the providers'

burnout is a common problem, but there has to be a cause (Robbins et al., 2019).

According to Robbins et al. (2018), providers' poor communication can be due to

burnout. In the presence of frustration, which leads to burnout, effective HTN, or MA

information could be limited (Robbins et al., 2018). Though patient-clinician

communication is meant to improve education for positive outcomes, Tavakoyl Sany et

al. (2018) reviewed that poor communication predisposes uncontrolled HTN and lack of

trust.

45

Disparities in HTN. The third subtheme for uncontrolled HTN is a disparity in

HTN, and it can affect HTN control. Al Kibria (2019) identified discrepancies in HTN

following the 2017 guidelines of the ACC/AHA. The researcher found the disparity in the

prevalence, treatment, and control of HTN among races, advancing age, genders, body

weights, and socioeconomic statuses. There is also disparity among populations with

specific diseases such as diabetes (Al Kibria, 2019). Despite the necessity of medication

adherence to prevent uncontrolled HTN, other conditions and disparities affect the care

and sustainability of controlled HTN (Cooper et al., 2020). Cooper et al. (2020) identified

a program that would reduce HTN care disparities by improving patients' lifestyles,

considering that reducing inequalities in HTN care would provide equal opportunities for

receiving comparable treatments to control HTN.

Similarly, the study of Song et al. (2019) explored the prevalence of risk factors

of HTN among the elderly with particular reference to China. It addressed the disparity in

their urban-rural area. According to the researchers, 27.8% of Chinese adults have HTN,

and they identified as being higher among men than women in both urban and rural areas.

The sample population comprised a stratified selection of hypertensive patients whose

data were extracted from the China Health and Retirement Longitudinal Study

(CHARLS) of 2015 (Song et al., 2019). In the study, the researchers interviewed 21,097

patients and analyzed 1,776 people for the survey, including a questionnaire about their

lifestyle, demographics and checking their BPs. The research findings were consistent

with the high prevalence of HTN among the elderly in China, which also appeared about

the same prevalence in urban and rural patients but associated with different risk factors

such as diabetes (Song et al., 2019). The disparity gap created with regards to the lifestyle

46

and risk factors can be implemented into the interventions for obesity and stress-related

health problems to improve HTN in elderly patients.

Another aspect of disparity that affects HTN care is socioeconomic status. East et

al.'s (2020) study is an example of the importance of reducing differences to prevent or

plan intervention for HTN. The purpose of the article, childhood socioeconomic hardship,

was to explain how the effects of early adversity can result in adverse health problems,

such as HTN (East et al., 2020). The samples were children from low-socioeconomic

families who were obese, which resulted in a large selection of 1,039 people. The

researchers used a questionnaire to obtain more data from older children in the study on

family conflict, financial strain, anxiety, and depression. The research findings showed

higher stress levels related to the family's socioeconomic hardship and disputes as they

were growing up. These were associated with the development of HTN in early life. East

et al. (2020) further explained that children of low socioeconomic families suffer HTN in

their early adulthood; 11% had elevated BP, while 15% had HTN. Considering these risk

factors, interventions to prevent or reduce the socioeconomic disparity will impact

control of HTN (East et al., 2020).

Though uncontrolled HTN is a universal problem, ethnic disparities are

significant among hypertensive patients; and Prendergast et al. (2018), in the literature,

reviewed that uncontrolled HTN is more prevalent among Hispanics and Blacks at 52.6%

and 51.5%, respectively. Prendergast et al. (2018) developed a randomized clinical trial

to discover how to decrease disparities among these populations. Since patients from

high-risk people, minorities, and had low socioeconomic status use the emergency

department as their primary care clinics, especially as most of them have no health

47

insurance and have uncontrolled HTN, a HTN Emergency Department Intervention

Aimed at Decreasing Disparities (AHEAD2) trial was developed. AHEAD2 aimed to

control patients' BP to prevent complications of CVD and then refer the patients for a

focused HTN treatment. Being an emergency department (ED), there was no particular

number of recruitment. However, the annual number of patients was about 46,000, out of

which 80% were adults. The study showed a positive quality outcome of reduced

disparities due to providing intensified care with subsequent HTN control. (Prendergast et

al., 2018).

In synthesis, while disparities exist in many aspects of healthcare, the article on

China and HTN discussed disparity and other associated risk factors. According to Song

et al. (2019), HTN is higher among men than women in rural areas; the prevalence of

HTN is higher among the elderly population. The trend is most likely due to the patients'

age-related comorbidities, lifestyles, and socioeconomic factors.

In summary, uncontrolled HTN is broadly the result of non-adherence to

antihypertensive medication. According to this literature on disparity, many factors such

as patients' lifestyle, diet, obesity, and stress lead to uncontrolled HTN, causing high

morbidity and mortality (Saradamma et al., 2019). The researchers, Saradamma et al

(2019) identified a mortality of 60% of all deaths associated with uncontrolled HTN. The

significant contributor to uncontrolled HTN is non-adherence to antihypertensive

medication. An associated factor such as family member as a caretaker for the elderly

hypertensive patient improves medication adherence at a rate of about eight times higher

than normal (Woodhama et al., 2018).

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A lack of education on HTN and its associative factors account for a substantial

part of the disease and the HTN improvement with patient-provider relationship (Brenk-

Franz et al., 2017; Schoenthaler et al., 2018). Communication between the patient and the

provider makes a lot of difference in their BP control. For instance, a face-to-face

discussion about the medicines improves the adherence to antihypertensive medications

(Million Hearts/CDC, 2016). With effective communication, the patient develops a

rapport and trust with the healthcare provider, leading to the patient’s acceptance of the

clinician’s advice. Poor communication could lead to distrust and non-adherence to

antihypertensive medications. The disparity is another problem affecting the control of

HTN but identified the improvement of patients’ disparities, such as lifestyles, as

contributory to hypertensive care (Song et al., 2019; Cooper et al., 2020).

Strategies for medication adherence (MA). The third theme for this DPI project

is the MA strategies, which focus on the various ways to achieve and sustain MA. The

subthemes are (a) patient education, (b) facilitators, and (c) sustainability. MA is the

capacity of taking the medications as prescribed by the healthcare provider for a health

condition (Bou Serhal et al., 2018). Though many factors such as cost, proximity to care,

and SES affect adherence to antihypertensive medications, forgetting to take the

medicines is more common among elderly patients (Abbas et al., 2020). With time, HTN

becomes uncontrolled. Non-adherence to antihypertensive medication can be decreased,

but it requires the cooperation of patients and healthcare providers (Nafradi et al., 2016).

This has led to the development of strategies to maintain MA in HTN. The patient

education strategy will improve knowledge of HTN, the effect of antihypertensive

medication, and lead facilitators to remind the patients to take their medications as

49

prescribed and increase outpatient monitoring to ensure the sustainability of MA to

prevent a relapse of uncontrolled HTN.

Patient education. The first subtheme for strategies to MA is patient education.

Patients' knowledge deficit is a problem because they need to understand the concept of

HTN, the effect of medications in controlling HTN, and the importance of continued

sustainability MA for a maximum quality outcome. Miranda et al. (2019) discussed the

cost-related medication underuse (CRMU), which patients need to understand, and made

recommendations to the problem. As a stepwise process, the problem was diagnosed, and

the solution was a collaborative effort between the patient, the health care provider, and

the patients' pharmacy. Patients in CRMU do not take their medications as prescribed,

skipping some days to make it last longer and substituting another less expensive

medicine for the antihypertensive medications despite their regular prescription (Miranda

et al., 2019). Considering the high cost of hospitalization and CVD treatment, these

researchers recommended the treatment strategy to improve MA to be education and

medication available to the patients through pharmacists.

Delavar, Pashaeypoor, and Negarandeh (2020) performed a randomized

controlled trial to evaluate the patients and determine if self-management education could

improve MA and impact BP control. Participants included 118 uncontrolled hypertensive

older adults with inadequate health knowledge were surveyed using the Morisky

Medication Adherence Scale (MMAS-8). Their MA and BP were assessed. The

intervention focused on the educational materials about HTN, its risk factors,

complications, and antihypertensive medications. The study results showed after the

50

intervention, the rate of medication adherence improved and were statistically significant,

with a p-value of less than 0.05 among the intervention groups (Delavar et al., 2020).

Ampofo, Khan, and Ibitoye (2020) did a systematic search that examined prior

studies to determine if educational interventions could improve MA among hypertensive

patients. The investigation used reliable databases such as CINHAL and PUBMED, and

they followed the Cochrane guidelines for systematic reviews (Ampofo et al., 2020). Per

Cochrane guidelines, the review was reported according to the Preferred Reporting Items

for Systematic Review and Meta-analysis (PRISMA). The period of data collection was

from 1999 to 2019. The review findings were consistent with some improvement to

health literacy and adherence to antihypertensive medications following the educational

intervention. However, an additional frequent verbal educational intervention could

increase MA's improvement among hypertensive patients (Ampofo et al., 2020).

In a cross-sectional study by Pan et al. (2020), the research aimed to assess the

patients' knowledge of HTN and MA. The study's purpose was to determine if post-

hospital discharged patients have experience of HTN and its risk factors associated with

MA among HTN and stroke patients. There were 440 patients surveyed after their

discharge from the tertiary hospital. Data collection was by telephone interviews and

medical records. The research findings showed that only 35.23% of the patients had

adherence to their antihypertensive medication. The researchers concluded that

hypertensive stroke patients' MA was poor; their knowledge of HTN was below standard

and recommended more strategies to improve the experience, which could subsequently

impact MA.

51

Another study to support strategies to MA by Cheema, Sutcliffe, Weickert, and

Singer (2018) was a randomized control trial conducted for five months. The study's

purpose was to determine if structured written and verbal education would improve

patients' knowledge of HTN and improve BP control. The study included 64 adult

patients, and the assessment was with a questionnaire at intervals of two weeks, four

weeks, and six weeks. The intervention was the structured written and verbal education

on HTN delivered by the community pharmacists. The research results showed an initial

decrease in systolic BP during the four-week follow-up visit and did not sustain any

further reduction during the 26 weeks follow up visit. Knowledge about HTN and its side

effects improved initially and maintained even at 26 weeks’ visit. In conclusion, this

randomized controlled study by Cheema et al. (2018) showed the intervention improved

the patients' knowledge about HTN but did not improve the patients' BP.

The research article by Escortell-Mayor et al. (2020) was a pragmatic cluster-

randomized study of 411 uncontrolled hypertensive patients recruited from 22 primary

care centers. Multilevel logistic regression was used for the analysis of the data. The

study's purpose was to determine if a strategy for communicating cardiovascular risk

factors to patients could impact their BP control over 12 months. The patients had no

prior knowledge of cardiovascular risks. Following the intervention period, the research

findings showed the BP of the intervention participants improved.

In synthesizing patient education, the cost-related medication underuse (CRMU)

is apparent, affecting patients and public health but could be remedied with knowledge

(Mirander et al., 2019). Patients with CRMU lack the understanding that antihypertensive

medication cannot be taken as needed because HTN is a chronic disease, and medications

52

should be taken as prescribed to control BP and sustain MA regardless of cost properly.

Delavar et al. (2020) agreed to the importance of educating the patients to decrease BP,

manage HTN, and improve MA. Most literature on education-based interventions

enhanced knowledge of the patients' BP and medication, resulting in HTN control and

medication adherence sustainability.

Facilitators. The second subtheme to MA strategies is facilitators. These

strategies support the MA. Reminder tools, such as cell phones, reminder cards,

pillboxes, and direct supervision, facilitate MA. Dillon, McDowell, Smith, Gallaher, and

Cousins (2019) surveyed and analyzed 258 online responses. The study aimed to

determine if adherence intervention from the pharmacist could facilitate adherence to

antihypertensive medications. The research survey found that pharmacy interventions

facilitated the patients' adherence to their antihypertensive medications.

Researchers identified that medication reminders and refill reminders, including

implementation of education to increase the patients' knowledge about HTN, can impact

BP control (Abbas et al., 2020). Evidence structured telephone technology for setting

alarms is a telephone reminder tool, and Morrissey, Casey, Glynn, Walsh, and Molloy

(2020) studied smartphone application for improving MA in HTN. The researchers used

an exploratory study of 24 patients with HTN, aged 50 years to 85 years old, and

explored their smartphone apps' perspectives. The smart phone apps reminded the

patients to take their BP medications and to check their BP too (Morrissey et al., 2020).

The purpose of the study was to explore the patient's smartphones using their smartphone

apps. The research found that many of the patients felt more comfortable using the apps

in monitoring their BP and felt concerned about the use of the apps for their medications

53

(Morrissey et al., 2020). These researchers reported a limitation of using very few

samples for the study. Large samples produce more accuracy with a low margin of error

because a large sample study is highly statistically significant (Khalilzadeh & Tasci,

2017).

Cimmaruta et al. (2018) performed a literature review of prior studies that

described the poly-pill strategy for blood pressure and medication adherence. The

researchers used principal observational and clinical trial data to evaluate MA in HTN in

the association of CVD risk factors. The literature review showed the poly-pill method, in

all circumstances, increased adherence to antihypertensive medication and CVD. Poly-

pill is safe and positively affects HTN and co-morbidities (Cimmaruta et al., 2018).

Abel, Jayner, Cornelius (2020) performed a qualitative descriptive design in the

study of 20 black women. The aim of the study was to describe the women's reported

self-care strategies for consistent antihypertensive MA and determine their lifestyle. The

audiotape was used for data collection, and the Hill-Bone Compliance Scale for high BP

(HB-MAS) was used for screening for inclusion criteria. The research results were not

clearly stated, but the researchers predicted adherence to their participants'

antihypertensive medications based on their self-care management strategies. This study

is recommended for further research (Abel et al., 2020).

Another facilitator to remind patients about their medications was proposed in

Maslakpak and Safaie's (2016) study. The study was comprised of 123 hypertensive

patients at a clinical education center. This study was a randomized controlled clinical

trial, and the aim was to compare the antihypertensive MA between short message

service (SMS) and reminder cards. The intervention consisted of weekly six text

54

messages for three months, while the other group of patients received training on how to

use the reminder cards. The patients' MA was tested with the Hill-Bone Medication

Adherence Scale. The research findings showed both interventions with SMS, and

reminder cards were consistent with the promotion of MA among the patients

(Maslakpak & Safaie, 2016).

In synthesis, some articles are in agreement that medication reminders are

effective strategies for MA. The choice of the reminder is dependent upon the need of the

patients. Abba et al. (2020) suggested using multiple reminders, including some

education implementation, to increase knowledge of HTN and improve MA. According

to Morrissey et al. (2020), smartphone applications are medication reminders but seem to

complicate some patients. The participants in their study used the applications mainly for

monitoring their BPs and not for their medications because they were not comfortable

using them (Morrissey et al., 2020).

Outpatient monitoring for sustainability. The third subtheme of strategies to MA

is outpatient monitoring for sustainability. In one study, patients were considered to be

adherent to their medications if they took 80% or more of their prescribed medication

days (Nguyen-Huynk et al., 2019). Outpatient assessment and monitoring of

antihypertensive MA can impact sustainability and prevent HTN treatment resistance

(Eskas et al., 2016). Eskas et al. (2016) identified direct and indirect methods of

monitoring antihypertensive medications. Self-reporting and pill count were regarded as

indirect methods, while witnessed intake and serum or urine sample analysis were direct

methods of monitoring MA (Eskas et al., 2016).

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One of the supporting strategies to MA is sustainability to prevent treatment

resistance. McGillicuddy et al. (2015) contracted 18 patients in a retrospective analysis to

determine MA's sustainability and controlled BP using their medical records. The

monitoring was at three months, six months, and 12 months intervals for BP and

medication taking. The research results showed a reduction in BP of the patients. The

study results also provided an example of the sustainability of MA in HTN. The authors

concluded that the interventions had a sustainable impact on MA and BP. After 12

months of the study, their BP remained controlled.

Shen et al. (2017) randomly enrolled 266 and 288 patients for intervention and

control groups, respectively, from the disease surveillance system. The study was

registered through the Chinese Clinical Trial Register. The study aimed to evaluate and

determine if family member-based supervision could impact BP control and sustain MA

over 12 months. The interventions were education on HTN and its risk factors,

supervision on the patients' MA, checking of their BP, and reminders to seek clinicians'

help with BP changes. The education tool was the use of short messages service (SMS) to

give health information. Data collection was by questionnaire and statistically analyzed at

six months and 12 months. The results showed a significant decrease in BP for the

intervention group during the six-month follow-up visit but not at the 12 months visit

(Shen et al., 2017). The researchers further reported at follow up visits that 32 patients of

the control had HTN complications, including six deaths, while 26 of the intervention

group developed complications. In conclusion, family member-based supervision could

impact HTN control and sustainable MA if there is consistent supervision.

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Conn, Ruppar, Chase, Enriquez, and Cooper (2015) performed a systematic

review and meta-analysis to synthesize MA with a focus on interventions for sustaining

MA in HTN. The sample and other data were coded, which was what they used for

measuring. Data search employed a reliable database following PRISMA guidelines.

There were 112 treatments which were compared with the control group outcome. The

interventions comprised the factors that enhance adherence, including the patients'

feedback, using pillboxes, and self-monitoring their BPs (Conn et al., 2015). Analysis of

the intervention compared to the control showed significant medication adherence

outcomes, especially over a long period among hypertensive patients.

Persell et al. (2018) enrolled 300 uncontrolled hypertensive patients in the

randomized controlled trial to determine if a mobile phone-based hypertension personal

control program (HPCP) is more effective than home BP monitoring alone in the control

of HTN. This HPCP study was associated with individualized support for the patients. It

also encouraged healthy life changes that promote HTN self-management (Persell et al.,

2018). Pre-intervention data was obtained, and at six months, there was a follow-up visit,

including data on adherence to antihypertensive medications. According to Persell et al.

(2018), HPCP is an artificial intelligence that is automated in a smartphone. It also gives

behavioral therapy, is set for medication reminders, and much more. This study provided

an example of the significance of using a telephone when combined with other

interventions that control HTN, improve quality care, and sustain adherence to

antihypertensive medications, especially as the device has medication reminders.

Sustainability is a significant concept in monitoring the patient, especially after a

stable BP is reached. McGillicuddy et al. (2015) agreed that patients should control their

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HTN, though intermittent monitoring can identify sustainability. Without occasional

monitoring of the BPs, long-term control of HTN cannot be ascertained. While

interventions such as education on HTN and supervision can enhance the patients' MA,

checking BP every three to six months can further enhance sustainability if it remains

stable. In one study, direct monitoring, involving education and family supervision,

resulted in improved BP within the first six months, but BP became uncontrolled during

the 12-month visit (Shen et al., 2017). The ultimate result was six deaths and the

development of comorbidities due to a lack of sustainability of MA. While the literature

reviewed that family members' education and supervision enhanced MA and HTN

control sustainability, Persell et al. (2018) added HPCP, artificial intelligence in a

smartphone, is beneficial for sustainability. HPCP can be set for medication reminders to

promote MA and BP control.

In summary, and according to the literature review, there are three strategies to

support MA: patient education, facilitators, and outpatient monitoring. Each section

contributes much knowledge to the control of BP and the sustainability of

antihypertensive MA. Education provides patients with knowledge of HTN, risk factors,

complications, and the need to control HTN. Though many factors such as cost,

proximity to care, and SES affect adherence to antihypertensive medications, forgetting

to take the medicines is more common among elderly patients (Abbas et al., 2020).

Miranda et al. (2019) discussed the cost-related medication underuse. Patients do not take

their medications as prescribed, skipping some days to make it last longer and

substituting another less expensive medicine for the antihypertensive medications. In

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their study, these researchers found uncontrolled HTN among these low-income people

due to affordability and proximity to the pharmacy.

Though education and reminders provide adequate control of HTN (Million

Hearts/CDC, 2016) and maintaining MA, sustainability remains a significant factor

without which patients' conditions become refractory to treatment (Shen et al., 2017). The

study of the educational intervention focused on the materials about HTN, its risk factors,

complications, and antihypertensive medications, showed that after the intervention, the

rate of medication adherence improved and were statistically significant, with a p-value

of less than 0.05 among the intervention groups (Delavar et al., 2020).

Facilitators give the patients a better understanding of the need to take all

medications as prescribed, and there are multiple reminder tools. The study of Dillon et

al. (2019) discussed the positive effects of pharmacy involvement in medication

adherence and found that pharmacy interventions facilitated the patients' adherence to

their antihypertensive medications. Medications and pharmacy refills were readily

available to the patients. Other facilitators reminded patients about their drugs and

improved compliance. The research findings showed that text messages and reminder

cards were consistent with promoting MA among the patients (Maslakpak & Safaie,

2016).

Summary

This chapter discussed the theoretical foundations of the DPI project and provided

a detailed review of the literature related to HTN and MA among hypertensive patients.

The theory undergirding this project was Azjen's TPB, which emphasizes how

perceptions and beliefs can be modified to address and enact changes and remove

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disparities. This theory was crucial to this project as the focus was on changing the

attitude and behavior of hypertensive patients to medication adherence to lead to more

positive health outcomes. Orem’s (2001) self-care theory related the patient and its

environment. In this project, the nurses applied this theory and determined the patients'

deficiencies in adherence to antihypertensive medication using the HB-MAS. Then the

nurses applied the intervention with Million Hearts education to remove the patients'

deficits to achieve medication adherence.

Non-adherence to antihypertensive medication is a significant problem in the

management of HTN. Non-compliance with medicines is the basis for this DPI project.

Similarly, a poor understanding of HTN is a substantial part of non-adherence to

medications, making the patient-provider relationship an essential and significant

contributor to MA (Schoenthaler et al., 2018). With effective communication, patients

can ask questions, learn, and increase their knowledge of their medications' expected side

effects and importance (Million Hearts/CDC, 2016). Many of the articles discussed

patients forgetting to take their medication as prescribed. Socioeconomic status and

attitude towards medicines are associated with non-adherence to antihypertensive drugs,

leading to uncontrolled HTN (Chetoui et al., 2016).

This DPI project held the teaching of the patients in high priority, considering the

importance of knowledge. Instruction on the Million Hearts education program website

would benefit the patients. Just as the literature reviewed the details of the contents of the

educational materials which the researchers used successfully in the articles, the Million

Hearts programs are very detailed and easy-to-follow.

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Another primary concept in the literature was patient and provider

communications. This relationship applied to the population in this project. Nurses were

instructed on the education materials, and the nurses then taught the patients. The nurses

had frequent communication with the population, thereby applying patient-centered care.

The patients took an active part in their care by measuring their BPs and reported them to

the nurses. In addition to the education, the patients received a weekly phone call, which

acted as reminders to take their medications as prescribed, and to foster their MA, which

was the central theme of the project. The HB-MAS was the tool for measuring their MA

and obtaining the weekly data.

Chapter 3 will provide a detailed description of the project's methodology and

elaborates on some topics from Chapters 1 and 2. Chapter 4 will present the results of the

project that were obtained using the methodology in Chapter 3. Chapter 5 will provide

the implication of the results as well as recommendations for future practice.

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Chapter 3: Methodology

Adherence to antihypertensive medication is the goal of the management of

hypertension (HTN) (CDC, 2020). Any systolic blood pressure (SBP) equal to or greater

than 130 mmHg or diastolic blood pressure (DBP) greater than 80 mmHg is regarded as

HTN (CDC, 2020). The focus of this project was to determine the effect of education on

maintaining adherence to antihypertensive medication. The literature described HTN as a

silent disease because a hypertensive patient is often asymptomatic (Achhab et al., 2019).

Routinely monitoring blood pressure could alert to worsening BP readings. As a chronic

disease, HTN control requires long-term continuous treatment. Therapeutic control of

HTN is the adherence of the patient to antihypertensive regimens such as medications,

diet, exercise, and weight management (Etebari et al., 2019). This project involved

educating the patients on adherence to their antihypertensive medicines and the

importance of monitoring their blood pressure.

The purpose of this quantitative, quasi-experimental project was to determine if or


the adherence to antihypertensive medication as measured by HB-MAS when compared

to current practice among adult patients 18 years and older with known hypertension in a

primary care clinic setting in New York over four weeks. The educational intervention

was implementing the Million Hearts education program (see Appendices D, E, and F).

The nurses educated the patients about HTN, its side effects, complications,

antihypertensive medications, and adherence to their medications. The MA measuring

tool, HB-MAS (see Appendix B), made up of nine Likert questions (Kim et al., 2000),

was introduced for four weeks. These questions tested the patients' antihypertensive

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medication adherence on a scale of one through four. The pre- and post-intervention and

weekly responses to the questionnaire provided the patients' MA level at those times. The

patients used Self-monitored blood pressure (SMBP) at home (CDC, 2013). Comparing

the pre-intervention with the post-intervention results determined the project's purpose,

which was the level of medication adherence.

This chapter will present the methodology and design of the project. It includes a

discussion of the problem and clinical question which guided the DPI design and

purpose. The population sample and instrumentation will be described. Then, after

presenting the reliability and validity of the instrument, the data collection and analysis

procedures will be described in-depth. The chapter will end with a discussion of bias

mitigation, ethical considerations, and project limitations.

Statement of the Problem

It was unknown if or to what degree the implementation of the Million Hearts

education program impacted adherence to antihypertensive medication as measured by

the Hill-Bone Medication Adherence Scale (HB-MAS), when compared to current

practice among adult patients 18 years and older with known hypertension in rural New

York state. The problem that was to be addressed was the patients' non-adherence to their

antihypertensive medication. The gap was filled to help the patients to take their

antihypertensive medicines as prescribed.

Though there were many reasons behind medication non-adherence, the Million

Hearts education program (2016) educated the patients on how to control their BP by

taking the antihypertensive medication. At the end of the intervention, it was expected

that the Million Hearts education program would solve the problem of non-adherence,

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and the patients would consistently take their antihypertensive medications as prescribed

by their healthcare clinicians.

Clinical Question

The DPI project was guided by the following clinical question:

Q. To what degree does the implementation of the Million Hearts education

impact the adherence to antihypertensive medication, as measured by HB-MAS

when compared to current practice among adult patients 18 years and older with

known hypertension, in a primary care clinic setting in upstate New York over

four weeks?

The DPI project used a quantitative method. The primary tool for the evaluation

of the intervention was the HB-MAS questionnaire. The HB-MAS questionnaire was

applied for the following assessments in sequence: (a) the pre-intervention questionnaire

evaluated the patients' baseline adherence to their antihypertensive medications, (b) the

weekly assessment questionnaire assessed the patients' progress of medication adherence,

and (c) the post-intervention questionnaire evaluated the patients' medication adherence

at the end of the fourth week of the project.

The independent variable in the DPI project was the Million Hearts education

program. This variable was the intervention for the project. The Million Hearts education

program contained the material for teaching the patients about HTN as a chronic disease;

complications of HTN, medications for control of HTN, and the importance of

medication adherence (see Appendix D). The project had two dependent variables. The

significant variable was the HB-MAS questionnaire, and it was used to obtain medication

adherence data at baseline, every week, and at the end of the fourth week. The purpose of

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the HB-MAS questionnaire was to measure the patients' medication adherence as

compared to the current practice of no education program in the primary care clinic

setting in upstate New York. Million Hearts/CDC (2016) is an educational program that

covered the information on HTN, association with heart disease, risk factors such as

tobacco use, cholesterol, and other risk factors and complications such as stroke and

kidney disease. The teaching included the possible side effects of medications and the

importance of taking antihypertensive medicines to prevent risk factors and

complications. There was a discussion on the best time to take drugs. Daily medications

were easier remembered if taken in the morning or in the morning and evening if the

dosing was twice daily. If no contraindications, the medications can be taken with

breakfast if daily dosing or breakfast and dinner if twice-daily dosing. The Million Hearts

education program has validity. The AHA instituted a campaign strategy for preventing

one million heart attacks, kidney disease, stroke, and death by the year 2022. Ciemins et

al. (2018) used the Million Hearts tool to study 8.92 million patients and predicted HTN

in the United States. In evaluating the Million Hearts plan to control HTN in the United

States there was positive progress towards meeting the goal (Patel et al., 2014).

The second dependent variable was blood pressure measurements using the

SMBP monitoring tool (CDC, 2013). Although the project's length would not show a

substantial change in blood pressure, the primary investigator (PI) included the blood

pressure measurements to look at the trends and relationship to medication adherence as

additional but not primary data. The dependent variable was the HB-MAS, which is made

up of nine questions. The responses are on a Likert scale of 1 to 4, and the level of

measurement is ordinal.

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Project Methodology

The methodology for this project was quantitative. Medication adherence was

assessed at baseline, every week, and at the end of the four weeks after intervention. The

tool for assessing medication adherence was a self-reported scale, developed by Hill-

Bone called HB-MAS, which asked patients to respond to numerical answers from 1 to 4.

The quantitative method was the best for the project because the data collection was

measurable and quantifiable. It had to be numerically measurable to enable a statistical

analysis of data (Ali & Bhaskar, 2016).

This methodology was reproducible. The significant measurable variable for this

project was the number of times the patient took the BP medication as prescribed during

the four weeks of the intervention to improve medication adherence. The number of times

the antihypertensive medication was taken during the intervention period was compared

to the number of times the medication was taken before the intervention to evaluate

adherence. The comparison was among the HB-MAS questionnaire results to assess their

medication adherence. The use of numbers, tables, and ratios were significant in

assessing the findings' interpretations in this quantitative DPI project.

An alternative methodology that could have been used for this proposed project

was the qualitative method. However, it was not appropriate for this evidence-based DPI

project because the qualitative approach is more of an exploration of occurrence. It uses

interviews or reviews of case records. According to Van den Berg and Struwig (2017),

the qualitative method is appropriate for explaining the events and development of

theories. Therefore, it was not appropriate for this project.

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Project Design

The design for this DPI project was the quasi-experimental design. This design

for evaluating the effect of the intervention required pre- and post-intervention. The

intervention was the Million Hearts education. The principal investigator instructed the

nurses on the education (about HTN, complications of uncontrolled HTN,

pharmacological and non-pharmacological interventions for the control of HTN, and

medication adherence) and how to use the HB-MAS. The intervention, the Million Hearts

education program, was taught to the patients by the nurses. The nurses measured the

patients' BP at pre-intervention to determine the baseline BP and post-intervention. The

PI included blood pressure measurement only as an additional, not a primary data, to look

at the trends and relationship to medication adherence. The length of the project would

not show a substantial change in blood pressure. The patients received a weekly

telephone call from the nurse to obtain the number of times each patient did or did not

take the antihypertensive medication, using the same HB-MAS questionnaire. At the end

of the four weeks, the post-intervention numerical data were obtained with the HB-MAS.

A statistical comparison of all the data determined the status of adherence to

antihypertensive medication.

The quasi-experimental design aligned with the quantitative methodology through

the relationship with the variables. There was a causal-comparative relationship between

the dependent variable and the independent variable (Bloomfield & Fisher, 2019). The

measurement of the patients' independent variable influenced the dependent variable. In

this project, the HB-MAS data result (dependent variable) was influenced by the Million

Hearts education program (independent variable). A quasi-experimental design was the

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best design for this DPI project because it addressed the clinical question more

appropriately than other methods. The HB-MAS questionnaire was used in obtaining data

for the patients' medication adherence. This tool was used for the pre- and post-

intervention (Million Hearts education). The quasi-experimental design was in the form

of pre/post-intervention. The pre-intervention tested the patient's adherence to

antihypertensive medication before the implementation of the Million Hearts education

program. The post-intervention was a measure of implementing the education compared

to current practice without education implementation.

Population and Sample Selection

This section discussed the setting, the population, and the project sample. The

project site was located at the facility outpatient clinic in a town in New York. The site

was an internal medicine clinic, and patients usually had scheduled appointments to come

in to see their primary care providers. Though some patients do walk-in, most of these

patients come for blood pressure checks with the nurse or medication refills. Walk-in

meant the patients do not need to have an appointment; instead, they came to the

provider's office for a quick service such as a blood pressure check or refill of

medications. They may or may not see the PCP while at the clinic, depending on the

reason for the visit.

The participants were adult patients 18 years and older who attended the primary

care clinic at the hospital facility. The clinic had about 1,200 patients, and about 900 of

them had HTN. The project population was recruited from the 900 patients depending on

meeting the inclusion criteria. The patients lived independently in the community, were

capable of self-care, and were mentally intact. There were four primary care clinic

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registered nurses for this population, and they worked with the principal investigator for

this project.

Though the clinic has about 900 hypertensive patients, not all of them had

uncontrolled HTN or non-adherent to antihypertensive medication. The project

population was recruited from the uncontrolled hypertensive patients based on their

persistent high BP data in the EHRs. The final sample recruitment for the project was

patients with non-adherence to their antihypertensive medications and who were willing

to partake in the project. Information from EHRs showing the prescription and refill

history of the medicine, aided the recruiting of non-adherence to medications. These

patients were recruited when they presented to the clinic for their regular appointments.

One of the significant aspects of participation in a study is informed consent. It

assures a full understanding of the study's participants, and it is entirely voluntary

(Mallia, 2018). According to Mallia (2018), the process of informed consent requires the

following: (a) information, which refers to full verbal explanation of the reason and

content of the project; (b) understanding, which requires the participant comprehend the

information clearly; (c) voluntariness, which assumes there is no coercion or pressure and

the participants can withdraw at any point of the project without consequences; (d)

competence, which shows the participants' capacity to make a decision; and (e) consent,

which is the actual signing of the written information which was already explained

verbally. However, the patients did not need to provide a signed authorization to

participate because this is a quality improvement (DPI) project, not a study or research.

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They signed the HIPAA waiver to enable the extraction of their data from the EHRs.

The inclusion criteria were diagnosis of HTN, must be 18 years of age or above,

speak and understand English, not adherent to antihypertensive medication (a scale of

fewer than three shows non-adherence as per HB-MAS), and registered nurses were

included to work with the patients. The exclusion criteria were patients without diagnosis

of HTN, less than 18 years of age, did not speak and understand English, adherent to

antihypertensive medication (a scale of three or greater showed adherence as per HB-

MAS), non-registered nurses.

The sample size calculation was based on the confidence level of 95%,

confidence interval of 5, the population of 30, and the sample size needed defaults to 28

(Creative Research Systems, n.d.). The confidence interval calculation required the

confidence level of 95%, a sample size of 28, a population of 30, a percentage of 50, and

it gave a confidence interval of 4.86 (Creative Research Systems, n.d.).

Instrumentation and Sources of Data

The instruments for the data collection were (a) The Hill-Bone Medication

Adherence Scale which was the primary dependent variable; (b) the Self-Measured Blood

Pressure (SMBP), which was another dependent variable for monitoring trends in BP;

and (c) the Electronic Health Records from the facility records.

Hill-Bone Medication Adherence Scale (HB-MAS). Hill-Bone medication

adherence scale (see Appendix B) was used for screening how adherent the patients were

to their antihypertensive medication. The nine simple questions with the four Likert

ratings were on a scale of 1-4 (one = all the time, two = most of the time, three = some of

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the time, four = none of the time). The HB-MAS was applied at baseline, weekly, and the

end of the four weeks.

HB-MAS scale was developed for the management of medication non-adherence

in HTN, which the developers said could not be achieved without understanding and

compliance with HTN treatment (Kim et al., 2000). These researchers reported that

compliance was linked to the patients' behavior towards salt intake, keeping their PCPs'

appointments, and taking their medications as prescribed. Kim et al. (2000) found self-

report of compliance to medications was simple, economical, and provided instant

feedback. The validity and reliability of the HB-MAS was tested and were supported

(Kim et al., 2000). According to Cheong, Tong, and Sazlina (2015), HB-MAS had

validity and reliability, as evidenced by the testing in America, Africa, and Turkey.

Self-Measured Blood Pressure (SMBP). SMBP was a tool that patients could

use to monitor their blood pressure at home. The participants checked their blood

pressure weekly, and they reported the result to their nurse when they received their

weekly evaluation call. The data from the SMBP was not for this project because the

project time was not long enough to show a significant difference in blood pressure.

Every hypertensive patient was issued a BP kit for monitoring their BP at home.

Electronic Health Records (EHRs). Patients' demographics and pre-intervention

records of medication adherence and hypertension were obtained from the EHRs.

Electronic Health Records have protected health information because they are parts of the

health care delivery that provide the pertinent history of the patients' events (Verma et al.,

2020). The EHRs retrieved such data as the patient's full name, date of birth, social

security number, allergies, diagnoses, current medications, and other historical data.

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Validity

Validity describes the usability of the instrument. It is the extent to which the data

measured what it was meant to measure. This measurement was supposed to be

consistent as expected. It is necessary to establish the reliability and validity of data or

intervention used in the research to give users confidence (Kilgus et al., (2019). The

researchers reported that if the validity of a data or research design is established, it

means the information is correct.

The HB-MAS scale for evaluation of medication adherence has validity.

Maslakpak and Safaie (2016); Chaetziefstratiou, Giakoumidakis, Fotos, Baltopoulos, and

Brokalaki (2019); and Etebari et al. (2019) used HB-MAS in their research of

antihypertensive medication adherence and more knowledge of HTN. The study of

Etebari et al. (2019) used the HB-MAS compliance scale for evaluating the commitment

to their antihypertensive treatment and had a statistically significant p-value of less than

0.018 (p < 0.018) for medication, a p-value of less than 0.01 (p < 0.01) for dietary, and p-

value of less than 0.01 (p < 0.01) for keeping their PCPs' appointments. In this project,

the HB-MAS questionnaire measured the patients' adherence to antihypertensive

medications, and that was what it was supposed to measure.

Electronic Health Records (EHRs) are valid and reliable because they have been

electronically stored, used, updated multiple times, and they are secured, protected health

information. Whenever patients went to their PCP's office visits, the EHRs were updated

with the patient. The principal investigator had no intention of developing a scale for this

project; instead, the PI used already existing, tested, and approved instruments that have

been discussed for the project.

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The SMBP was the tool for the patients to use in measuring their blood pressure

at their homes (CDC, 2013). Every hypertensive patient was routinely issued a BP kit.

The CDC (2013) provided validity for SMBP. It was recommended by the CDC (2013)

in support of the Million Hearts program for monitoring HTN, which could cause

complications. However, the SMBP was not used for data tracking in this DPI project.

The PI included blood pressure measurement only as an additional, not a primary data,

just to look at the trends and relationship to medication adherence because the length of

the project would not show a substantial change in the blood pressure.

Reliability

Reliability refers to the trustworthiness of the instrument. The HB-MAS is a

reliable tool because many researchers have used it many times, and it was adapted into

other languages. Chatziefstratiou et al. (2019), in their study about medication adherence

in HTN, tested the reliability of HB-MAS in comparison to Morisky Medication

Adherence Scale (MMAS) and A-14 Scale. HB-MAS had an alpha coefficient of 0.76,

while MMAS was 0.64, and the A-14 scale had 0.91, and the researchers concluded that

these scales were reliable (Chatziefstratiou et al.; 2019). The researchers also showed the

validity and reliability of the HB-MAS in their study. HB-HBP was meant to measure the

baseline medication adherence, weekly medication adherence to obtain the number of

times the patients took the antihypertensive medication and the medication adherence

information for the week, and post-intervention medication adherence. In the project, the

HB-MAS questionnaire was capable of obtaining an accurate report of how often patients

took their medications, which was a sign of their reliability to take their medications even

after the community project independently. In assessing the reliability and validity for

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HB-MAS Cronbach's alpha at 0.8, the p-value for the systolic BP (SBP) was less than

0.01 (p < 0.01), and the p-value for the diastolic BP (DBP) was less than 0.01 (p < 0.01)

(Song et al., 2011). Validation of the internal consistency of the HB-MAS for eight items

resulted in a p-value of 0.02 (p = 0.02) for SBP and DBP, respectively (Denguir,

Yakdhane, Gamra, & Zaabouti, 2019).

Data Collection Procedures

Before actual data collection, the primary investigator ascertained that all written

approvals and permissions were in place. Written consent was obtained from the

Institutional Review Board (IRB) of the project site and GCU (see Appendix A). Since

the project data had patients' personal and health information, confidentiality and ethical

considerations were upheld. The data collection was a face-to-face encounter with the

population. The lead nurse and the assisting clinic registered nurses were notified. Before

the first day of the project intervention, the principal investigator instructed the registered

nurses about HTN, its complications, antihypertensive medications, side effects, and the

importance of medication adherence, using the powerpoint presentation adapted from the

Million Hearts education program. The PI also instructed the nurses on how to use the

HB-MAS questionnaire for the project.

The steps taken for the data collection were:

Step 1: Recruited the sample from the primary care clinic, met the inclusion

criteria and consented to participate in the project.

Step 2: The nurses obtained the pre-intervention data using the Hill-Bone

medication adherence scale to get the baseline and antihypertensive medication

adherence data and documented the scores.

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Step 3: The nurses taught the patients what the PI instructed them during the

powerpoint presentation adapted from the Million Hearts education materials. The

teaching lasted for about 10 to 15 minutes, depending on each patient's possible concerns.

The nurses also ensured each patient knew how to use their BP kit appropriately.

Step 4: The nurse checked baseline blood pressure at the initiation of the

intervention.

Step 5: Each patient received a weekly phone call from the nurse to assess

medication adherence progress. The Hill-Bone was used by the nurse to obtain data

during the weekly telephone calls.

Step 6: At the end of the four weeks of the intervention, the patients were asked

to come for an office visit for a final BP check, and the Hill-Bone questionnaire was

administered for the last time.

Data Analysis Procedures

After the collection of data, the analysis was the next stage of the project. The

analysis was also a step-by-step procedure. The key elements of this section included the

data, the dependent and independent variables, and the statistical analysis. As a

quantitative method, numerical data were obtained for each variable. These were raw

data, and they were sorted, separated, and processed as follows:

1. A table of columns was drawn for arranging the data.

2. The weekly scores for each of the nine questions of the HB-MAS for each of

the participants were arranged in tables of columns.

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3. The corresponding period (weeks 1-4) was arranged on the same table. The

pre-intervention scores from the dependent variable (HB-MAS) for all the project

samples were organized in a column.

4. The weekly telephone data scores from the HB-MAS scores were put on the

same column.

5. The post-intervention scores from the HB-MAS for all the samples were

organized on the same table of columns.

6. The blood pressure from pre-intervention and post-intervention were arranged

on a separate table for comparison of BPs.

The PI included blood pressure measurement only as an additional, not a primary

data, to look at the trends and relationship to medication adherence. The length of the

project would not show a substantial change in blood pressure.

This organized data, now a database, was further organized on a Microsoft

spreadsheet for analysis. Descriptive statistics were applied using Statistical Package for

Social Sciences (SPSS) for analysis using the paired t-test. Finally, there was a

comparison of the variables to arrive at the outcome of the project. The threshold of p-

values analyzed the confidence interval. This test was chosen for more reliability,

validity, and applicability. These gave the project its repeatability status. Researchers set

a p-value of 0.05 as the cut-off value for significance (Mishra et al., 2019). P-value of

0.05 or less is statistically significant.

The primary investigator used descriptive statistics to explain the relationship

between the data and the variables. The PI also used inferential statistics for answering

the PICOT question. The comparison showed the difference between the data from the

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dependent variable (HB-MAS) and the data from after applying the independent variable

(Million Hearts education program) to show the effect of educational intervention on

medication adherence. The pre- and post-intervention blood pressure data were compared

using a graph to show any trend in the blood pressure reading and not for comparison to

show medication adherence. Blood pressure measurements were included only as an



pressure.

Potential Bias and Mitigation

Potential bias for this project would evaluate the internal validity, which could

affect the project's results. It could be from the collection of the data, obtaining the

sample population, or data analysis. The bias may or may not be purposeful. The primary

investigator anticipated a bias in this project from the sampling of the population as both

sexes were not equally represented. Though the number of hypertensive patients at the

project site was large, only about 33% of current patients at the clinic were females. The

tendency was to equalize the males and the females even if the males had worse BPs that

met the project BP inclusion criteria. It could have affected the results' reliability because

this would not have been an accurate representation of the actual sample. According to

Showalter and Mullet (2017), selection bias is a threat to validity.

Another possible potential bias was during data collection in using the

questionnaires. The data was based on unsupervised responses of the sample. It was

expected that the answers were accurate, but there was a probability for the responses to

be skewed, which would impact the internal validity of the results. Evaluating and

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knowing the risks of bias could enable avoidance of bias and provide positive outcomes

(Faggion, 2015).

Ethical Consideration

Electronic health records (EHRs) are protected health information. All patients'

data, clinical or demographic, such as names, date of birth, social security number, birth

sex, or any other information which identified the patient, constitutes protected health

information (Dehghan et al., 2017). EHRs provide valuable and trusted information that

could be shared with other healthcare agencies. The EHRs prevent duplication of

expensive tests such as CAT scans. Considering EHRs in ethics, the sharing of the

patients' information was strictly handled for the care of the patients (Sulmasy, Lopez, &

Horwitch, 2017). However, since data had to be collected for the project, respect for the

participants was very relevant. There are protocols to be followed to enable access for

data collection. The principal investigator recognized and obtained all participants' data

following the facility's IRB. Though there were more males than females in the clinic,

this project experienced an unequal ratio of 20% of females who met the recruitment

criteria.

Another essential aspect maintained during the EHR data collection was that the

Health Insurance Portability and Accountability Act (HIPAA) had to be strictly

maintained at all times. Following the Belmont Report of 1979, it was ethical to apply the

principles of respect, justice, and beneficence to studies since humans are involved

(Friesen, Kearns, Redman, & Caplan, 2017). Respect was not only for the person but also

for the person's documents for analysis. Informed consent was a significant aspect of the

ethical principles of respect for the population. The sample's privacy was respected

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accordingly while all information, including the risks about the project, was explained to

them. Following the Belmont Report's ethical principles, the persons were freed from

coercion, harm, and any threat, should the person refuse to partake in the project. The

IRB determined this is a quality improvement project and not research. Informed consent

would have been obtained after a full explanation of the process of the project if this was

research. The IRB determination declared this a quality improvement project, not a study.

Patients were notified that there would be no associated punishment or liabilities should

any patient decide to leave or not participate in the project.

Demographic data were already available in the electronic health records and they

are protected health information. Every data from the project was handled with utmost

privacy and not shared with anybody outside the principal investigator and the nurses.

Electronic data are stored with a password access according to the facility’s protocol for a

maximum of three years. When no longer required, the data will be permanently deleted

from the system.

Limitations

A limitation is a situation that affects the project, yet the project investigator has

no control over it (Theofanidis & Fountouki, 2018). According to Theofanidis and

Fountouki (2018), there are limitations and delimitations in every study regarding the

design, data, and other relationships. Theofanidis and Fountouki (2018) associated

delimitations as challenges that could have been better addressed.

The most outstanding limitation in this project was related to the small size. A

project with a large size likely produces better results compared to a small size, with a

narrow margin of error. The primary investigator defined the age range of the sample

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patients as 18 years and above. This project's available age group ranged between 46 and

97 years, which did not represent the general population.

The Hill-Bone questionnaire is a valid, simple, and inexpensive tool. The

responses from the patients were supposed to be reliable. However, the responses were

based on the patients' words. Even if the project used a pill count, it was still the same

patients' response, which had to be accepted. The patients will take their BPs weekly and

report to the nurse. Though the BP readings are not strictly for analysis, there could be

skewed blood pressure data since the patients have to do it at home. Another limitation of

blood pressure was that certain factors affect blood pressure, such as diet, exercise,

medication side effects, and other barriers that could have affected BP control differently.

Summary

In summary, Chapter 3 covered the methodology and preparation for the practical

aspect of the project. The purpose of the project was defined, the problem of medication

adherence in HTN was identified, and the clinical question to address the medication

adherence was discussed. This quantitative project used the HB-MAS questionnaire to

evaluate medication adherence in adults. The intervention to assess for a change was the

Million Hearts education program (see Appendices D, E, and F). The project was a quasi-

experimental design that used a pre/post intervention and finally drew the outcome by

comparing the difference.

The population and sampling were done during regular office visits. Inclusion

criteria were hypertensive patients with non-adherence to antihypertensive medication.

The sample size was small at 15 as per the participants' inclusion criteria and consent.

The project site is a primary care facility in a town in upstate New York. The process of

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recruitment of the sample had already been discussed. The data collection procedure was

simple but in a stepwise manner to prevent skewing the results. The intervention lasted

for four weeks, and weekly numerical data was obtained from the patients. The final

comparison of the variables in the clinical question was calculated using SPSS for

statistical results. The independent variable (Million Hearts education program)

influenced the dependent variable (medication adherence) measured by HB-MAS.

Chapter 4 will present the results of data collection and analysis. Results will be

presented in narrative and graphic form. Chapter 5, then, will provide the interpretation of

the results. It will also include the implications of the project and recommendations for

the future.

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Chapter 4: Data Analysis and Results

It was not known if or to what degree the implementation of the Million Hearts

education program impacted the adherence to antihypertensive medication as measured

by HB-MAS, when compared to current practice among adult patients 18 years and older

with known hypertension, over four weeks. The methodology for this project was

quantitative. Medication adherence was assessed at baseline and every week for the four

weeks of the intervention. Measurable and quantifiable data to determine medication

adherence was extracted with HB-MAS, which asked patients to respond to numerical

answers from one to four (1-4). Any data less than three, showed non-adherence to

antihypertensive medication. Data of three or more than three was regarded as medication

adherence.

The clinical question was: To what degree did the implementation of the Million

Hearts education impact the adherence to antihypertensive medication as measured by

HB-MAS, when compared to current practice among adult patients 18 years and older

with known hypertension in a primary care clinic setting in upstate New York, over four

weeks? Applying the Million Hearts education to the sample was what made the

difference in the data. Demographic data were obtained from the patients' electronic

medical records. The patients' medication adherence data was obtained from the patients'

responses using the weekly questionnaire from HB-MAS.

Chapter 4 explains the process of analyzing the data at the end of the four-week

intervention period. First, the descriptive data will be presented. Then, the data analysis

procedures will be further described. It will end with a presentation and summary of the

results of data analysis.

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Descriptive Data

The project site was located in an outpatient primary care clinic in upstate New

York. It was an adult internal medicine clinic, and the patients had appointments to see

their primary care providers (PCPs). The adult patients' population's age was 18 years and

above. However, the sample's age for the project varied between 46 and 97 years,

because uncontrolled HTN and non-adherence to antihypertensive medication were found

among these people. The sample size was 15, out of which 20% were females, while 80%

were males. The patients all had the primary education of a high school diploma. No

control group was required for the project.

The patients' data collection started after obtaining Grand Canyon University

(GCU) Institution Review Board (IRB) approval and the project site IRB approval. The

project site approval was granted on June 29, 2020. The project site approved the project

to take place at the facility on September 18, 2020. GCU IRB approved the

implementation of the project on September 22, 2020 (see Appendix A). Following the

final approval from the GCU IRB, the implementation phase of data extraction started on

September 23, 2020, and the estimated date of project completion was November 4,

2020. After approximately six weeks of the project implementation, including instructing

the nurses, recruiting the samples, and obtaining the data, the project came to completion.

Numerical data were obtained from the pre- and post-intervention using the HB-

MAS questionnaire. The sample's blood pressures were obtained on the first day of the

intervention and the last day. The various data were de-identified, arranged in tables, and

secured in a Microsoft Excel database by the primary investigator. The data were stored

on the project site. Descriptive statistics were applied. Table 1 described the demographic

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data from the sample: the youngest was 46 years, and the oldest was 97 years of age. The

proposed number of patients who met the inclusion criteria for the project was 28, but 15

patients out of these consented to partake in the project. Table 2 describes the sample and

their associated pre-intervention data, showing the baseline medication adherence,

weekly data, and post-intervention data.

Table 1

Demographics of Project Sample

Demographics n %

Age 40 – 50 2 13.5%

51 – 60 4 26.7%

61 – 70 5 33.3%

71 – 80 1 6.7%

81 – 90 1 6.7%

91 – 100 2 13.5%

Gender Male 12 80.0%

Female 3 20.0%

Ethnicity Caucasian 5 33.3%

African-American 10 66.7%

Note: n = number of patients; % = percentages.

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Table 2

Total scores of MA Data as measured with HB-MAS Tool

n Pre-

int. Week 1 Week 2 Week 3 Week 4 Post-int.

1 26 31 31 36 36 36

2 9 18 18 23 27 30

3 3 28 28 36 36 36

4 26 28 29 36 36 36

5 23 28 29 36 36 36

6 26 28 29 36 36 36

7 23 28 33 36 36 36

8 23 28 30 36 36 36

9 24 27 32 36 36 36

10 24 27 36 36 36 36

11 25 33 36 36 36 36

12 23 31 36 36 36 36

13 25 26 27 33 36 36

14 26 31 36 36 36 36

15 25 26 34 35 36 36

Note: MA = Medication Adherence; n = sample participants; int. = intervention; total

scores = sum of each sample’s responses to the nine questions of the HB-MAS scale.

(See detailed HB-MAS questions in Appendix B.)

The responses to the HB-MAS questions were rated from one to four, where one

represents the least level of medication adherence and four was the highest obtainable

adherence to antihypertensive medication. A total score of nine was the least, whereas a

sample with a score of 36 was considered absolute adherence.

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Table 3

Blood Pressure Comparison

n Pre-intervention Post-Intervention

1 142/65 129/80

2 175/109 170/99

3 158/98 147/89

4 163/110 156/96

5 162/71 148/76

6 164/84 132/70

7 164/82 148/84

8 172/87 122/64

9 194/88 135/82

10 167/77 145/77

11 170/88 160/78

12 166/88 137/67

13 145/90 130/76

14 160/80 129/79

15 182/103 146/91

Note: n = samples.

The sample's pre-intervention blood pressure was checked at the initiation of the

project's intervention phase to understand the baseline status. Post-intervention blood

pressure was also checked. Although the length of the project would not show a

substantial change in blood pressure, the primary investigator included the blood pressure


additional, but not primary data. The sample (n) numbers in Table 2 were the same

samples as in Table 3 for a better comparison of the relationships.

Data Analysis Procedures

The results of the descriptive were quantitatively and statistically analyzed using

the IBM SPSS version 27. The analysis process entailed an explanation of the clinical

question concerning the described data obtained from the project. The clinical question

was: To what degree did the implementation of the Million Hearts education impact the

adherence to antihypertensive medication as measured by HB-MAS, when compared to

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current practice among adult patients 18 years and older with known hypertension in a

primary care clinic setting in upstate New York, over four weeks?

Demographic data from the EMRs for each of the 15 participating patients

included the various age ranges, gender, and ethnicity. They were analyzed using the

description of the data in Table 1 with particular reference to the percentages to show

their relationships.

The next analysis was the pre-intervention data, showing the baseline data. The

tool used for measuring the medication adherence data was the HB-MAS. The number of

times that the patients did and did not take the antihypertensive medication due to the

nine reasons in the HB-MAS was numerical. The intervention was the Million Hearts

education program. The education was the teaching by the nurses to the patients about

MA concerning uncontrolled HTN. The pre-intervention data represented the current

practice, as stated in the clinical question, and it was obtained prior to education. The pre-

intervention data were analyzed to evaluate the level of fundamental adherence to

antihypertensive medication. The next significant data was the post-intervention data

obtained at the end of the four weeks was analyzed and subjected to inferential statistics

to compare the patients' medication adherence at the end of the four weeks. Analysis of

the weekly data was compared to the pre-/post data to establish a relationship.

Results

The clinical question was:

Q. To what degree did the implementation of the Million Hearts education impact

the adherence to antihypertensive medication as measured by HB-MAS, when

compared to current practice among adult patients 18 years and older with known

87

hypertension in a primary care clinic setting in upstate New York, over four

weeks?

Following the implementation of the HB-MAS tool, the medication adherence

data at baseline, before the Million Hearts education, was obtained. Weekly data, after

the education intervention, was obtained. The patients' medication adherence outcomes

were derived from data analysis (pre- and post-intervention and weekly responses).

Statistical comparison of all the data answered the clinical question. The relationship

between the data was expressed and explained with the mean, standard deviation, and p-

values.

The next analysis was the pre-intervention data, showing the baseline data. The

tool used for measuring the medication adherence data was the HB-MAS. The number of

times that the patients did and did not take the antihypertensive medication due to the

nine reasons in the HB-MAS was numerical. The intervention was the Million Hearts

education program. The education was the teaching by the nurses to the patients about

MA concerning uncontrolled HTN. The pre-intervention data represented the current

practice, as stated in the clinical question, and it was obtained prior to education. The pre-

intervention data were analyzed to evaluate the level of fundamental adherence to

antihypertensive medication. The next significant data was the post-intervention data

obtained at the end of the four weeks which was analyzed and subjected to inferential

statistics to compare the patients' medication adherence at the end of the four weeks.

Analysis of the weekly data was compared to the pre- and post-intervention data to

establish a relationship (see Figure 1).

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Figure 1. Bar Graph displaying the mean scores as measured by HB-MAS.

The next step was explaining all the data about the Million Hearts education and

medication adherence. The data were tabulated on table forms. The 15 sample

participants took part in the DPI project. Numerical responses to the nine-item HB-MAS

questionnaire were inferentially statistically analyzed while comparing a stepwise

explanation of the pre-intervention scores through the four weeks duration to the post-

intervention. A 2-tailed sample t-test revealed that the HB-MAS scores at one week of

the intervention showed medication adherence (MA) improvement of 19.1% and a p-

value of zero (p = 0.00). In week two, the overall responses displayed MA improvement

of 10.9% higher than week one and a p-value of zero (p = 0.00). The MA improved to

12.7% in week three more than week two, and the p-value was zero (p = 0.00). The

relationship of weeks three, four, and post-intervention was about the same, hence giving

similar scores compared to week two. This was evidenced by the similar high p-value of

0.12 (p = 0.12) in week three, and 0.33 (p = 0.33) in week four (see Table 4). Weeks

three, four, and post-intervention were very close to perfect scores of 36. Pre- and post-

intervention scores had a distinguished relationship, with an outstanding score of 52.1%

MA improvement higher than the pre-intervention (baseline) and a p-value of zero (p =

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0.00). The results were further supported by the mean and the standard deviation, as seen

in Table 4.

Table 4

Pre/Post-Intervention Comparison

n M SD

Pre-int. 15 23.4 1.08

Week 1 15 27.9 3.40

Week 2 15 30.9 1.24

Week 3 15 34.9 3.38

Week 4 15 35.4 2.32

Post-int. 15 35.6 1.55

Note: n = number of samples; int = intervention; M = mean; SD = standard deviation.

Paired t-test scores from SPSS version 27.

The comparison of the baseline data to the post-intervention showed the effect of

the Million Hearts education. The BP readings at pre/post-intervention were statistically

analyzed with IBM SPSS Version 27, using a 2-tailed paired sample t-test. Blood

pressure was not significant in this project. Blood pressure measurements were included

only as an additional, not a primary data, to look at the trends and relationship to

medication adherence. The length of the project would not show a substantial change in

blood pressure (see Figure 2).

Figure 2. Pre and post blood pressure comparison using the mean BPs.

90

Summary

The clinical question for the project was: To what degree did the implementation

of the Million Hearts education impact the adherence to antihypertensive medication as

measured by HB-MAS, when compared to current practice among adult patients 18 years

and older with known hypertension in a primary care clinic setting in upstate New York,

over four weeks? The outcome of the intervention showed improved adherence to

antihypertensive medication. The pre-intervention data among the 15 patients showed

non-adherence, as evidenced by the HB-MAS score of less than three in each of the nine

questions, with a mean of 23.4 and a standard deviation of 4.17, compared to the post-

intervention. Million Hearts education improved adherence to antihypertensive

medication within the first three weeks of intervention and had a sustained adherence

effect from the third week to post-intervention. Maximum compliance, as measured by

the HB-MAS, was 36, which represented the sum of the nine responses of the scale from

each patient. Weeks three, four, and post-intervention means of 34.9, 35.4, and 35.6

respectively, were close to 36 compared to 23.4, the pre-intervention score.

The 52.1% medication adherence at post-intervention higher than pre-intervention

answered the clinical question. The result supported a p-value of zero (p = 0.00), which is

very statistically significant. Researchers set a p-value of 0.05 as the cut-off value for

significance (Mishra et al., 2019). Hence, a p-value of 0.05 or less is statistically

significant, with a low margin of error. The significance is that the Million Hearts

education improved adherence to antihypertensive medication, and the PICOT question

was answered. The DPI project had statistical significance and clinical significance,

which was the change the participants experienced from their education. The patients

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changed from their habit of medication non-adherence to taking their medications as

prescribed.

The pre- and post-intervention data were statistically analyzed using IBM SPSS

Version 27, followed by interpretation of the analysis. The investigations were

statistically significant, with a resultant p-value of zero (p = 0.00). Researchers set a p-

value of 0.05 as the cut-off value for significance (Mishra et al., 2019). Hence the Million

Hearts education had a positive effect on improving the patients' adherence to their

antihypertensive medication. The improved blood pressures seemed to correspond with

the high scores from HB-MAS. Although the length of the project would not show a

substantial change in blood pressure, the primary investigator included the blood pressure


additional, but not primary data.

Chapter 5 will provide a summary of the total project. It will include the

conclusions that can be made from the findings. Additionally, the implications of the

results for theory, practice, and the future will be discussed. The project will end with

recommendations for future projects and practice.

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Chapter 5: Summary, Conclusions, and Recommendations

Non-adherence to antihypertensive medication was always a significant public

health problem, caused annual deaths of about 9.4 million worldwide (Nielsen et al.,

2017). The purpose of this quantitative, quasi-experimental project was to determine if or


the adherence to antihypertensive medication as measured by HB-MAS, when compared

to current practice among adult patients 18 years and older with known hypertension in a

primary care clinic setting in New York over four weeks. According to the guidelines of

the American Heart Association ([AHA] 2017), HTN is any blood pressure (BP) that is

equal to or greater than 130/80. It is estimated that by the year 2025, 29.2% of adults

would have HTN in the world (Veisani et al., 2019).

Hypertension is a significant precursor of heart and kidney diseases, causing

about two-thirds of the world's mortalities and claiming about 7.1 million deaths annually

(Nikparvar et al., 2019). There was increased mortality with uncontrolled HTN due to

patients not taking their antihypertensive medications as prescribed (Bansal et al., 2019).

Currently, about 900 of the patients at the project site have HTN, and 68% of them were

uncontrolled.

The main aim of this DPI project was to improve adherence to antihypertensive

medication. By so doing, BP would be controlled, and the complications of a stroke,

CAD, renal failure, and fatality caused by poorly controlled HTN would be reduced.

Medication non-adherence was a threat to healthcare at this project site, and other

interventions failed. Million Hearts education was a program designed by CDC/AHA

(2013) to prevent five million heart attacks by 2022. This program was the intervention

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for this project. The purpose was to teach the patients more about HTN, the adverse

effects of the complications of HTN, and the importance of antihypertensive medication.

Being a DPI project, the PI instructed the clinic nurses, and the nurses taught the patients.

According to Karaman and Akyolcu (2019), nurses spend more time with patients

and their relatives. Hence, the project participating nurses impacted the patients and

improved their medication adherence with the education program's input. The tool for

measuring the effectiveness of the intervention was the HB-MAS on a Likert scale of 1-4.

The analysis of the data was by IBM SPSS version 27, using the 2-tailed paired sample t-

test.

This chapter will provide a summary of the project. It will then present the

conclusions that can be made based on the results of data analysis. The implications of

the findings for theory, practice, and the future will be discussed. Finally,

recommendations will be made for future projects and practice.

Summary of the Project

The project was about non-adherence to antihypertensive medication. Primary

care providers and nurses had tried to improve the patients' adherence to the medicines,

but non-adherence persisted. Methods that were previously tried without success included

pharmacy involvement for an automatic refill of medication, talking with patients, and

reminding them to take their medications as prescribed. Hence, the focus for

implementing the DPI project lay in the clinical question:

Q. To what degree did the implementation of the Million Hearts education impact

the adherence to antihypertensive medication as measured by HB-MAS, when

compared to current practice among adult patients 18 years and older with known

94

hypertension in a primary care clinic setting in upstate New York, over four

weeks?

The project site is a primary care outpatient clinic with 1,200 patients, out of

which about 900 of them had HTN. A sample size of 15 was recruited from the

population, based on the inclusion criteria of diagnosis of HTN, non-adherence to HTN

medication, and consent to partake in the project. The purpose of the Million Hearts

education was to enable the patients to take their medications as prescribed by their PCP.

The nurses measured the sample's medication adherence data using the HB-MAS tool at

pre-intervention, weekly for four weeks, and at post-intervention. Blood pressure,

estimated at pre- and post-intervention, described the trend. Although the length of the

project would not show a substantial change in blood pressure, the primary investigator

included the blood pressure measurements to look at the trends and relationship to

medication adherence as additional, but not primary data. All the data were statistically

analyzed using SPSS version 27, and the findings were significant, with a p-value of zero

(p = 0.00).

Summary of Findings and Conclusion

Severe comorbidities of uncontrolled HTN include heart and kidney diseases

(Nikparvar et al., 2019). Although medicines lower blood pressures, consistency in

following the prescription guidelines reflect the control of HTN. Hypertension is a

complex public health disease worldwide (Nielsen et al., 2017), and the nursing

profession tries to improve the patient outcome. Though antihypertensive medications

control HTN, non-adherence has a negative outcome (Abbas et al., 2020). Despite the

nurses' efforts, the project site's high percentage of non-adherence to antihypertensive

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medication created a gap, which the direct practice improvement project was trying to

fill. The education tool to improve the patients' medication adherence controlled HTN

among the clinic patients. The findings in this project were consistent with the clinical

question: To what degree did the implementation of the Million Hearts education impact

the adherence to antihypertensive medication as measured by HB-MAS, compared to

current practice among adult patients 18 years and older with known hypertension in a

primary care clinic setting in upstate New York, over four weeks?

A paired t-test showed significant medication adherence improvement at the post-

intervention data of p-value of zero (p = 0.00), and 52.1% higher than the pre-

intervention data. A determination of adherence improvement progressed from the first

week of intervention through the project's four weeks. The Million Hearts education

intervention, which was the independent variable, made a statistically significant

difference in adherence to antihypertensive medication. Patients’ adherence to their

antihypertensive medication improved following the intervention.

Blood pressure measurements were included to look at the trends and relationship

to medication adherence. The length of the project would not show a substantial change

in blood pressure. The mean post-intervention systolic blood pressure, 142.27, showed a

decrease of 23 from the pre-intervention systolic blood pressure. Similarly, the trend

between the pre- and post-intervention diastolic mean blood pressures showed a little

difference between them. A determination of a significant change in blood pressure may

be seen over a more extended intervention period.

In conclusion, based on the p-value of zero (p= 0.00), the clinical question was

positively answered. The Million Hearts education improved medication adherence in

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HTN. The project sample of size of 15 was small, thus creating a high margin of error.

However, the project still had a clinical significance, which was that the patients took

their antihypertensive medications as prescribed, and might sustain the practice even after

this project. This quality improvement project closed the clinical practice gap and

contributed to the nursing knowledge body, as evidenced by the nurses' role in this

project.

Implications

The implications in this project were divided into theoretical implications,

practical implications, and future aspects. The conduction of this project was due to non-

compliance to antihypertensive medication. Facility nurses’ expertise and knowledge

recognized the lack of patients’ understanding of the importance of maintaining normal

blood pressure in relation to medication adherence.

Theoretical implication. The main theoretical framework for this project was the

self-care theory written by Dorothea Orem in 2001. The theorist described the role of

nurses in the care of patients. In the project, hypertensive patients lacked the capability of

taking care of themselves in adhering to their medications. Consequently, the clinic

nurses stepped in to address their non-adherence using the Million Hearts education and

measured the outcome with HB-MAS. Antihypertensive medicines control HTN, but

non-adherence to HTN medication is a significant cause of uncontrolled HTN (Pan et al.,

2020). This evidence-based project recognized the importance taking medications as

prescribed and used Million Hearts education to implement the information in the

patients and there was improvement of health. This theory will be advanced if there is

sustainability of adherence to antihypertensive medication.

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Another applicable framework was the theory of Planned Behavior (TPB),

developed by Icek Ajzen in 1985. In this DPI of medication adherence, the nurses'

weekly close monitoring eventually fostered the patients' relevance taking the

medications without monitoring or further education.

Practical implications. The project had limitations and biases. The project was

designed to accommodate all adult patients, 18 years, and older. However, this project's

available population was mainly the older adult patients, the youngest was 46 years, and

the oldest was 97 years of age. HTN is more prevalent among older adults (Al-Ruthia et

al., 2017). Another implication was the project timeline. The four-week time period for

the project's implementation was very short, considering the extended length of time for

recruiting the sample from the population. A further limitation was the participants'

geographical locations. They were outpatients in rural areas, and the nurses had to wait

for an opportunity for the patients to come in for PCP's office appointment visit. Another

practical implication was the small sample size, causing a bias, and creating a significant

error margin. However, the PI and the nurses investigated concisely with minimum error

and a zero p-value (p = 0.00). Inability to select the sample from the population within a

few days of one another predisposed the project to the selection bias.

Future implications. Nurses and their expert nursing skills, including their

decision-making capacity, can save the patients' lives by preventing stroke and other

complications of uncontrolled HTN. Nurses can utilize an evidence-based scope of

practice, such as the Million Hearts education program and weekly phone calls to the

patients to promote their medication adherence to HTN and other diseases.

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Data and findings could have been affected by bias due to the short duration of

the project. Therefore, an appropriate future implication would be to take at least ten

weeks to implement the project. The more extended period would provide enough time

for recruitment, more data extraction, and final analysis. Conducting the project in an

urban clinic was a considerable future implication. The current project, which was

conducted in the rural area, encountered the difficulty of having enough participants, both

nurses, and patients. With the few available registered nurses and their regular work

duties, the nurses were initially reluctant to participate in the project. Hence, a larger

facility in an urban area should be considered.

Recommendations

The DPI was a quantitative project, and the recommendations for future projects

and practice follow. Nurses are autonomous in decision making about nursing practice

and capable of recognizing health changes in their patients. Future recommendations for

the project and practice for other ways of improvement will be discussed.

Recommendations for future projects. Nurses should be empowered to

determine the patients' chronic conditions such as HTN. Nurses spend 24 hours with

patients, and they are the patients' advocates of care. Hence, they work with the patients

from the acute condition to their chronic state of health. Another recommendation was to

establish follow up projects with the same participants. The pitfall to this would be the

deterioration some of the patients could encounter in a chronic condition such as HTN,

which could prevent the patients from completing the project. Since attitude to

medication adherence varies from time to time depending on the individuals, a similar

scheme should be conducted over a period of three to six months to compare results.

99

The provision of transportation for participating patients is also recommended.

Other patients of this project site facility receive federal government funding for

transportation to healthcare appointments. This federal benefit should be extended to

project participants who visit the healthcare facility for the DPI project to encourage

participation. Though this project's main goal was to establish and improve medication

adherence in HTN, a recommendation was to expand the project to HTN control and BP

monitoring. The current project monitored only a trend of BP. The reason was the

timeline of the project implementation. Four weeks of intervention were very insufficient

for a statistically significant BP difference to impact control of BP. Thus, about 12 weeks'

intervention period was recommended. Hence, details of factors associated with the

control of HTN would be analyzed. Such factors include, but are not limited to,

medication regimen, health belief, social support, and socio-demographic characteristics.

Home telehealth monitoring BP and medication adherence in replacement for weekly

telephone calls to the patients could achieve the desired therapeutic effect.

Recommendations for future practice. Change of facility and participants were

recommended. This would produce a comparison with the current project. Thus, the

general support of the facility authorities would be involved. This recommendation can

turn into a facility project so that participating nurses should be freed from other duties

during the project implementation. The method can enable more dedication and

subsequent accuracy of data collection. The nurses complained of a lack of enough time

to combine regularly assigned duties and project assignments.

For future practice, the project's modification is to monitor two dependent

variables of medication adherence and its corresponding BP in one project, using the

100

same intervention of the Million Hearts education program. The Hill-Bone scale would

be used to measure the two dependent variables. A further recommendation is that the

project implementation will last for a minimum of 10 weeks, where there will be a

statistical comparison between the dependent and independent variables will also be

defined. This will show how and to what degree adherence to antihypertensive

medication can decrease and control BP.

Another recommendation for future practice is to monitor for project

sustainability. The reason for monitoring is to evaluate the continual success of the

quality improvement project. As evidence-based, there should be a repeat of data

collection of BP and medication adherence post-intervention, at three months, six

months, and 12 months. The statistical comparison will explain sustainability. The goal

of the DPI project is to engage the patients in their care. Finally, they will follow the self-

care model of Dorothea Orem without supervision. The quasi-experimental design for

this project did not define patients' active involvement. Future project is suggested for

reconstruction, to provide more light to the patients' activities.

101

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Appendix A

Grand Canyon University Institutional Review Board Outcome Letter

127

Appendix B

Hill-Bone Medication Adherence Scale (HB-MAS)

128

Appendix C

Permission to Use Hill Bone Scale (HB-MAS)

Please consider this message as permission to use the Hill-Bone Scale(s).*

Click the link below to access articles regarding scoring, validation and the original scales.

We request that you cite the scale using the references provided in the link. We appreciate

you sharing the findings of your project with us.

Link: https://nursing.jhu.edu/faculty_research/research/projects/hill-bone/hill-bone-scales-

confirmation.html

Please don't hesitate to reach out to us at [email protected] if you have any follow-

up questions.

Best,

The Hill-Bone Scales team

* Note: Please do not share these documents with anyone else outside your project. We ask

that anyone who wishes to use the scale should submit a formal request using the link

provided for proper authorization.

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129

Appendix D

Center for Disease Control and Prevention Million Hearts Tools

132

Appendix E

Permission to Use Center of Disease Control and Prevention Million Hearts Tools

Permission

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Permission to Use Tools: This is to request for permission to use the information on education on h

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Hello Chinyere,

Thank you for your interest in Million Hearts®.

You are free to use this content as you deem fit. All of our published online content is within

public domain and is available for use.

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