Vet COACH (Veteran Peer Coaches Optimizing and Advancing Cardiac Health)
Phase: NA
Conditions: Cardiovascular Disease (CVD), Hypertension, Hyperlipemia, Obesity
Sponsor: VA Office of Research and Development

Study Protocol
Title: Veteran Peer Coaches Optimizing and Advancing Cardiac Health 
Protocol ID: IIR 14-063 
NCT Number: NCT02697422 
Document Date: 12/3/2020 

IIR 14-063
Vet-COACH (Veteran peer Coaches Optimizing and Advancing Cardiac Health)
MIRB #: 00826
HSR&D
Principal Investigator: Karin M. Nelson, MD MSHS
[V2]
Human Subjects Protocol
VA Puget Sound IRB
VA Puget Sound IRB 2
Effective Date:
December 3, 2020

Abstract
BACKGROUND:  Cardiovascular disease (CVD) is the leading cause of mortality among 
Veterans, and suboptimal risk factor control is an important mechanism for the continued 
prevalence of CVD. Despite clinic based programming that includes nurse care management, 
pharmacy support, telephone care programs and intensive quality improvement efforts, CVD 
risk factors remain sub-optimally controlled among Veterans. Given the high prevalence and 
cost CVD within the Department of Veterans Affairs, cost-effective mechanisms are needed to 
manage the burden of prevalent CVD risk factors. Veteran peer health coaches may be one 
such mechanism; however, previous work has provided limited data of this model with VHA 
primary care. Previous studies of peer support in non-VHA populations report significant 
improvement in hypertension control and CVD risk reduction. 
OBJECTIVES:  The proposed project will test the effectiveness of Vet-COACH (Veteran peer 
Coaches Optimizing and Advancing Cardiac Health), a peer health coaching program to help 
reduce CVD risk among Veterans. The overall goal of this study is to test the effectiveness of a 
peer health coach intervention to promote health behavior change among Veterans with multiple 
CVD risk factors with a hybrid type 1 implementation study. To target a high risk population, we 
will focus on Veterans with poorly controlled hypertension and at least one other CVD risk 
factor.  
METHODS:  We will conduct a randomized controlled trial that will enroll n=400 Veterans to 
compare a peer health coach intervention consisting of telephone support, and linkages to 
appropriate community-based and clinic resources compared to usual VHA primary care. The 
primary outcome is reduction in systolic blood pressure from baseline to follow-up at 1-year. 
Secondary outcomes include a reduction in Framingham Cardiovascular risk score, individual 
cardiovascular risks (tobacco use, lipids), health related quality of life and health care use. We 
will also assess the effects of the peer health coach intervention on intermediate outcomes 
including social support, patient activation, patient/provider communication and health behaviors 
(e.g. medication adherence, physical activity, nutrition, alcohol use, and stress management). In 
addition, we will assess the cost of the intervention to inform feasibility for future studies, 
determine Veteran and staff satisfaction with the intervention, and identify barriers and 
facilitators to adoption.
IMPACT ON VETERANS HEALTH CARE:  Integrating peer health coaches into PACT primary 
care teams may improve the VA's ability to provide community outreach to Veterans. CVD risk 
reduction provides an ideal target for intervention given the prevalence of modifiable risks 
among Veterans. The proposed study will increase understanding of the utilization of peer 
support within PACT teams. If this study proves the main hypothesis, this evidence-based 
support model could be tested more widely among Veterans with other chronic conditions to 
improve health outcomes.  
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List of Abbreviations
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AHA
American Heart Association
ALVA
American Lake VA
AUDIT-C
Alcohol Use Disorders Identification Test
BMI
Body Mass Index
BRFSS
Behavioral Risk Factor Surveillance Survey
CAHPS
Consumer Assessment of Health Plans Study
CDW
Corporate Data Warehouse
CHW
Community Health Worker
CVA
Cardiovascular Accident
CVD
Cardiovascular Disease
DUA
Data Use Agreements
FFQ
Food Frequency Questionnaire
FRS
Framingham Risk Score
GIS
Geographic Information Systems
HLD
Hyperlipidemia
HPDP
Health Promotion and Disease Prevention
IHD
Ischemic Heart Disease
IPAQ
International Physical Activity Questionnaire
LDL-C
Low Density Lipoprotein
MOU
Memoranda of Understandings
MOVE
Weight Management Program for Veterans
OMHS
Office of Mental Health Services
PACT
Patient Aligned Care Team
PAM
Patient Activation Measure
PTSD
Post-traumatic stress disorder
PVD
Peripheral Vascular Disease
SBP
Systolic Blood Pressure
Vet-COACH
Veteran peer Coaches Optimizing and Advancing Cardiac Health
VFW
Veterans of Foreign Wars
VA Puget Sound IRB 2
Effective Date:
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Contents
Protocol Title:...............................................................................................................................5
1.0
Study Personnel................................................................................................................5
2.0
Introduction.......................................................................................................................5
3.0
Objectives.........................................................................................................................8
4.0
Resources and Personnel...............................................................................................10
5.0
Study Procedures............................................................................................................11
5.1 Study Design....................................................................................................................11
5.2 Recruitment Methods.......................................................................................................16
5.3 Informed Consent Procedures..........................................................................................17
5.4 Inclusion/Exclusion Criteria..............................................................................................18
5.5 Study Evaluations............................................................................................................19
5.6 Data Analysis...................................................................................................................20
5.7 Withdrawal of Subjects.....................................................................................................26
6.0
Reporting........................................................................................................................26
7.0
Privacy and Confidentiality..............................................................................................27
8.0
Communication Plan.......................................................................................................28
9.0
Information Security & Privacy........................................................................................29
10.0    References………………………………………………………………………………………28
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Protocol Title:  
1.0
Study Personnel (KEY)

Provide name, contact information, and affiliations/employee status for the 
following:
Principal Investigator: 
Karin M. Nelson, MD MSHS
Karin.nelson@va.gov   206.277.4507
Core Investigator/Assoc. Professor of Medicine
VA Puget Sound Health Care System
1660 S. Columbian Way, Seattle, WA 98108
Co-Investigators:
Tiffanie Fennell, PhD
Tiffanie.fennell@va.gov   206.277.4434  
Clinical Health Psychologist, Health Behavior Coordinator
VA Puget Sound Health Care System
1660 S. Columbian Way, Seattle, WA 98108
                                                                                                                          
Collaborators (at other institutions, not covered under the VA IRB approval): 
None
2.0
Introduction

Provide scientific background and rationale for study.  

Include summary of gaps in current knowledge, relevant data, and how the study 
will add to existing knowledge.  

Include rationale for including or excluding certain populations – in particular 
vulnerable populations.
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High prevalence and sub-optimal control of CVD risk factors among Veterans:
Cardiovascular risk is a composite measure of several modifiable risk factors including 
hypertension, dyslipidemia, and tobacco use. Sedentary lifestyles, unhealthy diets, and 
increasing obesity rates will likely continue to increase rates of hypertension, dyslipidemia and 
CVD.18-20 Because of these trends, a 2020 American Heart Association (AHA) goal is the 
promotion of ideal cardiovascular health, defined as the presence of 4 health behaviors (non 
smoking, BMI ≤ 25 mg/kg2, physical activity at goal level, and diet consistent with current 
guidelines) and the presence of at least 2 ideal health factors (untreated total cholesterol < 200 
mg/dl, untreated blood pressure < 120/80 mmHg, or untreated fasting glucose < 100 mg/dl).4 
The majority of U.S. adults meet very few of these goals.21,22 Similar to the US population, 
Veterans have high rates of CVD risks.2 Almost half of Veterans seen in primary care have a 
hypertension diagnosis and one quarter have poor control.23 Veterans who obtain care from 
VHA are more likely to be obese and physically inactive than the general population5 and the 
prevalence of tobacco use among Veterans is 25%.6  
CVD risk factor control will require a multi-faceted intervention:
Comprehensive approaches to control CVD risk will need to focus on multiple risk factors 
including blood pressure, high cholesterol, tobacco use, body-mass index, physical activity and 
nutrition.24,25 Control of hypertension and other modifiable CVD risks requires medication 
management in addition to behavioral interventions to change health behavior. National 
guidelines recommend that all individuals with hypertension undergo the following lifestyle 
modifications: loss of 5-10% of body weight, or maintain normal weight; moderate physical 
activity, change diet to be low sodium; smoking cessation and moderate alcohol consumption.26 
Focusing on more than one of these aspects of healthy lifestyle is synergistic and can lead to 
greater improvements in hypertension control.27 Existing studies suggest significant benefit in 
blood pressure control from lifestyle modifications26,28,29 with a decrease in SBP from 5 - 20 mm 
Hg with 10 kg loss of body weight, a decrease in SBP from 8 - 14 mm Hg with dietary 
changes,30 a decrease of 4 - 9 mm Hg with regular physical activity31,32 and 2 - 4 mmHg with 
moderate alcohol consumption.33 Given the high rates of medication non-adherence among 
individuals with hypertension,34 focusing on this topic is critical. 
Gaps in knowledge about peer support interventions among Veterans in primary care: 
Trained peers may be a novel and innovative addition to existing programs, as peers can be 
effective in supporting health behavior change7 and make healthcare more patient-centered.41,42 
Peer support, defined as the provision of support and information from a member of a social 
group who possesses experiential knowledge and similar characteristics to the target 
population, falls into the social support model, where social relationships improve health-related 
quality of life and well-being.43 To date, peers have been utilized in several studies at VHA, 
including two studies that showed significant clinical improvement among patients with 
diabetes.12,13 Previous research in non-VA populations suggests that peer coaches working in 
conjunction with nurses are effective at controlling cardiovascular risk factors,8,10,44 but work is 
needed to determine how to integrate peer support into PACT teams to help assist Veterans. 
One component of the PACT initiative is the utilization of RN care managers to coordinate care. 
Care management provided by registered nurses can be effective, but is expensive. Veteran 
peer health coaches are a potentially more cost effective mechanism to increase outreach and 
link Veterans to their PACT team and RN care managers.
Peer support and the unique experiences of the Veteran community:
The positive health benefits of peer support may be particularly strong in the Veteran 
community. Veterans have long organized into community organizations (e.g. VFWs) based on 
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their unique military experience, the powerful formative experiences of military service and 
unique post-discharge experiences (e.g. PTSD, integrating back into civilian life). Because of 
these common experiences, Veterans may find it easier to understand and accept the health 
recommendations of a peer health coach.45 Peer coaches may also be able to help Veterans 
and providers to understand each other’s perspective and priorities. This shared experience has 
been utilized effectively in the treatment of Veterans with mental health conditions. The VHA 
Office of Mental Health Services (OMHS) has a well-developed peer support program and has 
hired 300 Veterans to assist mental health clinical teams. The core features of the recovery 
model for mental health (e.g. peer support, holistic orientation, self-direction, and patient-
centeredness) are integral to most chronic disease self-management programs.15 However, the 
peer support approach has not received widespread testing among Veterans cared for in 
primary care. By leveraging the shared military experience and camaraderie of Veterans, the 
peer coach model may be an untapped opportunity to improve health among primary care 
patients and may work more effectively in the VA, but this model needs further testing. 
Contributions of the proposed work:
CVD remains the number one cause of mortality among Veterans and sub-optimal risk factor 
control contributes to the ongoing prevalence of CVD. Our goal is to decrease CVD risk among 
Veterans by addressing modifiable risk factors (hypertension, elevated cholesterol, 
overweight/obesity and tobacco use) with an innovative, patient-centered intervention. Our 
approach to multiple risk reduction with a novel peer coach intervention mirrors clinical practice, 
where multiple conditions and behaviors are considered simultaneously. Peer support models 
have been utilized effectively in other patient populations to manage CVD risk and improve BP 
control, but limited work has been done within the context of the PACT team or in Veteran 
populations. The intervention will be integrated into primary care clinics and PACT teams at two 
clinical sites, enhancing the potential for benefit and generalizability to other settings. The 
intervention is consistent with the PACT goals to provide more longitudinal and less episodic 
care.16 The proposed intervention could potentially decrease CVD risk among Veterans by 1) 
building upon previous work with peer support among non-Veteran populations; 2) focusing on 
multiple synergistic CVD-related behaviors and risk factors and 3) targeting a high risk 
population (e.g. Veterans with 2 or more CVD risks) thereby providing the greatest potential to 
improve morbidity and mortality. Our proposal is innovative in the use of a hybrid type 1 design, 
which will inform future implementation efforts. The Vet-COACH intervention was designed with 
our clinical partners and is integrated into the PACT team. Given the national prevalence of 
CVD and the low rates of risk factor control, easily disseminated interventions such as the one 
proposed could significantly improve health outcomes.
Relevance to VA Care:
Given the numbers of Veterans with sub-optimal cardiovascular control, developing models of 
care to best help this population is critical to the VHA mission. Peer support may provide a 
needed link between Veterans and available VHA clinical services and serve as a community-
clinic liaison to strengthen connections to community-based resources. Utilizing trained peers 
may be one mechanism to improve health among Veterans. However, much research is needed 
to determine the role and effectiveness of peer support. The VHA has a well-developed 
evidenced-based Health Promotion and Disease Prevention (HPDP) program. Expanding the 
reach of this program by the use of peer health coaches has the potential to provide cost-
effective health coaching. 
Unique and innovative features of the Vet-COACH intervention include: 
Veterans will not have to travel to a class or clinic, thereby increasing participation in 
self-management education, enhancing recruitment and retention. 
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Veterans will be more comfortable in their homes during the health coaching calls, and 
therefore more able to participate actively in learning activities and develop trusting 
relationships with the Veteran peer health coaches.
Peer health coaches will be able to role-model and observe participants in practicing 
self-management behaviors (e.g. managing medications).
Peer health coaches will be able to make suggestions that household members be 
enlistedto provide support for Veterans.
Peer health coaches will be able to link Veterans to pre-existing programs (e.g. disease 
self-management classes, MOVE, home tele-monitoring).
Peer health coaches have access to PACT teams and can assist Veterans engagement 
in care. 
The proposed research has the potential to contribute to the VHA mission to provide patient 
centered care, and also to develop, facilitate and integrate peer support into PACT teams. This 
proposal directly targets improving a Veteran-centric health care model to help Veterans 
navigate the health care delivery system and receive coordinated care. By providing training 
curricula and data on the effectiveness of peer health coaches, our goal is to present VHA 
policymakers with evidence regarding peer health coaches work to decrease CV risk and 
improve Veteran health. 
3.0
Objectives

Describe the study’s purpose, specific aims, or objectives. 

State the hypotheses to be tested.
Cardiovascular disease (CVD) is the leading cause of mortality among Veterans, and sub-
optimal risk factor control is an important mechanism for the continued prevalence of CVD.1,2 
Despite clinic-based programming that includes nurse care management, pharmacy support, 
telephone care programs and intensive quality improvement efforts, CVD risk factors remain 
sub-optimally controlled among Veterans.3 Modifiable CVD risks include hypertension, 
hyperlipidemia (HLD), obesity and tobacco use. These conditions are common, often co-exist, 
and are amenable to behavior change and disease self-management interventions.4 Among 
Veterans with hypertension, 25% have poor control (as defined by a blood pressure of >140/90 
mmHg). Similar to the US population, the majority of Veterans are overweight or obese, are 
sedentary and eat unhealthy diets.5 Over one quarter of Veterans smoke.6 To improve health 
and decrease CVD morbidity and mortality, CVD risk reduction is an important issue facing VHA 
and other U.S. health systems.
There is a growing literature about the positive health benefits of peer support on health 
outcomes and health behavior change.7 Previous studies of peer support in non-VHA 
populations report significant improvement in hypertension control and CVD risk reduction.8-11 
There are several peer support titles, including peer coaches, navigators, and community health 
workers (CHWs), with the common characteristic of sharing life experiences and social 
background with the patients being served, and promoting health by providing education, 
assistance, motivation and social support.7 Several models of peer support have been tested in 
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VHA, but have primarily targeted single conditions, e.g. diabetes12,13 or among Veterans with 
mental health conditions.14,15 
Specific Aims: 
1.
Test the effectiveness of a peer health coach intervention for improving health outcomes for Veterans with 
multiple CVD risks in a randomized controlled trial. The primary outcome is a reduction in systolic blood 
pressure (SBP) from baseline to follow-up at 1 year. Secondary outcomes include change in 
cardiovascular risk, as measured by the Framingham Risk Score17, other cardiovascular risks (tobacco 
use, lipids) and health related quality of life. Using administrative data at 1 year following randomization, 
we will examine healthcare utilization, hospitalizations, and emergency room visits.
2.
Assess the effects of a peer health coach intervention on intermediate outcomes that are intervention 
targets including social support, patient activation, patient/provider communication and health behaviors 
(e.g. medication adherence, physical activity, nutrition, alcohol use, and stress management). 
3.
Assess the cost of the intervention to inform feasibility for future studies. 
4.
Determine Veteran and staff satisfaction with the intervention and identify barriers and facilitators to 
adoption.
The recent VHA medical home model initiative, the Patient Aligned Care Team (PACT), is an 
ideal setting to test peer support, as this social support model aligns with the PACT focus on 
team-based, patient-centered, and comprehensive care.16 The PACT team includes a primary 
care provider, an RN care manager, and a LPN; as well as support staff including pharmacists 
and Health Promotion and Disease Prevention (HPDP) staff. The focus of the HPDP program is 
to support chronic disease self-management and promote healthy lifestyle choices. Trained 
Veterans working as peer health coaches may be a mechanism to expand the reach of 
the PACT team by (1) providing brief health education messages based on HPDP 
program materials, (2) acting as a community-clinic liaison to create stronger linkages 
between primary care and community resources and (3) by linking Veterans to 
community-based resources for healthy lifestyle choices. The overall goal of this study is to 
test the effectiveness of a peer health coach intervention (Vet-COACH “Veteran peer Coaches 
Optimizing and Advancing Cardiac Health”) to promote health behavior change among 
Veterans with multiple CVD risk factors with a 4-year hybrid type 1 implementation study. To 
target a high risk population, we will focus on Veterans with poorly controlled hypertension and 
at least one other CVD risk. 
Integrating peer health coaches into the PACT primary care team may improve the VA’s ability 
to provide community outreach to Veterans. CVD risk reduction provides an ideal target for 
intervention given the prevalence of modifiable risks among Veterans. The proposed study will 
increase understanding of the utilization of peer support within PACT teams. If this study proves 
the main hypothesis, this evidence-based support model could be tested more widely among 
Veterans with other chronic conditions to improve health outcomes.  
4.0
Resources and Personnel
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
Include where and by whom the research will be conducted. 

Provide a brief description of each individual’s role in the study.  Be sure to 
indicate who will have access to protected health information and who will be 
involved in recruiting subjects; obtaining informed consent; administering 
survey/interview procedures; and performing data analysis.

If applicable provide information on any services that will be performed by 
contractors including what is being contracted out and with whom.
N/A

If applicable provide information on any Memoranda of Understandings (MOUs) 
or Data Use Agreements (DUAs) that are being entered into including with whom 
and for what reason.  
N/A
Research will be conducted at VA Puget Sound Health Care by the Vet-
COACH project study staff:
Name
Role
Acce
ss to 
PHI
Recruitment/Informed 
Consent/Surveys/Interviews
Data 
Analysis
Karin Nelson
PI
Y
                     Y
Y
Tiffanie Fennell
Co-I
Y
N
Y
Leslie Taylor
Biostatistician
N
N
Y
George Sayre
Qualitative Analyst
Y
N
Y
Marie Lutton
Project Manager
Y
Y
N
Jennifer Williams
Research Assistant
Y
Y
N
Jeff Rodenbaugh
Programmer
Y
N
Y
Kristen Gray
Analyst
Y
N
Y
Matt Augustine
Analyst
Y
N
Y
Kristin Rosendahl
Nutrition expert
Y
N
N
Brittney Hamilton
Research Assistant
Y
Y
N
Charles Bradley Kramer
Graduate Research 
Student Assistant (RA)
Y
Y
Y
Elizabeth Presley 
Strewler
Research Social 
Worker / Research 
Coordinator
Y
Y
N
5.0
Study Procedures
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5.1 Study Design

Describe experimental design of the study.  Include sequential and/or 
parallel phases of the study, including durations, and explain which 
interventions are standard of care.  

Include a description of how anticipated risk will be minimized and include 
an analysis of risk vs. potential benefit.

Provide description of the study population (delineate all categories of 
subjects – patients, providers, family members, employees, etc.). Include 
anticipated enrollment numbers

As applicable, provide information on any added protections for vulnerable 
populations. 

If applicable include information on data and specimen banking.
Study design overview: 
We propose a randomized controlled trial to evaluate the effectiveness of Vet-COACH, a peer 
health coach program to control hypertension and reduce CVD risk among Veterans. The 
original program incorporated home visits by peer health coaches to deliver health education, 
counseling and goal setting support. Due to safety concerns and social distancing restrictions 
stemming from the COVID 19 pandemic, the program has transitioned to conducting all health 
coaching encounters, as well as enrollment and exit visits, via phone. This transition was 
implemented under IRB approval of the miscellaneous memo submitted at the beginning of the 
pandemic. These changes to conduct all health coaching encounters and exit surveys over the 
phone will be permanent for the remainder of the study. Our operations partners from NCP have 
developed extensive patient educational materials that will be used for the current study.55 We 
will train the peer health coaches to provide brief educational messages and link Veterans to 
existing clinical services at VHA, including their primary care PACT teams and community 
based programs. The main outcome will be a reduction in systolic blood pressure. Secondary 
outcomes are cardiovascular risk, as measured by the Framingham Risk Score (FRS),17 health 
care utilization and intermediate behavioral outcomes including patient activation, social support 
and health behaviors (e.g. diet and physical activity, medication adherence). We will randomize 
a total of  200 individuals to the intervention group and  200 individuals to the control group.
Our study design has limitations. Because of the nature of the intervention, we are unable to 
blind treatment assignment. The PI and Dr. Fennell will provide overall supervision to the peer 
coaches. This model is necessary for program development. Because the intervention is being 
conducted at two sites, we are not proposing an economic evaluation to estimate cost-
effectiveness, in part because such data would be of limited generalizability. Positive findings 
will lead to a larger multi-site trial that would include a cost-effectiveness analysis. These 
limitations are more than balanced by the strengths of this proposal. The proposed project is a 
prospective, randomized controlled trial that examines important outcomes with statistical power 
to detect clinically meaningful differences. 
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Description of Vet-COACH – a call-based peer health coach intervention:
The three goals of the peer health coach intervention include: (1) delivering brief health 
messages based on materials from the HPDP program, (2) acting as a community-clinic liaison 
and (3) providing expertise on the availability of community based resources for healthy lifestyle 
choices (e.g. places for physical activity, walking groups, grocery store tours, etc.) The focus of 
the intervention will be the provision of brief health messages, goal setting and action 
planning around health behavior changes shown to decrease CVD risk (e.g. healthy diet, 
regular moderate-intensity physical activity, tobacco cessation if applicable). Peer health coach 
education modules, examples of key messages and measures used to assess participant 
progress are outlined in Table 2. Required education modules for hypertension include: physical 
activity, nutrition, and medication adherence (and weight management if overweight or obese).56
Table 2. Veteran Peer Health Coach Required Education Module Topics,  Examples of Goals and Key 
Messages, Referrals to Community or VHA resources, and Measures Used to Assess Intermediate 
Outcomes
Behavioral 
targets
Goals and Key Messages
Referral to appropriate 
community or VHA 
resources
Intermediate outcome 
measures
Required modules – applies to all Veterans with Hypertension
Blood Pressure
What is high Blood Pressure? 
Understand systolic & diastolic 
measurements.  Tips to manage 
blood pressure.
Offer blood pressure 
cuff if subject does not 
have one.  Record 
blood pressure 
measurements & report 
to PI, study nurse 
and/or PCP as needed.
Standard protocols
Physical activity
Avoid inactivity. Every 10 minute 
session of physical activity 
counts.  Goal of moderate 
exercise for at least 30 minutes 
per day.
List of local physical 
activity resources 
provided to all 
participants
Offer pedometers
IPAQ57
Nutrition
Healthy plate concept. Areas of 
focus will include reducing 
portion size, reducing fast food 
intake, avoiding processed foods 
high in sodium and 
carbohydrates, reduction of salt 
intake, increase in fruit and 
vegetable intake and decrease in 
total and saturated fat.
Encourage referral to 
VHA nutrition
Offer healthy plate
Grocery store tour
Information on local 
resources (e.g., food 
banks, farmers 
markets)
Self-reported nutrition 
behavior57 and food 
frequency (FFQ)58
Medication 
adherence
Know your medications and which 
ones you take.  Have a written list 
and bring to each health care 
visit.  
Feedback to PCP, 
nurse case manager
Offer medication 
organizer
Self-reported 
medication adherence ( 
Voils, C. I. et al. )59
ReCOMP60
Communication 
with medical 
team/physician
Be involved with your health care. 
There are many ways to take an 
active role.
Feedback to PCP, 
nurse case manager for 
appropriate follow up
CAHPS-provider 
communication63
Optional Education modules- if applicable to individual Veteran
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Weight 
reduction, 
maintenance of 
normal BMI
Strive for a healthy weight.  If you 
need to lose weight, even a small 
amount can improve your health.  
If you are a normal weight, 
maintain it.  
Referral to MOVE 
program, assistance 
with enrollment 
questionnaire 
(MOVE23)
BMI
Smoking 
cessation
Be tobacco free!  If you are using 
tobacco, ask your health care 
team for help in quitting.
Referral to smoking 
cessation resources, 
provide quit line 
number
Self-report of smoking 
status
New medication for 
smoking cessation
Limiting alcohol 
intake
If you choose to drink, do so in 
moderation. If drinking, limit to <= 
2 drinks/day for men, <= 1 drink 
for women
Feedback to PCP, 
nurse case manager for 
appropriate follow up
AUDIT-C61
Stress 
management, 
depression and 
sleep
Pay attention to stress.  Tools are 
available to help you manage and 
reduce stress.  
Feedback to PCP, 
nurse case manager for 
appropriate follow up; 
Referral to Mindfulness  
based stress reduction 
class
PHQ-862
Participant Inclusion criteria: 
We will focus our intervention in the geographic area directly surrounding the VA Puget Sound 
(Seattle and ALVA clinics) that has a high prevalence of poorly controlled hypertension. As part 
of project planning, we have worked with the Office of Analytics and Business Intelligence to 
utilize Geographic Information Systems (GIS) to identify and target high risk areas. This type of 
patient mapping is available nationwide, so this mechanism to identify and recruit participants is 
potentially generalizable.
We developed our inclusion criteria to identify Veterans who will benefit the most, by focusing 
on Veterans up to age 75 years with poorly controlled risks that are amenable to change. 
Specific inclusion criteria include poorly controlled hypertension (mean systolic BP > 150/90 
mmHg) and one or more of the following CVD risks: overweight or obese (Body Mass Index 
(BMI) > 25 kg/m2), current tobacco use, or a diagnosis of hyperlipidemia (defined as low-density 
lipoprotein (LDL-c) >130 mg/dL). Although we are selecting common conditions that increase 
cardiovascular risk, we are not excluding Veterans with other prevalent conditions (e.g. 
diabetes, arthritis, renal disease, or COPD), whose presence will be noted in the enrollment 
visit. We chose to focus on Veterans with elevations in systolic hypertension above the stage 1 
level of 140 mmHg, given recent data regarding treatment of mild hypertension. 
Exclusion criteria: 
We will exclude those who have been hospitalized 3 months prior to enrollment for a CVD 
admission (IHD, CVA or PVD), as these Veterans may be too ill to participate in this 
intervention. We will exclude patients with dementia or severe cognitive impairment that would 
not allow them to participate in the program; patients with a suicidal ideation and/or disruptive 
behavior flag in CPRS; patients with end stage renal disease on dialysis, given the unique care 
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needs of this population; patients who have received palliative care or are enrolled in hospice 
care, given their limited life expectancy; Veterans enrolled in Home Based Primary Care, an all-
inclusive home visit nurse program or those who live in care facilities (nursing homes, assisted 
living facilities); homeless Veterans and women who are pregnant or planning to become 
pregnant. 
Enrollment and randomization:
a) Enrollment and exit visits
The research coordinators will interview participants during the enrollment and exit visits over 
the phone. If a participant expresses completion of the exit survey over the phone would pose 
difficulties for them, staff will provide the option to complete and return the exit survey by mail.   
If the participant agrees, staff will mail a copy of the exit survey with a postage-paid return 
envelope to mail the completed survey to the HSR&D office. Study staff in possession of a VA-
issued flip phone will use it to conduct the call.  Study staff who do not have a VA phone or 
laptop will use their personal smart phone and conduct the call using the Doximity app. 
Scheduled participants will be mailed a letter prior to their enrollment visit that will confirm the 
date, time, and location of their appointment and a brief summary of what will be covered in the 
visit and program.  The baseline enrollment visit and exit call will include blood pressure 
measurements and labs (lipids). If there are no lipid panel results in CPRS dated within 12 
months prior to the baseline/enrollment date or 3 months prior to the exit visit date, the PI will 
order a lipid panel test. If a participant moves out of the Puget Sound area and/or receives lipid 
test results from a non-VA provider or clinic, we will request they send the lipid panel test results 
from the non-VA lab or VA lab in another state to the Puget Sound VA Primary Care Clinic via 
mail or secure fax.  This is already done by VA patients who may get bloodwork at a non-VA 
facility. These results would be used as the lipid measurements typically collected at the exit 
visit. Juliana Bondzie (study coordinator and phlebotomist) will conduct the blood draw with 
participants completing the enrollment and/or exit visit with her.  Ms. Bondzie has completed all 
the required trainings and coursework to conduct blood draws at the VA Puget Sound.  Any 
results flagged as high will be reported by the PI to the participant’s PCP -- either as an 
addendum to the research enrollment note or as an alert to the PCP if they are not enrolled in 
the study -- using the following statement: “We ordered a lipid panel test as part of screening or 
follow up for the Vet-Coach research project.  Your patient may or may not participate in this 
study.” Three blood pressure measurements will be collected by the research coordinators at 
intervals during the enrollment call. For BP measurement, after the patient has sat comfortably 
for 5 minutes, three BP consecutive measures are obtained and then averaged per NHANES 
protocol. 57All BP measurements will be performed with electronic, upper arm cuffs.58 The 
average BP must be >150/90 mm Hg at the time of the data pull for Veterans to be eligible for 
the study. We will attempt to schedule enrollment visits within a week of their most recent 
primary care visit to recruit Veterans with uncontrolled hypertension. Height and weight will be 
measured at baseline and weight will be measured at exit. Measures collected include: chronic 
disease self-management behaviors, health history, health care access, and health care 
utilization. Urgent issues will be referred immediately to the PI. The PI will contact the PCP for 
urgent issues to ensure appropriate follow-up.
b)  Randomization
Following baseline assessments, a computerized randomization procedure will assign 
individuals to either the peer health coach intervention or to the usual care + education control 
group. Randomization of participants will occur in the order of completed enrollment visits. 
Randomization lists will be constructed in advance by the study biostatistician using variable 
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length blocks to ensure the groups are not unbalanced at any time. Concealment will be used to 
prevent the study staff from obtaining information on the sequence of assignment.
c) Usual care + education control arm
Usual care consists of enrollment in the Primary Care Clinic or Women’s Clinic at VA Puget 
Sound, plus an educational pamphlet with study materials provided at the baseline visit. The 
educational pamphlet will deliver the same information content as the intervention and consist of 
existing NCP materials (See Appendix 2 of attached IIR). We chose not to develop an attention 
control arm. Part of the process of the peer health coach intervention is the increased social 
support of the home visits. By providing “attention” in another way, we would not be able to test 
the effect of the increase in social support provided to intervention participants. Social support 
(or “attention”) has been shown to be a powerful resource to maintain both physical and mental 
quality of life, despite the impacts of multiple chronic conditions.67 Perceived social support has 
been significantly related to health-related quality of life.67 
Follow-up calls for Intervention Group: 
The same peer health coach will make  a total of 10 phone calls over the 12 month intervention 
period (Table 3), including 5 phone calls (to replace the previous home visits) plus 5 telephone 
follow up calls.  We are basing the intervention frequency and number of visits on our previous 
work (1R18DK088072-01) and on frequencies noted in successful blood pressure trials.10 To 
increase generalizability of this model, we chose a minimal intervention necessary to review 
education topics and address important behaviors for all Veterans with hypertension. The peer 
health coach will support the participant in plan implementation at follow-up calls taking place 2, 4, 
6 and 9 months after the initial call. Follow up telephone contacts  are being used in our current 
study to maintain contact and support for participants.
Table 3.  Schedule of home visits, telephone follow up and staff member responsible for the activity
Months
0
1
1.5
2
3
4
5
6
7
8
9
10
11
12
Staff member responsible 
for activity 
Baseline 
enrollment
X
Research Assistant (RA) 
Telephone 
calls
X
X
X
X
X
Peer health coach
Telephone 
follow up 
X
X
X
X
X
Peer health coach
Exit call
X
RA, 
Visit content and development of a health action plan:
All Vet-Coaches receive training in adherence to the study protocol and specific instruction on 
conducting research at the VA. Vet-Coaches complete the same online trainings in data security 
as well as the in-person Human Research Protection Program (HRPP) Orientation required by 
VA research staff. Vet-Coaches receive training in guidelines set by the VA and IRB to protect 
the rights of those participating in research, including an emphasis on maintaining participant 
confidentiality and keeping Personal Health Information secure at all times. Comprehensive 
trainings provide information on patient-centered communication, motivational interviewing, role 
modeling, comprehension of the health educational topics, health coaching skills, proper 
procedures for taking blood pressure measurements, goal setting techniques and proper 
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completion of data collection forms.  Study staff will directly observe practice role play sessions 
prior to Vet-Coaches meeting with participants. Randomly selected encounters of Vet-Coach 
calls with participants will be audio recorded and reviewed by study staff to provide ongoing 
feedback to coaches. Individual performance feedback will be provided to ensure health 
coaching is being conducted correctly. In addition, study staff will conduct an annual, in person 
“Vet-Coach Refresher Training” with the Vet-Coaches that will review study protocol & limits of 
appropriate subject contact.  The training will emphasize regulations and acceptable 
communications and contact with participants as set by both the VA Puget Sound employee 
code of conduct as well as the study protocol. There are bi-weekly meetings with the study team 
to discuss ongoing health coaching issues, problem-solve difficulties implementing study 
procedures or coordination of health care, and address concerns or questions specific to 
individual participants, etc.
Recommendations for potential health action plans, based on national guidelines and specific to 
the individual risk factor and patient motivation, will be generated at the enrollment visit. Using 
the results of the baseline assessment, the peer health coach will collaboratively develop an 
action plan with the Veteran. The protocols specify education content, Veteran skill development 
goals, participant and Veteran health coach actions. All Veterans will receive the five required 
education modules, including high blood pressure, medication adherence, physical activity, 
nutrition, and improved communication with medical team/physician (Table 2). The peer health 
coach will have participants prioritize their goals, ask what they would like to prioritize for their 
next call, and develop a goal-directed action plan [where the Veteran identifies a health related 
goal and decides how much time, when and how often they are going to complete the behavior 
(e.g. walk 10 minutes per day OR take my blood pressure pills every morning)], along with an 
assessment of how confident they feel in being able to complete the behavior. We will assess 
goal setting and goal completion rates in the Action Plan for the intervention participants. The 
peer health coach will document the skill or goal that was the primary focus for each call and the 
self-management strategies that were highlighted during that call on an encounter form. As 
progress toward the first goal is important for long-term motivation, a telephone follow up will 
occur 2 weeks after the first call. Blood pressure will be measured by the peer health coach at 
each call with a total of one blood pressure measurement at each call. The readings, if elevated, 
will be reviewed by the study coordinators and given to the provider. We will record these blood 
pressure readings in study data and use them to provide participant and PCP feedback. They 
will not be used as outcomes measures because we will not have equivalent data for the control 
participants. Initial and randomly selected phone calls with Vet-Coaches will be audio-recorded 
to ensure fidelity. Each Vet-Coach will audio-record initial calls until the PI deems they have met 
proficiency standards.  After initial proficiency standards are met, each Vet-Coach will continue 
audio-recording of randomly-selected calls to ensure ongoing proficiency. Audio recordings will 
be collected using secure, VA approved digital recorders or recording software.  Recordings and 
recording devices will be stored and transported in locked security bags to the VA Puget Sound 
office location every two weeks at study staff meetings.  Audio recordings will then be uploaded 
to the secure, electronic folder on the VA server. 
At follow up calls, the peer health coach will learn about patient challenges and concerns, review 
progress on implementing the self-management plan, provide targeted education to help with plan 
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implementation, revise self-management goals and the plan as the participant progresses, and 
make referrals to VHA and community resources. If deviations in medication adherence are 
noted, pillboxes will be offered. Blood pressure cuffs will be offered for home monitoring, as 
supported by a recent review of home blood pressure monitoring reporting moderate strength 
evidence.68 Participants will receive assistance with health system navigation. 
If an intervention participant moves out of the Puget Sound area and does not have an assigned 
VA provider, health coaching encounters will be discontinued because the PI would not be able 
to notify the provider of possible medical issues that may arise during the encounters.  If a 
participant moves out of the area and retains a VA provider (at either the VA Puget Sound or a 
VA in another state), we would continue to complete health coaching encounters and the PI will 
report medical concerns to their assigned VA provider listed in CPRS. Study staff will continue 
to complete the exit phone visit with participants regardless of continuation of health coaching 
visits. 
5.2 Recruitment Methods

State how many subjects will be needed. 

Describe when, where, how and by whom potential subjects will be 
identified and recruited. 

Describe materials that will be used to recruit subjects, e.g., 
advertisements.  Include materials as an appendix or separate 
attachment.  Only refer to attachments as A, B, etc. Do not refer to version 
#’s or dates of versions. During the course of the study, changes in the 
attachments will require IRB approval; however, those changes may not 
require a revised protocol.

Describe any payments to subjects, including the amount, timing (at the 
end of the study or pro-rated for partial study participation), method (e.g., 
cash, check, gift card), and whether subjects will experience a delay in 
receiving the payment.
Eligibility for participation will be determined by identification of potential participants and Vet-
Coaches from VA administrative data files from VA Corporate Data Warehouse, as well as the 
"Quality Improvement for Primary Care Clinic" project conducted through the Seattle VA Primary 
Care Clinic for relevant diagnostic and lab-based criteria. Census tract data from the Quality 
Improvement project will be linked to subject geographic data (address) in the VA administrative 
files. This information will be obtained by the project programmer. Using administrative data, we 
identified approximately 17,080 Veterans at VA Puget Sound (cared for at either the Seattle or 
American Lake Divisions) with hypertension, of whom n=2,955 have a systolic blood pressure 
that is > 150 mm Hg. Approximately 90% of this population is overweight or obese (a second 
criteria for entry into the study) (n=2,486). Our target sample size for recruitment is n=400. A 
letter from the study signed by the primary care provider (PCP) with an opt-out option will be 
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mailed to potential participants informing them of the project and encouraging participation. 
Project staff (project manager and research assistant) will then contact patients by telephone to 
assess eligibility and interest in participation and to arrange an enrollment visit. 
We will also recruit subjects by posting study flyers (see attached flyer with tabs) on research 
bulletin boards, research kiosks, and research information tables (on designated research fair 
days) at the VA Puget Sound.  The flyer contains a contact number potential participants may 
call to learn more about the study from study staff.  A copy of the study flyer without tabs will be 
included in the “Patient Education Programs” brochure, which is updated quarterly by the VA 
Health Behavior Coordinator and distributed at the VA Puget Sound.  Vet-Coaches will also 
distribute copies of the study flyer and will be available to speak to interested potential 
participants in the PCC waiting room. All interested callers will be asked to complete the phone 
screen with study staff to determine eligibility. Use of the recruitment flyers will occur during 
business hours through December 31, 2020.
Informed consent will be obtained at the time of enrollment. To facilitate enrollment and 
retention, the project will offer $50 for completion of baseline data collection and $50 for 
completing one year exit data collection. We will not offer an incentive for participating in the 
intervention in order to maintain study generalizability and feasibility of wider adoption. 
Vet-Coaches will be Veterans with VA employee or “WOC” status who have completed all the 
online VA Human Subjects trainings (including data security, privacy and confidentiality 
trainings) as well as in-depth instruction in health coaching and education.  Vet-Coaches will 
serve as study staff to provide peer health coaching to Veteran subjects enrolled in the study. A 
letter will be sent to the provider of potential Vet-Coaches to identify candidates for this position 
(see attached letter to providers).  The letter will include a list of eligible Vet-Coaches identified 
from the "Quality Improvement for Primary Care Clinic" project, and will ask providers to identify 
those on the list who would be good candidates to serve as Vet-Coaches. Selected candidates 
will be sent a recruitment letter to inquire if they would be interested in applying for a Vet-Coach 
position (see attached letter to potential Vet-Coaches). The project manager will conduct a 
follow up phone call to collect more information about their qualifications and interest in the 
position (see attached phone script), and the PI will conduct an in-person interview with the 
most qualified candidates to make a final hiring decision. Hired Vet-Coaches will be provided 
with an information statement at the end of the study to see if they would like to participate in a 
voluntary qualitative interview (see information statement approved in the initial IRB application 
and the following “patient and provider interviews” section in this protocol).
To facilitate enrollment and retention of eligible participants, the project will offer several 
incentives. After completion of the baseline visit, participants will receive an incentive of $50 and 
then $50 for completing year one follow-up data collection. Enrolled participants in the 
intervention group will receive a bag containing items that may encourage health related 
behavior including: a pill box/organizer; a scale; a place mat with information on healthy meal 
choices & portions (routinely distributed in the VA Primary Care Clinic); educational handouts 
(routinely distributed in the VA Primary Care Clinic); and a meal portion control tool.  
See Attachment A (Recruitment Letter)
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5.3 Informed Consent Procedures

Indicate if informed consent will be obtained and/or if you are requesting a 
waiver of informed consent or waiver of documentation of informed 
consent.  If the research involves multiple phases, specify for which 
phases of the research the waiver(s) is being requested and/or the 
informed consent will be sought.

Describe who will be obtaining informed consent, if applicable, and any 
circumstances that may need to be addressed (e.g. subjects with impaired 
decision making ability and the use of a legally authorized representative, 
etc.)

If applicable, indicate how local site study personnel will be trained 
regarding human subjects protections requirements and how to obtain and 
document informed consent.
Written informed consent will be obtained prior to enrollment by study staff 
(project manager and research assistant). At the enrollment visit, study staff will 
review a Commitment Script with potential participants prior to the consent 
process to discuss the study activities and commitments involved. This review 
will help participants determine whether the program is a good fit for them (in 
terms of the study activities, time commitments involved, etc.), and give them 
another chance to opt out prior to starting the consent process. The informed 
consent will also include information about audio-recording the Vet-Coach visits 
and phone calls as well as the semi-structured qualitative interviews. The 
consent will state that participants may decline to be audio-recorded at any time.  
Potential participants will be informed that participation is fully voluntary, that their 
decision regarding participation will in no way affect the services they receive, 
and that they may decline to answer any questions or decline any services 
offered as part of the project. Declining any one service will not affect their ability 
to receive other services from the project. They will also be informed that this 
study is a randomized trial and that they have an equal chance of receiving usual 
care or peer support intervention. The PI or study designee will review the study 
protocol and consent documents with all study personnel involved in consenting 
patients. Specifically, there will be an emphasis on explaining the enrollment 
process and clarifying that there are no consequences to their health care 
benefits whether they choose to participate or not.
5.4 Inclusion/Exclusion Criteria
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
Describe the criteria that determine who will be included in or excluded 
from the study. 
Participant Inclusion criteria: We will focus our intervention in the geographic 
area directly surrounding the VA Puget Sound (Seattle and ALVA clinics) that 
has a high prevalence of poorly controlled hypertension. As part of project 
planning, we have worked with the Office of Analytics and Business Intelligence 
to utilize Geographic Information Systems (GIS) to identify and target high risk 
areas. This type of patient mapping is available nationwide, so this mechanism to 
identify and recruit participants is potentially generalizable. Specific maps are 
shown in Appendix 1 of attached IIR. 
We developed our inclusion criteria to identify Veterans who will benefit the most, 
by focusing on Veterans up to age 75 (no age restrictions below age 75) with 
poorly controlled risks that are amenable to change. Specific inclusion criteria 
include poorly controlled hypertension (mean systolic BP > 150/90 mmHg) and 
one or more of the following CVD risks: overweight or obese (Body Mass Index 
(BMI) > 25 kg/m2), current tobacco use, or a diagnosis of hyperlipidemia. 
Although we are selecting common conditions that increase cardiovascular risk, 
we are not excluding Veterans with other prevalent conditions (e.g. diabetes, 
arthritis, renal disease, or COPD), whose presence will be noted in the 
enrollment visit. We chose to focus on Veterans with elevations in systolic 
hypertension above the stage 1 level of 140 mmHg, given recent data regarding 
treatment of mild hypertension. 
Exclusion criteria: We will exclude those who have been hospitalized 3 months 
prior to enrollment for a CVD admission (IHD, CVA or PVD), as these Veterans 
may be too ill to participate in this intervention. We will exclude patients with 
dementia or severe cognitive impairment that would not allow them to participate 
in the program; patients with a suicidal ideation and/or  disruptive behavior flag in 
CPRS; patients with end stage renal disease on dialysis, given the unique care 
needs of this population; patients who have received palliative care or are 
enrolled in hospice care, given their limited life expectancy; Veterans enrolled in 
Home Based Primary Care, an all-inclusive home visit nurse program or those 
who live in care facilities (nursing homes, assisted living facilities); homeless 
Veterans and women who are pregnant or planning to become pregnant. 
5.5 Study Evaluations

Describe all evaluations to be conducted (including screening; 
tests/questionnaires that will be administered; any procedures that 
subjects will be required to complete) and data collection methods.  
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Include materials as an appendix or separate attachment. Only refer to 
attachments as A, B, etc. Do not refer to version #’s or dates of versions. 
During the course of the study, changes in the attachments will require 
IRB approval; however, those changes may not require a revised protocol.
The sources of data for this project will be participant interviews and medical records. The 
participant interviews will be collected specifically for this project while the medical record data 
will be obtained from existing sources. In order to evaluate the effectiveness of the proposed 
intervention, the study will administer baseline and exit interviews, conduct limited physical 
examinations where blood pressure, height and weight are measured, and, if needed, we will 
request the primary care provider order a blood test for potential participants. The proposed 
interview and limited physical exam will be administered at baseline and after the intervention 
period and will be conducted  by study coordinators or research assistant. Only the study 
personnel will have access to any personally identifiable health information.  
M
  easures 
Specific Aim 1
Table 4 lists the health outcome measures. We will collect these outcome variables at baseline 
prior to randomization and 
 
 at 
  12 months in 
 
 both 
 
 the intervention and control groups
 
 . Process 
and outcome data will be collected via the following sources: Patient Surveys: Baseline and 12-
month surveys will be conducted by trained research staff. The administrative assistant and 
project manager will review all questionnaires and other data collection records, correct errors, 
and enter them into a password-protected database within 10 days of collection. Semi-
structured Interviews: These will be conducted with purposive samples of Veterans upon exit 
from the program and at one year. Primary care staff will be interviewed after completing the 
intervention phase. Time Logs: Logs will be used to track time spent by the peer health coaches 
in intervention, attempting to reach patients, and key information about the content of those 
interactions. Administrative and Clinical Data Systems: These will be used to track patients’ use 
of other VA inpatient and outpatient services.
 
Primary and secondary outcomes 
The primary outcome measures will be systolic blood pressure. At the baseline visit and the final 
12 month exit call, the study staff will ask the participant to measure blood pressure three times. 
At the time of scheduling, study staff will ask if the participant has a blood pressure monitor and/
or scale in their possession.  If the participant does not have a monitor or scale, staff will mail 
them one from the VA office. The mean value for these readings will be used for the baseline 
and exit measurements, respectively. 
Secondary outcomes will include Framingham Risk Score (FRS), individual CVD risks (BMI, 
LDL-c, tobacco use), health care utilization and health-related quality of life. A 10-year risk of 
total CVD (including myocardial infarction, angina, coronary revascularization, stroke, 
congestive heart failure and peripheral arterial disease) will be determined according to FRS 
algorithms,17 which include age, total and high-density lipoprotein-cholesterol, systolic blood 
pressure, treatment for hypertension, diabetes, and cigarette smoking. Individual components of 
this risk score are targets of the intervention (hypertension, hyperlipidemia, and smoking). The 
FRS algorithm has good predictive validity for CHD events (c statistics 0.74 and 0.77 for men 
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and women, respectively).69 Health care utilization will include outpatient visits, emergency 
department visits, and hospitalizations. Health care utilization will be obtained from VA 
administrative data and by participant self-report to capture non-VA health care utilization. 
Health-related quality of life will be measured by the Medical Outcomes Study 12-item measure, 
the SF-12.70 Two composite scales will be used to measure physical health (the physical 
component summary) and mental health (mental health component summary).70 
Intermediate endpoints 
a)
Patient activation, self-efficacy and social support
An important intermediate endpoint is Veteran self-efficacy and patient activation. We 
hypothesize that exposure to Vet-COACH will improve chronic disease outcomes and lead to 
greater patient activation. We will use the Patient Activation Measure (PAM), a brief previously 
validated 13-item scale that assesses patient’s self-rated ability to take preventive actions, 
manage symptoms of medical problems, find and use appropriate medical care, and work with 
their health care providers to make decisions about their care.71 The PAM includes important 
constructs including self-efficacy and is not disease-specific. We will use the multi-dimensional 
scale of perceived social support to assess overall social support.72,73 In addition, we will utilize 
a measure of community support for healthy lifestyles (the Chronic Illness Resources Survey—
Brief Form).74
b)
Self-management behaviors and patient-provider communication
Self-management behaviors will be measured with the following scales: The nutritional 
assessment of eating behavior will be a self-reported assessment “Starting the conversation”, 
an eight-item validated, simplified food instrument designed for use in primary care and health-
promotion settings.60 We will utilize a food frequency questionnaire (FFQ) developed by the 
Nutrition Assessment Shared Resource of the Fred Hutchinson Cancer Research Center to 
measure nutritional intake. The FFQ provides estimates for 30 nutrients and has acceptable 
accuracy and reliability.61 Intake of fruits and vegetables, fat, and fiber can be calculated based 
on published algorithms.75 Level of physical activity will be assessed using the International 
Physical Activity Questionnaire (IPAQ), a validated and reliable measure of physical activity.59 
All participants will have an assessment of medication adherence using a standardized 
participant interview.62 In addition, yearly medication adherence will be calculated from the 
electronic pharmacy data (ReComp).63 Tobacco use will be assessed with standard questions 
from the Behavioral Risk Factor Surveillance Survey (BRFSS).76 We will assess alcohol 
consumption using the Alcohol Use Disorders Identification Test (AUDIT-C), a 3-item screening 
test for heavy drinking and/or abuse.64 We will ask about utilization of stress management 
techniques65 and patient-provider communication using previously validated questionnaires 
(CAHPS ).66,77 
Table 4.  Outcome Measures; measured at baseline and 12 months
Measurement domain
Measurement instrument
Primary outcome
Blood pressure
Systolic blood pressure (SBP)
Standard protocols78
Secondary outcomes
Cardiovascular risk
Framingham risk score (FRS)
FRS algorithms17
Individual Cardio-
metabolic risks
Body Mass Index (BMI)
Low density lipoprotein cholesterol 
(LDL-c)
Standard protocols for height and 
weight
Laboratory data from CPRS if within 3 
months of enrollment, otherwise drawn 
by study RN at enrollment
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Health Care 
Utilization 
Outpatient and ER visits, 
hospitalizations, pharmacy 
utilization
Administrative data and participant self-
report for non-VA care
Health-related 
quality of life
Role limitations caused by physical 
health, emotional problems, 
physical functioning, and general 
health
SF-1270
Intermediate outcomes
Patient activation, 
Self-efficacy  
Self-rated ability to take preventive 
actions, manage symptoms of 
medical problems, find and use 
appropriate medical care, and work 
with their health care providers
Patient Activation Measure (PAM)71 
Social Support
Domains of Social support
Multidimensional Scale of Perceived 
Social Support72
Self-management
Behaviors – 
Measure of 
behavioral 
enactment
Physical activity
Nutrition – eating behavior, food 
frequency
Medication adherence 
Tobacco use
Alcohol use
Stress Management
IPAQ59
“Starting the conversation”60,FFQ61
Voils, C. I. et al. Medication adherence 
questionnaire62 ReCOMP63 Medication 
Possession Ratio
BRFSS76 
AUDIT-C64
Utilization of stress management 
techniques65
Patient provider 
communication
Communication with physician and 
health care team
Consumer Assessment of Health Plans 
(CAHPS)-patient-provider 
communication66 
Specific Aim 3: Determine intervention costs
These costs will include all labor and materials (pamphlets, home BP monitors, etc.) used in the 
intervention. We will administer weekly time sheets for all study personnel to estimate the 
amount of time they spend in various activities, and attribute the cost of these activities to either 
intervention costs or trial-specific costs, which are excluded from the intervention cost. 
Covariate data 
We will collect data on potential covariates that have been shown in previous studies to be 
associated with self-care and quality of life. We will use these covariates in our analysis to 
describe the patient population and to adjust for any differences across randomized groups. 
Demographic covariates include age, gender, household income, marital status, education, 
primary language and race/ethnicity (American Indian or Alaskan Native, Asian, Pacific Islander, 
black, white and their ethnicity as Hispanic or non-Hispanic). We will assess health literacy 
using a brief validated 3 - item screener.79 Depressive symptoms will be assessed using the 
PHQ-8.80
Measuring Intervention fidelity
Fidelity will be assessed to a) identify areas of needed improvement for ongoing remediation for 
the peer coaches through review of audio recordings (Section C.4.2); b) provide qualitative 
description of fidelity and needed changes to peer coaches at least quarterly (Section C.4.2); 
and c) include in the quantitative models to determine relationship between fidelity and 
outcomes (Section C.7.3). We will develop a manual for implementation of the intervention, very 
similar to our manual for our diabetes self-management trial (Appendix 3 of attached IIR). This 
manual consists of required and optional educational modules and educational materials that 
will be provided to the participant for each topic. To assess if participants received the 
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scheduled phone calls, the total number of phone calls will be recorded for each participant. 
Prior to study initiation and on a quarterly basis, peer support counselors must demonstrate 
competence in delivering content with fidelity (≥ 80% of components). We will require the peer 
health coaches to complete an encounter form for each intervention visit; which will consist of a 
checklist of required modules and if they were delivered. We have developed encounter forms 
for our current CHW study that will be adapted for the current study. The study coordinators will 
abstract participant records to assess whether each client received the interventions specified 
by protocols. Study staff (RA,  study coordinators, or Co-I) will also directly review audio 
recordings of one call per quarter to assess intervention fidelity. Fidelity will be measured using 
an observation form, and feedback will be given to each Vet-Coach.  Monthly control reports will 
ensure that each participant received the required components of the intervention.
Specific Aim 4: patient and provider interviews 
We will use theoretical purposive sampling to identify three groups of Veterans for semi-
structured interviews: 1) individuals who demonstrate significant improvement in hypertension 
control, 2) individuals without significant improvement and 3) individuals who discontinued the 
intervention after 1 or 2 sessions. Veterans within all groups will be interviewed upon exit (< 3 
weeks of last attendance) and Veterans in groups 1 and 2 will also be interviewed one year post 
program completion. We anticipate that interviewing 15 to 20 Veterans in each group (n = 45-
60). Groups will be purposively sampled to include both male and female Veterans. Sample 
interview guides are provided in Appendix 4 of attached IIR (Follow-up interviews questions will 
follow the same format and be developed from the initial interview findings). These participants 
will be contacted regarding willingness to participate in a 30-45 minute telephone based 
interview that will be audio recorded. The first 10–15 minutes will be open ended and elicit 
overall description of the participants’ satisfaction with the intervention and experience with the 
program. Follow up questions and prompts will focus on specific aspects of the intervention and 
barriers and facilitators. Interviews will be conducted in the clinic either before or after scheduled 
medical visits or over the telephone, based on participant preference. 
We will also interview a subset of PACT team members (including Vet-Coaches, PCPs, RN 
case managers, LPNs, and pharmacists) whose patients’ were enrolled in the program. 
Because we want to determine potential barriers and facilitators to implementation from the 
provider and PACT team perspective, the interviews will focus on staff perceptions of how the 
intervention helped, how it could be improved, potential barriers they can identify in 
implementation, and what changes in implementation strategy could potentially improve uptake. 
Vet-Coaches and PACT team members will be asked to participate in voluntary qualitative 
interviews at the end of the study.  They will be provided with an Information Statement detailing 
their subject rights and study activities they will be asked to participate in. Standard audio 
equipment will be used to record telephone-based interviews. At their exit interview, we will 
assess satisfaction with the program and offer opportunities to provide feedback. Although the 
exact number of subjects needed to generate meaningful qualitative results cannot be identified 
a priori, the main goals relate to developing deep case-oriented perspectives, selecting subjects 
with a range of characteristics and perspectives, and achieving saturation (meaning the point at 
which subsequent interviews fail to produce new findings) for overriding content themes. Even 
though the precise number of cases required to achieve thematic saturation cannot be 
predetermined, the clarity of the topic being studied, multiple interviews with participants over 
time, the use of focused research questions and researcher experience decrease the sample 
needed for meaningful findings. We anticipate interviewing 18 - 24 providers and PACT team 
members will be sufficient for meaningful findings. We will use purposive sampling to include up 
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to eight Vet-Coaches, 5 -7 PCPs, RN case managers, and LPNs, 3 staff Pharmacists, and 2 
outpatient nutritionists.     
Barriers and facilitators to implementation 
We will collect information on the barriers and facilitators of implementation. We include features 
in the study implementation to promote external validity such as inclusive enrollment criteria and 
using the minimum intervention needed for change (e.g. implementing with the minimum 
intensity we believe necessary for effectiveness). We will ascertain the degree of participation 
by eligible Veterans. We will use the following measures: (1) ability to contact potential 
participants (# reached/ # contact attempts); (2) study enrollment rate (#enrolled in study/ 
#eligible reached); (3) study participation rate (# with at least one follow-up home visit or 
participation in one project group activity/ # eligible reached); (4) program dropout rate (# 
discharged from program/ # participating in program); (5) study completion rate (# completing 
exit data collection/ # enrolled in study). The project manager will track feasibility by logging 
program costs, FTE used, space used, and logistical barriers encountered. Program staff will 
complete time study logs weekly during the first six months of the project and then for one week 
every quarter. The program manager will collect data on adaptability by logging changes in the 
research model protocols as the program is implemented. We will assess components that 
worked well or did not through participant satisfaction questions at the exit interview, and semi-
annual discussions among project staff and investigators.
5.6 Data Analysis

Provide sample size determination and analysis (include anticipated rate 
of screen failures, study discontinuations, lost to follow-up etc.).

Describe how, where and by whom the data will be analyzed.
Specific Aim 1
The primary outcomes are changes from baseline to one year in systolic blood pressure. We will 
test the primary hypothesis that among Veterans with poorly controlled hypertension and at 
least one other CVD risk, the Vet-COACH intervention targeting behavior change and disease 
self-management will decrease SBP by 4 mmHg compared to a usual care + education control 
group. 
Baseline Analysis and descriptive statistics  
Equivalence of participants in the intervention and control arms will be assessed on 
demographic and clinical variables, including outcomes, health status, co-morbidity, and 
utilization variables. Because this is a randomized controlled trial, no systematic bias is 
anticipated. However, we will conduct adjusted analyses and use as covariates those factors 
that are thought a priori to be related to the primary and secondary outcomes. We will report 
summary statistics for all baseline covariates and outcomes (means, standard deviations, and 
quartiles for continuous variables; frequencies and percentages for binary variables) by 
randomized group. 
Primary Effectiveness Analyses for Specific Aims 1 & 2
Since there are multiple patients enrolled per physician and multiple patients enrolled per peer 
health coach, a physician-level and peer health coach random effect will be included in the 
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primary analytic model to take this correlation into account. For the Aim 1 primary outcome 
analysis, we will evaluate change in systolic blood pressure, from baseline to 12 months, in the 
intervention versus controls using the following random effects model:
 is the change in blood pressure from baseline to 12 months for subject i having 
provider j (and k for peer coach intervention participants);  is the overall mean; 
 is group 
 are baseline 
 is the random effect for 
 is multiplied 
by the intervention indicator 
 so that the added peer coach correlation is accounted for 
only amongst intervention participants, as suggest by Roberts et al81). Our main goal is to test 
whether 
 which is the difference in BP change (from baseline to 12 months) between the 
intervention and control groups. All Aim 1 secondary outcomes and Aim 2 intermediate 
outcomes will be compared between intervention and control participants using the same model 
above for continuous outcomes and using a logit link for the same model for binary outcomes. 
We will include a sensitivity analysis that will explore whether intervention fidelity influences the 
effect of the intervention on primary outcomes, treatment receipt (“dose” of intervention: number 
of visits, phone calls, proportion of required modules delivered). 
Specific Aim 3
We will calculate intervention costs per patient. These costs will include all labor and materials 
(pamphlets, home BP monitors, etc.) used in the intervention divided by the number of 
participants.
Specific Aim 4 - Qualitative analysis  
Transcripts will be analyzed using simultaneous deductive and inductive content analysis. 
Inductive content analysis consists of open/unstructured coding and allows for the identification 
of emergent previously unidentified or unexpected themes while deductive content analysis is 
more structured and consists of identifying meaning units that fit within pre-identified a-priori 
categories.82 A-priori codes for patient interviews will include, but not be limited to: patient 
satisfaction, barriers and facilitators to participation, and acceptability.  A-priori codes for staff 
interviews will include, but not be limited to: barriers and facilitators to implementation, and 
sustainability acceptability, and changes in PACT team involvement in care. Coding will be done 
while simultaneously listening to the audio file and reading the transcripts. Sub-codes will be 
developed by identifying broad themes followed by sub-coding schemes based on 
representative recordings. Quotes that do not accurately fit existing sub-codes will be used to 
develop new sub-codes iteratively. Qualitative data collection and analysis will be blind 
regarding participants’ responder/non-responder status until the final merging stage of analysis. 
The results of the analysis process will be reviewed by members of the research team to assess 
their thoroughness and comprehensiveness for analytical rigor. Accountability will be supported 
by confirming results with respondents in subsequent interviews.
Missing data analyses
All appropriate efforts will be made to avoid missing data. Accruing data will be monitored for 
the presence of missing values, and the study coordinator will investigate causes and/or 
remedies for missing data. For key analysis variables that have 15% or more missing values, 
we will analyze patient and clinical factors that are associated with having a missing value. We 
will then perform analyses using multiple imputations to impute these key variables to allow 
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analysis for all subjects and reduce any bias associated with the missing data. We will perform a 
sensitivity analysis to determine if missing values have an effect on study outcomes.
Study power and sample size
We have powered our study to detect a clinically significant change in systolic blood pressure 
(SBP) of 5 mmHg) consistent with findings from other peer support and CHW studies.83,84 The 
sample size we project is n= 354 Veterans, which assumes 80% power, 15% attrition, alpha 
0.05, a PEER ICC 0.007, a provider ICC 0.015, provider cluster size of 5 (70 providers), PEER 
cluster size of 35 (5 PEER coaches).The SD of 14.2 mmHg was taken from a recently published 
review of CV risk factors among Veterans.85 We estimate we will lose 15% of the sample (n-53), 
which would result in a final sample size of N=400(or 200in each arm), similar to our rate in our 
ongoing CHW trial52 and previous CHW studies.86,87 Because of the potential for multiple 
patients enrolled per physician, we have adjusted both sample size calculations for potential 
clustering by physicians within the clinic, using estimates of ICC = 0.015 based on other 
published hypertension trials among primary care practices88,89 and clustering by Veteran peer 
health coach ICC = 0.007, based on a randomized trial of peer support among individuals with 
diabetes.90 We will randomize n=200 Veterans to the control and n=200 Veterans to the 
intervention group (which will ultimately be reduced to 177 Veterans in the control and 177 
Veterans in the intervention group after an estimated 15% loss of participants), to have a power 
of 80% to detect a difference of  5 mmHg in systolic blood pressure between groups. 
5.7 Withdrawal of Subjects

Describe any anticipated circumstances under which subjects will be 
withdrawn from the research without their consent. 

Describe the consequences of a subject's decision to withdraw from the 
research and the procedures for orderly termination of participation by the 
subject (e.g., the subject contacting the investigator for an end-of-study 
visit).
We do not anticipate any circumstances under which subjects will be withdrawn from 
the research without their consent.  In our previous peer support trials, this has not 
occurred.  The only circumstance where a participant would be withdrawn from the 
study would be in the event of threatening or unsafe behavior toward the study staff 
or peer health coaches.  If a participant decides to stop the study for any reason, the 
intervention visits would end and study personnel would attempt to schedule an exit 
visit.  
6.0
Reporting
`
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
Include procedures for reporting unanticipated problems, serious adverse events, 
and protocol deviations.
Study progress and safety will be reviewed monthly (and more frequently if needed). 
An annual report will be compiled and will include a list and summarization of 
adverse events.  In addition, the annual report will the study is justified on the basis 
that additional data are needed to accomplish the stated aims of the study; and (5) 
conditions whereby the study might be terminated prematurely. Safety information 
will be collected on the data collection forms at study visits, follow up phone calls and 
any additional contact with participants. PI will review all data collection (encounter) 
forms on an ongoing basis for data address (1) whether adverse event rates are 
consistent with pre-study assumptions; (2) reason for dropouts from the study; (3) 
whether all participants met entry criteria; (4) whether continuation of completeness 
and accuracy as well as protocol compliance. Encounter forms will be stored and 
transported in locked security bags immediately upon completion.  These bags will 
be used to transport the study data to the VA Puget Sound office location every two 
weeks at study staff meetings.  The encounter form will have a cover sheet 
containing the participant’s name, address & phone number (for identification 
purposes), which will be detached from the pages of the form containing data upon 
receipt by study coordinators at the VA Puget Sound location.  Encounter form pages 
containing study data will not contain any identifying information (such as name, 
phone number, etc.) Pages containing data have a study ID to link data. The cover 
sheet and study data will be stored separately in a locked cabinet.  Safety data 
collection starts with enrollment of subjects. This includes study visits, follow up 
phone calls and any additional contact with participants.
The frequency of data review for this study differs according to the type of data and 
can be summarized as follows: Subject accrual (adherence to protocol regarding 
demographics, inclusion/exclusion) will be reviewed quarterly by the PI. Adverse 
event rates (injuries) will be reviewed quarterly by the PI. Compliance to treatment 
will be reviewed by study investigator and statistician bi-monthly. 
7.0
Privacy and Confidentiality

Describe whether the study will use or disclose subjects’ Protected Health 
Information (PHI). 

Describe the steps that will be taken to secure the data (e.g., training, 
authorization of access, password protection, encryption, physical controls, 
Certificates of Confidentiality, and separation of identifiers and data)
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Several steps will be taken to minimize the risk of invasion of privacy.  Initial contact with 
prospective participants will be made via an introductory letter with a stamped post card 
allowing her/him to opt out of further contact by the study team thus limiting risk for 
invasion of privacy. A number of steps will be taken to ensure confidentiality and data 
protection throughout the rest of the study. All data gathered at the enrollment visit (the 
questionnaire, physical exam, health goals) and subsequent information will be 
confidential. Data will be kept in offices at VA Puget Sound HSR&D with locked filing 
cabinets and password protected computers. The investigators, project coordinator, and 
study staff will be the only staff to have access to confidential records. ID numbers rather 
than names will be used whenever possible. As part of the study, individuals will be 
reassured that information is to be kept confidential, no single individual will be identified 
by name and all data will be aggregated. All data files will be maintained on password 
protected PCs and password protected computer networks. Only aggregate data will be 
presented to external audiences. Individual identifiers will be deleted when they are no 
longer necessary for the project. 
8.0
Communication Plan

Include a plan for obtaining required coordinating site approval (if we are a 
participating site of a multi-site study).

Include plan for keeping all engaged sites informed of changes to the protocol, 
informed consent, and HIPAA authorization, if we are the coordinating center. If 
we are a participating site, include a plan for how this information will be shared 
with you by the coordinating center.

Include plan for informing local sites of any Serious Adverse Events, 
Unanticipated Problems, or interim results that may impact conduct of the study if 
we are the coordinating center.  If we are a participating site, include a plan for 
how this information will be shared with you by the coordinating center.
N/A – We have 1 primary site.
9.0
Information Security and Privacy
The principal investigator will review critical incidents (participant death and 
hospitalization). For each such event, Dr. Nelson will evaluate the potential for 
causal relations between the incident and study or intervention procedures. Any 
adverse effects of the study will be reported to the participant and his/her health 
care provider. Major adverse events requiring hospitalization will be reported to 
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the study project manager and the IRB. Dr. Nelson will be available to meet with 
the participant and provider to discuss any concerns. The participants will bear 
no financial risk from any adverse effects of encounters from this study. Including 
only numeric identifiers on all data collection instruments will protect 
confidentiality of collected information. Code keys and data collection documents 
(when not in use) will be kept in a locked file or password-protected terminals.
Several steps will be taken to minimize the risk of invasion of privacy.  Initial 
contact with prospective participants will be made via an introductory letter with a 
stamped post card allowing her/him to opt out of further contact by the study 
team thus limiting risk for invasion of privacy. A number of steps will be taken to 
ensure confidentiality and data protection throughout the rest of the study. All 
data gathered at the enrollment visit (the questionnaire, physical exam, health 
goals) and subsequent information will be confidential. Data will be kept in offices 
at VA Puget Sound HSR&D with locked filing cabinets and password protected 
computers. The investigators, project coordinator, and study staff will be the only 
staff to have access to confidential records. ID numbers rather than names will 
be used whenever possible. As part of the study, individuals will be reassured 
that information is to be kept confidential, no single individual will be identified by 
name and all data will be aggregated. All data files will be maintained on 
password protected PCs and password protected computer networks. Only 
aggregate data will be presented to external audiences. Individual identifiers will 
be deleted when they are no longer necessary for the project.
10.0 References
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