Collaboration to Improve Blood Pressure in the US Black Belt-addressing the Triple Threat
Phase: NA
Conditions: Hypertension
Sponsor: University of Alabama at Birmingham

1 
 
 
 
 
 
 
A collaborative project between: 
  
University of Alabama at Birmingham;  
Weill Cornell Medical College of Cornell University;  
University of Carolina at Chapel Hill;  
East Carolina University;  
North Carolina Area Health Education Centers;  
Alabama Area Health Education Centers;  
Health and Wellness Education Center of Livingston, AL;  
West Central Alabama Community Health Improvement League of Camden, 
AL; 
ConnectionHealth, Birmingham, AL; 
Open Water Coaching and Consulting, Cape Carteret, NC;  
and 80 primary care practices,  
peer coaches,  
and practice facilitators living in the Black Belt region 
 
Funded by NHLBI  
UH3 HL130691-05 
 
Study Protocol 
 
Version November 1, 2021 
NCT02866669    
Unique Protocol ID: X160722009 
 
 
 

2 
 
 
1. Background and Significance  
 
The background and significance section responds to PCORI Methodology Standard 1:RQ-1 “Gap 
analysis to support the need for the proposed study”.1 
 
 
1.1 African Americans, Hypertension, and the Region known as the ‘Black Belt’.  
 
 
African Americans have among the highest prevalence of 
hypertension (HTN) in the world.2 Figure 1 shows the areas of 
the US where HTN affects >60% of the US population, based 
on the 30,239-member REasons for Geographic And Racial 
Differences in Stroke (REGARDS) study which recruited 
African American and white subjects from the contiguous 48 
US states.3 As can be seen, the regions with the highest 
prevalence are in the Southeast, overlapping greatly with the 
Black Belt (Figure 2). The Black Belt is an agricultural rural 
region known for its steep poverty and largely African American 
population, and was described by Booker T. Washington as “a 
part of the country which was distinguished by the colour of the soil. The part of the country possessing this 
thick, dark, and naturally rich soil was, of course, the part of the South where the slaves were most profitable, 
and consequently they were taken there in the largest numbers. Later and especially since the (Civil) war, the 
term seems to be used wholly in a political sense—that is, to designate the counties where the black people 
outnumber the white.”4 The Black Belt is therefore a region that has all three of the priority populations 
identified by the request for applications for this grant opportunity: rural, low-income, and minority, a ‘triple 
threat’ to health and longevity. 
 
1.1.a Consequences of HTN in African Americans.  
 
 
After a meteoric rise throughout the mid-20th century, cardiovascular 
disease (CVD) mortality plateaued and has had a steady decline since 
the 1970’s.2 However, not all race and sex groups have experienced the 
same pace of improvement; racial disparities in CVD persist in the 21st 
century,5,6 with one of the most stubborn disparities related to HTN 
control.7,8 Although African Americans are now consistently more likely 
to be aware of their HTN and also more likely to be treated, they 
continue to achieve suboptimal control.8 In the 2003-2010 National 
Health and Nutrition Examination Survey (NHANES), 57.0% of African 
American participants with HTN were uncontrolled.9 HTN-related 
outcomes that are more prevalent in African Americans than white Americans include stroke, end-stage renal 
disease, heart failure, death at presentation with coronary heart disease (CHD), as well as premature 
mortality.2,5 Residents of the Black Belt have about the same life expectancy as Sri Lankans, and some 
counties have lower life expectancy than Malaysia, Ecuador or the Gaza Strip.10 African Americans continue to 
be at least 50% more likely to die of heart disease or stroke prematurely (i.e., <75 years of age) than White 
Americans.11  
 
In accordance with Patient-Centered Outreach Research Institute (PCORI) Methodology Standard 1:RQ-
3, which focuses on identifying “specific populations and health decision(s) affected by the research to produce 
information that is meaningful and useful to people when making specific health decisions, research proposals, 
and protocols,”1 this study will target African American participants. 
 
 
 
Figure 1. Areas of the US where HTN affects 
>60% of black and white adults age >45. Used by 
permission, Matthew Loop dissertation. 
Figure 2. The US Black Belt. 
 AL and 
NC         
Bl
k
HTN  
Prevalence 
-72% 
-63 

3 
 
1.1.b Healthcare in the Black Belt.  
 
Today, the Black Belt includes some of the most disadvantaged counties in the Nation, with poverty 
commonly affecting a third or more of the residents, and with less availability of healthcare services than in 
more populated areas. Availability of primary care is lower than national averages, with the Kaiser Family 
Foundation estimating 3-8 primary care physicians/10,000 population in the Black Belt, compared with 25 
nationally.12 Area residents face significant additional challenges in curbing their risks for poor health 
outcomes. Poverty and low educational attainment have been reported to be associated with lack of risk factor 
control, both very common in the Black Belt. The 2009-2013 US Census data indicate that of the 30-40% of 
Black Belt residents living below the poverty line, only 1-3% had a bachelor’s degree or higher, compared with 
11-12% of individuals living in poverty nationally.13 Distances are great, with many people traveling an hour or 
more to see the doctor, resulting in fewer visits and less monitoring of risk factors such as blood pressure (BP). 
In the NHANES 2003-10, visit frequency was strongly correlated with BP control (47.8% uncontrolled for those 
seen >2 times in the past year, 68.0% uncontrolled for those seen once, and 93.3% uncontrolled for those 
never seen). HTN control in Federally Qualified Health Centers (FQHC) in AL and NC Black Belt counties is 
shown in Table 1. As can be seen, FQHCs in both the AL and NC Black Belt served greater proportions of 
African Americans than their statewide counterparts, and they also achieved lower HTN control compared with 
others in their respective states, as well as nationally. Similar data are not available for private practices, but 
national data suggest that their risk factor control rates tend to fall below those of FQHCs.9 Of note is the larger 
number of FQHC’s in NC relative to AL, demonstrating variability in models of care available for Black Belt 
residents in the two states. 
 
Table 1. Characteristics of patients in Black Belt Federally Qualified Health Centers in NC and AL. 
  
Total Patients 
% Black 
<100% Poverty 
Hypertension 
BP Control* 
Alabama Grantees 
330,401 
48.1% 
70.7% 
29.4% 
56.6% 
Franklin Primary Health Center, Inc. 
34,363 
69.0% 
80.6% 
36.9% 
55.7% 
Health Services, Inc. 
37,589 
83.8% 
85.9% 
30.6% 
51.4% 
Rural Health Medical Program, Inc. 
5,837 
93.9% 
77.1% 
44.3% 
48.9% 
S.E. Alabama Rural Health Associates 
71,617 
30.7% 
34.2% 
34.5% 
53.3% 
Tri-County Medical Center 
8,334 
43.9% 
75.3% 
32.5% 
28.1% 
Whatley Health Services, Inc. 
23,672 
62.4% 
85.2% 
41.3% 
52.9% 
Alabama Black Belt 
181,412 
64.0% 
73.1% 
36.7% 
48.4% 
  
  
  
  
  
  
NC grantees 
454,675 
39.2% 
74.1% 
36.2% 
60.8% 
Anson Regional Medical Services 
4,001 
56.9% 
44.3% 
47.1% 
47.5% 
Carolina Family Health Centers, Inc. 
14,490 
43.1% 
76.1% 
53.5% 
48.6% 
First Choice Community Health Centers 
11,085 
36.7% 
79.3% 
22.1% 
56.1% 
Goshen Medical Center, Inc. 
38,760 
37.8% 
51.1% 
37.6% 
57.9% 
Kinston Community Health Center, Inc. 
9,227 
62.3% 
75.1% 
26.6% 
47.0% 
Opportunities Industrialization Center, Inc. 
16,785 
48.2% 
80.3% 
61.3% 
87.4% 
Robeson Health Care Corporation 
12,637 
29.7% 
72.3% 
35.3% 
49.4% 
Rural Health Group, Inc. 
28,368 
62.0% 
66.1% 
58.5% 
63.6% 
Stedman-Wade Health Services, Inc. 
4,111 
40.3% 
41.4% 
55.2% 
74.1% 
Tri County Community Health Council, Inc. 
20,857 
26.0% 
74.3% 
19.8% 
56.7% 
NC Black Belt 
160,321 
44.3% 
66.0% 
41.7% 
58.8% 
 
 
 
 
 
 
National Grantees 
21,726,965 
23.8% 
71.9% 
23.6% 
63.6% 
*Among patients with hypertension, the percentage with last blood pressure <140/90 mm Hg. Data from HRSA Primary Care: The 
Health Center Program (http://bphc.hrsa.gov/healthcenterdatastatistics/reporting/index.html). 
  
 
1.2 Literature Review and Scientific Justification for the Study 
 
This proposal advances the science through innovation in the following ways: 
 
1. Black Belt populations have great needs in terms of healthcare innovations, but they are rarely studied. 
 
2. To our knowledge, practice facilitation and peer coaching to improve (HTN), the two interventions to be 
tested here, have not been compared, especially not in rural underserved communities. 

4 
 
 
3. The study is designed from the beginning for scale-up throughout the Black Belt region, from Texas to 
Maryland. We accomplish this by situating the practice facilitators and peer coaches who will deliver the 
interventions in community-based organizations in AL, with plans to explore a similar community-based 
home in NC. The active involvement on our Community Advisory Boards (CABs) of health insurers and 
the State Departments of Health further strengthen the goal of designing a roadmap for other Black Belt 
communities, should our interventions prove effective and warrant wider scaling. 
 
4. This study is designed as a pragmatic trial, with additional detail provided in section 3.2.  
 
5. We advance methods of community-engaged research for CVD risk reduction, by engaging 
stakeholders at every stage of the research process. As discussed in section 3.1, we engaged patients, 
peer coaches, office staff, and practitioners in designing the proposal, and stakeholder will continue to 
be engaged throughout the project by using focus and discussion groups, CABs, and semi-structured 
interviews, following a collaborative, stakeholder engaged intervention development and dissemination 
approach. This study represents the culmination of 6 years of community-engaged research, with each 
subsequent study responding to community expressed needs. The study team’s first project in the AL 
Black Belt responded to community requests for diabetes programs;14,15 the second project responded 
to peer coach requests for programs to help individuals with diabetes and chronic pain to be able to 
exercise;16 and the third program responded to community member misconceptions about medications 
used for CVD risk reduction, preventing informed medication taking decisions.17 This proposed study 
also responds to a growing interest in rural primary care practices for help with practice transformation 
and the meaningful use of their electronic health records (EHRs). 
 
6. The conceptual framework guiding this study is highly innovative, proposing that different types of 
interventions may operate better for clinical situations with high vs. low uncertainty. We will test the 
concept that structural or procedural interventions, like practice facilitation, may be best suited to 
improve low uncertainty situations (e.g., algorithms for BP management), and that relationship-based 
interventions like peer coaching may be best suited to improve high uncertainty situations (e.g., 
medication or lifestyle adherence). As such, this study will encourage a paradigm shift for selecting 
types of interventions based on the level of clinical uncertainty.  
 
7. In response to our prior work with practitioners in the Black Belt, we use functional interventions ideally 
suited to stepping up care, since both practices and patients in rural areas have varied needs. Each of 
the interventions will operationalize key functions, encouraging customization at both the practice and 
individual levels, thereby maximizing the potential for widespread adoption. While not an 'adaptive trial 
design', which requires a prospectively planned opportunity for modifying the design of the study based 
on interim data analysis, the functional nature of the interventions permits stepping up where most 
appropriate. For example, in a practice that already knows how to construct registries, the approach to 
creating a HTN registry may require less intensive effort than in a practice still using paper records. 
 
8. We have designed the study as an implementation trial using the Reach Effectiveness Adoption 
Implementation Maintenance (RE-AIM) implementation framework and collecting substantial process 
data designed to enhance eventual scale-up in a wide variety of practice settings commonly 
encountered in the Black Belt and other rural areas.  
 
9. The Affordable Care Act provides a sustainability framework, strengthened by the January 2015 
Centers for Medicare and Medicaid Services (CMS) announcement for its plans to move rapidly to 85% 
value-based reimbursements within 2 years. This transition will greatly enhance efforts to introduce 
alternative models of care that are not volume-based, which has been challenging many Black Belt 
communities, which have been dominated by fee-for-service medicine until now. 
 
PCORI Methodology Standard 1:RQ-5 standard provides guidance on selecting appropriate interventions 
and comparators for researchers. The standard states: “When evaluating an intervention, the comparator 

5 
 
treatment(s) must be chosen to enable accurate evaluation of effectiveness or safety compared to other viable 
options for similar patients. Researchers should make explicit what the comparators are and how they were 
selected, focusing on clearly describing how the chosen comparator(s) define the causal question, reduce the 
potential for biases, and allow direct comparisons. Generally, non-use (or no specific treatment) comparator 
groups should be avoided unless no specific treatment is a likely option in standard care.”1 Thus, we have 
elected to utilize practice facilitation and peer coaching as the two interventions to be tested in comparison with 
enhanced usual care. These interventions are discussed next.  
 
1.2.a Practice Facilitation  
 
Practice facilitation is an increasingly widely used strategy to help practices transition from episode-based, 
reactive care to prevention of health outcomes and population health management, an approach that has been 
proposed as the model for primary care service delivery in the 21st century.18-21 Key features of practice 
transformation include shifting the focus from single patients to populations, and from physician-centric to 
team-based clinical management; it emphasizes self-management support and maximizes the use of EHRs, 
including the creation of registries, audit and feedback programs, and outreach.22 The National Committee on 
Quality Assurance (NCQA) offers formal recognition for practice transformation that now includes nearly 7000 
practices.18 The Centers for Medicare and Medicaid Services (CMS) announced on January 26, 2015 that they 
aim to have 85% of all Medicare fee-for-service payments tied to quality or value by the end of 2016, with 30% 
of these payments through alternative payment models, such as “advanced” patient centered medical homes.23 
In short, practice transformation has wide support nationally. 
 
Practice facilitation is a highly engaged, flexible consultative service designed to facilitate practice 
transformation. Practice facilitation certification programs have sprung up, providing a cadre of facilitators to 
assist primary care practices make the required structural and 
process changes. Practice facilitation involves a trained, 
certified individual visiting the practice regularly over several 
months to teach how to work in teams and fully utilize the 
potential of EHRs.  
 
According to Agency for Healthcare Research and Quality’s 
(AHRQ’s) Practice Facilitation Handbook, facilitators “support 
change in practices by focusing… attention on the process of 
change and by empowering members of the practice to engage 
in the change process together.”24 Dr. Lyndee Knox, lead 
author of the AHRQ Handbook, was a consultant on this project 
during the pre-award and UH2 planning phases. Facilitators 
establish trust with the practice team; help them to assess the 
practice, set goals, and build capacity to gather data to create 
performance metrics; and help the practice monitor its 
performance, map workflows, and implement plan-do-study-act 
cycles to improve the quality of care (see Table 2). Assumptions behind practice facilitation are that many 
practices are inadequately resourced and lack experience and skills to make transformative changes on their 
own. A key aspect of practice facilitation is the relationships facilitators develop with the practice staff, similar to 
the Cooperative Extension model, in which agents develop relationships with farming families to facilitate the 
implementation of evidence-based farming practices.25 By definition, practice facilitation interventions are 
highly tailored, stepping up activities if the practice is not accomplishing its goals as tracked through regular 
performance reports drawn from its own data. 
 
1.2.b The Effectiveness of Practice Facilitation and Practice Transformation  
 
While the enthusiasm for practice transformation is high, early evaluations of pilot studies are mixed. For 
example, a 2013 systematic review of 19 studies of practice transformation interventions demonstrated that 
practice facilitation increased NCQA recognition, but achieving recognition was associated with only a small 
Table 2. Facilitator functions and example 
activities within each function 
Functions 
Specific example activity 
Facilitate 
delivery system 
redesign/team 
management 
Group visits, nurse manages 
BP using algorithm, 
“huddles” (quick team 
meetings for communication) 
Integrate self- 
management 
support 
Logbook to track BP, HBPM, 
education binders in exam 
rooms, education videos, 
linkages to community 
nutrition counseling 
Improve access 
Telephone management 
Facilitate 
outreach 
Use EHR to create BP 
registry and population level 
reports; reach out to patients 
with missed appointments 
BP = blood pressure. EHR = electronic health 
record. HBPM = home BP monitoring. 

6 
 
positive effect on patient experiences, preventive services delivery, and staff experiences, with reduced 
Emergency Department (ED) utilization but no effect on overall costs or clinical outcomes.26 A 2014 report on 
the Southeastern Pennsylvania Chronic Care Initiative, an early and large multi-payer patient centered medical 
home (PCMH) pilot, showed that while all of the participating 32 practices achieved NCQA PCMH recognition 
status and adopted new structural capabilities such as registries, only one of 11 quality measures improved 
significantly with no significant changes in utilization or costs of care.27 A 2013 report on a Rhode Island pilot 
demonstrated substantial increases in NCQA scores but no changes in quality metrics.28 A randomized 
controlled trial of 32 practices in NY that included 18 months of practice facilitation, revised payments, and 
embedded care management support improved BP control by 23 percentage points in intervention practices, 
but the final control BP rate was only 36%, and there were very modest additional improvements in only one 
other of the 11 quality metrics.29 An evaluation of a 9-year practice transformation in 17 FQHCs in lower NY 
State revealed that mean A1c declined from nearly 11% to below 9% among those diabetes patients with A1c 
>9% as the program was implemented, but mean A1c for those with A1c <9% actually rose slightly, and overall 
glycemic control remained at 8%, well above the goal of 7% recommended by the American Diabetes 
Association (ADA).30  
 
A report by Leykum, et al, may help to understand what may be underlying these findings of relatively 
modest effectiveness and possible floor effects.31 Their qualitative study was designed to generate new 
theories to explain why some of their group’s collective studies worked and others did not. They proposed that 
uncertainty may play a central role in the effectiveness of interventions. They concluded that structure or 
process based efforts, like practice facilitation with its quality improvement (QI) focus, may be most effective for 
situations where required clinical decision-making is relatively simple with low uncertainty (e.g., algorithms for 
BP control, HTN patient who has not been seen for a year should be recalled). On the other hand, relationship 
based interventions like peer coaching may be more effective for more complex clinical management situations 
with high uncertainty (e.g., medication adherence, healthy eating). Most practice facilitation evaluations to date 
have focused more on quality, costs and objectively assessed experience of care, and less on the quality of 
the relationships that are established in the PCMH. In fact, high quality, trusting relationships with healthcare 
providers/teams may be especially challenging for minorities living in low socioeconomic circumstances, 
especially in rural areas.32 
 
1.2.c Peer Coaches  
 
Peer coaches, also called peer advisors, community health workers, 
community health advisors, or promotoras, are people who live in the 
same community as the targeted population. They have an in-depth 
understanding of the day-to-day challenges of living with a chronic 
disease like HTN. They receive training in motivational interviewing, 
which they use to coach other community members with HTN on how to 
improve self-management within the context of their own lives, helping 
them to overcome challenges to achieving a healthy lifestyle and taking 
medications (Figure 3). First and foremost, they provide social and 
emotional support and encouragement, but they also assist patients by 
motivating them to understand which behaviors are increasing risks and 
to engage in risk management. They link their clients into community 
resources and back to the practice, encouraging the development of 
continuous relationships with a usual source of care. The key functions of 
peer coaching interventions are therefore assisting, supporting and linking 
into resources and care. By nature, peer coaching interventions are multi-level, since they reach into the 
community as well as the health system, and multi-component, stepping up as warranted by the individual’s 
needs.  
 
Figure 3. Peer coaches in the context of 
the Chronic Care model. 

7 
 
Interacting with a live peer coach is a potent experience because 
participants have discussions with someone like themselves, 
building a supportive relationship while the peer coach assists them 
in carrying out the healthcare team’s recommendations and in 
understanding educational materials. At the core of peer coaching 
interventions are the relationships patients forge with the peer coach. 
In our past programs, 96% of participants were either extremely or 
highly satisfied with working with their peer coach. Many of our peer coaches continue to speak regularly with 
their former clients, even years after the formal program has ended. A participant in one of our studies 
summarized his relationship with his peer coach this way: “She really cared about me. When we first started 
talking I didn’t really know what to think, but she really helped me. I started growing a garden because of her, 
and now it’s so plentiful I want to share the vegetables with her.” 
 
In preparation for the proposal that led to the current study, we engaged 40 Black Belt residents with 
chronic diseases in 5 focus groups to understand their perspectives on the challenges they face in curbing 
CVD risk. While participants had many questions about their health, many did not feel comfortable asking their 
doctor or nurse. It is important to note that Tuskegee, site of the infamous syphilis experiment, is located in the 
AL Black Belt, and this experience has left a deep mark in the African American community, creating additional 
barriers to trust.33 One participant said, “I just want to get out of there as quickly as possible. You ask too many 
questions they start looking, and then they start finding things.” Misunderstandings are common; e.g., a 
participant noted, “They always experimenting on you with those high blood pills, changing up the pills every 
time I go.” Consistently, participants expressed greater comfort with their peer coach than with members of 
their healthcare team.  
 
1.2.d Evidence of Effectiveness of Peer Coaching for HTN  
 
The evidence of the effectiveness of peer coaches to improve BP control spans over 3 decades. A 2007 
review of 14 studies included 8 randomized controlled trials (RCTs), many engaging urban African Americans; 
their analysis favored intervention effects ranging from 0-8 mm Hg systolic blood pressure (SBP), and 
improved control ranging from 0-15%.34 The Centers for Disease Control and Prevention (CDC) is a strong 
supporter of community health workers and has promulgated training materials and policy briefs on how to 
implement such programs.35 However, few studies of peer coaching have been conducted in rural settings, and 
even fewer in the Black Belt region. Many interventions included face-to-face meetings or group meetings, 
which is not feasible in the Black Belt due to the distances and cost of transportation. It is unknown whether an 
entirely telephone-delivered peer coaching intervention can achieve significant reductions in BP in the Black 
Belt region, a knowledge gap this study will fill. 
 
 
 
“I can talk to her about anything and she 
always be nice. I just love working with 
her, it makes me want to do right. She 
really understands how hard it can be.”  
--Comment from a participant about his peer 
coach. 

8 
 
 
2. Study Objectives 
 
The central objective of the “Collaboration to Improve Blood Pressure in the US Black Belt – 
Addressing the Triple Threat” is to rigorously compare two strategies designed to improve BP control in 
primary care practices serving rural Southeastern African Americans with low socioeconomic status 
(SES). 
 
The AHRQ Disparities Report identifies individuals with rural residence, minority ethnicity, and low 
SES as being at high risk for poor health outcomes. The “Black Belt” region stretches from eastern Texas 
in an arc to Maryland and includes residents with all 3 of these characteristics – the proverbial triple 
threat. This traditionally agricultural region is characterized by steep poverty, low educational attainment, 
scarce resources, and mostly African American residents. The Black Belt is in the heart of the Stroke Belt, 
a geographic area long recognized to have the highest CVD mortality in the US. The AHRQ Disparities 
Report also cites that the Southeast has lower quality of care than the rest of the US, thus effective 
strategies to optimize CVD prevention in general and HTN control specifically are urgently needed here. 
 
We draw on the growing evidence that practice facilitation can speed the transition to high quality, 
evidence-based care. Practice facilitation is a highly customized, staged approach to helping a practice to 
implement process and structural changes to enhance the quality of care and improve patient and staff 
satisfaction, e.g., by implementing protocols for algorithm-driven BP medication management, and creating 
registries and audit and feedback systems using their EHRs. Evidence that practice facilitation can help 
practices to change their structure is strong, but evidence on outcomes such as achieving BP control is 
limited. An alternate approach to improving CVD risk factors that is more relationship-focused and with 
growing evidence of effectiveness involves the use of peer coaches. We and others have shown that peer 
coaches can be particularly effective in Black Belt communities, where mistrust of the healthcare system is 
common. Further, CVD risk reduction through BP control requires challenging behavior modifications that can 
be difficult to achieve using office-based interventions. Our study responds directly to the need for Black Belt 
communities to know how much benefit their communities can expect to derive from structural and process 
interventions like practice facilitation, or from relationship-focused interventions like peer coaching, or from 
both. Using well-established community-based partnerships and the RE-AIM implementation framework, our 
Specific Aims are: 
 
 
2.1 Year 1 
 
Aim 1: Engage rural primary care practices, HTN patients, peer coaches, and Community Advisory Boards in 
AL and NC to collaboratively finalize a practice facilitation intervention, a peer coaching intervention, and a 
hybrid intervention integrating peer coaching and practice facilitation, all designed to improve BP in African 
Americans. 
 
Aim 2: Create the data systems for the trial. 
 
 
2.2 Years 2-5 
 
Aim 3: Enroll 80 practices and 25 African American patients with uncontrolled HTN at each practice (total 
n=2000) in a cluster-randomized, controlled, pragmatic implementation trial to evaluate the three multi- 
component, multi-level functional interventions finalized in the UH2 phase compared with enhanced usual care. 
Our primary hypotheses are that each of the three interventions will improve BP more than enhanced 
usual care. Our secondary hypothesis is that the hybrid intervention will result in greater 
improvements in BP control than the other interventions. While we aim to control BP in >75% of 
participating intervention patients overall, the trial is designed to detect >15% difference in BP control (defined 
as <140/90 mm Hg, the primary outcome) between all three interventions and the enhanced usual care arm. 

9 
 
Secondary outcomes will include group mean BP differences between baseline and follow-up; quality of life; 
patient satisfaction; healthcare utilization; and provider and staff satisfaction. The study is designed to examine 
differences by sex, age, depression, health literacy, and numeracy. 
 
Aim 4. Establish scalability of the intervention throughout the entire Black Belt region using extensive process 
data intended to facilitate future implementation across a wide variety of practices. To accomplish this goal, we 
will utilize practice characteristics, patient characteristics, intervention implementation variables and fidelity 
measures, as well as focus groups and interviews with key stakeholders, including patients, peer coaches, 
facilitators, practice staff, and clinicians. 
 
 
2.3 Hypotheses 
 
The main hypothesis that will be tested in this study is that there will be statistically significant differences 
among the study groups. Specifically:  
 
1) The practice-levels rates of achieving hypertension control at one year will be higher in the practice 
facilitation group compared to the enhanced usual care group.  
 
2) The practice-levels rates of achieving hypertension control at one year will be higher in the peer 
coaching group compared to the enhanced usual care group. 
 
3) The practice-levels rates of achieving hypertension control at one year will be higher in the integrated 
practice facilitation with peer coaching group compared to the enhanced usual care group.   
 
We will test several secondary hypotheses, including a test of whether the combined interventions are superior 
to either intervention individually, and a series of analyses examining changes at the individual patient level. 
Prespecified subgroup analyses will be conducted at the patient level, including examination of differences by 
sex, age (above and below age 60), literacy/numeracy, and depressive symptoms. See section 8 for details of 
the analytic plans.  
 
 

10 
 
 
3. Study Design 
 
 
3.1 Research Design and Methodology: Stakeholder Engagement 
 
PCORI Methodology Standard 2:PC-1 is: “Engage people representing the population of interest and 
other relevant stakeholders in ways that are appropriate and necessary in a given research context. People 
representing the population of interest include individuals who have the condition or who are at risk of the 
condition and, as relevant, their surrogates or caregivers. Other relevant stakeholders may include clinicians, 
administrators, policy makers, or others involved in healthcare decision-making. Stakeholders can be engaged 
in the processes of: 
• 
Formulating research questions; 
• 
Defining essential characteristics of study participants, comparators, and outcomes; 
• 
Identifying and selecting outcomes that the population of interest notices and cares about (e.g., 
survival, function, symptoms, health-related quality of life) and that inform decision making relevant 
to the research topic; 
• 
Monitoring study conduct and progress; and 
• 
Designing/suggesting plans for dissemination and implementation activities. 
When applicable, research proposals should describe how these stakeholders will be identified, recruited, and 
retained. If engagement is not necessary or appropriate in these processes, explain why.”1 This study is 
designed to align with this Methodology Standard, using a highly stakeholder engaged approach. 
 
3.1.a Stakeholder Engagement for Input into the Study Design and Procedures  
 
This community-partnered research project engages stakeholders at every phase of the research. We 
started by engaging stakeholders during the planning phase to select the study question and we continue to 
engage them throughout the course of the study. Our general approach involves 1) embedding members of the 
stakeholder group on the research team; 2) conducting qualitative research prior to the start of the project 
planning; 3) conducting additional qualitative research (focus groups, nominal groups, and interviews) during 
the study; and 4) regularly reaching out to CABs for advice.  
 
3.1.b Input from Hypertensive African American Residents of the Black Belt  
 
In our past studies, we have embedded members of the targeted patient population into the research team, 
which has resulted in invaluable advice and modifications of our preliminary plans. We will again include on the 
research team a research assistant (T. Davis) who grew up in Boligee, AL, a Black Belt town with fewer than 
400 residents. Ms. Davis provides ongoing input at research team meetings. In addition to integrating members 
of our target audience in the research team, we conduct qualitative research to obtain input from a broader 
range of stakeholders.17,36,37 As part of the planning process for the proposal, we conducted 5 focus groups 
with 40 Black Belt residents with HTN or diabetes requiring ongoing medication management in 2013 to 
understand the barriers they face in attempting to control cardiovascular risk factors including HTN. Top 
barriers included inability to keep doctor appointments, lack of exercise, limited income, lack of will power, and 
pain as a barrier to physical activity. These findings have led us to target telephone support as a component of 
the practice facilitation intervention, and motivational interviewing in the peer coaching intervention. 
 
During the year-long planning phase of the study, we engaged in ongoing discussions with area residents 
with HTN in both AL and NC to further inform the design of the study as well as the interventions. These 
discussions included community member perspectives on the challenges they face accessing medical care 
and advice, barriers to medication adherence, community-level barriers to healthier diet and physical activity, 
attitudes toward working with a peer coach potentially from their same community (including potential 
concerns), attitudes toward home BP monitoring, as well as specific input on study design questions (e.g., 
preferences for recruitment and informed consenting, preferences for retention activities, input on selection of 
outcome measures). We recruited patients of area practices and individuals with HTN in the social networks of 

11 
 
our current cadre of over 60 trained peer coaches. We conduct in-person groups in community settings, either 
at the practice or in a community location. A trained moderator led the discussions, in many cases community 
coordinators based at the partnering community non-profit organizations (Health and Wellness Education 
Center of Livingston, AL, and the West Central Alabama Community Health Improvement League). 
 
 
 
3.1.c Input from Peer Coaches  
 
Our two community coordinators Ms. Clark and Ms. E. Johnson are both Black Belt residents and 
experienced peer coaches. They provide ongoing input on the peer coaching perspective, as well as 
supervising the AL peer coaches during the study.  
 
In preparing the proposal, we conducted 4 focus groups with 24 peer coaches and office staff to learn their 
perspectives on barriers to curbing CVD risk in the Black Belt. Lack of education was cited as the major barrier, 
followed by transportation and limited economic means. These results led us to incorporate the Patient 
Activated Learning System (PALS) as enhanced usual care and as a resource for the peer coaches in the 
intervention (see section 6.3.a). We will continue to engage peer coaches throughout the study period through 
biweekly conference calls to help with intervention development; participant, peer coach, and practice 
recruitment plans; and data collection plans, among other topics. These meetings occur weekly by 
teleconference and monthly when the study team travels to the Black Belt. 
 
3.1.d Input from Primary Care Providers Practicing in the Black Belt  
 
Our team includes practicing physician investigators, and Dr. Harrington leads the AL Practice Based 
Research Network (PBRN), assuring the physician perspective is represented on the research team. In 
addition, in preparation for this proposal, we engaged 12 primary care providers in 2 focus groups to learn their 
perspectives on barriers to curbing CVD risks in the Black Belt. Providers cited motivation, noncompliance and 
economic hardship as the top barriers. These perspectives led us to emphasize outreach, self-management 
support, and telephone support in the practice facilitation intervention, and motivational interviewing in the peer 
coaching intervention. We will continue to engage physicians and office staff in the course of the study using 
teleconferencing and face-to-face meetings. 
 
3.1.e Input from Experienced Practice Facilitators 
 
Drs. Viera, Halladay, and Cummings have conducted several studies of practice redesign, and their team 
includes experienced facilitators. We engaged them in the development and finalization of the practice 
facilitation intervention protocol, obtaining their input during intervention design through discussion groups. The 
experienced NC practice facilitators also serve as resources for the AL practice facilitators as they customize 
the practice facilitation intervention to individual practices during the intervention implementation phase. 
Lyndee Knox, PhD, author of the AHRQ Practice Facilitation Handbook, consulted for the study during the 
planning phases. 
 
3.1.f Community Advisory Boards 
 
The CABs were designed to obtain high-level input from stakeholders who will be critical for scaling the 
interventions throughout the Black Belt regions, should they be found to be effective. Each participating state 
has their own CAB, and the composition of these boards is shown in Table 3. The CABs meet annually and 
serve as a between-meeting resource.  
 
The first CAB meetings focused on challenges to implementing the practice facilitation and peer coaching 
interventions, and advice on how to design the interventions to enhance sustainability and widespread 
adoption. The format of this discussion was a nominal group, a structured group process designed to develop 
a prioritized list of responses to a question. Participants first generate a list of unique responses, then prioritize 
the most important among this list by voting for their top three choices. The total number of available votes is 
then used to generate the percent of available votes to facilitate comparison across groups. 

12 
 
 
 
Table 3. Composition of the Community Advisory Boards for the study. 
State 
Member 
Perspective 
 
 
 
 
ALABAMA 
 
Kierra Powell, Grants Coordinator, Constituent Service 
Representative, U.S. Representative Terri Sewell (AL-7) 
Elected representatives 
Dow Briggs, MD, Chief Business Officer, Blue Cross Blue Shield 
Private health insurance 
company 
Terry Knight, Senior Vice-President, Viva Health, Inc 
HMO, Accountable Care 
Organizations 
Maggie Jolly, Assistant Pastor of the Greater St. Paul CME Church 
and community health worker 
Faith-based organizations 
Sondra Reese, MD, Director, Bureau Health Promotion & Chronic 
Disease Bureau, Alabama Department of Public Health 
Public Health, safety nets 
 
 
 
 
NORTH 
CAROLINA 
Angela Bryant, NC Senator, District 4 
Elected representatives 
Sam Cykert, MD,  UNC Director, Program on Health and Clinical 
Informatics, PI, Fast Pace NC 
Health information technology 
Annette Dubard, MD, Director, Informatics, Quality, and 
Evaluation, Community Care of NC 
Population health management 
for Medicaid 
Jan Hutchins, Director, Medical Services UNC Physicians Network 
Physician networks 
Ben Money, MPH, CEO, NC Community Health Center 
Association 
Public Health, safety nets 
Al Richmond, Executive Director, Community-Campus 
Partnerships for Health 
Community-academic 
partnerships to promote health 
 
Table 4. Input of the CAB in the first year of the study. 
 
Practice Facilitation 
Percent 
available 
votes 
 
Peer Coaching 
Percent 
available 
votes 
ALABAMA 
Challenges to implementation 
Clinics under resourced 
19% 
Trust 
15% 
Practices are busy 
15% 
Coach reliability 
15% 
Convincing practices of value 
11% 
Acceptance of coach by professional 
11% 
Clinics under staffed 
9% 
Recruiting coaches long term 
9% 
Conservative/not open to new 
9% 
Defining value for patients (why would I want a coach) 
9% 
 
Tailoring coach to patient, chemistry 
9% 
How to design for sustainability 
Reimbursement model 
19% 
Robust reimbursement 
39% 
Highly tailored 
19% 
Ensure provider buy-in 
11% 
Burden neutral/doesn’t hurt 
17% 
Cost effectiveness 
9% 
Demonstrate long-term outcomes 
9% 
Stopping limits – when is enough 
9% 
Build in feedback on QI metrics 
9% 
Metrics for pts, peers, providers 
9% 
NORTH CAROLINA 
Challenges to implementation 
Practices overwhelmed 
44% 
Training, competencies 
22% 
Impact on practice, patient flow 
20% 
Being aware of coaching activities already in place 
13% 
Competing interests/similar projects 
9% 
Getting the practice to accept coaches 
13% 
Financial pressures not aligned 
9% 
Identifying coaches 
11% 
How to design for sustainability 
Clear messaging on impact on 
patient outcomes 
24% 
Implementation details and costs of the program 
33% 
Work to align incentives 
22% 
Assure coaches are part of clinical care team 
24% 
Training for practice staff 
18% 
Build on existing efforts already in the community 
13% 
 
 
Engage stakeholders to advocate for program 
13% 
 

13 
 
The results of the first CAB meetings are shown in Table 4, limited to only those items that received at least 
9% of available votes. The CABs had some advice that was similar across the two states, for example, both 
CABs emphasized that the under resourced and overwhelmed state of many practices will be an 
implementation barrier for practice facilitation, and that data on the benefit to patients of this type of program 
will be important for long-term sustainability. On the other hand, the AL CAB members voiced concerns about 
the conservative nature of doctors in the rural Black Belt, whereas the NC CAB members advised that 
numerous projects ongoing in the state may pose a challenge.  
 
The advice from the CABs was used to shape the approach to recruiting practices, with a set of talking 
points developed for recruitment discussions. The advice also shaped the type of data collected, emphasizing 
process and cost data to facilitate implementation. 
 
3.1.g Community meetings 
 
In the final year of the study, we will plan a series of community meetings to share the findings of the study 
and plan for sustainability should the results prove favorable. We will work with our community partners to 
identify suitable venues for these meetings and feature community members prominently in the presentations. 
 
 
3.2 Design of the Study  
 
This study is a cluster randomized trial with pre-planned subgroup analyses (Figure 4). We will compare 
the effectiveness of 3 distinct interventions to achieve BP control in comparison with enhanced usual care in 
our targeted high-risk communities. This design in essence allows us to carry out three trials simultaneously, 
sharing a single control group. In addition to testing each intervention versus the control group, this design will 
also allow us to test the interventions against one another. Since our conceptual framework posits that a 
structure/process intervention will operate differently than a relationship-based intervention, this design is 
optimal for testing the effectiveness of each type of intervention on BP control. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 4. Design of the Cluster-Randomized, Controlled, Pragmatic Trial. All practices receive enhanced 
usual care (Patient Activated Learning System [PALS], home BP monitors, practice tips, see 6.3.a). 

14 
 
 
 
3.3 Study Population: Inclusion / Exclusion Criteria 
 
The inclusion and exclusion criteria for trial participants are shown in Table 5. Concordant with the 
pragmatic trial context, inclusion and especially exclusion criteria are kept to a minimum to maximize 
generalizability. 
*Uncontrolled hypertension will be determined by a mean systolic blood pressure >140 mm Hg calculated using at least 1 BP value 
documented in the medical record in the preceding year AND a value >140/90 mm Hg assessed by the research assistant at the time of 
screening.  
 
3.4 Definition of Hypertension  
 
Hypertension (HTN), or high blood pressure, is a common disorder affecting about 70 million Americans 
according to the CDC.38 As described in the Background and Significance, it disproportionately affects African 
Americans, and it increases risks for a host of health outcomes including stroke, heart attack, kidney failure 
requiring dialysis, vascular disease, and heart failure, among others.  
 
Hypertension has long been defined as blood pressure that is 140/90 mm Hg or greater. Table 6 shows the 
categories of abnormal BP according to pre-2017 guideline, including pre-hypertension and hypertension. 
Hypertension is commonly categorized into Stage 1 or Stage 2, depending on the degree of elevation.  
 
Table 6. Stages of High BP in Adults. 
Stages of High Blood Pressure in Adults 
Systolic 
 
Diastolic 
Prehypertension 
120-139 
OR 
80-89 
High Blood Pressure – Stage 1 
140-159 
OR 
90-99 
High Blood Pressure – Stage 2 
160 or higher 
OR 
100 or higher 
 
According the seventh Joint National Committee on the Prevention, Detection, Evaluation, and Treatment 
of High Blood Pressure, individuals with a reading in the Stage 1 range should have a second measurement 
within 2 months to confirm the BP elevation. Those with Stage 2 hypertension need not wait for confirmation 
prior to initiation of evaluation and treatment. 
 
As a practical matter, BP even within a single patient is highly variable from visit to visit. The Counseling 
African Americans to Control Hypertension (CAATCH) community based intervention to control hypertension 
enrolled patients with BP >140/90 mm Hg at baseline; the investigators found that >40% of both intervention 
and control subjects were controlled at follow-up39,40. This suggests that unless more stringent criteria are used 
to identify uncontrolled hypertension, the results of this study could also be impacted by a similar regression to 
the mean. However, although at least two trials in pragmatic settings have used higher thresholds of BP higher 
than 140/90 mm Hg as inclusion criteria, none had an empiric justification for the higher levels used. It is worth 
noting that in one of these trials, the use of the higher threshold was prompted by community practitioner 
requests to focus on higher risk patients. 
 
Table 5. Patient inclusion and exclusion criteria for the trial. 
Inclusion criteria 
Exclusion criteria 
• African American adults aged 19-85 years 
• Uncontrolled hypertension* 
• Black Belt resident 
• English speaking 
• Willing to work with a peer coach 
• Willing to sign informed consent 
• Has access to a telephone 
•  Plans to move out of the area within the next two years 
• Advanced illness with limited life expectancy 
• Pregnant or plans to get pregnant in the next year 
• Advanced chronic kidney disease (estimated glomerular 
filtration rate <45 ml/min/1.73 m2) 
• Unwillingness to work with a peer coach or to sign 
informed consent 
• Lack of phone access   

15 
 
Absent an established approach to minimizing regression to the mean in hypertension trials, we examined 
data from the Antihypertensive and Lipid-Lowering Treatment to Reduce Heart Attack Trial (ALLHAT), which 
was a large, pragmatic, hypertension trial in which 50% of participants achieved BP control at 1 year.41 We 
therefore used all BP measurements through the first 9 months of the trial to predict whether hypertension 
would be controlled at one year. Overall we found that approximately 39% of those uncontrolled at 9 months 
were controlled at 12 months, a similar regression to the mean as in the CAATCH trial. Using classification 
trees we found that the most important predictor was a mean blood pressure through 9 months of >148 mm 
Hg. This group comprised approximately 60% of those uncontrolled at 9 months but had a lower control rate at 
one year of 30%. To simplify logistics, in this study, uncontrolled hypertension was to be defined as a mean 
systolic blood pressure >150 mm Hg in the year prior to enrollment including at least one blood pressure 
reading over the preceding 12 months. Participants would also be required to have a measurement by the 
research assistant on the day of enrollment of 140/90 mm Hg (140 systolic or 90 diastolic) or greater.  
 
In November, 2017, the 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline 
for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults was announced. 
This guideline proposed that hypertension should be defined as a blood pressure of >130/80 mm Hg, and that 
blood pressure between 130/80 and 139/89 mm Hg should be defined as Stage 1, with values of 140/90 mm 
Hg and above defined as Stage 2 hypertension. This major shift in the definition of hypertension prompted the 
study group to reconsider our inclusion criteria. Our recruitment experience showed that many patients were 
referred for consideration for enrollment in the study, having been informed by their physician that their blood 
pressure was uncontrolled. The requirement to have a mean systolic blood pressure of 150 mm Hg or higher 
over the previous year as well as a blood pressure of 140/90 or greater on enrollment day made many of these 
patients ineligible for the trial. This created confusion in our partnering clinics. In addition, recruitment was not 
completed within the allotted 90 day period at some clinics. These considerations coupled with the new 
definition of hypertension led us to modify the inclusion criteria to require a mean in-clinic systolic blood 
pressure of 140 mm Hg over the previous year (i.e., the 150 mm Hg criterion was lowered to 140 mm Hg). This 
modification resulted in the trial focusing on treatment of Stage 2 hypertension according to the 2017 
guidelines.  
 
3.5 Study Outcomes 
 
3.5.a Primary Outcome Defined 
 
The RFA for this study required that the primary outcome be the improvement in BP control to less than 
Stage 2 hypertension between baseline and follow-up between practices in any of the intervention arms (A, B, 
or C in Figures 4 and 5) and the enhanced usual care arm (D) (Table 7). We operationalize this as a patient-
level outcome of the proportion of patients with controlled Stage 2 hypertension in the relevant trial arm at the 
one-year follow-up. 
 
3.5.b Secondary Outcomes Defined 
 
Secondary outcomes include the change in systolic BP between baseline and follow-up; quality of life 
(depressive symptoms, physical and mental functioning); and patient and practice team satisfaction.  
Preliminarily, we propose a target of controlled Stage 2 hypertension to mean <140/90 mm Hg for all 
participants because of the very high risk African American sample and because a single BP goal is easier to 
implement in real-world settings. However, several evolving developments may influence this goal. First, there 
was considerable controversy following the 2014 Evidence-Based Guideline for the Management of High Blood 
Pressure in Adults (JNC8) recommendation to relax the BP target for patients with hypertension aged >60 
years. Second, the Systolic Blood Pressure Intervention Trial (SPRINT) was stopped earlier than its projected 
project period due to unexpectedly strong beneficial effects of BP control to a target of 120/80 mm Hg.42,43  
 
 
 
 

16 
 
 In accordance with PCORI Methodology Standard 1:RQ-6, 
we will “provide information that supports the selection of outcomes 
as meeting the criteria of “patient-centered” and “relevant to 
decision makers,”1 such as patient and decision-maker input from 
meetings, surveys, or published studies.” Our discussions with 
patients, providers, peer coaches, practice facilitators, and the 
stakeholders engaged in the CABs shaped the selection of the 
study outcomes, which are both patient-centered and relevant to 
decision makers. As described in the Background and Significance 
(section 1), high blood pressure is a leading killer among African 
Americans, and leads to significant morbidity. Control of high blood 
pressure is a high priority in our partnering communities, confirming 
that this outcome is patient-centered.  
 
3.6 Pragmatic Elements 
 
This study is designed as a pragmatic implementation trial. The elements which meet the Pragmatic- 
Explanatory Continuum Indicator Summary (PRECIS) criteria for pragmatic trials are shown in Table 8. 
 
Table 8. Our study’s features that meet PRECIS Criteria for pragmatic trials. 
PRECIS Domain/ 
Pragmatic  Principle 
Design Approach and Estimated  Levels of Clinical Research Pragmatism 
(1 = Extremely; 2 = Moderately; 3 = Somewhat Pragmatic) 
Participant eligibility 
criteria  
Minimal exclusion/ inclusion criteria: adult African American adults with uncontrolled HTN (1)  
Participant adherence 
Patient adherence captured via self-report, medical record review, cell phone data (1)  
Practitioner expertise 
PF intervention draws on each practice’s self-knowledge; peer coaching draws on coach 
training and experience (1) 
Practitioner adherence 
Practice adherence captured via self-assessments (1); peer coaching adherence captured 
via cell phone use and manuals (1) 
Flexibility and complexity 
of the intervention 
Multi-level, multi-component functional interventions, both maximally flexible and tailored to 
local/individual needs and circumstances (1). Flexibility adds a degree of complexity (2) 
Allocation concealment 
and blinding 
Data collectors not blinded to allocation (1). Practices not blinded due to nature of interv’n 
(1). Pts blinded to EUC vs. PF allocation (1), not blinded to peer coaching allocation (1). 
Sample size  based on 
hypothesized effect size 
Large number of practices with 25 patients/practice maximizes power for main analysis at 
practice level, while allowing for subgroup analyses at the patient level; incorporate 
conservative attrition estimates (1) 
Randomization scheme 
Block randomization stratified by practice type (FQHC or not) (2); cluster randomization (1) 
Clinically meaningful pt.- 
centered outcomes 
BP and BP control directly and causally linked with CVD outcomes; quality of life and 
satisfaction highly patient-centered (1) 
Follow-up intensity 
3 data collection visits at practice over 1 year, follow-up phone calls to practice 1 year later 
for large subsample (2) 
Analytic approaches 
Primary analysis intent to treat, adequately powered subgroup analyses for especially high-
risk groups (men, age <60 years, low literacy, depressive symptoms) (1)  
BP = Blood Pressure, CVD = Cardiovascular Disease, EUC = Enhanced Usual Care, FQHC = Federally Qualified Health 
Centers, HTN = Hypertension, PF = Practice Facilitation. 
 
 
3.7 Randomization 
 
3.7.a Cluster Randomization 
 
We use a cluster randomized design for two reasons. First, the practice facilitation intervention acts at the 
practice level, requiring practices to be the unit of randomization. Second, patients are nested within practices, 
thus the design should reflect this non-random distribution of the study population for analyses at the patient 
level. We also respond to a recent call for designs that engage more practices with fewer patients per practice 
in studies of practice change interventions.18,22 As discussed in section 8, the inclusion of 80 practices provides 
sufficient power to detect clinically important differences in BP control to <140/90 mm Hg between the 
intervention arms and the enhanced usual care arm. While the RCT design is the most robust experimental 
design available, it is often not feasible in real-world settings. However, several things make this design 
Table 7. Primary and secondary 
outcomes  
Type of 
measure 
Measure 
Primary 
outcome 
Difference in BP control 
between trial arms 
Secondary 
outcomes 
Difference in change in BP  
   between baseline and f/u 
Depressive symptoms 
Physical and mental  
  functioning 
Patient, provider, staff  
   satisfaction 

17 
 
feasible for the study. First is our experience implementing RCTs in practice-based and community-based 
research in the Black Belt. Second, we offer enhanced usual care as a comparison condition, which is 
attractive to practices and participants alike, who often wish to avoid being in the “control arm” and “getting 
nothing.”   
 
3.7.b Practice Randomization 
 
There are some structural differences between practices located in the Black Belt region. For example, 
FQHCs tend to have well developed EMRs and quality reporting systems and interventions, whereas the 
private practices tend to have fewer activities in these areas and are more likely to use a traditional model of 
care delivery. These structural differences may impact baseline measures and response to the interventions. 
Therefore, at each stage of the implementation, we will actively work to balance allocation across these two 
practice types: FQHC and non-FQHC. We will also work to achieve balance by state (AL and NC). The study’s 
biostatistician, Dr. Richman, will use a random number generator to randomize the practices and will be 
responsible for assuring balance across practice type, state, and study arm using permuted block 
randomization with sizes of 2 and 4 to minimize imbalance. Randomization will occur for each stage-group 
when they are randomly selected for implementation. We will not randomize practices at recruitment because 
attrition between recruitment and readiness could cause imbalance. 
 
The RCT portion of this study has two distinct stages, beginning with the initial vanguard phase described 
below in section 6 followed by staged implementation (see Figure 5). From among the practices ready for 
randomization by June 2016, we will select 4 as the ‘vanguard.’ The 4 vanguard practices will be randomized 
to each of the 4 treatment arms/cells of the trial, such that one practice is in each of the 4 arms/cells.  
 
Randomization assignments for the rest of the trial will be drawn from the remaining pool of recruited 
practices meeting readiness criteria. This second implementation phase will be rolled out in stages as shown in 
Figure 6. Because the pool of recruited practices will change due to recruitment, readiness, and attrition, 
approximately 3-6 months before each stage, that stage’s participating practices will be chosen in groups of 
10-12, with Dr. Richman assuring balance across practice types (FQHC vs not) and also across states (AL vs. 
NC) using a block randomization approach. The goal is to recruit 50 practices in AL and 30 in NC, reflecting 
the relatively larger geographic region in AL. The allocation will be examined carefully prior to the final two 
stages and, depending on the proportions of practice types and number of practices in each state, the 
randomization may be changed slightly to ensure balance of the final cohort. Because recruitment occurs well 
in advance of randomization, Dr. Richman will be able to ensure balanced allocation without compromising 
random assignment. 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.8 Blinding  
 
Ideally, participants, practices and data collectors as well as any study staff interacting with participants 
should be blinded to the practice’s randomization status in order to minimize biases. However, in many trials of 
behavior change interventions like this one, this is not possible. Nevertheless, we will implement blinding 
where feasible. Data collectors will be separated from research team members engaged in intervention 
implementation. Patients in the enhanced usual care and practice facilitation-only arms will be blinded to the 
Y2 
  
  
  
Y3 
 
 
 
Y4 
  
  
  
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
4 (VANGUARD) 
 
 
 
 
  
 
 
  
  
 
10 
  
  
  
 
 
  
 
 
  
  
 
 
10 
  
  
  
 
  
 
 
  
  
 
 
  
12 
  
  
  
  
 
 
  
  
 
 
  
 
12 
  
  
  
 
 
  
  
 
 
  
 
 
12 
  
  
  
 
  
  
 
 
  
 
 
 
10 
  
  
  
  
  
 
 
  
 
 
 
 
10 
  
  
  
Figure 5. Staged implementation scheme for the 80 participating practices. 
Numbers indicate the number of practices per wave. Actual accrual pace may vary. 

18 
 
practice’s randomization status. However, it will not be possible to blind practices to their randomization status, 
and it will not be possible to blind patients in the peer coaching arms to the practice’s randomization status. 
 
 
3.9 Expected Duration of Subject Participation 
 
The expected duration of subject participation is one year. 
 
 
 

19 
 
 
4. Recruitment of Practices, Facilitators, and Coaches 
 
This study will recruit practices (section 4.1), practice facilitators (section 4.2), peer coaches (section 4.3), 
and participants (section 5). In accordance with PCORI Methodology Standard 2: PC-2 we will “identify, 
select, recruit, and retain study participants representative of the spectrum of the population of interest and 
ensure that all data are collected thoroughly and systematically from all study participants.”1 
 
 
4.1 Recruitment of Practices 
 
4.1.a Number of Practices 
 
We will recruit 50 practices in AL and 30 in NC with a higher target in AL because this region demonstrates 
slightly worse BP control than NC, based on BP control rates reported by FQHCs in each state’s Black Belt 
counties (Table 1). AL also contains a larger portion of the Black Belt by area (see Figures 1 and 2), and AL 
has more single physician practices, which have been shown to face considerable challenges to improving BP 
control in their patients with HTN.18 We will therefore make special efforts to reach out to single physician 
practices. As part of the proposal phase of this study, we obtained letters of support from over 300 practices 
(Table 9).  
 
As of June 2016, we have received signed letters of 
agreement from 29 practices; the practices cannot be named 
in this protocol until they have received Federal Wide 
Assurance numbers, and this application process is in 
progress. These practices were selected for the first wave 
because the recruitment team, led by Dr. T. Michael 
Harrington, Chair of Family Medicine at UAB and a large 
presence in the Family Medicine community in the 
Southeast, has personal connections with these physicians. 
The earliest physicians have been engaged to further shape 
the design of the study, including patient recruitment and 
intervention finalization. 
 
4.1.b Practice Inclusion/ Exclusion Criteria  
 
All practices located in counties in either AL or NC 
considered to be part of the Black Belt will be eligible. We recognize that there is no formal definition of the 
Black Belt, and various sources define the included counties slightly differently, particularly around the borders 
of the Black Belt.44 In AL, the Black Belt will include rural counties in the south central part of the state 
spanning from Mississippi to Georgia. In NC, the Black Belt will include rural counties in the eastern part of the 
state.  
 
For this project, the practice inclusion criteria are: 
• 
Location in the Black Belt 
• 
Serve a predominately rural population 
• 
High proportion of indigent patients 
• 
High proportion of African American patients 
• 
Internet access at the practice 
• 
Willingness to sign a Letter of Agreement to participate 
• 
Willingness to identify a Practice Champion 
• 
Willingness to modify structure and processes of care with the help of a practice facilitator 
• 
Willingness to work with peer coaches  
 
Table 9. Sampling frame for practice recruitment 
Recruitment Source 
Practices 
AL PBRN 
30 
Dr. Safford’s Black Belt programs 
130 
AL AHEC 
150 
Deep South CME Network – AL rural 
200 
AL Primary Care Association  
7 FQHC’s 
Medical Alumni Society of AL 
220 
TOTAL AL 
220 
Vidant of NC 
68 
Opportunities Center of NC 
2 
Carolinas Healthcare 
5 
Goshen Medical Center of NC 
25 
Robeson Healthcare Centers of NC 
7 
Kinston Medical Specialists of NC 
5 
TOTAL NC 
95 
AHEC = Area Health Education Center. CME = Continuing 
Medical Education. PBRN = practice-based research network.  

20 
 
We will not require EHR implementation for inclusion in the study, because some of the targeted practices 
have not yet implemented electronic records, and those that have not done so are often also those in greatest 
need of assistance in achieving BP control. Because the introduction of an EHR requires considerable 
attention from the physician and practice staff, we will require that EHR implementation is completed at least 6 
months prior to participation. We will require that the practice has Internet access, because our data system 
and the PALS education portal are web-based. In our experience, practices have the highest speed Internet 
access available in their area. 
 
Practices that do not meet these inclusion criteria will be excluded. 
 
Once a practice meets inclusion criteria and commits to participating, a Letter of Agreement is signed by 
the appropriate practice official and the practice is placed in queue for readiness assessment, described below 
in section 4.1.e.  
 
4.1.c Practice Engagement Methods  
 
We use several strategies to engage practices in the Black Belt with sufficient numbers in the sampling 
frame to assure feasibility (Table 9). Dr. Harrington, a respected leader in primary care in the state of AL and 
leader of a PBRN leads the AL team’s practice engagement, and Drs. Halladay and Cummings lead the NC 
team’s practice engagement efforts. Dr. Cummings leads a PBRN in NC.  During the proposal development 
phase, we secured letters of interest from over 100 practices or practice organizations. Dr. Safford’s team 
engaged over 600 patients from 130 mostly single physician practices in the Black Belt in their work to date, 
and these practices will be engaged to participate by direct invitation from Dr. Safford. Dr. Harrington will not 
only approach the AL PBRN practices in the Black Belt, but will also make presentations at local meetings of 
the Medical Association of the State of AL (see letter of support) and the local chapter of the American 
Association of Family Physicians. Our and the NC AHEC work extensively with primary care practices in their 
regions to place medical students in these practices for their ambulatory medicine training, thus they are 
familiar with many of our targeted practices. They will assist with recruitment as well as providing their 
qualitative assessment which will inform decision-making on individual practice readiness as part of the 
Recruitment and Retention Workgroup deliberations. Of note, demand for assistance with practice 
transformation in both AL and NC is high, as meaningful use criteria are fully implemented and as CMS moves 
rapidly to value-based reimbursement. 
 
The process of practice engagement is sketched out in Figure 6 and Appendix 1. The process begins with 
a lead letter and an informational sheet providing an overview of the study (see Appendix 1). Within 2 weeks, a 
telephone call takes place between a study investigator and the practice physician. The feedback from the 
Community Advisory Boards and NC AHECs was used to develop talking points for how to respond to potential 
resistance. The telephone call is followed by additional calls and/or an in-person visit. Once a practice agrees 
to participate, a Letter of Agreement is obtained from the practice physician or other authorized official, and the 
practice’s Champion is identified (see 4.1.d below). Once the Letter of Agreement is signed, the study team 
assists the practice with obtaining a Federal Wide Assurance number if the practice does not already have 
one, and the practice is assessed for readiness to be randomized, as described below in section 4.1.e. If the 
practice has not previously had a Federal Wide Assurance number, the study team will work with the relevant 
Institutional Review Board to assure that practice staff participating in the research have received training and 
certification in human subjects in research. 
 
To assess reach in the RE-AIM framework, we will track the number of practices approached (lead letter 
sent, initial telephone call completed), the number eventually agreeing to participate (Letter of Agreement 
signed), the number randomized, and the number completing the intervention period. We will collect 
information about reasons why practices declined to participate, why they did not move forward to 
randomization, and why they did not complete the intervention period.  
 
 
 

21 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 6. Practice engagement scheme from initial contact through practice readiness for 
randomization. 
 
4.1.d Practice Champion 
 
A critical requirement for each practice will be a Practice Champion. The Champion agrees to be the point 
person for communication about the project. Ideal Champions have a vested interest in the success of the 
project, and are willing to advocate with their fellow practice members to make the project a success. 
Champions are often nurses but can be anyone on the team. Each practice will be asked to select their 
Champion.  
 
4.1.e Practice Readiness  
 
A major driver for this proposal is the recognition that some of the highest need populations in terms of 
uncontrolled HTN and CVD risk receive their healthcare in a wide variety of practices, ranging from single 
physician practices still using paper records to more sophisticated health center networks actively working on 
practice transformation. Some variety in practice structure and process is desirable in this implementation 
context, but too much variation can also create threats to validity. Therefore, based on the NC team’s 
extensive experience with practice facilitation and practice transformation, we have developed practice 
readiness criteria to assure that a minimum standard is met prior to moving a practice forward to 
randomization. We have devised a ‘speed to readiness program’ for those practices committing to participating 
but not deemed ready by the study team (see below). Furthermore, it is likely that some practices that express 
commitment initially may experience changes over time. Because the study design calls for waves of practices 
being engaged over a 2-year period, it is likely that some practices may not be approached for randomization 
until several months after they signed. Therefore, we will assess readiness on signing the Letter of Agreement, 
and again just prior to randomization.  
Practice meets eligibility 
criteria 
Practice declines to participate, 
reason recorded 
Practice declines to participate, 
reason recorded 
Practice never meets readiness 
criteria, reasons recorded 
Lead letter and initial contact 
Practice ready to be 
randomized 
Practice agrees to participate: 
Letter of Agreement signed 
Practice assessed for 
readiness to participate 

22 
 
 
In brief, the readiness criteria include: 
• 
Financial stability over the study period and no plans to close the practice in the next 3 years for 
reasons such as retirement  
• 
Engagement and commitment by the leadership of the practice to support change 
• 
No major disruptions over the study period (e.g., key staff position vacant, key staff member going 
out on family leave, new EHR being implemented) 
 
The assessment of practice readiness for making structural practice changes is a very new concept and 
the validation of instruments used to assess various domains of capacity for change is limited. The practice 
readiness assessment includes items from the Organizational Readiness for Implementing Change (ORIC) 
scale,45 which includes two subscales assessing change commitment and change efficacy. The ORIC has 
acceptable psychometric properties in practices similar to those that will be engaged in the proposed study. A 
copy of the practice readiness survey (along with the survey of practice characteristics) is provided in Appendix 
2.  
 
Readiness is assessed by the Recruitment and Retention Committee, led by Drs. Shikany and Cummings. 
The data that are considered in determining readiness include: 
• 
Results of the Practice Readiness assessment  
• 
Practice characteristics (assessment tool provided in Appendix 2) 
• 
Qualitative report by the workgroup member who interacted with the practice 
• 
Area Health Education Center (AHEC) team’s feedback 
• 
Any additional information known to the study team  
 
These data are considered in making the decision whether to move forward to randomization or whether 
the practice may need to be placed in the “Speed-to-Readiness” program (described next) and reassessed at a 
future date. The main driver of the decision is whether the practice is deemed able to complete the year-long 
intervention, and whether there is agreement or strong agreement on at least 4 of the 8 domains assessed by 
the Practice Readiness assessment.  
 
The multiple waves of randomization over two years permit practices that are not ready for time-limited 
reasons, such as implementation of a new EHR, or a staff member away on maternity leave, etc., to enroll at a 
later date. 
 
4.1.f “Speed-to-Readiness” program  
 
Because some practices may be implementing electronic record systems, or have internal temporary 
circumstances that may preclude meeting readiness criteria, or have hesitation about participating, we will 
implement a program designed to help practices meet readiness criteria, hence the name “Speed-to-
Readiness”. This program is guided by Bandura’s social cognitive theory, which posits that practice leaders 
may learn from others like themselves, and modify their own behavior accordingly.46 Peer testimonials are 
effective in modeling results of actions taken by others, a core tenet in social cognitive theory.  
 
In our team’s experience with practice redesign interventions, an important impediment to readiness is 
ambivalence on the part of the practice leaders. Practice leaders are more enthusiastic about peer coaching 
interventions, which are less disruptive to practice flow. Since a practice has a 50% chance of being 
randomized to receive the practice facilitation intervention, the peer modeling aspect of the Speed-to-
Readiness program will focus on practice facilitation.  
 
We will offer academic detailing for practices in the Speed-to-Readiness phase delivered by Drs. 
Harrington, Cherrington, Oparil, Cene, Halladay, or Cummings. Practices will receive monthly telephone check-
ins by study leaders to assess progress, provide supportive encouragement, and use motivational interviewing 
techniques to help the practice leaders work towards overcoming barriers to participation and increasing their 
self-efficacy.  

23 
 
 
We will create a video of testimonials of practicing primary care physicians who have experience with 
practice facilitation or peer coaching interventions. We will ask these physicians and their staff to relate their 
satisfaction with the interventions, to share some of the challenges encountered in implementing the 
interventions and how they overcame them, and to include the feedback from patients. Practices in the Speed-
to-Readiness phase will be engaged in discussions during which we will view segments of the video as a 
springboard for discussion with ample opportunity for questions.  
 
We may also invite practices in the Speed-to-Readiness phase to join biweekly practice facilitation 
Collaboratory conference calls at which practices enrolled in the study and receiving the practice facilitation 
intervention confer about their progress and brainstorm solutions to challenges they are facing. (Practices not 
receiving the practice facilitation intervention will not participate in this Collaboratory to avoid contamination.) 
This will permit practices in the Speed-to-Readiness phase to hear first-hand from other physicians and staff 
similar to themselves about the intervention in near real-time.  Practices in the Speed-to-Readiness phase will 
also be offered a peer mentor in the form of a participating practice for one-on-one discussions and support. 
 
We will evaluate success of the Speed-to-Readiness program by tracking the number of practices that 
enter the program and the number that achieve readiness to be randomized by the end of Year 3, which will be 
part of our adoption metric in the RE-AIM framework. We will also track frequency of contacts, participation in 
the Collaboratory teleconferences, and engagement with the peer mentor. The study investigator making the 
Speed-to-Readiness calls will take notes during the call and immediately afterward provide qualitative 
impressions of progress, reporting back to the study team for input and collaborative problem-solving. 
 
4.1.g Practice Compensation  
 
Each of the 80 participating practices will receive a total of $4000. The first payment ($500) is made upon 
enrollment of the practice, defined as having both a Letter of Agreement signed and randomization completed. 
Another $1500 will be paid when the 25 patients have been enrolled and have completed baseline data 
collection, $1000 upon completion of the 6-month follow-up assessment, and $1000 upon completion of final 
data collection. In addition, each practice will receive a laptop computer with access to the Patient Activated 
Learning System and 25 home blood pressure monitors, which are theirs to keep.  
 
4.1.h Under Recruitment  
 
Recruitment may be difficult at some practices for a variety of reasons. Every effort will be made to recruit 
25 participants at each practice. However, after vigorous attempts over at least 2-3 months, if at least 19 but 
fewer than 25 participants have been recruited, the program manager and site PI can request an exception to 
the recruitment target of the Recruitment and Retention Workgroup. This should be an exception and not the 
rule.  
 
Despite vigorous recruitment efforts, in rare cases, fewer than 19 participants may be recruited over the 2-3 
month recruitment period. In such cases, after consultation with the Recruitment and Retention workgroup, 
recruitment can be stopped at the practice and over-recruitment at other practices may be initiated to make up 
the shortfall. The guidelines to operationalize over-recruitment are listed below:  
 
1. If a practice has enrolled fewer than 19 participants by 2-3 months, the project manager and PI should 
obtain approval from the Recruitment and Retention Workgroup to look for same-arm practices for 
over-recruitment, first at their own site and then at other sites. 
2. For every one patient less than 19 recruited at a given practice, the over-recruiting practice must enroll 
2 patients. For example, if a practice closes enrollment with 17 enrolled patients, the over-recruiting 
practice must enroll 4 extra patients to address analytic issues related to power, sample size, and intra-
class correlation. The 4 extra patients could be recruited from one single practice within the same arm, 
or from more than one practice within the same arm (in fact, the second option is preferred from a 
statistical point of view but not required). 

24 
 
3. Practices cannot be considered for over-recruitment unless they have reached 25 enrolled patients. 
 
Payment for practices that over and under recruit will be modified as follows: 
1. A practice that enrolled 19-25 will receive the full payment amount ($1500.00). 
2. A practice that enrolls less than 19 patients will be paid per participant at a rate of $60 per participant. 
3. A practice that enrolls more than 25 patients may be offered an additional $60 for each extra patient 
recruited, depending on the relationship between the study team and the practice and the practice’s 
expectation. The decision whether to discuss extra payment with the practice will be at the discretion of 
the site’s program manager and site PI. 
 
It is imperative that all practices recruit at least 19 participants, and stopping short of 25 should be an 
exception and not the rule. However, in some cases, recruitment may be very slow. If a practice is 
encountering exceptionally slow recruitment and it has not reached at least 10 patients by 8 weeks, this should 
be discussed during the Recruitment and Retention Workgroup calls and consideration may be given to 
dropping that practice altogether. Dropping practices due to slow accrual of participants should be a rare 
occurrence given the process of selecting only the most promising practices under the purview of the 
Recruitment and Retention Workgroup.   
 
4.1.i Practice Withdrawal/Dropout Criteria 
An occasional practice may need to be withdrawn from the study for a variety of reasons. Some practices 
may close over the study period, whereas others may modify their structure so that the practice no longer 
meets eligibility criteria, or enrollment is too slow for the pace of the study.  
 
When a program manager and site PI identify changes at a randomized practice that they feel warrants 
consideration of withdrawal of that practice, they will present the following to the Recruitment and Retention 
Workgroup with the proposal to withdraw the practice:   
• 
Description of the change in the practice; e.g., changing to a concierge medicine model, insufficient 
population, practice closure, staff opposition to participation 
• 
The practice’s original eligibility criteria  
• 
Study arm practice was randomized to 
• 
Number of participants enrolled and how far along they are in the study  
 
The Recruitment and Retention Workgroup will discuss the case and render a decision on the practice’s 
status. Depending on the study arm, participants at that practice may be managed differently.  
1) 
Practice Facilitation practices: The intervention will be terminated and retention activities will cease. 
Participants will be contacted and notified that the practice has been withdrawn from the study. Data 
already collected may be used in some analyses.   
2) 
Peer Coaching practices: Participants will be notified that the practice has been withdrawn from the 
study and they will be offered the opportunity to complete the intervention if they would like to. For 
patients electing to complete the intervention, the program manager, site PI, and Peer Coaching 
intervention Workgroup will assist the study team and peer coach in managing high blood pressure 
readings on the home monitor that would normally have been communicated to the patient’s practice. 
The following guidelines will be followed: 
• 
SBP >180 or DBP >110, no symptoms: coach encourages patient to reach out to their new 
provider, follows up after the reach out to learn what advice has been given; if patient has not 
followed up, coach reaches out to study team for assistance. 
• 
SBP >180 or DBP >110, with symptoms: coach follows study protocol and reaches out to study 
team for assistance. 
• 
Other non-life threatening situations: coach follows study protocol; if the patient has not yet 
identified a new provider, coach reaches out to study team for assistance.  
• 
Monthly reports that would normally go to the Practice Champion will be sent to the study team.  
No follow-up data will be collected, with one exception. Participants will be offered the opportunity to 
join an existing practice in the Peer Coaching arm should one be available nearby. If the participant 

25 
 
chooses to join another Peer Coaching practice, the follow-up data collection schedule will be followed 
for that practice, and monthly reports will be sent to the new practice’s Practice Champion.  
 
 
4.2. Recruitment of Practice Facilitators 
 
4.2.a Number of Practice Facilitators 
 
Practice facilitators typically manage several practices at once when they work full time. The ideal number 
of practices is not well defined, but the NC team’s experience indicates that no more than 10-15 practices at 
once is desirable to achieve full engagement and support for the practice facilitator’s entire portfolio. For this 
study, the intervention implementation is staged across a period of several months (see Figure 6, page 15). 
We will therefore plan on 3.5 FTE facilitators, 2 in AL and 1.5 in NC. 
 
4.2.b Practice Facilitator Inclusion/ Exclusion Criteria 
 
Facilitators will have at least 2 years of experience in a healthcare setting and have high confidence in 
interacting with busy practices and practice staff. Although not required, an advanced degree in a healthcare 
field is desirable. Facilitators will be certified through the same program at the University of Buffalo, with 
additional training provided by the NC Area Health Education Center practice facilitation team. Individuals who 
meet the inclusion criteria and who are willing to undergo training and commit to the project for at least two 
years will be eligible. 
 
4.2.c Practice Facilitator Recruitment Methods 
 
Facilitators will be hired by the AHECs in AL under subcontract. They will be responsible for recruitment. 
As of February 1, 2016, three individuals from AL have entered facilitation training with the University of 
Buffalo, one of whom expects to be a full-time facilitator. Facilitators in NC will be recruited in collaboration with 
the NC AHEC or the UNC Chapel Hill team, which collectively have a cadre of certified facilitators active 
throughout the state.  
 
4.2.d Compensation of Practice Facilitators 
 
Facilitators will be employees of their hiring institutions with salary commensurate with their experience and 
local hiring practices. 
 
4.3. Recruitment of Peer Coaches 
 
4.3.a Number of Peer Coaches 
 
There are a number of peer coaching models, spanning from full-time community health workers who are 
employed by a practice on the one hand to volunteers spending a few hours per month providing education or 
navigation assistance on the other hand. In the Black Belt, FQHC’s may have resources to hire a full-time 
community health worker, but other practices typically do not. For this reason, a model which engages part-
time coaches who can work as much or as little as they would like works best. Therefore, the number of peer 
coaches is contingent on the case load each one of them would like to handle. In our team’s past work this has 
ranged from one client at a time to a dozen or more.  
 
We have engaged and trained over 60 peer coaches for our programs in AL and many have expressed 
strong interest in being involved in the proposed study. We anticipate requiring 3-5 peer coaches per clinic, 
thus we will train more in order to assure availability. We plan to recruit peer coaches from each clinic 
randomized to the peer arm. This is a strength of the program, since for scale-up, a major issue will be how to 
find suitable individuals to be peer coaches if the peer coaching intervention proves to be effective in lowering 
BP and improving BP control.  

26 
 
 
4.3.b Peer Coach Inclusion/ Exclusion Criteria 
 
Peer coaches by nature seek to help others in their community. In keeping with Bandura’s social cognitive 
theory of behavior change, we will seek peer coaches who themselves have high blood pressure, or care for a 
family member or close friend with high blood pressure. However, they must also be willing to accept help from 
the research team and community coordinator, especially regarding intervention fidelity. There are additional 
realities of participating as a peer coach in a research study, such as commitment to the study’s duration, 
willingness to undergo training such as HIPAA and IRB, and willingness to communicate with their client’s 
doctor or nurse. Therefore, to be invited to participate in the study, peer coach candidates must answer “yes” 
to the following questions: 
1. Do you have the desire to help others? 
2. Are you willing to accept help? 
3. Are you willing to become a ConnectionHealth (AL peer coaches) or Open Water Coaching and 
Consulting (NC peer coaches) employee or contractor? 
4. Do you have high blood pressure or do you help a close friend or family member take care of their high 
blood pressure? 
5. Are you willing to attend and complete the Peer Advisor training? 
6. Are you will to work with approximately 5-7 clients over 12 months, by telephone? 
7. Are you willing to attend weekly group phone calls with other peer advisors and study doctors? 
 
Of note, the peer coach training and certification programs are excellent filters, with the less committed 
dropping out prior to completing the program. 
 
 
4.3.c Peer Coach Recruitment Methods 
 
A key aspect that informs peer coach recruitment is the structure that peer coaching programs are likely to 
take in the Black Belt region moving forward, as the Affordable Care Act continues to be fully implemented. An 
important part of this Act is provisions to pay for community health workers, but community health workers are 
currently not implemented in many practices in the area. In AL, practices are predominately private single or 
two-physician practices or FQHCs. A community coalition meeting on the topic of peer coach implementation 
for chronic disease self-management held in Camden, AL in September 2014 engaged over 100 community 
leaders and revealed that the current fee-for-service model that predominates in AL currently has been a major 
barrier to implementation of peer coaching programs. This is largely because many of the practices are too 
small to be able to afford their own peer coach, even in the wake of the January 2015 CMS announcement 
about the aggressive timeline for transitioning to value-based reimbursement within 2 years. Community 
members were supportive of a model in which peer coaches worked under community-based organizations 
(CBO) such as the nonprofit organizations led by our community coordinators rather than in a specific practice. 
This way, practices (or Regional Care Organizations) could reimburse the CBO for peer coaching services 
without taking on the human resources management aspects of this type of care extender.  
 
Another key insight during the development of the peer coaching intervention was the need to integrate 
peer coach into the practice. The peer coach stakeholders that are assisting with intervention development 
recommended we make efforts to recruit coaches from each of the practices, from among their pool of 
patients. This increases the likelihood of true integration into the care team, since the person being integrated 
is already well-known to the practice. We estimate that we will need between 3-5 coaches per practice. A peer 
coaching program in San Francisco reported that recruiting peer coaches from practices was feasible.47 We 
will therefore make efforts to recruit peer coaches from each practice, drawing on our reserve of 65 trained 
coaches in AL and 15 in NC should recruitment at the practice prove difficult. 
 
In the community capacity building model of community-based participatory research, the Health and 
Wellness Education Center of Livingston, AL, will be the administrative home for all AL peer coaches, 
expanding the reach of this CBO and anticipating sustainability on conclusion of the funding period. The Health 

27 
 
and Wellness Education Center and the West Central Alabama Community Health Improvement League will 
work with the study team and the practices to identify potential peer coaches from among their patients, and to 
identify suitable coaches from among their pool of trained coaches. The goal will be to identify coaches who 
can easily travel to participating practices such that travel to the practice will not be burdensome for the coach, 
since at least one trip to the practice will be required. 
 
In contrast to AL, the NC team members have less experience with peer coaching in collaboration with a 
CBO. Like in AL, most practices do not currently use a peer coaching model. However, there are a number of 
peer coaching programs in existence in the NC Black Belt region, as we learned from the NC CAB meeting in 
February 2016.  Therefore, we will partner the coaching coordinator in NC with the coordinators in AL in a 
mentoring relationship to assure that the structure of the coaching programs in the two states are similar. We 
will also actively explore partnerships with existing CBO’s in NC over the course of the study to plan for long-
term sustainability. Coaches will be recruited at the practices as in AL, assuring feasibility of travel to the 
practice. 
 
4.3.d Compensation for Peer Coaches  
 
Peer coaches in our past studies have expressed strong preferences for a fee-for-service model of 
reimbursement, which will again be used here. As such, compensation for peer coaches will follow the 
schedule below:  
• 
Peer coach training consists of 8 courses. Peer coaches will receive $50 for completing each 
training course, regardless of passing certification for a total of $400 
• 
For each participant: 
o $200 for completing the first 8 program sessions (~2 months) 
o $150 for completing program session 14 (~6 months) 
o $150 for completing program session 20 (~12 months) 
o $25 per month for each additional calls should the participant’s blood pressure become 
uncontrolled with a maximum of 2 months for a total payment of $50  
 
4.3.e Peer Coach Coordinators  
 
A critical aspect of successful peer coaching programs is the ongoing support provided to coaches. This 
role is filled by the peer coach coordinators. The role of the coordinator is to reach out frequently to the 
coaches to assure that they have the support that they need, especially social support. Peer coaches greatly 
enjoy monthly get-togethers with other coaches and the coordinator to discuss challenges, brainstorm 
solutions, and socialize. The bonds forged in these programs are an important part of satisfaction for the 
coaches. The coordinator’s role is to assess each coach’s level of functioning and assure that they remain 
enthusiastic and committed to the program. 
 
In AL, we have worked with two community coordinators for over 6 years, and these experienced 
coordinators once again fill this role for the present study. In NC, the coordinator is an experienced peer coach 
who has worked on previous research studies with the NC team. As with the AL peer coaches, the NC peer 
coaches will be situated in a CBO led by the coordinator. The coordinators are critical in setting the supportive, 
collaborative tone and maintaining enthusiasm for the program. The mentoring relationship will assure 
consistency of implementation across the two states. 
 
4.3.f Peer Coaching Program Session Schedule 
  
The Peer Coaching program is designed to provide an intensive intervention phase, followed by a 
maintenance phase with boosters as required to keep the participant’s blood pressure controlled (see Figure 
6A). Because of the implementation context, it is important to recognize that strict adherence to the protocol 
may not be feasible in some cases. Therefore, we have devised the following goals, which incorporate the real-
world issues that often arise and create delays in program implementation.  
 
• 
Goal: complete session 1 within 30 days of patient signing informed consent  

28 
 
o Peer coach and participant should be matched within 2 weeks of participant is enrolled in the study. 
o Session 1 should be scheduled within 2 weeks of the date that the peer and participant are matched.  
o Sessions 1 – 8 should be scheduled and completed 
every 7 days.  
o Sessions 9 and 12 should be scheduled and completed 
every 14 days. 
o Monthly sessions should be scheduled every 4 weeks 
• 
Program Goal: complete session 20 by month 12 of 
baseline enrollment  
o Compress monthly sessions no more than to be 3 
weeks apart. If monthly sessions need to be completed <3 
weeks apart to keep on schedule, use the following the 
guidelines below to drop sessions:  
 
Sessions 1 - 8 must be completed 
 
Sessions 9 – 12 Should be completed 
 
If needed - drop sessions 13-18 
 
Sessions 19-20 should be completed 
• 
Goal will be to complete session 20 by month 12.  
o 12-month data collection will be scheduled during the 
30 days after the 12-month date 
If the 20th session is completed before the 12-month date, an 
alert with will send to the data collection team notifying them 
that the pt is ready for data collection. 
 
4.3.g Contacting Non-Responsive Clients in the Peer Coaching Arm  
 
The goal of this section is to provide guidance regarding participant contacts to peer coaches and program 
staff. This plan should be tailored for each participant by the peer coach and community coordinator with input 
from program staff. 
 
Table 9A. Schedule of call attempts by coaches and study staff.  
Week 
Description 
0 
Peer and participant matched 
1- 2* 
Peer makes frequent call attempts, varying days and times. Minimum call attempts: every other day 
2- 3 
Community coordinator and program staff begin strategizing ways to reach out to participant (program staff should 
work with clinic to check contact information, reach out to participants to assess interest in study and verify 
times/days available, making sure that patient knows the peer’s number to ensure they are not screening the peer’s 
calls). Participant is flagged as “at risk.” 
3-4* 
Peer makes frequent call attempts, varying days and times. Minimum call attempts: every other day 
5-8* 
Peer makes intermittent call attempts, varying days and times. Minimum call attempt: once/week. 
9 
Peer, community coordinator, program staff, data collection staff review non-responsive ppts. Potential outcomes:  
1. Peer coach continues call attempts. A plan for continued peer coach contact is developed at the meeting. Part of 
plan will be determining a date that the contact plan will be reviewed.  
2. Participant is given back to program staff.  
a. Participant will be classified as inactive and peer coaches paid $200. 
b. Program staff / data collection staff will call monthly or retention calls to see if participant can be contacted. If 
contacted, staff will ask participant if they would like to speak with their peer coach (verifying times available, 
contact info, and give peer’s number) 
c. 
If patient is scheduled for 6-month data collection, staff will ask ppt if they would like to work with peer coach 
(verifying times available, contact info, and give peer’s number).  
d. Participants will be returned to peer coaches if participant requests peer calls to resume. At this time, ppt will 
be re-classified as active and peer calls resume. See Revising program session schedule protocol.  
* Peer coach should be in frequent communication with community coordinator, who, with help of program/data 
collection staff, will work with peer coach and practice staff and try different methods to contact participants. 
 
 
 
 
Month 1 
- 
Session 1: Welcome to the program, Blood 
Pressure Basics 
- 
Session 2: Blood Pressure Medications 
- 
Session 3: Healthy Eating 1 
- 
Session 4: Healthy Eating 2 
Month 2 
- 
Session 5: Physical Activity   
- 
Session 6: Stress and Health 
- 
Session 7: Family, Friends, and Health 
- 
Session 8: Getting the most out of your doctor’s 
visits 
Month 3 
- 
Session 9: Planning for the future 1 (bi-weekly) 
- 
Session 10: Planning for the future 2 (bi-weekly) 
Month 4 
- 
Session 11: Planning for the future 3 (bi-weekly) 
- 
Session 12: Planning for the future 4 (bi-weekly) 
Months 5-20 
- 
Sessions 13-18: Monthly calls 1-6 (check-in) 
- 
Sessions 19-20: Preparing for the end of the 
program 1-2 
Special calls: Intensification calls if client needs 
additional help during sessions 13-20 
Figure 6A. Program Schedule for the 
Peer Coaching Intervention.  

29 
 
4.3.h Peer Coaching Participants at Risk of Not Completing Intervention and Dropouts  
 
Information on when a peer coaching participant is hard to reach, missing sessions, has suffered a 
significant illness or life event, or other situation which would cause the patient to miss coaching sessions or 
become unresponsive to coach calls can come from many sources. This information may be obtained from 
retention calls, six month and 12 month interviews, speaking to peer coaches or coordinators, or coaching 
monthly reports. The following are guidelines on what to do once an investigator or a research assistant or 
data collector identifies a peer coach participant who would like to drop out from the peer coach arm:  
1) Program Managers should be notified, and supplied with all the information, including if possible, the 
peer coach call logs showing all the calls the coach made to connect with the patient. This information 
should be entered into the peer coaching database in ClinvestiGator, and the patient marked “At Risk.” 
 
2) At Risk Participants: Patients can be considered at risk of not completing the peer coaching program for 
any reason.  It can be a temporary status, or it can lead to eventual peer coaching intervention 
withdrawal. 
1. Program staff should work with coaches and practice champions to make sure the patient 
contact information is up to date.  
2. Peer Coaching protocols should be followed with the minimum number of calls to the patients, 
texting etc… and documented in the peer coach workbooks for that patient.  
3. If a patient continues to be unreachable or tells study staff or their peer coach they wish to 
withdraw from the intervention, the appropriate project manager should be notified.  All Non-
responsive patients should be referred to program managers. Program managers should make 
one last attempt to reach the patient and make sure the patient is aware that they can continue 
in the study, and withdraw ONLY from the coaching intervention.  As needed the PM will mark 
patient as Withdrawn from Peer Coaching. 
 
3) Patients Withdrawn from Peer Coaching  
1. Patients who choose not to participate in peer coaching are still enrolled in the study.  They 
should be continued to be tracked, and attempts to complete the follow-up data collection 
should be made. 
2. In addition, once a patient is withdrawn from peer coaching, the alert banner will automatically 
show up on the patient dashboard each time the patient record is opened in ClinvestiGator. 
3. All staff who have contact with this patient record will see this alert, and check to see if the 
‘withdrawal from peer coaching’ event form has been filled out. This form is located at the very 
bottom of the patient database in ClinvestiGator called “Withdrawn from Peer Coaching 
Intervention.”  
4. All staff who have contact on the phone, or at a 6 month or 12 month interview will try to 
complete the form; only one is needed. 
 
 
 
 
 
 
 
 
 
 

30 
 
5. Recruitment of Subjects 
 
 
5.1 Number of Participants per Site 
 
This study will include a total of 2,000 African American participants. Participant recruitment will take place 
in participating practices, and 25 patients with uncontrolled hypertension per practice will be recruited. Because 
some practices in the Black Belt are very small and we wish to optimize generalizability, we will accept a total 
of 23 participants if recruitment has been ongoing for at least 3 months and the full target of 25 participants has 
not been recruited by that time point.  
 
An important aspect of a pragmatic trial is the ability to examine the heterogeneity of treatment effects in 
high-risk subgroups of interest that are often difficult to recruit into research studies. We preplan subgroup 
analyses on 1) men, 2) those younger than age 60 years, 3) those with low health literacy/numeracy, and 4) 
those reporting mild or greater depressive symptoms. Past reports have shown that male sex and younger age 
are associated with higher risk for uncontrolled CVD risk factors, and health disparities are also greatest in 
younger individuals.2,11 Low health literacy, numeracy and depression have also been shown to be associated 
with uncontrolled CVD risk factors.48-52 We will therefore recruit at least 10 men and 12 individuals younger 
than 60 years of age at each practice; based on our past trials, we know that mild depressive symptoms are 
present in 50% of this population, and health literacy is also very low. The background prevalence and 
oversampling of men and younger individuals will provide enough power to conduct these pre-specified 
subgroup analyses (see also Analysis Plan, section 8). 
 
5.1.a Participant Inclusion/ Exclusion Criteria 
 
Inclusion and exclusion criteria are shown in Table 10. 
Concordant with the pragmatic trial context, inclusion and 
especially exclusion criteria are kept to a minimum to maximize 
generalizability. In order to minimize regression to the mean and to 
select patients at highest risk, an important goal for our partnering 
practices, we will select individuals with uncontrolled hypertension, 
defined as a mean systolic BP over the previous year at least 140 
mm Hg plus an enrollment day BP >140/90 mm Hg as assessed by 
the research assistant. 
 
Because the control of BP in people with advanced chronic 
kidney disease (CKD) is more difficult and requires special 
approaches, we focus this study on more average patients with 
estimated glomerular filtration rates (eGFR) greater than 45 
ml/min/1.73 m2. We use 45 as a cut point to maximize reach 
without selecting a population that requires management that is too different than that for more average 
patients. We considered 60 mL/min/1.73 m2, which is the threshold for Stage 2 CKD, but this threshold may 
exclude too many individuals in this pragmatic setting. In the national REasons for Geographic And Racial 
Differences in Stroke cohort study comprised of over 30,000 African American and white community dwellers 
aged 45 and over at baseline, 4.2% of African Americans had eGFR mL/min/1.73 m2. However, another 7.1% 
of African Americans had eGFR between 45 and 60 mL/min/1.73 m2, which would exclude one in 10 
prospective participants. Based on input from Dr. Oparil, a well-respected expert in the field of HTN, the 
threshold of 45 mL/min/1.73 m2 is a reasonable threshold for the study, balancing inclusivity with the need for 
simplicity in the treatment algorithm, which was updated to reflect the new HTN guidelines.  
 
 
5.2 Withdrawal Criteria  
 
        Because of the pragmatic design, this study will not have withdrawal criteria. However, over the course of 
the study, a participant may develop an exclusion criterion (e.g., become pregnant); in this case, the participant 
may be withdrawn from the study by the Recruitment and Retention Workgroup.  
Table 10. Patient inclusion and exclusion 
criteria for the trial. 
Inclusion criteria 
Exclusion criteria 
• African American 
adults aged 19-85 
years 
• Uncontrolled HTN, 
defined as >140 
mean systolic BP 
over the past year 
AND BP>140/90 
mm Hg at the time 
of study enrollment 
• Black Belt resident 
• English speaking 
• Telephone 
available 
 
• Plans to move out of 
the area within the 
next two years 
• Advanced illness 
with limited life 
expectancy 
• Chronic kidney 
disease with eGFR < 
45 ml/min/1.73 m2 
• Unwillingness to 
work with a peer 
coach  
• Unwillingness to sign 
informed consent 
• No telephone 
available 

31 
 
 
5.3 Participant Recruitment Method 
 
Participant recruitment approaches will be adapted to individual practices needs. Recruitment materials 
(posters, pamphlets) are displayed prominently in each practice (see Appendix 3), along with a certificate of 
the practice’s participation. The practice staff led by the Champion encourage patients to consider 
participating; those who express interest fill out an interest card that includes the patient’s contact information 
and signature indicating willingness to be contacted by the study team.  
 
Our experience shows that despite enthusiastic support for the study, practice staff members rarely refer 
many patients because they have too many competing demands.15 Therefore, a study research assistant 
schedules a time to visit the practice to conduct in-person recruitment with the help of the practice’s staff in 
accordance with HIPAA regulations and guided by our respective institutional review boards. In AL, recruitment 
staff members are African Americans from the Black Belt, lessening mistrust as a barrier to participation, and 
the NC teams similarly will strive to have African American staff. Since the prevalence of HTN is so high in the 
targeted population, and more than half of African Americans are not controlled, each practice is given 1-3 
months to recruit the target number of 25 patients. If a practice is not able to meet the target number of 
patients in the given time period, the site research team should refer to section 4.1.h for guidance.  
 
 
5.4 Participant Screening and Consent 
 
The number of patients with uncontrolled HTN approached for participation is tracked as part of the Reach 
metric of the RE-AIM framework by the research assistant stationed at the practice for recruitment purposes. 
These data are entered by the research assistant into the study’s web-based data system. 
 
 
Once a participant has expressed interest, the study research assistant screens the prospective 
participant. For eligible prospective participants, the research assistant then provides an explanation of what 
participation entails:  
• 
Completing a baseline in-person assessment at the practice,  
• 
Completing a baseline telephone interview,  
• 
Providing several alternative telephone numbers to facilitate contact,  
• 
Completing 6-month and 12-month follow-up assessments,  
• 
Using a home BP monitor, and  
• 
Possibly working with a peer coach.  
 
The research assistant also explains randomization, which occurs at the practice level. Willing participants then 
provide informed consent, which is explained and read to the participants by the research assistant. The study 
research assistant answers any question the participant may have, and the participant then signs the informed 
consent (see Appendix 4). A copy of the consent form is provided to the participant. Only trained and quality 
controlled research assistants provide the information required to obtain informed consent. 
 
 
5.5 Participant Compensation  
 
Participants are expected to complete 3 assessment visits over one year. They will receive $40 per visit for 
a total of $120. 
 
 
5.6 Coordination of Practice Recruitment, Peer Coach Recruitment and Training, and Participant 
Recruitment 
The recruitment of practices, coaches, and participants must be carefully coordinated. The goal of the 
study is to have all participants exposed to the interventions for as close to one year as possible. However, for 
the practice facilitation intervention, it can take up to 3 months to complete self-assessment, identify and plan 

32 
 
for the first activity, and finally implement it. If participant recruitment begins on randomization, the participants 
recruited earliest could have considerably less exposure to actual practice change than those recruited later. 
Similarly, coaches ideally are identified from the practice, followed by 2-3 months to complete training. For 
practices receiving both interventions, participants should be recruited only once the practice is ready to start 
on its first activity and the coaches have been trained.  
 
In order to address these issues, there will be a 3-month run-in phase after practice randomization and 
prior to participant recruitment, as shown in Figure 7. Practices that meet readiness criteria will be batched into 
stages for randomization 3-6 months prior to anticipated start of patient recruitment.  
 
Run-in activities for those practices randomized to the coaching intervention include: 
(1) identifying coaches who can travel easily to the practices, followed by  
(2) training any new coaches.  
 
      Run-in activities for those practices randomized to the practice facilitation intervention include:  
(1) establishing rapport,  
(2) conducting the self-assessment,  
(3) providing an overview of the intervention,  
(4) helping the practice to select their first activity, and  
(5) planning for the implementation of that activity.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 7. Run-in phase between practice randomization and start of participant recruitment. Schematic 
shows activities for the 20 practices that receive both practice facilitation and peer coaching. Those practices 
randomized to the coaching-only arm would not receive the practice facilitation run-in activities. Those 
practices randomized to the practice facilitation-only arm do not receive the coaching run-in activities. 
Schematic not to scale. 
 
 
 
 
Practic
e ready 
Practice 
randomize
d 
Peer 
coaches 
identified 
Start  
coach 
training 
End 
coach 
training 
Practice 
self- 
assessmen
t
Practice 
selects, 
plans 1st 
ti it
Begin participant 
recruitment 
Practice 
begins 1st  
activity 
Facilitator 
meets 
practice 
~3 month run-in phase 
Could be 
several  
months 

33 
 
 
6. Interventions 
 
 
6.1 Conceptual Framework 
 
The Affordable Care Act’s provisions for alternative models of healthcare (like practice transformation and 
community health workers) along with CMS’s recent announcement that they will move to mostly value-based 
reimbursement within 2 years together create a unique opportunity to study these two components alone and 
in combination in a very high-need region of the US from the perspective of HTN. This study will implement 
programs that will be designed with practices, peer coaches, and patients with HTN residing in the Black Belt, 
assuring that the interventions are sustainable and scalable throughout the region.  
 
For the multi-level practice facilitation intervention, we draw on Donabedian’s structure-process-outcomes 
paradigm and Wagner’s chronic care model.53-56 Donabedian proposed that healthcare systems should be 
structured to facilitate the provision of high quality care. This long-standing paradigm has guided quality 
improvement and health system design for decades, and is now being applied at the individual practice level. 
The chronic care model posits that care should be patient-centered and responsive to individual needs and 
preferences, drawing on community resources to optimize health outcomes. Practice facilitation is specifically 
designed to restructure practices and introduce new processes of care with an emphasis on patient-centered, 
proactive care. Practice facilitation in this intervention will help practices to fulfill 4 key functions:  
 
1) Team-based care that engages members of the healthcare team other than the physician for BP 
medication management (structure and process change);  
2) Self-management support through home BP monitoring and engagement of community resources 
(chronic care model);  
3) Standardized Care Process, for example through telephone management (structure and process                
change);  
4) Providing outreach, based on audit and feedback reports generated from HTN registries (structure and 
process change).  
 
In this functional intervention, facilitators will assist practices in making highly tailored changes in structure and 
process to accomplish these 4 functional goals, aiming to improve BP control, health, and patient satisfaction.  
 
Despite emphasis on patient-centered care, practice facilitation focuses on processes of care that address 
low uncertainty clinical situations, such as titrating BP medications when BP is not controlled. However, more 
difficult patient behavior modification may respond more to the relationship-focused peer coaching intervention, 
since behavior change is complex and filled with uncertainties. Bandura’s social cognitive theory posits that we 
learn by watching others like ourselves and underlies the effectiveness of peer coaches, who are “someone 
like me with problems like mine.”46 Peer coaching is another functional intervention, fulfilling 3 key relationship-
based functions:  
 
1) Assisting clients in carrying out the care plan;  
2) Supporting clients emotionally, establishing meaningful, supportive relationships, and encouraging 
them to take an active role in their healthcare; and  
3) Linking clients into care and community resources.  
 
Adult Learning Theory posits that adult learners are internally motivated, goal and relevancy oriented, and 
highly practical.57 They also bring life experiences and knowledge to learning experiences, and they like to be 
respected. By interacting with another community member who understands and supports them, patients share 
experiences and barriers to behavior modification. Importantly, our formative work shows that they prefer to 
interact with the peer coach for health-related questions, allowing the peer coach to be the link to the 
healthcare team to find answers together. In the peer coaching functional intervention, the relationship is the 

34 
 
operator to accomplish the 3 key functions, aiming to improve BP control and satisfaction, but through different 
influences compared with practice facilitation interventions. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Figure 8. Conceptual framework for the study. BP = blood pressure. EMR = electronic medical record. HBPM = home BP 
monitoring. 
We propose that both structure/process improvement and strong relationships are needed to overcome 
distance, trust, and psychosocial barriers to optimize BP control among African Americans living in the Black 
Belt region. We anticipate that both practice facilitation and peer coaching will have clinically important effects 
on BP, but that together they will generate a greater improvement in BP control trough their complementary 
pathways of influence (Figure 8). As healthcare reform moves forward, the results of this study will inform 
policy decisions at the regional and local levels to help communities and practices in vulnerable regions like the 
Black Belt to decide which approach is right for them, informed by how much effort is required for each 
intervention, and how much benefit they can expect to derive from implementing either practice facilitation or 
peer coaching, or both. 
 
 
6.2 Implementation Framework: RE-AIM  
 
Because this is a pragmatic trial seeking to test scalable, sustainable approaches to improving HTN control 
in the Black Belt, we use an implementation framework to inform other Black Belt practices as they consider 
the results of the study and implications for their own patients. A widely used framework is Glasgow’s RE-AIM, 
which stands for Reach, Efficacy/effectiveness, Adoption, Implementation, and Maintenance of the intervention 
effects.58-60 We integrate the framework throughout the project as shown below.  
 
RE-AIM Domain 
How accomplished 
 
 
 
 
 
 
Section in protocol 
Reach  
 
Track the number of participants approached for participation, 
 
4 
compare with the number enrolled  
Effectiveness   
Baseline and follow-up BP assessments  
 
 
 
          7, 8 
Adoption 
 
Track the number of primary care practices approached,  
compare with the number agreeing to participate  
 
 
 
4 
Implementation  
Intervention fidelity  
 
 
 
 
 
 
          6.6 
Maintenance   
1-year follow-up calls to practices 
 
 
 
 
          7.d 
 
 
 
 

35 
 
6.3 Intervention Approach/ Description 
 
6.3.a Enhanced Usual Care 
 
Enhanced usual care will be the comparator for the study. All practices receive enhanced usual care 
regardless of randomization status, which includes: 
 
1) A laptop computer.  
2) The freely available web-based PALS education system. Patients and practice staff will be able to 
access evidence-based information using the PALS question-and-answer searchable system using a 
user name/logon ID to track utilization. This system offers short, engaging content including liberal use 
of video clips to provide education.  
3) 25 home BP monitors and BP logs that are theirs to keep on conclusion of the study. 
4) A binder of practice tips that will include flow sheets and the same BP medication advancement 
algorithm used in the practice facilitation and peer coaching interventions (Appendix 6).  
 
Past research has shown that education and simply providing practices tools without more intensive 
intervention does little to change outcomes.61-63 Nevertheless, the practices we have engaged while preparing 
this proposal requested some sort of program regardless of the arm of the trial, and novel education materials 
plus home BP monitors was acceptable to these stakeholders in this real-world setting. Our experience with 
community-based interventions also indicates that “control” arm participants strongly prefer some sort of 
program rather than only usual care. Therefore, enhanced usual care directly responds to requests from 
stakeholders while creating little chance of compromising the ability to observe control-intervention differences 
and aligning with PCORI Methodology Standard 1:RQ-6 which suggests that researchers “select outcomes 
based on input directly elicited from patient informants and people representative of the population of interest, 
either in previous studies or in the proposed research”.1  
 
6.3.b Practice Facilitation 
 
6.3.b.i 
Practice Facilitation Intervention Development  
 
Practice facilitation is a highly customized, staged approach to helping a practice to implement process and 
structural changes to enhance the quality of care and improve patient and staff satisfaction. Facilitators are 
certified to have 4 core competencies:  
 
1) Interpersonal skills to build support for and facilitate change;  
2) Methods for accessing and using data to drive change;  
3) Quality improvement and change management strategies; and  
4) Health information technology optimization.24  
 
They build rapport and trust with the practice team, and they work together to assess their practice, and decide 
what process and structural changes would create the greatest chances for achieving the desired outcome, in 
this case, improving BP control in their patients. As such, practice facilitation is a functional intervention that 
naturally steps up efforts based on data-driven feedback reports from the practice itself. Practice facilitation is 
often focused on improving a key quality metric such as HTN control. Based on the evidence, practices will 
implement 4 key functions, including:  
 
1. Team Management: Medication titration algorithm implemented by a nonphysician. We anticipate that 
many practices will implement telephone-based medication titration using the patient’s home blood 
pressure measures. Implementing an algorithm that advances intensity of treatment has been shown to 
improve BP control in a variety of settings and studies, many of which have used nurses or pharmacists to 
titrate the doses.41,64,65 Physicians often do not intensify the regimen even after several encounters with 
patients with uncontrolled BP,66,67 practice facilitation will result in another healthcare team member such 
as a nurse taking over algorithm-guided medication titration (Table 11 and Appendix 6). The algorithm used 

36 
 
here is guided by the 2010 Consensus Statement issued by the International Society of Hypertension in 
Blacks, the JNC8, the 2017 AHA Guideline for the Prevention, Detection, Evaluation, and Management of 
High Blood Pressure in Adults, as well as the recently concluded SPRINT trial algorithm (see Appendix 
6).42,68,69,96  
 
An important aspect of this algorithm is the attempt to institute chlorthalidone (CHLD) therapy, which is the 
diuretic used in the major clinical trials of HTN. In practice, physicians more often use hydrochlorthiazide 
(HCTZ) because it is less expensive and causes less hypokalemia. However, Dr. Oparil’s 30+ year 
experience in the UAB Hypertension Clinic show that CHLD is a more effective antihypertensive agent: an 
observation supported by a wealth of literature.  When used in doses of no more than 25 mg, CHLD is an 
extremely safe medication which does not cause the profound hypokalemia seen with doses of 50 mg or 
100 mg.  Dr. Oparil therefore advises that CHLD be utilized in all African Americans with uncontrolled 
hypertension.  She also advises against the indiscriminate use of angiotensin converting enzyme inhibitors 
(ACEI) in African Americans, citing an ineffective BP lowering profile and a higher incidence of angioedema 
compared with angiotensin receptor blockers (ARB): she recommends that ACEI and ARB only be used for 
the patient subpopulation with chronic kidney disease (CKD), defined as eGFR < 60 mL/min/1.73 m2, and 
that under these circumstances ARB should be preferentially employed.   Additionally, she recommends 
we avoid the use of beta blockers, which have little BP lowering effect in African Americans and have a 
high side effect profile. Beta blockers can, however, be used for other guideline indications, namely in the 3 
years following a heart attack or in the setting of systolic heart failure. Finally, she contends that loop 
diuretics are not to be used as antihypertensive agents and that they should be used only if there are other 
indications such as systolic heart failure.  The algorithm has been formulated to incorporate all of these 
recommendations. 
 
An important consideration in this trial is the likelihood that most of the trial’s participants will be living in low 
socioeconomic circumstances, and cost will likely be a considerable issue for them. For this reason, we will 
include in the algorithm less expensive alternatives like HCTZ. However, we will recommend the 
medications with the most robust evidence of efficacy as first line, and those with less robust evidence as 
second line.  
 
Similarly, we recognize that pill burden may be substantial in many of the trial’s participants because of the 
well-known clustering of cardiovascular risk factors in African Americans, especially those living in low 
socioeconomic circumstances. Therefore, we will encourage the use of fixed-dose combination pills, 
several of which are low in cost. We will also include extensive relative cost information which will be as 
locally relevant as possible. 
 
Table 11. BP Management Algorithm for Medication Intensification for Uncontrolled BP (see Appendix 6) 
Current Therapy 
Options if BP Uncontrolled 
No medications 
Start 12.5 mg chlorthalidone (if diabetic or eGFR 45-60 mL/min/1.73 m2, add 
ACEI or ARB (prefer ARB); if BP > 160 mm Hg, start 25 mg chlorthalidone) 
HCTZ monotherapy 
Switch to chlorthalidone (if diabetic or eGFR 45-60 mL/min/1.73 m2, add ACEI 
or ARB (prefer ARB)  
ACEI or ARB monotherapy* 
Add 12.5 mg chlorthalidone (25 mg if BP > 160 mm Hg) and switch ACEI to 
ARB 
DhCCB monotherapy 
Add 12.5 mg chlorthalidone (25 mg if BP > 160 mm Hg) (if diabetic or eGFR 
45-60 mL/min/1.73 m2, also add ACEI or ARB, prefer ARB)  
HCTZ + ACEI/ARB 
Switch to 12.5 mg chlorthalidone (25 mg if BP > 160 mm Hg) and increase 
dose of ACEI or ARB (if not already at maximum dose), or add dhCCB 
HCTZ + maximum dose dhCCB 
Switch to 12.5 mg chlorthalidone (25 mg if BP > 160 mm Hg) and add ARB  
ACEI/ARB + maximum dose dhCCB 
Add 12.5 mg chlorthalidone (25 mg if BP > 160 mm Hg), change ACEI to ARB 
ACEI/ARB + dhCCB + thiazide-like 
diuretic 
If all at maximum dose, consider adding 25 mg spironolactone 
4-5 agents, all at maximum tolerated 
doses 
A study Clinical Hypertension Specialist will provide recommendation 
ACEI=angiotensin converting enzyme inhibitor. ARB=angiotensin receptor blocker. CCB=calcium channel blocker. dh=dihydropyridine. 
HCTZ=hydrochlorothiazide.*ACEI and ARB are not to be used together in any regimen. †Equivalent doses of chlorthalidone are more potent and longer-
lasting than HCTZ. If cost of chlorthalidone is a barrier to adherence, consider using indapamide. 
 

37 
 
Both Drs. Oparil (in Alabama) and Viera (in North Carolina) run HTN clinics at their hospitals. Questions 
about care for truly resistant HTN will be directed at them for tailored care.  
 
2. Self-management support has evidence for modest benefit.70 A 2005 meta-analysis of RCT included 13 
studies of HTN, and concluded that there was modest benefit (~5 mm Hg reduction) of self-management 
support, and earlier studies supported this conclusion.71 Self-management support can take the form of 
group classes, educational materials for self-administration, one-on-one sessions in the clinic, goal-setting, 
among others.72 Practice facilitators will customize self-management support based on the practice’s 
preferences and local feasibility. Practice facilitators will also train practice staff on how to use the PALS 
with their patients; the PALS includes engaging educational materials on HTN, BP medications and side 
effects, healthy eating in accordance with the DASH diet and modified to Southern culinary tastes, and 
physical activity.  
 
An important multi-level aspect of the self-management support function is tapping into community 
resources, which include nutrition counseling through the Department of Health and the Cooperative 
Extension. Additional community resources include farmer’s markets, community gardens, walking groups, 
and church-based health programs. To facilitate community linkages, Practice facilitators will train practices 
how to use mydiabetesconnect.com, a diabetes-related resource bank for the Birmingham area developed 
by UAB investigators. This site has been expanded into the AL Black Belt counties, and we are further 
expanding this website for the NC Black Belt communities surrounding our partnering practices, drawing on 
community resource guides developed by the NC team,73,74 as well as suggestions from patients, peer 
coaches and practice staff (see section 3.1.b above). The web site includes local community resources that 
practice staff will be able to use to help patients with self-management support. 
 
Additional self-management support will be through home BP monitoring. A 2011 systematic review of 37 
RCTs concluded that there was evidence of modest benefit, especially when combined with telephone 
support, as will be done here. Home BP monitoring is endorsed by the Million Hearts campaign75 and 
JNC8.42 Practice facilitators will teach practice staff and physicians how to use home BPs and how to train 
patients in the use and reporting of home BP readings. Participants will use their home blood pressure 
measures to reinforce the need for medication adherence, medication titration, and lifestyle changes, and 
will report home blood pressure measures to practice staff during telephone management calls. Practice 
staff will use home blood pressure measures to make treatment decisions and to reinforce messages on 
medication adherence and lifestyle adherence. 
 
Cultural sensitivity is an important aspect of successful BP management in the targeted population. 
Patients living in poverty are often embarrassed by their inability to follow physician recommendations due 
to limited resources or confusion and lack of understanding. They will not readily disclose nonadherence 
for these reasons. Part of the study-specific practice facilitation training will include training in cultural 
sensitivity, based on numerous workshops conducted at UAB under the auspices of its Minority Health 
Research Center. Drs. Safford and Cherrington have both led such workshops. 
 
3. Improved access. Distances combined with poverty create large access barriers in rural areas like the 
Black Belt. Practices will overcome access barriers by expanding telephone management based on home 
BP readings if patients cannot attend clinic. As value-based reimbursement is fully implemented, past 
barriers to providing more telephone advice and support, which is not reimbursed in AL, will be removed. 
Practice facilitators will assist the practices in developing protocols for telephone-based management. 
 
4. Outreach through use of the EMR: registries, audit and feedback. Facilitators assist practices in the 
meaningful use of their EMRs, where present, to create a registry of their HTN patients, with audit and 
feedback reports to identify individuals who are uncontrolled, and/or have missed appointments. These 
reports are used for outreach and to re-engage individuals at high risk for uncontrolled HTN. Visit 
frequency is directly correlated with BP levels.76 Outreach can include sending reminder cards or telephone 
calls. Audit and feedback reports also prompts plan-do-study-act cycles for improving processes that the 
practice and the facilitator identify as barriers to achieving the goal of 75% HTN control in their HTN 
patients. 

38 
 
 
Each practice randomized to receive the practice facilitation intervention will work with their facilitator to 
implement these 4 core functions. Similar to the peer coaching intervention, the specific activities that will be 
undertaken to accomplish this implementation will vary from practice to practice. For example, in practices 
without EMRs, their billing and scheduling systems may be used to create registries and identify patients for 
outreach. Such practices may need to conduct chart audits to create their feedback reports rather than learning 
how to extract reports from their EMR. Similarly, the team member identified for implementing algorithm-based 
BP medication management may vary from a nurse to an experienced nursing assistant, depending on the 
makeup of the practice team.  
 
Although the specific activities across practices may vary, each facilitator will be trained to encourage the 
implementation of at least one activity in each of the 4 key areas over the 1-year intervention period. We 
anticipate that all practices will work toward developing a data-driven approach to improvement, to consider 
having some form of telephone management using home BP readings in place, to implement the algorithm to 
guide BP medication titration (Appendix 6), and to enhance self-management support. Some practices may 
implement several activities under each key function, but all will be asked to implement at least one under each 
key function. 
 
An important aspect of this intervention is the successful engagement and activation of African American 
patients. While all of these practices have extensive experience with African American patients, emerging 
evidence suggests that even experienced practitioners may not utilize approaches and practices that maximize 
patient engagement. For example, although cost is a barrier to medication adherence, many patients do not 
feel comfortable raising this issue with the provider, and few providers systematically ask about affordability of 
the treatment regimen. Doing so in a supportive, culturally sensitive manner enhances the practice’s ability to 
assure that all of its patients are on an affordable medication regimen. Cultural sensitivity will be a key focus of 
practice facilitation training to assure that all of the activities undertaken by the practice are implemented in a 
culturally concordant manner.  
 
The current draft of the practice facilitation guide is appended in Appendix 7. 
 
6.3.c Peer Coaches 
 
6.3.c.i 
Peer Coaching Intervention Development  
 
The peer coaching intervention is modeled on lifestyle and medication adherence interventions we have 
developed for diabetes in collaboration with community partners now spanning over 6 years. The peer coaches 
prefer structured programs, thus we use that approach here. 
 
We use a partnership approach to intervention development. We have learned from our participants that 
they greatly value lifestyle modification in any health-related intervention, as reflected in the fact that 93% of 
Encourage study participants chose to work on diet and exercise to improve their diabetes “numbers” rather 
than working on medication adherence. Responding to this request, the intervention includes chapters on 
healthy eating and exercise to enhance engagement. 
 
The intervention is developed iteratively in partnership with existing peer coaches. We draft key evidence-
based content elements for each chapter and our peer coaches provide feedback, which is then incorporated. 
We then create a full draft of the chapter and tape record the interaction between a mock peer coach and a 
patient. The peer coaches listen to the recording and view the fully developed chapter, and again provide 
feedback. They then practice with each other in pairs until they are ready to be certified on the chapter by 
playing the role of the peer coaches with one of our research assistants playing the role of the patient. We 
repeat this process weekly until each peer coach has been certified; for an 8-session program, this takes about 
10 weeks. We anticipate 8 chapters for the structured phase of the intervention as shown in Table 12, followed 
by booster contacts at least once per month for a full year. 
 

39 
 
 
 
 
Table 12. Peer coaching intervention topics and timing 
Topic 
Overview; 
what is 
HTN 
BP meds, 
home BP 
monitoring 
Healthy 
eating 1 
Healthy 
eating 2 
Physical 
activity 
Stress and 
Health 
Family, 
friends, and 
health 
Getting the 
most out of 
MD visits 
Planning for the 
future and 
Booster sessions 
+ intensification 
calls as needed 
Timing 
Week 1 
Week 2 
Week 3 
Week 4 
Week 5 
Week 6 
Week 7 
Week 8 
Week 9 and 
<Monthly 
 
 
The interventions include engaging video presentations with visual images and few written words instead of 
didactics, and embed community members telling their perspectives and stories to personalize the intervention, 
and to incorporate Adult Learning Theory and Social Cognitive Theory. The educational material is presented 
on DVDs, since many community members do not have access to the internet. Participants are asked to watch 
the week’s chapter prior to their telephone call with the peer coach. During the call, they discuss the content of 
the video and the peer coach reinforces key points. The participant is given an activity book, and the peer 
coach has a peer coach manual and a client plan book, both of which are coordinated to facilitate the 
discussion (see Appendix 7 for examples of a chapter in an Activity Book and coordinated coaching manual 
from an ongoing study that will be adapted here). The participant is given homework at the conclusion of each 
session, which they track in their Activity Book and which is reviewed at the beginning of the next session. The 
peer coach helps the patient to set goals around self-management, including medications, home monitoring, 
and diet and exercise, and she helps the patient to strategize how to accomplish the goals, using motivational 
interviewing techniques. 
 
Peer coaches may also use the expanded mydiabetesconnect.com website developed at UAB to link their 
clients into community resources. An attractive feature of the website is the peer coach’s (or practice staff’s) 
ability to enter new resources or make corrections to existing listed resources, such as a change in hours or 
location. The website thus serves as a dynamic resource, constantly being updated by its users. NC also has 
web-based links to community services that will be emphasized as a resource during training. Furthermore, 
during the peer coach trainings, the peers as a group complete an asset mapping activity to help identify and 
share additional resources located in the clinic’s community. These are added to mydiabetesconnect.com. 
 
An important component of the peer coaching intervention is linking back to the practice about the patient’s 
progress. Each peer coach will meet the Practice Champion in person at the start of the intervention period to 
establish rapport. Practice Champions are briefed on the value of peer coaches and a synopsis of the evidence 
supporting peer coaching interventions in HTN. Each practice will tailor their communication approach with 
peer coaches, whether by telephone or in person visits to the practice, assuring timely communication of 
progress and issues that arise during the interactions between the patient and the coach. For example, if the 
patient discloses that they cannot afford the HTN medication regimen, the peer coach will notify the practiced 
through the agreed upon communication channel, and the physician will review the medications and 
recommend an affordable regimen that the peer coach then assures is received by the patient. The study 
provides a resource for medication price comparisons for practice staff through the PALS web portal. The 
coach reaches out to the practice every two weeks during the first 2 months, then monthly, using a structured 
form to report on progress. This form will include home BP readings, which will be used by the peer coaches to 
assess progress, reinforce educational messages, reinforce the importance of adherence to medications and 
lifestyle changes, and during the maintenance phase, they will use these measures to assess the need to 
intensify contacts if blood pressures begin to rise. 
 
6.3.d Hybrid Intervention: Practice Facilitation with Integrated Peer Coaches 
 
The 4th arm of the trial combines practice facilitation with peer coaches. During the intervention 
development and practice engagement process, it became clear that practices were enthusiastic about the 
peer coaching intervention and how it could be integrated into the practice facilitation intervention. For 

40 
 
example, practices reported difficulties in getting their patients to understand medication titration instructions, 
and they identified a role for the peer coaches in which they would assist patients with implementing these 
instructions, providing the extra help and reinforcement to assure that the patient understands what they are 
supposed to do. This was felt to be especially critical for telephonic medication management. Another area 
where our partnering practices felt peer coaches could be instrumental was in providing self-management 
support, especially with lifestyle changes. Based on extensive discussions with our partnering practices, it is 
likely that peer coaches may be integrated into the activities in several of the 4 Key Driver domains, making it 
difficult to tease apart the effects of the practice facilitation intervention and the peer coaching intervention. 
Practices were also enthusiastic about the peer coaches assisting with outreach, especially if telephone 
numbers change and the practice has difficulty reaching the patient. They looked forward to having the peer 
coach be tasked with obtaining new contact information and encouraging the patient to keep follow-up 
appointments. For these reasons, it is likely that the combination of the two interventions – practice facilitation 
and peer coaching – will result in an intervention that is more than a simple sum of the two interventions.  
 
Practice facilitators and peer coaches will receive the same training for this hybrid intervention, but the 
practice facilitator change packet will add examples of activities that integrate peer coaches such as those 
listed above.  
 
 
 
6.4 Training 
 
6.4.a Facilitator Training 
 
We will certify facilitators using an AHRQ-funded certificate program available through the State University 
of New York at Buffalo/Millard Fillmore College. This web-based program spans 13 weeks and includes 1.5 
hours/week of webinars, plus 26 hours of reflective learning. The certification program is designed to build 
competency in interpersonal skills, accessing and using EHR data, quality improvement strategies, and health 
information technology optimization. A 40-hour practicum experience with another certified facilitator is also 
required. The NC AHEC program has trained several certified facilitators, who will provide practicum 
experience for the project’s facilitators, also serving as mentors for the AL AHEC program, which currently 
does not have any certified facilitators. AL facilitators will be part of the AHEC program, building a work force of 
facilitators for the state of AL, and laying the groundwork for a sustainable practice facilitation program. 
 
Once certified, facilitators receive additional training to provide study-specific skills. They receive training 
on HTN and its treatments, become familiarized with the HTN treatment algorithm (Appendix 6), learn skills 
related to cultural sensitivity, and practice motivational interviewing skills. This training will be conducted by 
webinar and teleconference as well as in person during the 40-hour practicum that the AL Practice facilitators 
will spend in NC with the NC AHEC team. An important objective of the in-person time spent in NC is to 
establish relationships with mentors who serve as a resource and support throughout the study period. Once 
trained, facilitators participate in biweekly calls to troubleshoot and brainstorm ideas. Practice facilitators also 
reach out to their mentors for ongoing help and advice.  
 
6.4. b Peer Coach Training 
 
Peer coaches are trained using the programs we have developed in the course of our work in the Black 
Belt.14,15 Unlike practice facilitation, there is no nationally recognized certification program for peer coaches. 
Training is made up of 8 courses that take place in-person and by phone or webinar. The goals of the training 
include: peers are confident to implement the program as designed, peers understand ethical obligations of 
being part of a research study team, and to establish an infrastructure for continued support and education for 
that clinic’s peer group. Peer coaches are certified for each of the first 8 program sessions and the 
maintenance phase after each training course. Our training approach begins with 1 or 2 in-person workshops, 
which take place in community settings. We spend the day covering techniques of motivational interviewing 
and supportive counseling, with live modeling and ample opportunities for role-playing and practice. Coaches 
also learn how to use a BP home monitor. Certifications are scheduled to be completed over the phone after 

41 
 
each training course, with opportunities for later telephone remediation for those coaches who do not meet 
minimum standards of motivational interviewing and supportive counseling.  
 
Training continues by telephone or webinar through a series of 
conference calls over 4 to 6 weeks. We provide basic information 
about HTN and its consequences, along with basic information on 
medications used to treat HTN along with common side effects and 
costs. We provide information on self-monitoring and the 
interpretation of BP readings. We familiarize the coaches with the 
same algorithm used in the practice facilitation intervention 
(Appendix 6), with instructions to reach out to the practice if they 
discover that the patient is not able to tolerate a new dose or newly 
added medication, or if the home BP is consistently above goal. 
The coaches learn common titration recommendations (e.g., 
double the dose of this medicine and then fill the new prescription 
at the pharmacy), allowing them to reinforce the plans with 
patients. Our discussions with practicing physicians during practice engagement have revealed that many 
patients have a great deal of difficulty with even the simplest medication titration instructions, and we will be 
sure that coaches understand how to follow these types of instructions.   
 
We also teach the peer coaches about healthy eating using the plate method (Figure 9) and emphasizing a 
few key messages in the form of easily remembered “sound bites” (e.g., “respect the border” to reinforce 
portion size control by leaving the border of the plate unobstructed by food; “be sweet on yourself” to avoid 
sugar sweetened drinks; “one and done” to avoid second helpings). This simple approach resulted in weight 
loss in the Encourage study even though weight loss was not a specific goal of that study. We add specific 
lessons on lowering salt intake, and serve a buffet lunch so that coaches can immediately put into practice 
what they learned. We also have a post-prandial exercise session to reinforce learning about physical activity. 
We finish the afternoon by providing an overview of the intervention, and practicing the first session using a 
buddy system and trainers that float between pairs, providing reinforcement of key skills. Coaches receive their 
manual and review the participant activity books and self-monitoring calendars.  See Appendix 8 for a peer 
coaching training manual that is being adapted for the present study. 
 
Since they are not healthcare professionals, peer coaches are often uncertain about their clients’ questions 
related to health, especially the numerous questions about medications. Therefore, coaches are trained on 
how to use the PALS, providing a resource for peer coach interactions with their clients designed to give them 
confidence in the reliability of the information they provide. As described above in section 6.3.b.i, the PALS is a 
web-based question-based system with evidence-based, referenced answers that covers basic facts about the 
pathophysiology of HTN, its long-term consequences, the medications used to treat HTN, and their cost and 
side effects. Answers are short, and when there is a need for didactics (e.g., “what is HTN?”), answers are in 
the form of engaging videos designed to encourage the viewer to watch the segment several times. The PALS 
will be made available to each practice on the laptop provided by the study, with the intent of providing factually 
correct education material for the practice’s patients (and staff). The PALS is also available wherever there is 
an internet connection, thus its use as a resource for the peer coaches provides the opportunity to encourage 
wider use outside the healthcare setting.  
 
After the in-person trainings, coaches meet on weekly conference calls or by webinar to discuss the next 
chapter in the intervention, after which they practice the intervention at least twice, once playing the role of the 
patient and once of the coach. When they feel confident, they schedule a call with the research assistant, who 
plays the role of the patient, and the coach works through the session to become certified. Research assistants 
have the opportunity to reinforce skills over the course of this training program, which takes approximately 8-10 
weeks to complete for an 8-session program and booster/maintenance sessions. 
 
The peer coach training is timed to finish close to the start of intervention delivery. This timing resulted from 
requests from the peer coaches to maximize their confidence in their ability to deliver the intervention as 
Figure 9. Placemat used in the 
peer coaching intervention 

42 
 
intended. Because of the duration of the study, peer coach training sessions will be held in both AL and NC in 
the later years of the study period in order to assure availability of peer coaches.  
 
 
6.5 Duration of Intervention 
 
The duration of the invention is one year. 
 
 
6.6 Implementation of Intervention 
 
6.6.a Staged Implementation across the 80 Participating Practices  
 
We will implement the interventions across randomized practices in stages to maximize feasibility in this 
real-world setting. We will first implement the intervention at 4 practices, each randomized to one of the 4 arms 
of the study, which will constitute the vanguard. The vanguard will allow for minor modifications to study 
procedures based on the real-world challenges we will encounter, prior to wider implementation across all 80 
practices. Following the vanguard, we will implement the study in stages of 10-12 practices at a time, as shown 
in Figure 11. This approach maximizes feasibility within the constraints of the available funds under this 
funding opportunity. We have designed the implementation to aim to complete data collection by the end of 
year 4, allowing sufficient time to complete data collection and data analysis in Year 5. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.6.b Implementing the Interventions at the 80 Participating Practices  
 
6.6.b.i 
Implementation of Enhanced Usual Care 
 
At the time that patient recruitment starts at the practice, we will implement the enhanced usual care 
condition at all practices (see also section 6.3.a). Each practice will determine the best location for the laptop 
with the education system, along with a set of headphones for patient use. All practices will also receive a 
binder of practice tips, including the BP medication management algorithm (Appendix 6). All patient 
participants regardless of study arm will also receive a HPBM at the time of baseline data collection, and the 
research assistant will instruct each patient in its use.  
 
6.6.b.ii 
Practice Facilitation Intervention Implementation 
 
For practices randomized to receive the practice facilitation intervention arm, a practice facilitator will 
contact the practice within one week of the start of recruitment and initiate the practice facilitation intervention. 
The practice facilitator will meet with the practice face-to-face within 2 weeks of the initial call, and initiate 
collaborative planning with the practice team using the readiness assessment tool, called the Key Drive 
Implementation Scale (KDIS). This tool serves dual purposes with roles during recruitment as part of the 
assessment of the practice’s ability to participate as well as during the intervention itself as a kind of barometer 
Y2 
  
  
  
Y3 
 
 
 
Y4 
  
  
  
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
4 (VANGUARD) 
 
 
 
 
  
 
 
  
  
 
10 
  
  
  
 
 
  
 
 
  
  
 
 
10 
  
  
  
 
  
 
 
  
  
 
 
  
12 
  
  
  
  
 
 
  
  
 
 
  
 
12 
  
  
  
 
 
  
  
 
 
  
 
 
12 
  
  
  
 
  
  
 
 
  
 
 
 
10 
  
  
  
  
  
 
 
  
 
 
 
 
10 
  
  
  
Figure 10. Staged implementation scheme for the 80 participating 
practices. Numbers indicate the number of practices per wave. 

43 
 
of the progress that the practice is making. Practice facilitator will make face-to-face visits at least monthly for 
the duration of the intervention period. In addition, the practice facilitator is in frequent telephone contact with 
the Practice Champion in order to provide ongoing consultative advice on the practice’s transformation efforts. 
At each monthly visit, practice facilitators will assess the practice’s progress using the KDIS, and compare this 
assessment with the practice’s self-assessment. This comparison is designed to stimulate conversation, action 
planning, and build rapport. Both the practice facilitator assessment and the practice’s self-assessment serve 
as process measures for the intervention. 
 
The BP titration algorithm is a central focus of practice facilitator activities (Appendix 6). If patients are 
adherent with medications and lowering salt intake, BP can be controlled in upward of 80% of African 
American patients. However, many may not achieve a BP <140/90 mm Hg despite following the algorithm. In 
these cases, Drs. Oparil (in Alabama) will be consulted for tailored advice on medication titration. Dr. Oparil is 
a leading clinical trialist in the field of HTN, having served on the 7th JNC and co-chairing the 8th JNC. She was 
also the PI of the SPRINT. In addition, she has led a HTN referral practice for over 30 years.  
 
An important aspect of practice facilitation is the management of change fatigue. The practice facilitator 
Collaboratory is designed to provide peer support among practices undergoing transformation.77-81 75-79 The 
practice facilitator Collaboratory is a biweekly conference calls with a short presentation from one of the 
practice facilitators discussing how they overcame barriers in collaboration with the Practice Champion and/or 
team and succeeded at implementing the 4 key functions. Facilitators are partnered with experienced practice 
facilitator mentors from the NC AHEC, and they are encouraged to reach out to their mentors for help and 
advice. If needed, the study’s physician leaders may be asked to communicate with the practice team to 
provide advice as academic detailers, drawing on their collective experience with practice change 
interventions. The calls are recorded for those that miss a call. Others bring their challenges to the group for 
brainstorming. In addition to the conference calls, a study specific list serve is being used by the practice 
facilitators; this messaging capability allows practice facilitation practices to share experiences and successful 
strategies for overcoming barriers. The Practice Facilitation lead investigator, Dr. Halladay, and the AHEC 
point person, Ms. Mackey, are available by cell phone for in-the-moment consultations. These support 
mechanisms serve as an important source of invigoration, overcoming change fatigue.  
 
 
6.6.b.iii 
Peer Coaching Intervention Implementation  
 
Practices assigned to the peer coaching intervention arm have a peer coach assigned to each recruited 
patient. The coaches meet the Practice Champion face-to-face at the start of the coaching intervention, and 
they firm up communication plans. Peer coaches contact the practice monthly to provide updates on progress 
using a structured form that may be placed in the patient’s record at the practice’s discretion. In between these 
monthly contacts, telephone contact is maintained with the Champion as needed to meet the patient’s needs. 
 
At enrollment, each participant receiving the coaching intervention receives a packet with their DVD and 
activity book. We had originally planned to provide study phones to participants but were unable to do so due 
to financial constraints. All participants will be briefed on the availability of so-called ‘Obama phones’ that are 
available free of charge to individuals with low incomes. 
 
The peer coach contacts the participant within 2-4 weeks of enrollment, and sets up a time to conduct the first 
telephone session of the intervention. They instruct the participant to watch the first chapter of the educational 
DVD in preparation for their first intervention session. They work through each intervention session on the 
telephone, reviewing the content of the DVD as the springboard to their discussion. The coach encourages the 
participant to examine their barriers to achieving BP control, including barriers to medication adherence, 
healthy eating, physical activity, and keeping their appointments. They collaboratively set a realistic, achievable 
goal, which the participant tracks daily until their next session. The coach also encourages the participant to 
monitor their BP using the home monitor and to record their numbers to familiarize themselves with normal 
levels of BP and their own progress toward achieving control. The coach assists the patient in reaching out to 
the practice for problems such as inability to afford medications, side effects, or high readings that may trigger 

44 
 
escalation of medication doses. The PC start date is the date of consent and the intervention ends exactly 365 
days later. For example if a participant provides informed consent on January 15, 2018, they end their PC 
intervention on January 14, 2019. 
Once the initial 8-session program has been delivered, the monthly calls will be intensified to weekly calls 
for patients who have high home blood pressure levels as well as reaching out to practice champion. For 
patients who cannot be controlled despite appropriate titration of medications by the practice, Drs. Oparil and 
Viera will advise the practice on alternative approaches to achieving control on a case-by-case basis.  
 
Once the BP is consistently in the controlled range (or as controlled as possible after guidance provided by 
Dr. Oparil), contacts become less frequent. Coaches are asked to contact clients at least monthly to assess 
progress on personal healthcare behavioral goals and to check on home BP monitoring numbers. Should BP 
become uncontrolled, contacts are intensified with reassessment of medication and dietary adherence and 
outreach to the practice for medication titration or medical management, including an additional office visit as 
deemed necessary by the doctor or nurse practitioner. The coach assists the client in making arrangements to 
keep any appointments at the practice. Weekly contacts are maintained until the BP is controlled or as 
controlled as possible, where after contacts are again made less frequently, at least once per month until the 
end of the intervention period. 
 

45 
 
7. Measurements 
 
7.1 Overview of Measurements 
 
The study will collect outcome measures based on physiologic data, patient-derived data in the form of 
surveys, medical record-derived data, and a variety of process measures designed to understand which 
aspects of the interventions were most successful in driving change. The potential change drives and their 
associated outcomes are shown in Table 13. Each of these data elements and the frequency and timing of 
their assessment is discussed in 
more detail in this section. 
 
 
7.2 BP (Primary Outcome) and 
Height and Weight  
 
Physiologic measures are 
assessed in the practices by a 
trained, quality controlled 
research assistant following 
standardized protocols guided by 
JNC recommendations. The 
protocol for these assessments is 
shown in Appendix 10.  
 
To measure the BP, the 
research assistant first measures the upper arm to determine the appropriate cuff size. The participant is 
seated with both feet on the ground and asked to rest for 5 minutes prior to assessing the BP using an Omron 
IntelliSense™ digital BP machine. Two measures are taken and the second is used for analyses. Height and 
weight are assessed using a digital scale and a stadiometer. All research assistants use identical equipment 
for data collection.  
 
BP, height, and weight will be assessed at baseline. BP and weight will also be assessed at the 6-month 
follow-up and the 12-month follow-up. 
 
 
7.3 Patient survey  
 
Quality of life and patient satisfaction are assessed as part of the study’s secondary outcomes. These 
measures meet PCORI Methodology Standard 2:PC-3 which recommends the use of patient-reported 
outcomes when patients or people at risk of a condition are the best source of information. Where available, 
we use validated instruments with acceptable psychometric properties in the targeted population (Appendix 10) 
The use of validated instruments meets PCORI Methodology Standard 3:IR-4 (Document validated scales 
and tests - Studies should include documentation of the name of the scales and tests selected, reference(s), 
characteristics of the scale, and psychometric properties).1 The instruments included in the patient survey are 
shown in Table 14. Two questions related to the gender and race of the patient’s primary care provider were 
added to the survey. 
 
Minimizing participant burden is a major emphasis in pragmatic trials. In this study, one of the interventions 
acts through relationships, which can only be assessed through participant report. Further, health behaviors 
are targeted, which are poorly documented in medical records. In our past work we have learned that 
community members value programs targeted at CVD risk reduction that include diet, exercise and stress 
reduction, thus they are included here. 
 
 
Table 13. Change drivers and driver outcomes and how they will be assessed. 
See also Figure 4 on page 12. 
Intervention 
Change  Drivers (example 
activities) 
Driver Outcomes 
Peer 
Coaching 
Reinforce care plan: CM 
Affordable medications: PS 
Emotional, behavioral support: PS 
Side effects, adherence: PS 
Self-monitoring support: CM, PS 
Healthier diet: PS 
Overcome barriers: CM, PS 
More physical activity: PS 
 
 
Link to care: CM, PS 
Stress: PS 
Link to community: PS, CM, web use 
 
Practice 
Facilitation 
Registries: PrS 
Outreach: PS, PrS 
Audit and Feedback: PrS 
Timely medication titration: MR 
Home BP monitors used: PrS, PS 
Case management: PS, PrS 
Telephone management: PrS, PS 
 
RN applies algorithm: PrS 
 
Refer for nutrition: PrS, PS  
 
CM = coach manual. PS = patient survey. PrS = practice survey. MR = medical record review. 

46 
 
 
 
Table 14. Domain, instruments used to assess the domain, and assessment schedule of the patient 
survey 
Domain 
Instrument 
B 
6m 12m 
Demographics 
Insurance  
Education 
Employment 
Income 
Marital status 
Ethnicity 
Provider Demographic 
Y 
Y 
Y 
Y 
Y  
Y 
Y 
Y 
N 
N 
N 
N 
N 
N 
Y 
N 
N 
N 
N 
N 
Y 
Satisfaction (outcome) 
Patient Assessment of Care for Chronic Conditions 
(20) 
Perceived Usefulness of CHW 
Y 
N 
Y 
Y 
Y 
Y 
Quality of life (outcome) 
Short form 12 (12) 
Patient Health Questionnaire (8) 
4-item Perceived Stress Scale (4) 
Questionnaire for verifying stroke-free status  
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Social Support (outcome) 
PROMIS Social Functioning – 3 subscales (12) 
Y 
Y 
Y 
Health literacy  
Numeracy  
CHEW Health Literacy Scale (3) 
3-item subjective numeracy scale (3) 
Y 
Y 
N 
N 
N 
N 
Knowledge (barrier)  
Barriers 
Hypertension Knowledge and Attitudes (11) 
Barriers to Medication Adherence (20) 
Y 
Y 
N 
Y 
Y 
Y 
Patient Activation (activation) 
Medication adherence 
3-item Patient Activation Measure (3) 
4-item Morisky Medication Adherence (4) 
Y 
Y 
Y 
Y 
Y 
Y 
Fruit & vegetable intake 
(behavior) 
 
Physical activity  
 
 
Tobacco use 
 
Alcohol Use 
 
Goals and Attainment of Self-
Define Goals 
Pfp FV question (1) 
 
 
REGARDS / NHANES PA question (1) 
Framingham Heart Study PA question (1) 
 
NHIS Tobacco use questions (2) 
 
AUDIT-C (4) 
 
Patient goals and attainment of self-defined goals 
(15) 
Y 
 
 
Y 
Y 
 
Y 
 
Y 
 
Y 
Y 
 
 
Y 
Y 
 
Y 
 
Y 
 
Y 
Y 
 
 
Y 
Y 
 
Y 
 
Y 
 
Y 
Safety/side effects (safety) 
Falls (1) 
Side effects re: BP meds (10) 
Utilization – Hospital 
Utilization – ED or Urgent care 
Utilization – Primary care doctor / NP 
Question to assess if PC office called to discuss 
HBP 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Cognitive Function 
6-item screener to identify cognitive impairment (6) 
Y 
Y 
Y 
Comorbidities 
Diabetes questions (2) 
Y 
N 
N 

47 
 
Comorbidities questions (8) 
Y 
N 
N 
Discrimination / Trust 
Discrimination in healthcare scale (11) 
Y 
N 
N 
 
We recognize that several of the proposed domains are not ideally assessed using brief self-reported 
measures, specifically diet, physical activity, and healthcare services utilization. However, given the pragmatic 
trial context and the main interest in BP, we use brief measures that have been widely implemented in well-
established surveys, minimizing participant burden. Health services utilization has been shown to be reliably 
assessed through patient report when the interval being assessed is shorter than one year.82  
 
If the interview cannot be completed in person, the interview is administered by a research assistant on the 
telephone shortly after the data collection visit in the practice. Research assistants are trained and certified for 
cultural sensitivity and interviews are recorded for quality control. The elements of the survey collected at 
baseline, 6-month follow-up, and 12-month follow-up are also shown in Table 14. The steps to completing the 
6-month and 12-month interviews with enrolled patients are listed below:  
 
7.3.a Completion of 6-month and 12-month interviews with enrolled patients 
 
All enrolled patients will be contacted for follow-up interviews at approximately 6 and 12 months after their 
date of consent.  
 
a. The ‘gold standard’ for all interviews is a ‘face-to face’ meeting where the patient’s BP and weight are 
assessed by the data collector. 
 
b. In special circumstances, data collectors will be allowed to conduct a follow-up survey over the 
telephone, but the patient must meet a data collector and have their BP and weight assessed to receive 
the $40 incentive payment. These cases should be discussed with the program manager. 
i. A minimum of 15 calls should be made to patients in attempts to arrange interviews.   
ii. Additional postcards and texts can be sent, alerting the patient that the study team is trying to 
reach them.  
iii. Calls to the practice champion should be made to check for new contact info, and to strategize on 
how to reach these difficult patients. 
iv. If you reach patient: emphasize the $40 incentive, much shorter interview than baseline 
 
c. Remind patients to bring in their BP machines, or their hand written logs for the study team to copy or 
keep. Always give the patient extra logs, even at 12 months for their continued use and sharing with 
their provider. 
 
d. 12-month interviews have higher priority. Extra efforts should be made to complete 12-month data 
collection.  
 
e. Due to COVID-19, we have continued to encounter barriers to in-person data collection. Due to the time 
sensitive nature of our data collection schedule, we sacrificed in-person visits to conduct follow-up visits 
via phone/Zoom to complete the surveys. We also obtained IRB approval to allow participants to 
assess their blood pressure at home at the time of the survey and we recorded those values, but these 
values will not be used in analyses 
 
7.3.b Timing of interviews 
The schedule for completing interviews is shown in Table 14A and Figure 11.  
 
a. To complete a 6-month interview on time, conduct the interviews within 30 days before or 30 days after 
the date 6 months after informed consent. After this window closes, researchers should shift their focus 
to prioritizing 12-month interviews. 
 

48 
 
b. To complete a 12-month interview on time, conduct the interviews within 30 days before or 60 days 
after the date 12 months after informed consent. Note that the 12-month interview is due 12 months 
from the consent date – not six months after the 6-month interview date. 
 
c. 
Interviews can still be conducted up to 60 days after the official due date, but they will be considered 
late. Interviews that are past their time window should be prioritized to complete late 12-month 
interviews over completing 6-month interviews if resources are too scarce to permit completion of both.  
 
Table 14A. Interview Completion Timing* 
Interview 
Timing* 
Baseline  
Within 30 days after consent date 
6-Month Follow-Up 
Within 30 days before and 30 days after 6-month target date 
12-Month Follow-Up 
Within 30 days before and 60 days after the 12-Month target Date  
*Target date for the interview is determined by consent date +6 months for 6-month follow-up or +12 months for 12-
month follow-up. See Figure 11. 
 
 
Figure 11. Ascertainment of windows for follow-up data collection.  
 
For all unreachable patients, Program Managers should be notified.  Program Managers will help strategize 
and change the patient status in ClinvestiGator to either “non-responsive,” “lost to follow-up,” or “dropped out”. 
The ClinvestiGator scheduling report automatically calculates interview due dates, and color codes them when 
they are ‘do-able.’  
 
For example, for a patient consented on January 1, the official 6-month mark is July 1 and the official 12-
month mark is January 1 of the following year.   
a. Six month ‘ON TIME’ can be completed as early as June 1 and as late as August 1. 
b. Six month ‘LATE’ can be completed as late as September 1.   
c. Twelve month ‘ON TIME’ can be completed as early as December 1 and as late as February 1. 
d. Twelve month ‘LATE’ can be completed as late as March 1. 
 
 
7.3.c Participant Follow-up Phone Call Attempts 
 
Recognizing that there are constraints on available resources, this section provides guidance on the 
number of calls made to a participant to schedule a follow-up study visit. Up to 15 calling attempts will be made 
for each phone number in the sample. These attempts should be made at various times to increase the 
chances of reaching the participant. For example, 20% of surveys have been completed on weekdays and 
80% on week nights and weekends. Changing the schedule to accommodate holidays and special events is an 
important strategy. Make weekday calls just after the dinner hour. Make appointment callbacks during hours 
that are not scheduled for other interviews, generally on weekdays.  
 
7.3.d Text Messaging   
 
Text messaging is available in ClinvestiGator for research assistants to assist with follow up scheduling 
and reminders, as well as retention messages. Text messages can be sent from the patient data base in 
ClinvestiGator with responses recorded within the database to track correspondences. The text messaging 
option is available to all sites under the guidance of the program managers. This is not a requirement but is 
available as an additional resource if desired. The two main purposes of text messaging are:  

49 
 
1.  To remind study participants of their upcoming 6 or 12 month follow up appointments to reduce the 
number of “no show” for follow up visits. The approved verbiage is:  
 “You have a UAB visit at [Practice name] tomorrow, [date], at [time]. Call xxxxxxxxx for questions” OR 
   “You have a UAB visit today at [Practice name], at [time]. Call xxxxxxxxx for questions”. 
 
2.  To inform study participants in the peer coach arm to expect a phone call from their peer coach. 
Messages include the peer coach’s name, cell phone # (xxx)xxx-xxxx, and the date/time of the 
scheduled call. Participant are more likely to answer the peer coach’s initial contact, if they know the 
number in advance to avoid confusing the call with telemarketing. The intent of this text message is to 
improve participant compliance with the Peer Coaching intervention.  The peer coach cell phones are 
UAB owned. The proposed verbiage is “[name], your peer coach, will call you on [date], at [time] from 
this #: xxx-xxx-xxxx.” 
 
Text messaging will only apply to newly enrolled patients who have read the communications study page 
and gave permission to be contacted by text messages for the 2 reasons mentioned above. Moving forward, 
this communication page will be added to the consent form as an additional page.  
 
Study staff will use the approved verbiage that is embedded in the system to send an alert message from 
the data system and not from an actual cell phone. 
 
The day of consent: 
1- Make copies of the communication page and add to your consent form 
2- Help patient understand it and ask them to initial where indicated (whether yes or no) 
3- Enter or update the patient cell phone number at the time of enrollment in the contact information 
section in ClinvestiGator and specify that this a mobile phone. 
4- Once you do that, a box will appear next to the mobile phone # to include the carrier name (i.e, AT&T, 
Verizon, Sprint……etc.). Enter the carrier name (the carrier name is the most important piece of 
information). Without the carrier name, a text message can’t be sent.  
 
How to send an alert text message: Go to the patient data base¡ select your patient¡ go to Reports ¡ 
select “send text message via email” report¡ confirm that your patient is selected in the box¡ select approved 
verbiage¡ update phone number and the peer name if indicated¡ send. 
 
7.4 Medical Record Derived Data 
 
Medical records are abstracted for the following data at baseline and follow-up: 
 
• 
Health insurance  
• 
Medical conditions  
o Renal function (eGFR, creatinine, urinary albumin to creatinine ratio) 
o Chronic medical diagnoses that are part of the Charlson comorbidity index 
• 
Medications (name, dose, frequency) 
• 
Titration of antihypertensive medications in the past year 
• 
Number of in-office encounters (including outreach and case management efforts by the practice) 
• 
Number of hospitalizations with reason for hospitalization 
• 
Emergency Department (ED) utilization, and telephone outreach 
• 
For patients at practices randomized to the peer coaching arm: number of peer coaching chart entries 
 
These data are abstracted using a structured abstraction form on the study’s web-based data entry system. 
Abstractors will be trained and certified and quality controlled to assure >95% reliability.63,83-86 Medical record 
abstraction is conducted in the practice by the research assistant into laptop computers into the web-based 
study data collection system. In some cases, electronic records may be accessed remotely, in which case 
abstraction will take place remotely using an identical protocol as for on-site abstraction. Records will be 
abstracted at baseline, 6 months and 12 months. 

50 
 
 
Medical record abstraction will meet PCORI Methodology Standard 3:IR-1, which recommends assessing 
data sources for accuracy when selecting variables for confounding adjustment.1 Alternatives are to ask 
participants directly, but the reliability of patients living in low socioeconomic circumstances for these types of 
data is not certain. Therefore, the most suitable data source available is the medical record.  
 
7.5 Safety Measures 
 
This study will not test the efficacy of a new BP medication, and the interventions are designed to 
implement guideline-concordant, evidence-based care that should represent the standard of care. However, 
although no novel treatments are being tested, we recognize that the efforts to lower BP to <140/90 mm Hg 
may result in some participants experiencing hypotension and resulting adverse events. We monitor adverse 
events through active surveillance at the time of data collection, asking participants whether they were 
hospitalized or had ED or office visits for falls or dizziness, and whether they experienced any symptoms that 
they attributed to BP medications. We also abstract this information from the medical records, including data 
on renal function, as shown in Table 15. All participants are provided a toll-free number to notify study staff of 
potential adverse events. Adverse events will be tracked in the study data system as described in section 8 
and interim results will be monitored by the Data Safety Monitoring Board (DSMB). 
An adverse event is defined as any untoward or unfavorable medical occurrence in a human subject, 
including any clinically significant abnormal sign (for example, abnormal laboratory finding), symptom, or 
disease, temporally associated with the subject’s participation in the research, whether or not considered 
related to the subject’s participation in the research. The burden of collecting and reporting data on every 
possible AE in this trial would require a great deal of effort, therefore all serious adverse events will be 
reported, and selected non-serious adverse events will be reported. 
Consistent with NHLBI guidelines and OHRP policy, adverse events are events that meet any of the 
following criteria: 
• 
Fatal 
• 
Life-threatening (immediate risk of death from the event) 
• 
Result in significant or persistent disability 
• 
Requires hospitalization or prolongs hospitalization 
• 
Important medical events that investigators judge to represent significant hazards or harm to 
research participants and may require medical or survival intervention to prevent one of the other 
outcomes listed in this definition (e.g., hospitalization, death, persistent disability) 
Any event that meets any of these criteria will be documented and reported as a serious adverse event. 
 
Table 15. Adverse Events and Source 
Adverse Event 
 
Source 
Practice 
Facilitation 
(N =) 
Peer 
Coaching 
(N =) 
Both 
 
(N =) 
Enhanced 
Usual 
Care (N =) 
 
P 
value 
Death 
Chart review 
 
 
 
 
 
Ever had a stroke 
Patient Survey/ 
Chart Review 
 
 
 
 
 
Ever had a myocardial infarction 
Chart Review 
 
 
 
 
 
Ever have heart failure 
Chart Review 
 
 
 
 
 
Dizziness on standing 
Patient Survey 
(Falls/Side Effects) 
 
 
 
 
 
Fainting (syncope) 
Patient Survey 
 
 
 
 
 
Falls 
Patient Survey 
 
 
 
 
 
Falls precipitating medical treatment 
Patient Survey 
 
 
 
 
 
Falls with head injury 
Patient Survey 
 
 
 
 
 
Falls with fracture 
Patient Survey 
 
 
 
 
 
Hospitalizations 
Patient Survey/ 
Chart Review 
 
 
 
 
 
ED/urgent care visits 
Patient Survey/ 
Chart Review 
 
 
 
 
 

51 
 
Hypotension, SBP <90 or DBP <60 
mmHg 
Chart Review 
 
 
 
 
 
Bradycardia, heart rate <40 beats/min 
Chart Review 
 
 
 
 
 
Hypertension, SBP ≥180 or DBP 
≥110 mmHg 
Chart Review 
 
 
 
 
 
Hyponatremia, serum Na < 130mEq/L 
Chart Review 
 
 
 
 
 
Hypernatremia, serum Na >15 mEqL 
Chart Review 
 
 
 
 
 
Hypokalemia, serum K < 3.0 mEq/L 
Chart Review 
 
 
 
 
 
Hyperkalemia, serum K > 5.5 mEq/L 
Chart Review 
 
 
 
 
 
Serum creatinine increase by at least 
50% since previous measure 
Chart Review 
 
 
 
 
 
Abbreviations: DBP = diastolic blood pressure; SBP = systolic blood pressure. 
 
In reports to DSMB, all events will be reported, and a separate assessment will be made whether they are 
considered related or not related to the trial interventions. For DSMB reports, self-report of a stroke, heart 
failure, myocardial infarction, side effects, falls, hospitalizations, and ER visits will be combined with data from 
chart review.  
All laboratory values found to be outside the safety range will be brought to the attention of the primary 
care office staff. Adverse events should only be documented in the 6 month and 12 month follow-up at the time 
that all 6 month and 12 month follow-up data are collected for a participant. The only exceptions are as follows:  
• 
Participant dies  
• 
Participant withdraws from the study and their reason for withdrawing was an adverse event (example, 
had a stroke or MI).  
For these participants both a withdrawal and an adverse event form should be completed.  
 
7.6 Process Data  
 
7.6.a Process Measures for the Peer Coaching 
Intervention 
 
The study has several sources of data that will be used to 
assess the peer coaching intervention dose and fidelity: cell 
phones, peer coach manuals, monitored interactions, and 
participant report through both spot checks and survey at final 
followup, as shown in Table 16. Each of these are described in 
greater detail in the following section. 
 
7.6.a.i 
Cell Phone Data 
 
Peer coaches will be provided cell phones to collect data on intervention dose. Cell phone data include the 
telephone number of ingoing and outgoing calls, as well as minutes per call. These data are used to total the 
minutes spent on the telephone for each session and the number of total telephone contacts between peer 
coach and client as a measure of intervention dose. In addition, minutes spent in contact with the practice by 
coaches is tracked, providing a measure of intervention fidelity related to frequency of contacts with the 
practice. 
 
These data will be entered into the study’s web-based data collection system. 
 
7.6.a.ii 
Peer Coach Manual Derived Data 
 
Peer coaches use a paper manual for each participant designed for multiple purposes: 
 
1) 
A practical tool for coaches to document details about each client that is used over the course of the 
intervention (such as contact information, personal goals, etc.) 
2) 
A tool to enhance intervention fidelity 
Table 16. Measures of peer coaching 
intervention fidelity 
Domain 
How assessed 
Intervention 
dose 
Frequency and duration of 
contacts (cell phone minutes) 
Degree of 
intervention 
implementation 
Peer coach intervention 
manual data, monitored calls, 
participant spot checks 
Emotional 
support  
Participant report at final follow-
up 

52 
 
3) 
A tool for process data collection 
 
A copy of a chapter of the manual and client Activity Book are provided in Appendix 7. The coach has a 
separate manual for each client and records process data such as: 
• 
Completion of each session 
• 
Goal setting, including advancing the goal over time 
• 
Adherence to self-monitoring, including home BP monitoring 
• 
Medication adherence and barriers to medication adherence 
• 
Adherence to low salt diet, physical activity, stress reduction 
• 
Clinic outreach frequency and outcome 
• 
Use of community resources 
• 
Timing and frequency of booster contacts when BP becomes uncontrolled 
 
Manuals are collected at the conclusion of the 1-year intervention period and data will be abstracted into a 
form on the study’s web-based data collection system by trained and quality controlled research assistants. 
 
7.6.a.iii 
Monitored Telephone Interactions 
 
Intervention fidelity will be assessed by randomly selecting interactions for tape recording by the coaches. 
These sessions will be monitored by study staff with corrective actions taken as warranted to reinforce 
intervention implementation as planned, and to retrain coaches if necessary. 
 
7.6.a.iv 
Participant Satisfaction: Spot Checks and Survey at Follow-up 
 
Two strategies are implemented to assess intervention fidelity based on participant report. First, study 
personnel will make random telephone contacts with participants in the peer coaching intervention arms and 
assess whether all intervention sessions are being delivered in timely fashion, and also whether the coach is 
being supportive and helpful. Second, the final follow-up participant survey includes questions assessing 
satisfaction with interactions with the peer coach for those participants receiving the peer coaching 
intervention.  
 
7.6.b Process Measures for the Practice Facilitation Intervention 
 
The process data to be collected to assess intervention fidelity are shown in Table 17. There are measures 
of intervention dose as well as degree of intervention implementation, described next.  
 
7.6.b.i 
Measures of Intervention Dose 
 
Practice facilitators track frequency of contacts on forms 
that are part of the study’s web-based data collection 
system. These forms serve the dual purpose of allowing the 
practice facilitator to track contacts across multiple practices 
in their caseload and to allow assessment of intervention 
dose. The total number and type (telephone brief and 
extended follow-up, in-person) of contacts is captured. 
 
7.6.b.ii 
Measures of the Degree of Intervention Implementation 
 
 
A practice assessment tool is used to assess intervention implementation monthly by the practice 
facilitator. The tool is filled out by the practice facilitator within the study’s web-based data collection system. 
Separate sections assess the progress of the practice’s transformation in relation to the 4 key functions of self-
management support, use of the electronic record, team-based management, and outreach. We use a tool 
developed by Dr. Halladay called the Key Driver Implementation Scale (KDIS) which is adapted for the present 
study and focused on HTN.37 The adaptation of this tool has been finalized through collaboration with the NC 
Table 17. Measures of practice facilitation  
intervention fidelity 
Domain 
How assessed 
Intervention  
dose 
Frequency, type (in-person, 
face-to-face) and duration of 
practice facilitator contacts 
Degree of intervention 
implementation 
Monthly practice facilitator 
assessments of 
implementation of 4 key 
functions 

53 
 
AHECs and the AHRQ materials on practice facilitation. In brief, the KDIS assesses progress by the practice 
on leadership, team engagement, use of clinical information systems, standardized care processes, and self-
management support (see Appendix 11). Sections on use of outreach and telephone management are being 
added for this project. 
 
 
In addition, practice facilitators will track specific activities being implemented under each of the 4 key 
functions. Below, we provide some examples of the types of activities the practices may engage in. The 
facilitator will enter the specific activities into the study data system monthly, along with a qualitative 
assessment of the current stage of implementation (e.g., planning, early implementation, evaluation, etc.). 
 
1) Self-management support 
• 
Implement a process for using home BP monitors for patients with uncontrolled HTN 
• 
Implement education on dietary salt restriction in a culturally concordant manner (i.e., use 
customized dietary advice that incorporates the kinds of foods local people eat) 
• 
Assess medication adherence systematically at every visit 
• 
Implement a process for supportively helping the patient to overcome barriers to adherence 
(such as finding the cheapest pharmacy, or switching to a more affordable regimen) 
 
2) Use of the electronic record for population health management (Clinical Information Systems/Outreach)  
• 
Create a registry of HTN patients in the practice 
• 
Create a report identifying patients who are overdue for an encounter 
• 
Create a report of the practice’s HTN control rate, by race and gender 
 
3) Team-based management 
• 
Implement a protocol for BP titration carried out by a non-physician 
• 
Implement standing orders for BP titration, laboratory tests, recall appointments 
• 
Implement processes that permit non-physicians to provide self-management support 
• 
Implement systematic assessment of medication adherence and barriers to medication 
adherence completed by non-physician staff member 
 
4) Standardized Care Processes 
• 
Work with practices to reach out to HTN patients who have not been seen recently 
• 
Work with practices to use the medication algorithm to guide medical decision making for their 
patients, specifically their AA population with uncontrolled HTN 
• 
Implement telephonic BP medication titration based on home BP measures 
• 
Implement protocol to use reports from the electronic record to recall patients who are overdue 
for visits 
 
 
It is not expected that each practice implement all possible activities under each key function. However, it is 
expected that each practice attempt to implement at least one activity under each function over the one-year 
intervention period.  
 
As discussed above, it is expected that it will take up to 3 months for the practice to implement its first 
activity. At the first monthly visit, the facilitator and practice staff will first get to know one another with ice 
breaker activities. At the next visit, the facilitator and staff members complete the practice self-assessment 
consisting of the KDIS (Appendix 11). They discuss the results and begin to learn basics of quality 
improvement including plan-do-study-act (PDSA) cycles. The first activity centers on using the practice’s data 
to assess their current performance.  The facilitator helps the practice to plan for how to obtain the data, 
whether from the electronic record or from a limited chart review of 30 patients with HTN recently seen at the 
practice. Many electronic record systems now include the ability to create registries and create reports such as 
on the practice’s HTN control, but staff often have not had the time to learn how to create such reports. This is 
the role of the facilitator. The facilitator will teach the practice how to estimate their population-level BP control 
rate by using either the EHR or billing or scheduling data. Ideally, PDSA cycles would use 30-day 
denominators for estimating population-level BP control rates to assess the success of the QI intervention. 

54 
 
However, by using the model for improvement, the PF’s work with the practices to use any data that is relevant 
to testing if their changes result in improvement, for instance if barriers to appropriate BP measurement are 
lessened over time, the PDSA data may simply reflect survey data from staff quantifying barriers monthly. 
Such barriers can include, but are not limited to, broken equipment, lack of right sized cuffs, physical 
environment not conductive to appropriate patient positions, and others. It may prove difficult in many practices 
to do this without some chart review due to challenges with customizing the data reports available in the EHR. 
Therefore, facilitators will teach practices to identify all patients with HTN (based on ICD-10 codes) seen in the 
past 30 days. If there are sufficient numbers (90 or more), a random sample of the 30 can be drawn by 
selecting a number n between 1-3, and then reviewing the record of every nth patient to abstract only the last 
recorded BP. If there are not sufficient numbers (<90), the last 30 patients seen will be reviewed. The hope is 
that over time practices learn and see the value in higher quality data, thus will invest in processes that provide 
high quality population level BP control data. This is a key skill facilitators can build with practice staff.   
 
Once the practice has examined its performance, the team is ready to plan its first improvement activity. 
The facilitator assists them in selecting their first improvement activity under one of the key functions, and the 
facilitator coaches them in setting an achievable, measurable, and realistic goal with detailed implementation 
plans for the first PDSA cycle. The first activity is carefully selected to be particularly achievable to let the 
practice achieve momentum. The facilitator documents these plans and then contacts the practice Champion 
weekly by telephone to track progress and help the practice overcome barriers they encounter. The facilitator 
visits the practice in-person monthly, with telephone contacts in between. All contacts are recorded and the 
facilitator completes the KDIS in the study’s data system which includes a graph of BP control data over time 
that can be shared with the practice as part of their QI work. 
 
As the practice makes progress, the facilitator assists the practice in selecting another improvement 
activity, encouraging them to eventually select at least one activity under each key function. Activities are 
evaluated as part of the PDSA cycles, and adjustments are made until the new process is deemed successful 
and ready for permanent implementation. The facilitator helps the practice to keep adding new activities under 
each function and documents progress for a total of 12 monthly visits and at least weekly calls between visits.  
 
 
Practice facilitation will be assessed using questions that query general satisfaction with participation, 
workload, acceptance by the practice, difficulty in carrying out their expected duties, and support by fellow 
practice facilitators and mentors.  
 
7.6.c Measures of Practice Satisfaction 
 
Practices that receive either the practice facilitation or coaching interventions (or both) will be asked to 
complete an assessment of their satisfaction with the interventions. For practice facilitation, this will consist of 
the Practice Facilitation Provider Satisfaction Survey, recently used in a statewide program evaluation in 
Oklahoma (see Appendix 12). 
 
7.6.d Measures of Peer Coach Satisfaction 
 
 
Peer coach satifaction will be assessed using a set of questions used in several past studies that assess 
domains related to support from the coordinators, peer-to-peer mentoring, and ease of communication with the 
practices as well as how well the coach felt integrated into the practice team. See Appendix 16. 
 
7.6.e Measures of Practice Facilitator Satisfaction 
 
 
Practice facilitation will be assessed using questions that query general satisfaction with participation, 
workload, acceptance by the practice, difficulty in carrying out their expected duties, and support by fellow 
practice facilitators and mentors.  
 
7.6.f 
Baseline Population-level BP Control Rates 
 

55 
 
 
Preliminary findings of practice-level BP control rates in hypertensive patients reveal that some practices 
have control rates <30%. FQHC’s report higher rates, in some areas as high as 60%. Because practices with 
very low control rates may be more sensitive to intervention effects, we will attempt to estimate baseline 
population-level BP control rates in the practice’s hypertensive patients for each practice separately. These 
values will not be used in the main analyses for the study since we will not be able to collect these data in a 
rigorous enough fashion to support more than exploratory analyses. Nevertheless, this will be a highly 
informative view of small private practice-level control rates in the heart of the Stroke Belt’s rural areas, to our 
knowledge the first in the state of Alabama, as reflected in the Alabama State Department of Health’s request 
to share these estimates as they accrue (advice offered at February 2017 Community Advisory Board 
meeting).   
 
 
In order to obtain these rates, we will first request the past year’s HTN control rate, which may or may not 
be readily available in EHRs. Ideally we will examine the practice-level control rate in the 365 days prior to the 
date of the first patient recruited at the practice. Preliminary experience indicates this may not be available at 
many practices. In this case, the practice’s billing and scheduling databases will be queried for a list of all HTN 
patients seen in the 365 days prior to the date of the first patient’s recruitment, using ICD-9 or ICD-10 codes. 
Duplicate visits will be removed, resulting in the denominator of patients with HTN, D. We will design the data 
system to select a random number n from the range (rounded to the whole number) {[D/30] + .1*D}. Every nth 
patient chart will be reviewed for the last BP recorded until 30 patients have been reviewed. The formula 
assures that the sample includes patients seen over the entire course of the year. The BP control rate will be 
calculated automatically in the study’s data system. 
 
 
 
We considered whether to limit these population-level control rates to just African American patients, 
concordant with the emphasis of this study. However, race data are so incompletely captured in these 
practices’ data systems and medical records that this proved unfeasible. Therefore, population-level control 
rates will be estimated for this purpose on the practice’s entire patient population with diagnosed HTN seen 
over the prior year. 
 
7.6.g  Collection of Home BP Data at 6-Month and 12-Month Follow-up Visits  
 
All participants in the Southeastern Collaboration Study are asked to use a home BP monitor provided by 
the study free of charge, and are asked to record home BP in logs provided at enrollment, the 6-month, and 
the 12-month follow-up. While they are not to be used for the main analyses of the study, these data have 
multiple other uses to our study team, the practice facilitators and coaches, and to practice personnel.  
The research assistants will program each new home BP monitor with the time and date before giving the 
monitor to a patient. This will facilitate accurate retrieval of data over the study period.  
7.6.g.i To program the BP cuff: 
1. Hold down the SET button (with the people and clock) until the year flashes at the bottom of the screen. 
Use the up and down arrows to select the year. 
2. Push SET again to switch to date. Use the up and down arrows to select, hitting SET to switch between 
month and day. 
3. Push SET again to switch to time. Use the up and down arrows to select the hour. Push SET to switch 
between hour and minute. 
4. Hit SET a final time to complete setup. 
7.6.g.ii Collecting BP data at six and twelve-month interviews 
1. REMIND: Remind patients coming in for 6-month and 12-month follow-up visits to BRING WITH THEM 
their home BP monitor, and/or their home BP logs. 
2. Scan/Copy/Secure Fax: If the patient brings in paper home BP logs, please obtain a copy. The 
method used will vary by implementation site and technology available. As always, treat patient 
information as confidential, and secure it in a HIPAA compliant manner.    

56 
 
3. UPLOAD: Once back at your university site, please upload the monitor data and/or scanned images 
into a computerized file. Please make sure that there is a patient ID associated with each set of home 
BP measurements. 
4. REPORT: Share with the program manager that you have collected this home BP data and uploaded it. 
We will utilize work study students or others to enter this data into ClinvestiGator or other database. 
7.7 Qualitative Assessments Post-Intervention 
 
In addition to the quantitative individually completed assessments described in section 7.5 above, on 
conclusion of the intervention, we will collect qualitative data from all study participants – patients, coaches, 
practice facilitators, primary care practitioners, and practice staff to learn their perspectives on the 
interventions. We will develop discussion guides including participant perspectives on what went well and what 
did not go as well, in addition to their recommendations for long-term implementation and scale-up. These data 
will be collected via discussion groups as well as semi-structured interviews as detailed next (see also 
Appendix 15).  
 
7.7.a Patients 
 
We will conduct semi-structured individual interviews with patients in each of years 4 and 5 of the study, 
shortly after they have completed final follow-up. We will randomly select patients, assuring that we include 
men and individuals aged <60 years in the focus groups. For patients who participated in practices that 
received practice facilitation, we will include their qualitative impressions of the changes in the practice 
structure and how well they believe these changes improved their experience of care. For patients who worked 
with a peer coach, we will include their qualitative impressions of working with a peer coach, both positive and 
negative, and their opinions about working with a coach for a longer period of time, and how well telephone 
interactions met their needs and expectations (see Appendix 15). 
 
Program managers at each site will work with their study team to determine which study team member will 
administer the interviews. Most will be administered at the time of the 12-month follow-up by the research 
assistant, but to reduce respondent burden, some may be administered within 30 days over the telephone. The 
program manager and study team at each site will select up to 5 participants at each practice for these 
interviews, aiming to achieve similar demographic composition as the study’s overall sampling strategy to 
obtain insights from sufficient numbers of men and younger patients. Data will be entered into ClinvestiGator.  
 
7.7.b Providers and Practice Staff 
 
As with patients, we will survey the Practice Champion and provider after completion of the intervention 
period in ongoing fashion in years 4 and 5 of the study to obtain their perspectives on the interventions (see 
Appendix 15). The survey is designed for self-administration and includes open-ended questions. Only 
practices that received the intervention will be surveyed. Both provider and staff interviews are distributed via 
paper surveys for self-administration, and the data are entered into ClinvestiGator on receipt of the completed 
survey at the respective university.  
 
7.7.b.i Post Intervention Survey Implementation  
 
The survey should be fielded approximately 13 months after the first patient was consented, regardless of 
the recruitment period. In some cases, recruitment may last longer than the target 2-3 months. The timing of 
the Post Intervention Survey will be tied to the date of first consent, not the duration of recruitment.  
 
There may be differences in how the survey is implemented according to intervention arm. In Practice 
Facilitation practices, the Practice Facilitator will notify the site’s program manager via email after the last 
intervention session has occurred and provide the names and contact information of the individuals who were 
involved in the intervention activities that could provide relevant feedback on the intervention. The Practice 
Facilitator will recommend the most involved person, but in some practices, there may be more than one 

57 
 
individual identified. The number of surveys will be left to the discretion of the site PI and program manager, 
recognizing that the goal of these surveys is to obtain insights on the intervention implementation. 
 
 
The knowledge of individuals at the practice by the study team is likely to differ at Peer Coaching practices. 
Because the main engagement in these practices will be with the Practice Champion and possibly the provider, 
it is likely that these two individuals will be the ones identified as those most likely to provide meaningful 
feedback. However, there may be exceptions where additional practice staff have been identified by study 
personnel as particularly engaged in the intervention. These names will be forwarded by the Peer Coaching 
intervention Workgroup to the study’s program manager for survey administration. 
 
The program manager will send out the survey to the identified personnel at each site and be responsible 
for collecting completed surveys within 30 days. While the surveys are designed for self-administration, if the 
practice personnel request a telephone interview to expedite completion, this will be left to the discretion of the 
program manager at each site. Timing of the surveys may differ by intervention arm. The intervention period for 
the Practice Facilitation intervention is from the date of the first recruited participant to 365 days after this date. 
The survey will be administered at any time after that date. The intervention period for the Peer Coaching 
intervention is determined by each individual participant’s consent date, thus if recruitment is prolonged, the 
intervention period may be longer than 365 days after the first participant is enrolled at that practice. For these 
practices, the program manager will use the date of the last participant’s enrollment to add 365 days to 
determine the end of the intervention period.  
 
An additional Post intervention Semi-Structured Interview Brief Survey and Guide About Practice Facilitation 
was added. This will be complete among Practice Champions (see Appendix 12).  
 
7.7.c Peer Coaches 
 
We will have monthly meetings with peer coaches throughout the study period, actively seeking their 
feedback on implementation challenges in an ongoing fashion. We will conduct debriefing discussions with the 
peer coaches in year 5 of the study period to seek their advice about implementation and long-term 
sustainability.  
 
7.7.d Practice Facilitators 
 
We will interview each of the practice facilitators separately and as a group to learn their perspectives on 
the practice facilitation intervention and their opinion about its success, in addition to their perspectives on the 
special challenges that practices wishing to restructure to improve BP management may encounter. As for the 
peer coaches, we will teleconference monthly with the facilitators while the interventions are ongoing, obtaining 
ongoing feedback on the intervention. The final year discussions will therefore focus mainly on maintenance, 
sustainability and scale-up plans, as for the peer coaches. 
 
7.7.e Maintenance Interviews with Practice Champions  
 
An important part of the RE-AIM framework is maintenance, defined as how well the intervention can be 
sustained after conclusion of grant-funded support. Therefore, we will conduct semi-structured interviews with 
a sample of intervention Practice Champions one year after concluding the intervention period to assess which 
elements of either the practice facilitation or the peer coaching interventions were sustained over the year 
since they completed the interventions. These interviews will also serve to obtain further insights now that the 
intervention period is more remote. We anticipate that the practice facilitation intervention will result in lasting 
changes at the practice, therefore the sustainability of this intervention is likely to be high. We will ascertain 
whether practices moved on to NCQA recognition, and if so, which level they achieved. We will ask whether 
further improvements in their patient population’s BP control have been observed in the interim since the last 
data collection was completed.  
 
For the coaching intervention, we anticipate that ACA-related changes may have resulted in wider 
implementation of peer coaching in practices serving communities with a high prevalence of poverty, thus for 

58 
 
those practices that received the peer coaching intervention we will ascertain the degree to which the practice 
continues to work with peer coaches to improve the quality and outcomes of care. 
 
 
 
7.8 Data Quality   
 
Data quality is optimized through several strategies. First, we train and certify research assistants to follow 
protocols, most of which have been previously field tested. Second, we create checklists for data collection that 
guide data collectors through the protocol to assure adherence; these checklists are closely monitored with 
appropriate action taken for protocol deviations. Third, the web-based data entry systems have built-in range 
and quality checks, minimizing the entry of erroneous data. These systems also have robust reporting 
capabilities, permitting data collectors and their supervisors to track which participant is due for which type of 
follow-up to assure the timely collection of data. Fourth, we monitor the quality of data collected in the field 
through monitoring at the data coordinating center located at Weill Cornell, reaching out to field-based 
research assistants in near real-time to correct problems identified through monitoring (see also section 9). 
Last, we send two research assistants to the same site to conduct site quality checks (e.g., monitor protocol 
adherence) for 5% of the field data collection days. Quality issues are addressed through retraining and 
recertification as needed.  
 
A major threat to data quality is low retention for the final follow-up, a problem that has challenged several 
studies in similar low income, minority settings, achieving 1-year retention in the 60-65% range.87-89 We have 
achieved 85-95% retention in our studies using several strategies. Perhaps most effective is the use of trained 
community members to assist with outreach to participants. We ask for at least 3 contact numbers for family 
members and close friends for each participant on enrollment. The community-based study staff are highly 
supportive and assist participants to overcome transportation barriers in order to complete follow up visits.  

59 
 
 
8. Data Analysis 
 
 
8.1 Overview of the Statistical Analysis of the Trial  
 
In this section, we discuss the approach to preliminary analyses, the general analytic approach, the 
approach to testing the main hypothesis, additional practice-level and patient-level analyses, analyses to 
examine the heterogeneity of treatment effects, how we will handle missing data, sensitivity analyses, and 
power and sample size calculations. The analysis approach meets PCORI Methodology Standard 3:IR-3, 
which states that plans for data analysis should be specified a priori and should be designed to correspond to 
the major aims of the study.1  
 
 
8.2 Preliminary Analyses and Data Summaries 
 
All analyses will begin by examining numerical and graphical summaries of patient and practice 
characteristics, and outcomes (e.g., HTN control and BP at both the patient and practice levels). Smoothed 
bivariate plots will be used to examine unadjusted pairwise associations between variables and variability 
among stages of the trial and over time throughout the trial’s duration. Particular attention will be paid to 
assessing whether distributions appear to be approximately normal within each study group and whether there 
appear to be any secular trends, conspicuously nonlinear relationships, or outlying observations. We will use 
analysis of variance (ANOVA) (potentially with rank-transformation if non-parametric tests are needed) and 
distribution-appropriate bivariate tests for pairwise and overall differences between and among study groups in 
baseline characteristics. Preliminary analyses will be shared with the DSMB as required by the sponsor. 
 
 
8.3 General Analytic Approach 
 
Strictly speaking, this is a cluster-randomized RCT factorial trial. However we believe that there is likely to 
be a negative interaction between the practice facilitation and the peer coaching interventions so that the effect 
of receiving both interventions will not be additive. For this reason, this trial can be better understood as a four-
arm trial testing three interventions versus a single control group. While the traditional analysis of a factorial 
trial would assume the absence of an interaction (which it would likely be under-powered to detect) and 
proceed to test main effects, the presence of even a moderate interaction considerably reduces to power to 
detect main effects, even when the effect in the group receiving both interventions is larger than for either 
group receiving a single intervention. However, in this case there will be more than adequate power to detect 
the larger effect in the group receiving both interventions compared to the enhanced usual care control. The 
analysis plan and design have taken this into account to ensure adequate statistical power for bivariate tests of 
main effects between each the three intervention groups and the enhanced usual care group (control). All 
analyses will be intention-to-treat. 
 
In this RCT, one of the interventions acts at the practice level (PF) and the other at the patient level (PC). 
Nevertheless, the outcome of interest is patient-level hypertension control. Therefore the main analysis will be 
at the individual patient level with appropriate modeling to account for the clustering of patients within 
practices. Recognizing that some experts recommend a practice-level analysis when the intervention operates 
at the practice level, secondary analyses will be done with practice-level data. The main hypothesis is that the 
proportion of patients with controlled hypertension will differ among study groups when analyzed without 
adjustment for covariates with the individual as the unit of analysis. Recognizing the stepped nature of the 
study implementation (see Figure 9), further analyses will also consider adjustment for baseline measures and 
secular trends. Patient-level analysis will have greater sample size, allowing for much more precise analyses 
and consideration of heterogeneity of effects among subgroups. For each patient-level analysis we will 
estimate the intra-class correlation (ICC) of patient-level measures within practices. If they are negligible (both 
statistically insignificant with point estimate <0.01), main patient-level hypothesis tests can proceed in the 

60 
 
same fashion as the practice-level analysis. If ICCs are non-negligible, unadjusted testing will use regression 
accounting for clustering with generalized estimating equations (GEE) or random effects but with adjustment 
for a limited number of baseline covariates such as age and baseline systolic blood pressure. All further 
patient-level analyses will use distribution-appropriate regression models (linear regression, generalized linear 
models, or generalized additive models) with additional covariates in addition to accounting for clustering within 
practices. Secondary parallel analyses will be conducted using the practices as the unit of analysis. Although 
likely to have less power, these analyses will not require accounting for clustering and will therefore have fewer 
assumptions, Unless otherwise specified, all statistical tests will be two-sided, and a p<0.05 will be considered 
to be significant. The analyses described in detail below are specific to changes in the rates of controlled HTN 
at the practice and patient levels. Analyses of all other endpoints will be carried out in parallel form, but with 
distribution-appropriate tests and regression models. All analyses will be intention-to-treat, regardless of 
intervention fidelity, intensity, and dose. 
 
 
8.4 Testing the Main Hypotheses 
 
By virtue of its factorial/multi-arm design, this study will provide evidence for the efficacy of three separate 
interventions, practice facilitation, peer coaching and an integrated hybrid intervention incorporating both 
compared the enhanced usual care control. The main analyses will consider the patient-level outcome of Stage 
2 hypertension control (<140/90 mm Hg) at the 12-month follow-up.  
 
There is thus a single primary hypothesis: that there will be statistically significant differences in rates of 
hypertension control among the study groups using logistic regression with adjustment for a limited number of 
baseline covariates such as age and baseline systolic blood pressure, and accounting for clustering using 
generalized estimating equations (GEE).  
 
If the omnibus test is significant, we will proceed to identify which interactions had significant effects, 
testing three subsidiary hypotheses, one for each intervention:  
 
1) that patients in practices randomized to practice facilitation have higher levels of hypertension control at 
one year than patients in practices randomized to enhanced usual care (EUC);  
2) patients in practices randomized to peer coaching will have higher levels of hypertension control at one 
year than patients in practices randomized to EUC; and  
3) that patients in practices randomized to both interventions will have higher levels of hypertension control 
at one year than patients in practices randomized to EUC.  
 
Because patient-level Stage 2 hypertension control is a dichotomous outcome, the main test will be a two-
sided chi-square test for differences in the proportion of hypertension control between study groups with 
p<0.05 serving as the threshold for statistical significance.  
 
There is considerable controversy in the literature about whether the tests of each treatment group versus 
EUC require adjustment for multiple comparisons. To aid in interpreting findings, in addition to the standard p-
values, we will also report p-values adjusted for the multiple comparisons using Dunnett’s method.  
 
 
8.5 Patient-Level Analyses 
 
All additional unadjusted tests for differences between pairs of study groups will use the Benjamini-
Hochburg approach to control the false-discovery rate at 0.05.  These planned comparisons are1) practice 
facilitation vs. peer coaching, 2) practice facilitation alone vs. the hybrid intervention; and 3) peer coaching vs. 
the hybrid intervention.  
 
Having performed the unadjusted analyses we will proceed through several more nuanced analyses 
accounting for particular characteristics of this trial. First, we will repeat the analyses above using linear 

61 
 
regression to estimate intervention effects adjusting for patients’ baseline systolic blood pressure to reduce 
variance. We will then include terms representing secular trends, and time from baseline to follow-up of 
patients within each practice. Finally, we will use generalized additive models to explore whether any observed 
relationships are nonlinear in a statistically meaningful way.   
 
Additional patient level analyses will allow us to use data observed at all time points as well as a much 
more granular analysis of moderating factors and differential efficacy among subgroups of patients. Two sets 
of patient-level analyses will proceed in parallel, one examining hypertension control as a dichotomous 
outcome (the primary outcome), and the other considering systolic BP as a continuous outcome. Patient-level 
analysis of hypertension control will use logistic regression accounting for clustering as described above. Initial 
analyses will proceed by examining smoothed longitudinal plots of study measures at each time point stratified 
by study group to characterize how intervention effects may evolve over time. Generalized additive mixed 
models will be used to model the outcomes over time to test for non-linear trends while accounting for the 
clustering of patients within groups and multiple observations per patient. If no evidence for nonlinear trends is 
seen, generalized linear models will be used in subsequent steps. Further analyses will include indicators for 
phase of the trial and calendar time as well as patient-level factors of explicit interest such as baseline SBP, 
practice type, age, literacy, depression, and gender.   
 
 
8.6 Practice-Level Analyses 
 
Modeling patient-level outcomes requires accounting for the cluster-randomization and findings may be 
somewhat sensitive to distributional assumptions. Although they will have less statistical power, we will perform 
parallel secondary analyses at the practice-level. Unadjusted analyses will use ANOVA considering the 
practice-level hypertension control rate as a continuous outcome. Modeling strategies will be similar to those 
described for the patient-level analyses adjusted for mean patient characteristics within practices. Because 
some of these analyses may use more degrees of freedom than is recommended for our number of practices, 
these will be treated as exploratory, and any findings will be carefully weighed against these limitations.  
 
 
8.7 Heterogeneity of Treatment Effects 
 
Although not the primary goal, an analysis of the heterogeneity of treatment effects is crucial for efficiently 
targeting interventions to patients for whom they are most likely to be successful. These analyses will be 
carried out at the patient level. Whether or not there is a significant difference between the group receiving the 
hybrid intervention vs. either alone, we will also be able to explore which of the three interventions is more 
effective for specific patient subgroups. The large number of patients will also allow us to examine this 
differential effectiveness within and between interventions by adjusting for predisposing factors (e.g. low 
literacy) and through analyses stratified by these factors. The explicitly planned subgroup analyses include 
stratification by gender, health literacy (as measured by the REALM), depressive symptoms (as assessed by 
the PHQ8), and age dichotomized as <60 vs. ≥ 60 years.  An additional patient-level heterogeneity analysis will 
consider an interaction term between each patient’s SBP and the intervention group. 
 
We will formally conduct separate pre-specified heterogeneity of effects among practices by stratifying by 
FHQC status, practice size, and mean practice-level SBP of participants at baseline. These heterogeneity 
analyses will be done at the patient level with the formal test of heterogeneity determined by the interaction 
term between the practice-level stratification variable and the intervention. We will also examine associations 
with the variables collected in the practice characteristics questionnaire at baseline.   
 
The planned analysis of the heterogeneity of treatment effects meets PCORI Methodology Standards 
5:HT-1,2,3, and 4, which state that the goals of any heterogeneity of treatment effects analysis should be 
stated clearly (HT-1); the analysis plans should be pre-specified and any hypotheses related to heterogeneity 
should be pre-specified with supporting evidence provided (HT-2); all heterogeneity claims must be based on 
appropriate statistical contrasts among groups being compared, such as interaction tests or estimates of 

62 
 
differences in treatment effect (HT-3); and for any heterogeneity of treatment effect analysis, all pre-specified 
analyses should be reported as should, at a minimum, the number of post hoc analyses including all 
subgroups and outcomes analyzed (HT-4).1   
 
 
8.8 Preplanned Subgroup Analyses   
 
An important aspect of a pragmatic trial is the ability to examine the heterogeneity of treatment effects in 
high-risk subgroups of interest that are often difficult to recruit into research studies. We preplan subgroup 
analyses on:  
 
1) Men,  
2) Those younger than age 60 years,  
3) Those with low health literacy/numeracy, and  
4) Those reporting mild or greater depressive symptoms.  
 
Past reports have shown that male sex and younger age are associated with higher risk for uncontrolled CVD 
risk factors, and health disparities are also greatest in younger individuals.2,11 Low health literacy and 
numeracy and depression have also been shown to be associated with uncontrolled CVD risk factors.48-52  We 
will therefore recruit at least 10 men and 12 individuals younger than 60 years of age at each practice; mild 
depressive symptoms are present in 50% of this population, and health literacy is also very low. The 
background prevalence and oversampling of men and younger individuals will provide enough power to 
conduct these pre-specified subgroup analyses. 
 
These subgroup analyses meet the recommendations of PCORI Methodology Standard 1:RQ-4, which 
states that participant subgroups of interest should be identified and assessed.1 
 
 
8.9 Sensitivity Analyses  
 
We have planned other analyses to assess the robustness of our findings. The first set will include any 
outlying variables excluded during data cleaning. The next set will trim the upper and lower 5% tails of 
observations with continuous distributions to identify any associations that may be due to or exaggerated by 
extreme, but not spurious, observations. The final set of planned sensitivity analyses will consider process 
measures and measures of intervention fidelity to consider the association between variable exposure and 
outcomes. This will be particularly important both for planning future studies and for efficient resource 
allocation when planning for scale-up and wider implementation. Additional sensitivity analyses may be 
undertaken if missing data is a serious concern, as discussed below. 
 
Sensitivity analyses are recommended in PCORI Methodology Standards 3:IR-5 (which recommend the 
use of sensitivity analyses to determine the impact of key assumptions) and 4:MD-5 (which recommend that 
the sensitivity of inferences to missing data methods and assumptions should be examined and incorporated 
into the interpretation of the results).1 
 
 
8.10 
Sample Size Estimates 
 
We plan to recruit 80 practices and 25 patients per practice for a total projected sample size of 2,000 
patients. We estimate patient attrition at 20% (a conservative estimate given our past 85% retention in prior 
Black Belt studies), resulting in a reduced sample of 1,600. Because patients are sampled within practices, we 
accounted for clustering using a design factor D=1+ρ(n-1), where ρ is the ICC and n is the number of patients 
per practice. The effective sample size (Neff) is then N/D. In our Encourage trial the estimated ICC for systolic 
BP was 0.02, although it was not statistically significant. With 2,000 participants, Neff=1351, or 337 per study 
group. We conservatively assume 20% practice-level attrition, resulting in dropping to 16 practices per group, 

63 
 
which decreases power more than reducing the patients per practice; the resulting Neff=1081 with 270 per 
group. Given the readiness criteria required by practices in this study, we expect practice attrition to be much 
lower. We thus expect that the effective sample size estimate for 20% attrition with ICC=0.02 is highly 
conservative, and use it in the following power calculations to show what we expect to be our minimal 
detectable differences with 80% power.  
 
 
8.11 
Power and Significance Levels 
 
All power calculations are based on two-sided tests with type one error rate of 0.05% and 80% power 
(Table 18). Practice-level analyses will generally rely on t-tests or Wilcoxon tests for differences between the 
change in HTN control between groups. Power calculations are given for pairwise tests assuming the ‘worst 
case’ scenario of a large interaction so that the effect in the group receiving both interventions is the same as 
the groups receiving a single intervention. For all scenarios presented, the power of the omnibus test is >80%. 
Given a less extreme interaction power increases rapidly both for the omnibus test and for the pairwise 
comparison of Given that only patients with uncontrolled HTN at baseline will be eligible, at follow-up we 
expect to observe that 5% to 35% will be controlled in the control group, and at least 15% more among the 
groups receiving an intervention, e.g. 20% to 50%. Patient-level analyses assumed a standard deviation of 16 
mm Hg in individual-level systolic blood pressure measurements.  For practice-level analyses, data from the 
Encourage trial conducted in the AL Black Belt suggests a standard deviation of 10 percentage points for 
cluster-level HTN control rates and a standard deviation of 16 percentage points was observed in a study of 60 
primary care practices in North Carolina.90 In this trial, because we will be starting with a more homogeneous 
sample of uncontrolled hypertensive patients we expect the standard deviation (SD) to be lower among the 
control group, and somewhat higher among the intervention group. Table 18 displays power calculations for 
individual-level analysis and for practice level analyses assuming standard deviations of 10% and 16% in 
practice-level rates for the control and intervention groups, respectively, and for SD of 8% and 10%, 
respectively. Because the observed SD among practices varies with the number of patients per practice, power 
calculations were based on simulation studies. To further guard against deviations from distributional 
assumptions, simulations also examined the power using Wilcoxon tests, which was found to be very similar. 
 
 
Table 18. Detectable differences in the main study outcomes and examples of driver variables. 
Measure 
Enhanced 
Usual Care 
% or Mean 
(SD) 
Detectable Alternative: 
Patient Level 
Practice Level 
Neff=1351  
(337 per arm) 
Neff=1081  
(270 per arm)  
N=80           
(20 per arm) 
N=64           
(16 per arm) 
HTN Control Rate 
  
5-20-35% 
(SD 10%)  
11.2-29.7-45.9% 
12.0-30.8-47.3% 
18-35-50% 
(SD 16%) 
20-37-52% 
(SD 16%) 
5-20-35% 
(SD 8%)  
 
 
17-32-47% 
(SD 10%) 
18-33-49% 
(SD 10%) 
HTN Control Rate with 
Dunnett’s adjustment 
 
 5-20-35% 
(SD 10%) 
 
 
22-38-54%        
(SD 16%) 
24-40-56%        
(SD 16%) 
5-20-35%  
(SD 8%) 
11.7-30.5-47.1% 
12.7-32.1-48.5% 
18-34-50%        
(SD 10%) 
20-36-52%        
(SD 10%) 
Detectable Difference in 
SBP change (mmHg) 
Individual-
level sd of 
16mm Hg 
3.1mm 
3.4mm 
4.9 mm  
(SD 4) 
5.5mm  
(SD 4) 
Detectable Difference in 
SBP change: Dunnett’s 
3.9mm 
4.4mm 
5.5mm  
(SD 4) 
6.2mm  
(SD 4) 
MCS 12 
53.6 (9.2) 
55.6 
55.8 
62.0 
63.0 
PHQ8 
6.6 (5.5) 
7.8 
7.9 
11.6 
12.2 
PACIC 
2.6 (1.0) 
2.8 
2.8 
3.5 
3.6 
Patient Activation 
27.9 (6.1) 
29.2 
29.4 
33.5 
34.1 
HTN Tx Compliance 
21.4 (5.1) 
22.5 
22.6 
26.0 
26.6 
MCS 12 = mental health component summary score from the Short Form 12. PACIC = patient assessment of care for chronic conditions PHQ = 
patient health questionnaire. SBP = systolic blood pressure. SD = standard deviation. HTN compliance assessed via the Hill Bone scale.  Tx= 
treatment. In the HTN control lines, we present three different hypertension control rates in the EUC arm, with corresponding detectable 
alternatives as shown for 1351 and 1081 patients, and also for. 80 practices and 64 practices For example, if the hypertension control rate in the 
EUC arm is 5% and the practice-level SD is 10% in the EUC arm and 16% ‘in the intervention arms, with 80 practices, we will be able to detect 
control rates in the intervention arms of 18% or greater with 80% power with 80 practices and 20% or greater with 80% power with 64 practices.  
 

64 
 
 
Power for subgroup analyses: As indicated above, for patient-level analyses of pairwise differences 
between groups we can assume an effective sample size of at least 270 patients per group. For a patient-level 
analysis, only 80 patients per group are required to detect a difference of 5% vs. 20%. The implication is that 
subgroup analyses, even when limited to a third of the sample, will have sufficient power for the minimum 
anticipated main effect of a 15% difference.  The further implication is that with a sample size 3 times larger 
than that required for testing main effects, the work of Brookes et al., suggests that we will likely have 80% 
power to detect interaction effects as small as 1.4 times the size of the minimum expected main effects.91  
 
 
8.12 
Procedures for Accounting for Missing, Unused, and Spurious Data  
 
In a real-world study, some missing data is inevitable even with careful training, web-based data entry 
forms, and active quality controls. Our prior studies have taught us many effective approaches for minimizing 
loss to follow-up even among a disadvantaged and geographically dispersed population. In our Encourage trial 
we maintained over 85% follow-up over the course of nearly two years. In this trial, due to the readiness criteria 
required of participating practices, including data collection combined with routine visits in a known clinical 
environment with some data obtained by chart abstraction, we anticipate that follow-up will be even higher. 
Nevertheless if any data items are more than 15% missing we will analyze patterns of missingness and, if the 
data is plausibly missing at random, we will repeat analyses using multiple imputation via 10 chained equations 
to address the missing covariates. This approach results in retention of the sample, and results in less biased 
estimates. A common covariate with missing data is annual household income, which is often missing in 15-
20% of the study sample. The complete case method would drop those without income information from the 
analysis, introducing biases. We have used multiple imputation with chained equations to retain the sample.  
 
We will also pursue analyses of changes over time that will use data from all available time points, and thus 
make more complete use of the data where a participant’s data are missing only at a few time points.  
 
Unfortunately, in studies of this nature, missingness due to incomplete follow-up cannot often be treated as 
missing and is plausibly related to the study outcome. In these case where there is concern for imbalances in 
loss to follow-up among study groups, we will conduct sensitivity analyses assuming outcomes for those lost to 
follow-up that will assess the potential of their loss to have biased findings against the null hypotheses. 
 
Our plans to address missing data meet the recommendations of PCORI Methodology Standards 4:MD-
1,2,3, and 5. Standard 4:MD-1 recommends describing methods to prevent and monitor missing data. 
Standard 4:MD-2 recommends describing statistical methods that will be used to handle missing data. 
Standard 4:MD-3 recommends the use of validated methods to deal with missing data that properly account for 
statistical uncertainty due to missingness. Standard 4:MD-5 recommends examining the sensitivity of 
inferences to missing data methods and assumptions and incorporating this information into the interpretation 
of the study’s results.1  
 
 
8.13 
Analyses to Assess Dose-Response 
 
A particular interest in implementation settings is the effect close adherence to the intervention vs. less 
intensive implementation. To assess intervention dose in relation to effectiveness of blood pressure lowering, 
we plan several analyses to examine dose-response for each of the interventions. 
  
For the peer coaching intervention, we will assess dose both quantitatively and qualitatively. We 
hypothesize that greater quantity and higher user-rated quality of interactions as well as self-efficacy for high 
blood pressure self-management will be associated with better outcomes. We will assess quantitative and 
qualitative dose through variables and data sources as shown in Table 19. We will test the dose-response 
hypothesis by examining the association between these variables and the outcome measures among those 
participants who received peer coaching. We will first examine the bivariate association between the dose 

65 
 
variables and each outcome measure separately, then we will examine the role of participant characteristics in 
this relationship by entering sociodemographic (age, gender, social support) and physiologic variables 
(duration of hypertension, baseline systolic blood pressure, number of antihypertensive medications used at 
baseline, presence of chronic kidney disease, presence of diabetes, use of insulin, number of comorbid 
medical conditions) into a multivariable model. We will observe the effect of entry of the covariates on the 
parameter estimate for the dose variable in each of these models. We will first examine each dose variable 
separately, then construct a model in which all dose variables are entered simultaneously, separately for each 
outcome. We will examine interactions with dose-response variables to explore whether subgroups are more 
or less sensitive to any observed dose-response effects, recognizing that the power for these analyses will be 
limited by the available sample size. We will also explore the feasibility of a dose-response score that 
incorporates all dose variables that are bivariately significantly associated with the outcome and weighting 
each variable according to the strength of the association, following the approach of Charlson.92  
 
Table 19. Data for dose-response analysis of each intervention 
Domain of 
Dose-
Response 
Peer Coaching 
(data source) 
Practice Facilitation 
(data source) 
Peer Coaching  
+ Practice Facilitation  
(data source) 
Quantitative 
Number of 
intervention sessions 
delivered (peer 
coaching manual), 
mean number of 
minutes spent per 
session (cell 
phones), total time 
spent with the peer 
coach (cell phones) 
Number of in-person contacts, 
mean time per in-person 
contact, total time spent in-
person, number of telephone 
and email contacts between 
in-person contacts (data entry 
system) 
As for Peer Coaching and Practice 
Facilitation; peer coach report of 
number of contacts with practice 
(peer coach manual); practice report 
of number of contacts with peer 
coach (6 and 12-month practice staff 
assessment); number of activities at 
practice that integrate peer coach 
(practice facilitator monthly entries 
into data system) 
Qualitative 
Satisfaction with 
peer coach, 
perceived 
supportiveness of 
peer coach, self-
efficacy for high 
blood pressure self-
management (12-
month follow-up) 
Key Driver Implementation 
Scale (KDIS) at 12 month 
follow-up (practice facilitators 
enter into data system); 
practice staff assessments of 
practice commitment to 
change, helpfulness of the 
practice facilitator (staff survey 
as 12 month follow-up). 
As for Peer Coaching and Practice 
Facilitation; peer coach report of 
quality of interaction with practice 
staff (peer coaching manual); 
practice staff assessment of quality 
of interaction with peer coach (6 and 
12-month practice staff assessment); 
intensity of integration of peer coach 
(practice facilitator monthly entries 
into data system) 
 
For the practice facilitation intervention, we will assess intervention dose both quantitatively and 
qualitatively. We hypothesize that greater quantity of interactions, more intensive activity in each of the 4 Key 
Driver domains, and higher user-rated quality of interactions with the practice facilitator will be associated with 
better outcomes. We will assess quantitative and qualitative dose as shown in Table 19. We will analyze dose-
response by examining the association between these variables and the outcome measures among those 
participants who received care at practices in the practice facilitation arm in analogous fashion to the analysis 
of dose-response for the peer coaching intervention. We will assess whether each of the quantitative and 
qualitative variables are associated with better outcomes first in bivariate analyses, followed by multivariable 
analyses examining the effect of participant characteristics on these associations, as well as tests of 
interaction. Analyses will also explore subdomains of quality of dose by examining the intensity of activity on 
each of the 4 Key Drivers assessed by the KDIS, first examining each Key Driver separately, then all 4 
simultaneously. Members of our team have examined the KDIS as a simple ordinal scale and demonstrated 
associations of higher KDIS scores with better outcomes.93 This analysis will explore whether intensive activity 
in one of the domains is more strongly associated with outcomes than intensive activity in another domain, for 
example, whether more intensive activity around self-management support is more effective than more 
intensive use of the practice’s data systems. We will use a similar approach as outlined above for the 

66 
 
evaluation of a dose response scale for practice facilitation in the peer coaching intervention, following the 
approach of Charlson.92 
 
For the hybrid practice facilitation with integrated peer coaching intervention, we will examine all the same 
variables as for each of these interventions separately, in addition to variables that assess the blended 
intervention specifically (see Table 19). The analysis will be analogous to that described for the peer coaching 
and practice facilitation interventions, adding the variables specific to the blended intervention.  
 
 

67 
 
 
9. Quality Control and Quality Assurance 
 
9.1 Overview of Study Quality Control  
 
Study quality control is a process that begins with the planning of the study and extends through the 
completion of data archiving. The implementation of this process will be under the direction of Dr. Joshua 
Richman at UAB and Dr. Hollenberg at Weill Cornell through the standing Data Work Group (DWG) that meets 
weekly to plan, implement, and review data reports to produce the highest quality data upon which to base 
study findings.  The domains to be addressed by the DWG include focusing of study design and data variables, 
documentation, training, design of the data management systems, data entry monitoring, auditing of data entry, 
exercising of data, scheduled review of study progress, and data closure, described next. These approaches 
meet recommendations set forth in PCORI Methodology Standard 3:IR-1 (assess the data source 
adequacy).1 
 
9.2 Focusing of Study Design and Data Variables  
 
Perhaps the most powerful factor in study data quality is a tight and strong study focus to collect only the 
required information in the most efficient manner. This focus has been a factor in the conceptualization of the 
Triple Threat study as a pragmatic trial, placing minimal burden on participants and practices.  
 
9.3 Documentation  
 
Having clearly written instructions for the trial is a vital component of data quality. The protocol will be the 
guide for the development of a much more dynamic Manual of Procedures (MOP) maintained by the DWG 
where decisions on the implementation of the protocol will be documented, thereby ensuring that the same 
approaches are applied uniformly. The MOP is viewed by the DWG committee as the guiding operational 
document of the study, and is subject to review and modification as the study progresses. The DWG will work 
with the field-based data collectors to ensure that current MOPs are maintained and that study procedures are 
followed rigorously.   
 
These approaches meet recommendations set forth in PCORI Methodology Standard 1:RQ-2, which 
recommend developing a formal study protocol.1  
 
9.4 Training 
 
A shared understanding of both the protocol and MOP is critical to ensuring high quality data, and the key 
to this shared understanding is a strong and on-going training program. Each data collector will undergo 
training and certification in addition to an in person refresher training every 6 months as needed under the 
direction of each site’s Program Manager, overseen by the DWG. The data collectors will meet weekly by 
teleconference and webinar for cross-training and the development and review of training materials. Training 
activities will include mock exercises, review of the biometrics measurement protocol, BP machine checks, and 
cuff size selection. New data collectors will be trained individually via phone and web-based training programs 
and in person. All training materials will be available on the trial web site managed at the DCC. 
 
9.5 Design of Data Management Systems 
 
One of the advantages of an integrated data system is extensive data checks that are performed at the 
time of data entry, which have been refined over 30 years of field use for the ClinvestiGator system. Range 
and validity checks (including cross-form checks) are performed as data are keyed, and the AL and NC 
program managers are informed immediately regarding data that do not meet the pre-defined validations on 
the program manager dashboard. The system allows for restricting data to specific options where violations are 
not permitted (for example, sex is restricted to either men or women, with no other acceptable options) and 
validating data that is entered, such as weight, where suspicious values are allowed with confirmation (for 
example, weights above 400 pounds are possible, but require confirmation by the data collector before adding 
to the database).  In addition, data can be checked across CRFs to prevent conflicting information from being 

68 
 
entered and data from previously entered CRFs can be auto-populated in subsequent CRFs to prevent 
conflicting information from being entered. 
 
9.6 Data Entry Monitoring 
 
While data errors arising from data entry are a relatively minor source of errors in studies, tight data control 
will be instituted to ensure the highest quality data.  Data entered will be assessed for patterns of unlikely 
options within a participant and practice, e.g., large weight fluctuations within a short period of time. If the DWG 
notice unacceptable error rates (i.e, consistently above 0.5%), we will undertake retraining of the field-based 
staff member.  
 
9.7 Auditing of Data Collectors  
 
Random audits of 10% of each field based staff with data entry activities will be performed to ensure that 
data entered into the computer system matches CRFs and retraining will be undertaken when appropriate. 
 
9.8 Exercising of Data  
 
Many data issues are identified when data analyses are performed. There will be an early and active 
program to produce draft DSMB reports and blinded reports similar to those that will ultimately be produced to 
interpret study results. Producing blinded reports early allows for time to ensure the correct programming to 
produce reports and provide documentation of approaches.  
 
9.9 Scheduled Review of Study Progress  
 
The DWG will be charged with weekly review of reports on recruitment, data completeness and data 
quality, and will monitor these reports at the level of individual practice sites. If recruitment does not meet the 
expected goal at each site within 30 days of recruitment initiation, site-specific plans will be developed. 
 
9.10 Data Closure 
 
As the study reaches completion, the DCC will actively work with data collectors and the practice sites to 
resolve any outstanding queries with the goal of data closure and documentation.    
 
The DWG is one of the most important committees in the study organization. It is empowered to request 
additional information from any study unit (e.g., practice sites, facilitators, peer coaching committee, Executive 
Committee), to implement a stepped program to resolve discrepancies, where data collectors are first notified 
of issues, and then the relevant PI (Drs. Cherrington, Viera, Cummings) is involved to resolve issues with 
retraining or replacement of staff, as warranted. The DWG will provide a standing report to the Executive 
Committee at each of its meetings. 
 
9.11 Audit Trails 
 
The DWG will use well established approaches to create data audit trails for data and data entry (e.g., login 
attempts, selection of forms), requests for changes in the system, any changes to servers/software, system 
tests used in application validation and development, and physical security.  
 
 
9.12 Data Security 
 
The DWG is committed to ensuring the privacy and integrity of the data and systems under its authority. 
Best practices dictate adequate security measures are achieved in a multi-layer approach: physical, electronic, 
application, detection, and response to breech and training.  
 
 
Physical security is maintained through video surveillance of the server room and hallways; two different 
systems of environmental surveillance; electronic locks on all doors providing access to servers; physical 

69 
 
securing of desktop PCs; onsite backup media are kept in a secure room and offsite backup media are kept in 
a fireproof safe in a secure room; and PCs and laptops are placed so that they are not publically viewable.  
 
 
Electronic security is assured through PGP encryption; firewall Patchlink screensavers and installed 
antivirus packages; required login IDs and strong password authentication with passwords changed every 180 
days; “least needed” access granted by the DWG; Event Sentry software to provide secure remote logging and 
notification of exceptional events.  
 
 
Applications are designed following the Clark-Wilson model.  User credentials alone will not possess 
sufficient rights to access study data via any other means than the application provided. Applications 
containing sensitive data will use Federal Information Processing Standard (140-2) compliant software to 
encrypt/decrypt the data.  Passphrase used to initiate access to secured data is held in memory and not hard 
coded into the application.   
 
 
Detection. Campus IT Security operates twice daily scans of every computer on the network for known 
security risks, such as open ports, missing software patches, weak administrative passwords, and 
misconfigurations. When a computer is identified, campus security notifies the responsible system 
administrator and sets a deadline for remediation.  In egregious cases, the network port supporting the 
computer will be shut off.  Campus IT Security operates network monitoring system which scans network 
packets for signatures of known malware, data streams addressed to known malware or suspect sources, or 
other anomalous (heuristic detection) network traffic.  In the cases of known malware or known traffic to 
suspect sources, campus security will shut off the network port supporting the computer and notify the 
responsible system administrator.  Anomalous network traffic is examined and may result in the shut off of the 
network port supporting the identified computer. Applications employing decryption mechanisms (as described 
earlier) will remotely log access attempts to data it manages; logging mechanism will have filters that can be 
set to send alert messages to responsible administrators if access attempts exceed guidelines and have the 
ability to completely halt access to secured data. 
 
Security Response to Breech. It is institutional policy that all instances of data security breaches be 
reported to campus IT Security to initiate an investigation to document and determine the nature of the breech, 
what information is involved, how best to stop further loss, what remediation is necessary and if the breech is 
reported to authorities.  Campus IT Security staffs an active response unit that provides forensics and 
maintains a close working relationship with State and Federal authorities.  
 
Training. All DWG employees take part in annual training regarding data security. Application developers 
are required to read the “Application Development Guidelines SOP” and provide signed affirmation. Application 
developers are required to read and stay abreast of the guidelines provided by Open Web Application Security 
Project (www.owasp.org). 
 
9.13 
Data Handling and Recordkeeping 
 
This study will utilize ClinvestiGator, under the direction of Dr. James Hollenberg, as its data management 
system (Appendix 13). ClinvestiGator will provide full service electronic data capture (EDC), data management, 
and reporting. Data management includes: database specification, development and testing; edit check 
programming; data management plan development and maintenance; ongoing manual data review and query 
management; and data cleaning and locking. ClinvestiGator will generate monthly reports during the study to 
monitor enrollment and maintain and improve the quality of the study database and will facilitate the ability to:  
  
(1) Collaborate and communicate with the study PIs to review the proposed protocol and contribute to 
finalizing that document;  
(2) Develop case report forms;  
(3) Develop relevant Standard Operating Procedures (SOPs);  
(4) Develop and maintain full service EDC and data management that will include a web-based data entry 
system;  
(5) Create and distribute data entry processes;  
(6) Train and certify users in the data entry systems;  

70 
 
(7) Receive, collect, process, store, and analyze data collected from the participating clinical practices; and  
(8) Participate in preparing and distributing quality control reports to the participating practices, study 
committees, and the sponsors and Research Coordination Unit. 
 
 
9.14 Data Management  
 
ClinvestiGator has been successfully used to support over 40 studies involving over 2500 patients at 
multiple sites over the past decade. These studies have included externally funded projects with over $26 
million in funding.  
 
For studies with moderate or heavy activity (such as this proposed trial), a web-based data management 
system, where field-based data collectors are responsible for the entry of their own data, is both cost effective 
(as it removes a large proportion of the query process) and results in higher quality data and a reduced need 
for retraining. At the practice level, participant data will be entered directly into the web-based integrated 
system.  
 
The integrity of the data is ensured by limited access and password protection. Each is assigned access to 
only the portions of the database they need.  Access is provided under “hard” password protection (at least 8 
characters and including both symbols and numbers) that are changed at 6 month intervals. All data are 
encrypted and data transfers into the system are one-way (data is not transferred out of the system). 
Incremental data back-ups are made on a daily basis, and complete data backups are made on a weekly basis 
and stored at an off-site repository. As a SQL database, interfaces for reporting with SAS are an ordinary 
feature of that package. Finally, the system being proposed is FDA audit ready, with appropriate Systems Life 
Cycle Documentation. The functionalities of the system are shown in Table 18. 
 
Table 20. Functionalities of the data system that will support the trial. 
Component 
Comment 
Establish eligibility 
Inclusion/exclusion criteria built into system. 
Manage 
participant flow in 
practices 
System updates data collection schedule at baseline, 6 and 12 months. Scheduling portion of system 
provides “real time” reports of expected assessments to be delivered for each participant. System 
presents participant-specific forms for each encounter, ensuring that the correct forms (and only the 
correct forms) are completed with each visit. 
Platform for data 
entry 
At each participant encounter, CRFs entered into laptops with secure internet access; data keyed 
into database at DCC. System tracks each CRF through its “life-cycle” from first data entry to 
completion and “locking” (i.e., all data fields completed, all pass data range and validity checks). 
System includes visual color-coded alerts for coordinator to instantly know of forms pending or 
overdue for specific participants.  Once form is locked, data collector can review but not change data 
on form; data changes require DCC request with appropriate justification and approval prior to one-
time use, participant- and form-specific, time-limited unlock code being issued.  
Data quality 
System enforces participant schedule with visits entered within windows; also monitors and tracks 
other components of data quality, including missed visits and missed forms and data lag for entry 
(i.e., overdue forms). In addition, system reports status of data quality to both local site (both 
summary and participant-level reports) and to the standing Data Work Group. 
Participant safety 
Tracking system for each AE. All CRFs associated with an AE event generate separate AE form for 
completion at practice site. When AE form entered, study safety monitor at UAB notified of AE 
through automatically generated e-mail. Safety monitor has access to details of AE through separate 
interface to system; as s/he evaluates AE (determine likelihood of association with BP drug, severity 
of AE, expected/unexpected nature of AE, resolution of AE), event can be closed and locked in 
system.   
AE = adverse event. CRF = case report form. DCC = data coordinating center. 
 
The plans for data management meet PCORI Methodology Standard 2:IR-1, which state that data 
sources should be examined for accuracy to assure the robust capture of the needed covariates.1  
 
 

71 
 
 
10. Challenges and How we will Overcome them 
 
Although we have an experienced team with established relationships in the communities we target, as 
well as highly engaged community members, pragmatic trials face several challenges. Recruitment of practices 
could lag, which is why we have planned for a staged process, with only half the total number of practices 
(n=40) ready to be randomized by the start of recruitment. While the emphasis on small practices engages the 
very practices that most need help, conducting the study in these practices will also be more difficult. We have 
therefore designed the study to allot no more than 10 practices per facilitator, a relatively low number across 
practice facilitation programs, but allowing facilitators to provide more intensive consultation if needed. 
Recruitment of African American patients is also notoriously difficult, especially for men and younger 
individuals. We have therefore minimized the number of patients per practice to 25. The team’s past 
experience with similar interventions involving both practice facilitation (at UNC and ECU) and peer coaching 
(at UAB and Weill Cornell) permits the interventions to be refined using previously collaboratively developed 
intervention materials, speeding the intervention development timeline.  
 
Once fielded, additional challenges arise. This implementation trial engages real-world interventionists, a 
strategy that enhances long-term sustainability at the potential expense of intervention fidelity. We will 
overcome this challenge by having engaged both facilitators and peer coaches in the intervention development 
process, which serves to empower them and make the study “their” study, enhancing internal motivation to 
adhere to the intervention protocol. We have developed multiple strategies to monitor intervention fidelity as 
detailed above in section 7.  
 
Data quality in real-world settings can be compromised by nonadherence to high quality protocols for data 
collection. We therefore plan to have all study variables collected by trained research assistants rather than 
practice personnel. This is especially true for BP measurement, which has well documented departures from 
JNC recommendations in clinical care. Data collection will present additional challenges because patients may 
not be able to attend appointments at the practice. The community coordinators have been successful in 
assisting study participants to overcome barriers to attending study appointments in our past projects, and 
these same strategies will be employed in the present study.  
 
Data systems for complex data entry and management needs for a study of this nature are challenging to 
create, especially in a relatively short timeframe. We use a well-established data collection system, 
ClinvestiGator, which has over 30 years of field experience. Data security is a challenge in all trials, but 
especially in trials conducted in real-world settings; the well-established approaches to data security outlined in 
section 9 that will be used by our DWG will lessen this potential threat. The depth of experience on the 
investigative team will be critical to the success of the trial, and the CABs, the DWG, and the sponsors all 
represent important resources to help and advise on how to overcome unforeseen challenges.  
 
 
 

72 
 
 
11. Ethical Considerations 
 
 
11.1 Confidentiality  
 
The confidentiality of all participant information must be protected at the Clinical Sites and within the data 
management system. Paper records and computer files must be appropriately safeguarded from unauthorized 
access. Paper and/or electronic records for study participants will be stored at the Clinical Sites. Copies of 
records identified by participant identification number pertaining to SAEs and study-defined clinical events, 
including necessary medical records, will be stored at the clinical data management system, ClinvestiGator 
and within the offices of the investigative team. These records will receive the same care as would ordinary 
medical records. They will be stored in locked filing cabinets and/or filing rooms within secure office space. 
Only study personnel who have completed STUDY training in data handling will have access to study forms. 
 
 
11.2 Informed Consent  
 
Before individuals may participate in any screening procedures, informed consent must be obtained. As 
described in section 5 above, informed consent will be obtained from all participants after a presentation by the 
trained study research assistants. Because low literacy is prevalent in the targeted region, the study will 
provide consent in a video format, an approach that will also standardize the consent process. The consent 
video will be integrated into ClinvestiGator and will include periodic comprehension assessments (mini 
quizzes) to assure that the content is being understood by participants. In the event a significant protocol 
change occurs, the informed consent will be adjusted appropriately and sites will submit the revised documents 
to their IRB for approval. Local IRB’s will determine whether it is necessary to re-consent participants.  
 
 
11.3 Institutional Regulatory Requirements  
 
Annually, each participating institution will submit to the Principal Investigator stamped IRB approval letters 
and current copies of all consent forms. These records will be maintained within a central archive. Upon 
request, the consent forms may be released for internal IRB review. The study will be conducted in accordance 
with Good Clinical Practice (GCP), all applicable subject privacy requirements, and the guiding principles of 
Helsinki, including but not limited to: 
 
1. Local Institute Review Board (IRB)/Central IRB review and approval of study protocol and any 
subsequent amendments. 
2. Subject informed consent for the study.  The study consent will contain the six essential elements from 
GCP guidelines that include: 
• 
Research statement, reasonably foreseeable risks or discomforts, reasonably expected benefits 
to subjects or others, appropriate alternatives, extent of confidentiality, compensation or treatment 
for injury. 
• 
Additional elements where appropriate such as unforeseeable risks to subjects, investigator-
initiated termination of participation, additional costs, significant new findings, authorization for release 
of protected health Information for research purposes. 
3. Investigator reporting requirements.  
 
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization must 
be obtained from each person prior to enrollment into the study. The study team will provide full details and 
template documents for the above procedures in the MOP and provide training to the investigators and clinical 
staff on regulatory and ethical considerations. All study personnel will be responsible for completing and 
remaining current with all applicable human subjects’ protection, good clinical practice and data security and 
privacy training requirements 

73 
 
11.4 Ethical Considerations Related to this Patient Population and Peer Support Studies 
 
There are a number of specific ethical issues that arise in relation to the study population and peer-support 
studies. African American residents in the Black Belt have deep felt, historically based distrust of the health 
care system. Peer coaching interventions have been utilized because of the strength of the trusting 
relationships that can be leveraged to foster health behavior change. Potential ethical challenges have been 
identified along with strategies for addressing them and are reproduced here for informational purposes.94,95 
 
1. Honouring the Dignity of Persons  
Any relationship between persons must be premised on an understanding and acceptance that all 
people have an inherent dignity that has been variously codified in international documents. Peer 
support relationships must be founded on mutual respect.   
   
2. Selection and Training of Peer Supporters  
This will be determined by the setting and may be through an open call for expressions of interest 
and/or an approach involving a person (e.g., a health care professional) who is acquainted with the 
potential peer supporter. Information governance principles need to be adhered to in this process. The 
selection process for those with, or without, given characteristics needs to be transparent, justifiable 
and fair. Peer supporters need to be trained in confidentiality. Peers have the right to confidentially 
refuse a given peer supporter: this may be more or less common with friends, relatives or neighbors.  
 
3.   Professional-Lay Boundaries  
Standard professions have delineations for boundaries within which relationships may be ethically 
practiced. While peer supporters are not professionals, support relationships are breeched when there 
are conflicting roles that compete with the primary goals of peer support. This means that peer sup-
porters need to carefully negotiate the kinds of contacts and activities they enter into with their peers 
and have appropriate guidelines for support from clinical personnel. 
 
4. Simplified Informed Consent  
The need for full informed consent for peer support interventions is a matter of some debate. Some 
have proposed that there are two aspects where implied consent may constitute an appropriate 
standard: intervention and the surrounding research.  Agreeing to pair up with a peer or attend a group 
within an IRB approved framework should imply consent. Similarly, there are research activities where 
an individual gives consent by implication from his/her actions (e.g., completing an IRB approved 
questionnaire). However, more intrusive research activities (e.g., measurements, recorded activities, 
blood sampling) should require standard consent processes and these will be followed here.  Medical 
record review needs to follow standard information governance procedures.     
 
5. Documentation of Peer Relationship and its Activities  
Formalizing peer relationships requires establishing some basic standards of documentation of the peer 
relationship and of the activities and outcomes of such a relationship. While documentation in standard 
professions is elaborate, standards and scope of peer documentation are not well-defined. Certain 
critical cross cutting issues like ensuring completeness and accuracy, confidentiality, avoiding falsifying 
of records, and truth telling must be adhered to.  
 
6. Confidentiality and Privacy of Person’s Records and Information.  
The freedom to be left alone should extend to all peer support relationships. Patients do not have to 
document a written release in order to voluntarily share their own personal health information with a 
peer supporter.  They can assume that it will be treated confidentially.  They can freely choose whether 
to have a peer supporter and whether or not to share any personal health information. 
 
7. Involvement in Illegal Activities  
Parties involved in peer relationships should not abet or foster crime including involvement with illegal 
drugs. Helping a peer partner in crime and covering it up is immoral and should be discouraged.  

74 
 
 
8. Non-licensure to Practice Medicine  
Peer supporters are not qualified nor licensed to diagnose, give medical advice or recommend 
medications. Their interventions involve support that in many aspects aids the implementation of the 
licensed medical practitioner’s recommendations.  
 
9. Payment/Volunteerism  
Any payments made to peer supporters must be carefully considered. A tension exists between the 
benevolence of volunteers and the capacity for health systems to exploit this benevolence which might 
undermine evidence-based (but more costly) structures and system changes. If a health system 
finances peer supporters, then there is an obligation to provide adequate training and support for their 
work.  
 
10. Support for Peer Supporters 
Peer support volunteers must receive emotional support and adequate supervision in order to address 
potential emotional issues and other practical concerns that arise from their activities in working with 
patients.  
 
 
 
 

75 
 
 
12. Publication Policy  
 
The purpose of the policy is to encourage and facilitate the presentation and publication of the study 
background, rationale, design, and analyses; ensure appropriate use of the study data, timely completion of 
manuscripts and presentations, equitable access to authorship, and adherence to established principles of 
authorship; and coordinate the reporting of trial results. The policy applies to all investigators analyzing, 
presenting, and publishing data from the study. There are several principles underlying this policy:  
 
1. Research questions and hypotheses to be addressed using study data should be formulated a priori 
and clearly stated in a manuscript proposal to reduce the likelihood that study results are attributable to 
type I error.  
 
2. Publication of scientific findings from the study should proceed in a timely fashion once relevant 
analyses are complete.  
 
3. The publications arising from the study should avoid overlap and conflicting representation of study 
findings. Overlaps are, however, acceptable for review articles.  
 
4. Recognition through authorship will be distributed among the study investigators so that all study 
investigators and team members have equitable opportunity to lead and co-author study publications.  
 
5. The study should promote the career development of trainees and junior faculty by providing them the 
opportunity to lead and be recognized as co-authors of study publications, as appropriate.  
 
6. Standards for authorship on study publications will adhere to the Uniform Requirements for Manuscripts 
Submitted to Biomedical Journals of the International Committee of Medical Journal Editors (NEJM 
1997;336:309-315) and those established by the destination journals.  
 
7. The concept, in the form of a proposal, for all manuscripts must be approved by the P&P Subcommittee 
prior to preparation. There are three categories of manuscripts and anticipated authorship: 
 
i) 
Main results developed based on core study data and study aims/hypotheses (which will 
bear the corporate authorship). The design and main baseline papers will also be corporate 
authored. 
 
ii) 
Manuscripts developed and authored by investigators using data that are not considered to 
be main study results. 
 
 
 

76 
 
13. Study organization 
 
The study is a collaborative effort spanning four universities and several community-based organizations. 
This team is organized into an Executive Committee composed of the study investigators and lead staff, 
supported by work groups and the CAB, as shown in the organizational chart (Figure 11).  
 
 
 
 
 
 
 
The study is organized as a multiple PI study. Dr. Safford is the overall scientific lead of the study as the 
submitting PI; Dr. Cherrington is the co-PI and contact PI in the multiple PI arrangement, since UAB is the 
recipient organization.  
 
The internal Steering Committee meets monthly to obtain input from the group on major study decisions. 
Most of the work is conducted through the Workgroups. The Steering Committee is chaired by Dr. Safford, and 
co-chaired by Dr. Cherrington. Drs. Safford, Cherrington, and Andreae set the agenda for the Steering 
Committee. All investigators and the sponsors are invited to the monthly internal Steering Committee meetings. 
Once the study has begun to collect data, the internal Steering Committee will serve as the Publications and 
Presentations committee, approving study manuscript proposals, assuring appropriate authorship, and 
reviewing manuscripts prior to submission. 
 
The Work Groups are designed to include investigators and staff from each of the four participating 
universities, and are each led by experts in the field. Work Groups meet every two weeks, and create time 
delimited ad hoc Work Groups as needed. For example, an ad hoc work group led by Dr. Oparil led the 
development of the BP titration algorithm for the study, which is integrated into both interventions (Appendix 6).  
 
Figure 11. Organizational chart for the study. The Executive Committee is supported by practice facilitation, peer coaching, 
administrative, data, recruitment and retention, and community engagement work groups. Leads of each work group are underlined. 
The EC is also supported by the Community Advisory Board and university centers. The proposed study will collaborate with the 
sponsors, Research Coordination Unit and the other funded study. CTSA = Center and Translational Science Award. CHD = Center for Health 
Disparities. MHRC = Minority Health Research Center. 

77 
 
The Recruitment and Retention Work Group has been led by Drs. Harrington and Viera, but is now led 
by Drs. Shikany and Cummings, with Dr. Harrington’s retirement and Dr. Viera’s transition to a new institution. 
This group is responsible for developing the recruitment plan, recruiting practices, deciding on whether a 
practice is ready to be randomized, and conducting retention activities. This work group also oversees patient 
recruitment.  
 
The Practice Facilitation Work Group is led by Dr. Halladay. This work group is charged with finalizing 
the practice facilitation intervention, overseeing the training of the practice facilitators, and overseeing the 
ongoing support of the facilitators. It will be responsible for monitoring intervention fidelity and taking corrective 
action should facilitators demonstrate lack of ability to implement the intervention as designed. The web-based 
data system permits reporting in near real-time, assuring the ability to closely monitor progress. 
 
The Peer Coaching Work Group is led by Dr. Cherrington. This work group is charged with finalizing the 
peer coaching intervention, assisting with peer coach recruitment, overseeing the training and certification of 
the peer coaches, and monitoring intervention implementation as well as peer coach coordination and support. 
 
The Community Engagement Work Group is led by Dr. Safford. This work group is charged with 
engaging stakeholders to obtain input on the design of the study, its implementation, and plans for scaling up. 
This work group coordinates community advisory board meetings, and in addition obtains input from practice 
facilitators, peer coaches, and practicing primary care physicians.  
 
The Data Coordination Center is led by Drs. Richman and Safford. It is charged with establishing and 
maintaining the study’s data systems and in-servicing study staff in their use. It is charged with providing 
randomization assignment for each practice, and assuring balance across practice types during the enrollment 
phase. It is charged with maintaining the integrity of the data, as well as providing interim reports to the DSMB. 
The Data Coordination Center will analyze the study’s data for scientific manuscripts as well as reports for a 
wider lay audience. 
 
The Administrative Work Group is led by Dr. Safford and includes study program managers from each 
university as well as the leads of the community-based organizations. It is charged with providing meeting 
support, assuring IRB approvals are obtained in timely fashion, creating and updating the study’s protocol and 
manual of operations, creating reports as required by the sponsor, and managing the budgets and 
subcontracts.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

78 
 
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