Peer Support to Enhance Diabetes Shared Medical Appointments: Examining Comparative Effectiveness in VA Health Systems
Conditions: Diabetes Insipidus
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
 
 
Peer Support to Enhance Diabetes Shared Medical Appointments: 
Examining Comparative Effectiveness in VA Health Systems  
Health Services Research and Development Service (HSR&D) 
Michele Heisler, MD  
Version: 06/19/2020 
 
 
 
 
 

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Abstract 
 
Objectives: Providers are often unable to communicate as frequently as needed with diabetes 
patients who have poor risk factor control and face significant self-management challenges. 
Moreover, many VA patients face barriers to attending frequent face-to-face visits. This project 
will evaluate the implementation of a novel program found in a recent VA randomized, controlled 
trial to significantly improve VA patients’ diabetes-specific social support, insulin starts, and 
glycemic control compared to usual nurse care management. The program uses periodic group 
sessions in conjunction with calls between paired patients with diabetes to promote more effective 
care management as well as peer-to-peer (P2P) communication among diabetes patients who 
both have poor glycemic control and are working on similar care goals. Participants are matched 
with another patient of similar age and facing similar self-management challenges. “Peer buddies” 
are encouraged to talk by phone at least weekly to provide mutual support and share their 
progress on meeting their self-management goals. The goal of this service is to enhance the 
effect of shared medical appointments (SMAs), a service model demonstrated to be effective in 
improving outcomes among patients with diabetes and other chronic conditions and now being 
widely implemented in VA. Based on the success of the efficacy trial of this intervention, we now 
seek to evaluate a wider-scale implementation of this program. 
 
 
Methods: During implementation of the P2P program in conjunction with shared medical 
appointments (SMAs) in five diverse VA facilities, we will evaluate the effectiveness of SMAs 
alone and SMAs+P2P compared to usual care, and study the implementation process in order to 
gather information required to disseminate the program more broadly in Veterans Health 
Administration (VHA). 

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List of Abbreviations 
 
 
 
BP: blood pressure 
 
CFIR: Consolidated Framework for Implementation  
CCMR: Center for Clinical Management Research 
HbA1c: hemoglobin A1c 
 
HBC: Health Behavior Coordinator 
 
HSR&D: Health Services Research and Development 
IVR: interactive voice response 
MI: motivational interviewing 
 
NCPD: National Patient Care Database 
OTS: Office of Telehealth Services 
PACT: Patient Aligned Care Teams 
P2P: Peer-to-Peer 
QUERI: Quality Enhancement Research Initiative 
 
QUICC: University of Michigan Quality Improvement for Complex Conditions 
RC: Research Coordinator 
RCT: randomized controlled trial 
SBP: systolic blood pressure  
SM: self-management 
SMA: shared medical appointment 
VHA: Veterans Health Administration 

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Contents 
Protocol Title: ................................................................................................................................ 5 
1.0 
Study Personnel ................................................................................................................. 5 
2.0 
Introduction ........................................................................................................................ 6 
3.0 
Objectives ........................................................................................................................ 10 
4.0 
Resources and Personnel ................................................................................................ 11 
5.0 
Study Procedures............................................................................................................. 14 
5.1 Study Design ..................................................................................................................... 14 
5.2 Recruitment Methods ........................................................................................................ 18 
5.3 Informed Consent Procedures .......................................................................................... 20 
5.4 Inclusion/Exclusion Criteria ............................................................................................... 21 
5.5 Study Evaluations.............................................................................................................. 22 
5.6 Data Analysis .................................................................................................................... 22 
5.7 Withdrawal of Subjects ...................................................................................................... 28 
6.0 
Privacy and Confidentiality ............................................................................................... 28 
7.0 
Communication Plan ........................................................................................................ 29 
8.0 
References ....................................................................................................................... 30 

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Protocol Title: Implementation Study of the Peer-to-Peer Program for Patients with 
Diabetes 
1.0 
Study Personnel 
 
Project Team Member 
Project Role 
Affiliation 
Phone # 
Michel Heisler, MD 
PI 
VA 
734-845-3504 
Julie Lowery, PhD 
Co-I 
VA 
734-845-3619 
Timothy Hofer, MD, MSc 
Co-I 
VA 
734-845-3504 
Wyndy Wiitala, PhD 
Biostatistician 
VA 
734-845-3601 
Jennifer Burgess, MPH 
Project Manager 
VA 
734-845-5608 
Christine Kowalski, MPH 
Qualitative Analyst 
VA 
734-845-3620 
Naomi Kane, MA 
Qualitative Analyst 
VA 
734-845-3005 
Jennifer Burns, MHSA 
Data Manager 
VA 
734-845-3607 
Dana Horowitz 
Research Associate 
VA 
734-845-3543 
Caroline Clingan 
Research Associate 
VA 
734-845-5608 
Cynthia Ellis 
Transcriptionist 
VA 
734-232-0404 
Leah Gillon 
Database Manager 
VA 
734-845-3640 
Susan Kirsh, MD 
Consultant 
VA 
216-701-0519 
Donna Zulman, MD 
Site PI Palo Alto 
VA 
650-493-5000 x29113 
Cindie Slightam 
RC Palo Alto 
VA 
650-493-5000 x27155 
Amy Gregory 
RC Palo Alto 
VA 
650-493-5000 x23428 
Aaron Tierney 
RC Palo Alto 
VA 
650-493-5000  
Isabella Romero 
RC Palo Alto 
VA 
650-493-5000 
Wen-Chih Wu, MD 
Site PI Providence 
VA 
401-273-7100 x6237 
Megan Crete, PharmD 
Site Consultant Providence 
VA 
401-273-7100 x2198 
Melanie Parent 
RC Providence 
VA 
401-273-7100 x6293 
Troo Tucker 
RC Providence 
VA 
401-273-7100 x6294 
Lorrie Strohecker, MD 
Site PI Sacramento 
VA 
916-366-5637 
Jeffrey Cass, PharmD 
Site Consultant Sacramento 
VA 
916-843-2829 
Kevin Chun 
RC Sacramento 
VA 
916-843-2877 
Alexander Guirguis, PharmD 
Site PI West Haven 
VA 
203-932-5711 x7137 
Vera Gaetano 
RC West Haven 
VA 
203-932-5711 x5562 

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2.0 Introduction 
 
2.1 The Challenge of Supporting Patients’ Diabetes Self-Management 
Twenty-five percent of VHA patients have type 2 diabetes, representing about 1.5 million Veterans. VA 
initiatives have improved diabetes care quality, but in FY14, 20-30% of VA diabetes patients still had 
poor glycemic control (A1c > 9%), poor blood pressure control (>140/90), or were not on a statin.1 In light 
of strong evidence that complications from diabetes can be significantly reduced with glucose and blood 
pressure control and statin treatment, improving management of these is essential. While there are now 
effective treatments for diabetes, success of these therapies depends on how well patients self-manage 
over a sustained time: taking prescribed medications; following diet and exercise regimens; self- 
monitoring; and coping emotionally with the rigors of living with diabetes. Yet, many patients face 
multiple barriers to effective diabetes self-management (SM). These include lack of sufficient SM 
knowledge and skills; lack of self-confidence (‘self-efficacy’) and/or motivation; and problems from other 
co-morbidities and physical limitations. In addition, many adults with diabetes lack effective support from 
their families and friends to help them manage their diabetes, a lack that represents an often-neglected 
barrier to successful diabetes care.2,  
 
2.2 The Effectiveness of Shared Medical Appointments 
Group visits, including Shared Medical Appointments (SMAs), bring patients with the same chronic 
condition and facing similar SM challenges together with a team of providers and are a highly effective 
and efficient way to provide SM education and support. SMAs are defined by groups of patients meeting 
together over time for comprehensive care, usually involving a practitioner with prescribing privileges. 
They incorporate many of the core components of high-quality chronic disease care, such as planned, 
scheduled contact with a with an interdisciplinary team of providers; a targeted focus on improving SM 
skills; peer support from and interaction with other patients facing similar challenges; and regular review 
and adjustment of treatment plans.6-9 Several recent meta-analyses of randomized controlled trials 
(RCTs) of diabetes SMAs, including a 2014 review led by co-investigator David Edelman for the VA, 
have found that SMAs are more effective than usual care in improving A1c levels and systolic blood 
pressure (SBP).8-10 A recent RCT in VA found improvements in cholesterol levels among Veterans with 
poorly controlled diabetes and hypertension who participated in group medical clinics compared to usual 
care. 11 In the face of this evidence form efficacy trials, researchers noted the need now for large-scale 
trials and implementation studies that measure real-world impacts on patient-centered and staff-centered 
outcomes, costs, and utilization. 
 
2.3 The Need for More Effective, Scalable Models to Maintain Achieved Gains 
As with other evaluated programs, most studies of SMAs to date have examined outcomes during and 
immediately after participation in SMAs. There is growing evidence that no matter how effective a short-
term, more intensive diabetes SM support program is in improving outcomes immediately after completion 
of the program, many patients do not succeed in maintaining SM and clinical improvements achieved 
through the program.12-15 In the face of resource and staff constraints, novel approaches to help patients 
sustain SM improvements are needed that do not rely exclusively on face-to-face or professionally led 
programs. Sustaining gains may be especially difficult for the many VA patients who lack social support. 
Both receiving and providing social support is associated with improved SM and clinical outcomes.16-19 
Many VA patients not only lack an extensive social network, but also opportunities to be of service 
formerly available through jobs or military service. 
 
2.4 Peer Support as a Means to Enhance and Maintain Gains from SM Programs 
Peer support among patients with the same chronic health problem may be a particularly potent 
intervention, combining the benefits of both receiving and providing social support. “Peer support” is 
defined as “support from a person who has experiential knowledge of a specific behavior or stressor and 
similar characteristics as the target population.”20 Because peers share similar characteristics, this 
approach is intrinsically culturally sensitive. A 2015 meta-analysis of 13 RCTs testing peer support 
interventions’ effectiveness in improving glycemic control in adults with type 2 diabetes concluded that 

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peer support programs resulted in a significant reduction in A1c [pooled mean difference between arms: -
0.57 (95% CI: -0.78 to -0.36)].21 Most of this effect was from programs with moderate (one or two 
contacts a month per patient) or high (more than two contacts in a month per patient) frequency of 
contact. Programs with low frequency of contact showed no significant reduction. 
 
Other recent systematic reviews have found similar benefits of peer support in diabetes.22-24 In response 
to the growth of evidence on peer support’s effectiveness, the World Health Organization (WHO) has 
endorsed further development and evaluation of peer support programs for improving diabetes 
outcomes.25 In VA, peer support is a strong and growing part of VA services for people with serious 
mental illness. Programs such as Vet-to-Vet for Veterans with psychiatric diagnoses are now implemented 
at many VA facilities,26, 27 and one-on-one peer interventions target Veterans recently returned from 
combat.28, 29 In the field of diabetes, efficacy trials have examined two models of predominantly telephone-
delivered one-on-one peer support: 1) peer coach models in which one Veteran provides support to 
another; and 2) reciprocal, or mutual, peer support models in which both Veterans give and receive 
support. Both of these models have been found to be more effective than other comparison groups in 
improving glycemic control.30-32 As described in Section 1.6, the reciprocal peer support model tested by 
M Heisler et al. was more effective than nurse care management in improving glycemic control and other 
diabetes outcomes.30 This mutual peer support model may be a particularly effective complement to 
SMAs, as SMA participants have the chance to get to know each other over time and can continue to 
work together through telephone calls and periodic patient-directed group sessions with other SMA 
participants to improve SM behaviors and sustain gains achieved through the SMAs.  
 
2.5 Examining the Effectiveness of Implementation of SMAs Combined with Reciprocal Peer 
Support in Diverse VA Facilities 
In light of the evidence from efficacy trials that examined diabetes SMAs and reciprocal peer support 
models separately, important next steps are to: 1) evaluate these programs in a large-scale, multi-site 
pragmatic clinical trial to examine effectiveness in diverse real-life VA settings compared to usual care; 2) 
assess whether a reciprocal peer support program among Veterans participating in SMAs can sustain 
gains achieved through SMAs; and 3) rigorously evaluate the process and costs of implementation of 
these interventions as clinical programs in a diverse set of VA facilities.  
 
2.6 Previous Work 
This study builds on the work of Michele Heisler, MD, MPA (PI) and research team members David 
Edelman, Susan Kirsh, Michael Goldstein, Julie Lowery, Timothy Hofer, and site PIs Hank Wu, Donna 
Zulman, and Alexander Guirguis. Dr. Heisler has extensive experience running large-scale, multi-site 
health system and behavioral RCTs and implementation studies.30, 33-35 She has developed and tested a 
range of peer support models in both VA and non-VA settings.15, 30, 33, 35 Dr. Edelman has led some of the 
definitive RCTs showing the short-term effectiveness of SMAs and is a national leader in the 
development and evaluation of diabetes SMAs,8, 9 as is Dr. Kirsh.6, 9, 36-38 Drs. Jeffery and Wu have also led 
RCTs showing the effectiveness of SMAs in diabetes,39, 40 and Dr. Zulman brings expertise in 
interventions targeting complex patients.41, 42 Dr. Lowery brings in-depth expertise and experience in 
conducting mixed methods implementation studies.41-46 Dr. Hofer has expertise in advanced statistical 
methods and research design.47, 48 He has particular expertise in the design and analysis of cluster 
randomized trials, working with Dr. Heisler on the cluster RCT of the Adherence and Intensification of 
Medications (AIM) program funded by NIDDK and VA. 30, 34  
 
Prior P2P Efficacy Trial 
The proposed pragmatic clinical trial will extend findings from Heisler et al.’s RCT comparing a 
reciprocal peer support program (P2P) with a nurse care management model (NCM) funded through an 
HSR&D IIR (04-239). Patients in the P2P group attended an initial group session to set diabetes-related 
behavioral goals, receive peer communication skills training, and be paired with another age-matched 
peer in the same cohort of study participants. Both peers had poor glycemic control and were 
encouraged both to give and receive support from each other in their joint efforts to improve glycemic 
control. Peers were encouraged to talk weekly using a telephone platform that recorded call occurrence 

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and provided reminders to promote peer contact. Optional group sessions were offered at 1, 3, and 6 
months. NCM patients attended an initial educational session, were assigned to a nurse manager, and 
were helped to make follow-up appointments with that NCM. 
 
The 244 participants were from 2 VA health care facilities and had A1c levels greater than 7.5% during 
the 6 months prior to enrollment. In the 216 patients (89%) who completed the A1c assessments at 6 
months, mean A1c level decreased from 8.02% to 7.73% (-0.29%) in the P2P group and increased from 
7.93% to 8.22% (+0.29%) in the NCM group (between-group difference 0.58%,P = 0.004). Among 
patients with a baseline A1c level >8.0%, those in the P2P group had a mean decrease of 0.88%, 
compared with a 0.07% decrease among those in the NCM group (between-group difference, 0.81%; P 
< 0.001). Eight patients in the P2P group started insulin therapy, compared with 1 patient in the NCM 
group (P = 0.020). Patients in the P2P program expressed high levels of satisfaction with their 
participation. While this RCT examined P2P as a stand-alone program, its design is well-suited to 
complement and extend formal professional-led programs such as diabetes SMAs, as is proposed in the 
current application. 
 
Consolidated Framework for Implementation Research (CFIR) 
We will use the Diabetes QUERI CFIR to guide the design of the qualitative phase of the study.49 (The 
electronic version of this article can be found online at: 
http://www.implementationscience.com/content/4/1/50.) The CFIR comprises common constructs from 
across implementation frameworks and models already in the literature, including Greenhalgh, Rogers, 
and Kitson et al.50-52 The CFIR’s five major domains are the intervention, inner and outer setting, the 
individuals involved, and the process by which implementation is accomplished. 
Pettigrew and Whipp, more than 20 years ago, emphasized the essential interactive dimensions of content 
of intervention, context (inner and outer settings), and the process of implementation.53 This basic 
structure is also partially echoed by the PARiHS framework, which describes the three key domains of 
evidence, context, and facilitation.52 The CFIR has an additional domain for the individuals involved to 
acknowledge their important role in implementation. Within each of these five major domains is a 
comprehensive list of constructs that have empirical or normative support for their influence on 
implementation effectiveness. We have already used the framework for the formative evaluation of three 
different national implementation projects in VA (MOVE!, digital screening for diabetic retinopathy, and 
MOVE! telehealth; reports and manuscripts in preparation). Based on this previous work, we have 
developed a methodology for coding and analyzing qualitative data using the framework, which is 
described below in section 3.0, Formative Evaluation, Aim 3. 
 
2.7 Significance and Impact 
The proposed project supports HSR&D research priorities to improve Veterans’ health care by 
developing, testing, and disseminating effective, innovative interventions that: (1) increase access to high-
quality care to vulnerable Veterans; and (2) provide ongoing equitable health care and support services 
that improve long-term outcomes among all Veterans. Interventions such as the ones proposed are 
designed to be feasible in the face of resource constraints  and simple enough to be integrated into 
standard care processes. In addition, the intervention is designed to interface with and support efforts 
within VA to expand the use of SMAs as a strategy to improve outpatient care and access. Beginning in 
2005, the VA has mandated shared or group medical appointments as a means to improve clinic 
efficiency and quality of care.6 Both local and national Advanced Clinic Access meetings endorsed this 
methodology for decreasing waiting times, improving patient access and outcome measures, and 
minimizing costs. The PACT initiative has promoted SMAs or group visits as they promote team- based, 
patient centered access and quality of care components of PACT. The P2P program is consistent with—
and builds on—this approach. Both SMAs and P2P emphasize the importance of peer support, active 
Veteran engagement with care, and SM. The P2P program takes SMAs a step further by providing an 
infrastructure for the peer support component to continue on a regular basis beyond the face-to-face 
meetings, something especially important to Veterans who face barriers to accessing VA-based care. In 
addition to studying the implementation of P2P in diverse sites, this study will evaluate whether the 
addition of P2P can improve patients’ SM efforts and outcomes above and beyond the use of SMAs alone 

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over a longer period of time. Finally, the post-implementation evaluation will provide important information 
and specific tools to facilitate broader dissemination of the program, as well as contribute to the field of 
implementation science by identifying contextual factors associated with implementation success or 
failure.

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2.8 Vulnerable Populations: 
No children will be included in this study. Women and minorities will be included to the extent that they 
are enrolled to the SMA program at the participating sites. We will not take special efforts to focus our 
recruitment efforts on any particular sub-group of eligible patients. The research includes surveys, 
interviews, and medical record review. 
 
VA Patients 
As this study is an effectiveness trial conducted under real-world implementation conditions we will 
conduct the study in those who 1) are eligible to participate in SMAs, and 2) who can give informed 
consent. This excluded individuals with impaired decision making capacity, those who do not speak 
English proficiently, and prisoners. It includes all other groups. There are no medical interventions as part 
of this study, so we will not exclude pregnant women. 
 
VA Employees 
VA Employees will be asked to participate in interviews based on their role in the SMA and/or P2P 
programs. The director of primary care, clinicians participating in the SMAs, the P2P group facilitators, 
and other key staff involved in diabetes patient care (e.g., nurses, dieticians, pharmacists) will be asked to 
participate in semi-structured interviews. These employees could be pregnant. There are no medical 
interventions as part of this study. 
 
 
3.0 
Objectives 
 
We propose to evaluate the implementation of a novel program found in a recent VA randomized, 
controlled trial to significantly improve VA patients’ diabetes-specific social support, insulin starts, and 
glycemic control compared to usual nurse care management. In two prior randomized trials, we found that 
automated telephone assessment and self-care support calls increased use of guideline-concordant 
services, decreased symptoms, and improved glycemic control. However, providers are often unable to 
communicate as frequently as needed with diabetes patients facing self-management challenges. 
Moreover, many VA patients face barriers to attending frequent face-to-face visits. Accordingly, we 
developed and tested an intervention using group sessions in conjunction with phone calls between peers 
to promote more effective care management as well as peer-to-peer communication among pairs of 
diabetes patients who both had poor glycemic control and were working on similar care goals. 
Participants are matched with another patient of similar age and facing similar self-management 
challenges. These “peer buddies” are encouraged to talk by phone at least weekly to provide mutual 
support and share their progress on meeting their self-management goals. The goal of this service is to 
enhance and sustain the effect of shared medical appointments (SMAs), a service model demonstrated to 
be effective in improving outcomes among patients with diabetes and other chronic conditions and now 
being widely implemented in VA. Based on the success of the efficacy trial of this intervention, we now 
seek to evaluate a wider-scale implementation of this program. 
 
In this study, as the Peer-to-Peer (P2P) program is implemented in conjunction with shared medical 
appointments (SMAs) in five diverse VA facilities. One of these facilities, Palo Alto, includes four distinct 
clinics in different cities. We will evaluate the effectiveness of SMAs alone and SMAs+P2P compared to 
usual care in these sites, and study the implementation process in order to gather information required to 
disseminate the program more broadly in VHA. The specific aims of the study are presented below. 
 
Summative Evaluation of Program Effectiveness 
Aim 1: Evaluate the effect of SMAs and SMAs+P2P on diabetes patients’ glycemic control, systolic blood 
pressure, anti-hypertensive use, statin use, and insulin starts at 6 and 12 months post-enrollment. 
Aim 2: Assess the impact of SMAs and SMAs+P2P on service utilization and patient-centered outcomes 
at 6 and 12 months post-enrollment. 

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Formative Evaluation of Implementation Process 
Aim 3: Use constructs from the CFIR to conduct a post-implementation evaluation of the implementation 
process at the five participating sites (including 3 CBOCs at the Palo Alto site). 
We will also obtain data throughout implementation on the staff effort to calculate the costs of the program 
(Aim 4). 
 
In summary, the P2P program builds on the demonstrated strengths of group medical visits and peer 
support on self-care behaviors and health outcomes. This study will provide important information on its 
effectiveness and the barriers faced in different VA facilities when implemented as part of existing clinical 
processes. 
 
 
4.0 
Resources and Personnel 
 
4.1 Where Research will be Conducted 
The study will be based at the VA HSR&D Center for Clinical Management Research (Ann Arbor 
Health Care System). This site has extensive expertise conducting VA and other federally-funded 
research and has the resources necessary to carry out the proposed research project. The Ann 
Arbor study team will be responsible for hosting the servers where the study data are stored, and 
for granting permissions as required for the conduct of this study. All employee participants will be 
recruited for interviews by Ann Arbor study staff. Patient participants who have been selected for 
telephone interviews and who have given verbal consent when contacted by a RC from their site 
will be contacted and interviewed by Ann Arbor study staff by telephone. 
 
Patient participants will be recruited from five VA Medical Centers: Ann Arbor, West Haven, Palo 
Alto, Sacramento, and Providence. The Palo Alto site will include four locations: Palo Alto, 
Monterey, San Jose, and Livermore clinics. 
 
4.2 Project Team 
The major components of the study, and the investigators responsible, are: 
 
Design and implementation of P2P (Heisler) 
 
Formative evaluation (Lowery) 
 
Summative analysis (Hofer, Wiitala, Heisler, Edelman) 
 
Integration of P2P with SMAs (Kirsh) 
 
Design, oversight, and assessment of motivational interviewing (MI) training 
for group facilitators and peers (Heisler, Goldstein) 
 
The specific responsibilities of the project team are described below. 
 
Michele Heisler, MD, Principal Investigator. Dr. Heisler will oversee implementation of P2P at 
the participating sites, including working with Drs. Lowery and Kirsh to interview key stake holders 
and adjust implementation of the program as needed to the context of each of the sites. She will 
work with Dr. Goldstein to develop and implement the training program for the group facilitators, 
and with Dr. Edelman to design a methodology for assessing the fidelity of the P2P program. She 
will be responsible for ensuring adherence to the project timeline, and directing the work of the 
project manager and data analyst. 
 
Julie Lowery, PhD, Co-Investigator. Dr. Lowery is the Associate Director of the Ann Arbor 
HSR&D Center for Clinical Management and Research (CCMR) and Co-Implementation Research 
Coordinator for the Diabetes QUERI (with Laura Damschroder). Ms. Damschroder and Dr. Lowery 
developed the CFIR, which will be used in this project, and have used this framework for 
developing the interview guides, coding, and analyzing data for three VA implementation projects 
thus far. Dr. Lowery will be responsible for overseeing the conduct of the pre- and post-

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implementation formative evaluation, including developing the interview guide, overseeing the 
conduct of the interviews, and assisting the qualitative analyst with coding and analyzing the 
interview data. During the pre-implementation period, she will use the findings from interviews with 
key stakeholders to assist the sites in implementing the P2P programs. As part of her work on the 
interviews, Dr. Lowery may have access to PHI, recruit participants (including obtaining informed 
consent), administer interviews, and conduct data analyses. During the post-implementation 
evaluation, she will use the findings from the interviews to assist Dr. Kirsh with development of the 
dissemination plan. 
 
Tim Hofer, MD, Co-Investigator. Dr. Hofer is Associate Director for Measurement and 
Information Technology at CCMR, and a core faculty member of the Diabetes QUERI. Dr. Hofer 
has expertise in statistical methods related to patient profiling, quality measurement, and research 
design. Relevant to this study, he has particular expertise in the design of cluster randomized 
trials, serving in such a capacity for a recently completed cluster randomized trial funded by the 
VA and National Institute of Diabetes and Digestive and Kidney Diseases, for which Dr. Heisler 
was co-PI. Dr. Hofer worked with Dr. Heisler to devise the design and analysis for this 
resubmission in response to reviewers’ concerns. Dr. Hofer will be responsible for overseeing the 
study design and analyses. 
 
Wyndy Wiitala, PhD, Biostatistician. Dr. Wiitala supervises the data managers at CCMR, 
provides consultation on research design and statistical analysis, and serves as the primary 
data analyst on a variety of projects. She has expertise in the use of VA databases, as well 
as use of multi-level modeling and imputation for missing data. She will be responsible for 
conducting the analyses of the summative data in year 4. Dr. Wiitala will have access to 
PHI. 
 
Susan Kirsh, MD, Consultant. Dr. Kirsh is Associate Professor of Medicine, Case Western 
Reserve University, School of Medicine, Cleveland, Ohio, and an attending physician at the Louis 
Stokes Cleveland VAMC, Ohio. She is also the National Director for Clinic Practice Management 
and Access. As part of this responsibility she has the opportunity to work with clinical teams 
across the country in support of the implementation of team models for diabetes care and, in 
particular, to facilitate implementation of shared medical appointments as a PACT priority. As a 
consultant on this study, she will serve as the SMA expert and will lead the dissemination effort, 
by working to identify opportunities and tools for implementation of the program as part of SMAs 
and PACT. Dr. Kirsh will also review patient materials and data collection instruments. 
 
David Edelman, MD, Co-Investigator. Dr. Edelman is a research scientist at the Center for 
Health Services Research in Primary Care, Durham VA Medical Center, and Associate Professor, 
General Internal Medicine, Duke University Medical School. He has extensive research and 
clinical experience with group- based interventions in chronic illness. He will work with the 
participating sites to implement and evaluate P2P as part of their existing group visits, drawing on 
his previous experience in the evaluation of group medical clinics for patients with diabetes and 
hypertension. As part of this work he will assist the research team with designing the post-
implementation interviews for the formative evaluation, designing a measure of fidelity 
assessment for the group visits, providing consultation on the analyses of the summative data, 
and assisting with interpretation of the analyses of the qualitative data. 
 
Michael Goldstein, MD, Consultant. Dr. Goldstein is Associate Chief Consultant for Preventive 
Medicine, VA National Center for Health Promotion and Disease Prevention. He has significant 
experience and expertise in training providers and counselors in MI and health behavior 
counseling skills. For the proposed research, he will design a training program that the Health 
Behavior Coordinators (HBCs) at the SMA + P2P participating sites can use for training the P2P 
group facilitators, who will be teaching MI techniques to the P2P peers, as well as modeling the 
use of these techniques when they serve as facilitators for the group sessions. He will also work 
with the research team to design an instrument for assessing the fidelity of the P2P group visits, 

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including the initial visit when the facilitator trains the peers in MI techniques, and the subsequent 
visits when the facilitator enforces and models those techniques. He will assist with analysis of the 
fidelity data. 
 
Jennifer Burges, MPH, Project Manager. Ms. Burgess will be responsible for preparing and 
submitting all IRB documents. She will assist the PI with hiring and training the site RCs and P2P 
facilitators, as well as monitoring study progress to ensure accomplishment of enrollment goals and 
adherence to protocol requirements. She will be responsible for overseeing the establishment and 
maintenance of the participant tracking database, overseeing the administration of the follow-up 
surveys, and monitoring the quality of the study data as it is collected. She will work with the site 
RCs to resolve problems with recruitment and data collection as they arise. Ms. Burgess with also 
work with the clinical teams conducting SMAs and P2P groups at the sites to document the 
similarities and differences in these programs between sites. She will have access to PHI. 
 
Dana Horowitz and Caroline Clingan, Research Associates. The RAs will be responsible for 
assisting clinical personnel to recruit Veterans receiving care at the Ann Arbor VA into SMAs as 
needed to assure that the SMAs are operating to capacity. This includes conducting eligibility 
screens and scheduling patients for their initial SMA appointment. She will recruit for the study from 
all Veterans participating in SMAs. This includes obtaining HIPAA waivers, mailing/collecting study 
surveys, entering data into the enrollment and tracking database, and entering survey data into the 
study database. They may also assist the sites with their recruitment efforts. The RAs will provide 
assistance to the sites in creating calendars for the SMAs and P2P drop-in sessions, assuring 
rooms are reserved, SMA and P2P facilitators understand which SMAs will be providing P2P, and 
those who will be assessing fidelity know which visits to attend. They will make sure fidelity 
assessments and self-assessments of the SMAs and P2P drop-in sessions are done when 
required, and will conduct the assessments when the HBC (or other designated assessor) cannot 
attend. They will assist the Ann Arbor qualitative analyst in recruiting and obtaining consent for 
those Veterans selected for patient interviews, as well as staff selected for interviews and 
sustainment assessments. They may also assist with transcription of staff and patient interviews. 
The RAs will be responsible for the creation of P2P protocols and tools for participants (handbooks, 
calendars, etc.), and will maintain a SharePoint site as a central data repository including the most 
up-to-date study procedures and clinical tools. They will have access to PHI. 
 
Christine Kowalski and Naomi Kane, Qualitative Analysts. Ms. Kowalski has significant 
experience with conducting semi-structured interviews of VA staff and with using the CFIR to code 
and analyze interview data. She will be responsible for conducting the staff and patient interviews 
for the proposed study, and for coding and analyzing the interview data using the CFIR, with 
assistance from Dr. Lowery. Ms. Kane will assist Ms. Kowalski with conducting the patient 
interviews and with coding analyzing all interview data. Ms. Kowalski and Ms. Kane may have 
access to PHI, recruit participants (including obtaining informed consent), administer interviews, 
and conduct data analyses. 
 
Jennifer Burns, MHSA, Data Manager. Ms. Burns will be in charge of identification of eligible 
candidates for all sites using VA databases, the random selection of eligible candidates to be 
offered SMAs, extracting the secondary data (Aims 1 and 2) from centralized VA databases, 
preparing the data for analysis, and conducting preliminary analyses under the supervision of Dr. 
Wiitala. She will have access to PHI. 
 
Cynthia Ellis, Transcriptionist. The transcriptionist will transcribe the recordings of the 
interviews with employee participants and patient participants. Any identifying data in the 
transcripts (e.g., names of other patients, providers, facilities) other than study ID will be removed 
during the transcription process. The transcriptionist may have access to PHI if it is discussed 
during an interview. 
 
Leah Gillon, Database Manager.  Ms. Gillon has immense experience in the administration of 

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Access databases.  She will be responsible for the design and maintenance of all of the sites’ 
databases and, as such, will have access to PHI. 
 
Melanie Parent, Troo Tucker, Vera Gaetano, Kevin Chun, Cindie Slightam, Amy Gregory, 
Aaron Tierney, and Isabella Romero, Site Research Coordinators. The RCs will be 
responsible for inviting all patients who are joining an SMA group at their site if they are willing to 
participate in this study, obtaining signed HIPAA authorizations and study surveys for all study 
participants, providing incentives to participants, entering data into the enrollment and tracking 
database, and entering survey data into the study database. They will also help the clinical team 
mail letters of invitation to SMAs, recruit these patients by phone, conduct eligibility screens, and 
schedule patients for their initial SMA. They will conduct fidelity assessments of the SMA and P2P 
group meetings. The RCs are responsible for notifying the CIRB and the Ann Arbor project 
manager of any adverse events, complaints, or issues that arise at their study site. The RCs will 
have access to PHI only for the participants at their site. 
 
Alexander Guirguis, Donna Zulman, Lorrie Strohecker, and Wen-Chih Wu, Site Principal 
Investigators. The Site PIs will be responsible for ensuring adherence to the project timeline and 
protocol, and directing the work of the site RCs.  In addition, they may assist the site RCs with any 
of their study duties. 
 
Megan Crete, Jeffrey Cass, Site Consultants. The site consultants will assist with the training of 
new SMA and P2P facilitators in MI.  They also may assist with recruitment and SMA fidelity 
assessments. 
 
4.3 
Contractors/DUAs  
 
None. 
 
 
5.0 
Study Procedures 
 
5.1 
Study Design 
 
5.1.1 Overview 
This study represents Steps 4 and 5/6 of the QUERI Process55, which are also described under 
“Implementation Trial with Evaluation” in the new Research/Implementation Pipeline used for the 
most recent QUERI Annual Reports (Appendix 1 to this protocol). Specifically, this will be a hybrid 
1 effectiveness trial conducted under real-world implementation conditions in multiple sites and 
regions. The focus is on assessing the impacts of the program on patient outcomes (research aims 
1-2), as well as optimization of the implementation strategy (aim 3). 
 
This project is being conducted at five VA facilities (including eight clinics) implementing SMAs as 
part of usual care. These sites have been selected because they are interested in implementing 
P2P groups as an add-on to the SMAs as part of usual care. As these programs are starting, 
resources at each site do not permit all eligible patients to receive these two new programs. 
Therefore there are three groups being studied, all receiving usual care for their facilities: (1) usual 
care without SMAs, (2) usual care with SMAs, and (3) usual care with SMAs and P2P. 
 
The study design is a multi-site, modified cluster randomized controlled design. Our first analysis is 
a comparison of two active treatment arms, one involving SMA and the second involving 
SMA+P2P. Some sites may only conduct one group at a time depending on variability of their 
resources over time, but all sites will conduct a number of groups over the study period and the two 

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treatments will be offered in a random sequence within site, providing the clusterized random 
assignment required for comparability of the two treatment arms. In a modification of the classical 
cluster randomized design, patients are not assigned to groups prior to the group randomization to 
treatment but are recruited from a population of eligible patients when the site is ready to run a new 
group. If patients are then selected differentially into the groups we will lose all the advantages of 
the randomization step. Thus patients will be randomly sampled for invitation from eligible patients 
and recruited for each wave of the group treatment with a standard script that is identical whether 
the group is SMA only or whether P2P will be offered as an additional optional part of the 
intervention. All invited patients will be told that they are being invited to participate in SMAs, 
provided a brief description of what the SMAs involve, and informed that some groups will also be 
offered an additional (optional) opportunity to participate in P2P as a supplement to the SMAs. All 
invited patients will also be told that they are being offered an additional (optional) opportunity to 
participate in this research study. Participation in the research study is not required to participate in 
the SMAs or SMAs + P2P. 
 
The study population will consist of diabetes patients who have poor glycemic control. Because not 
all eligible patients will be able to be invited to participate in one of the two programs during the 
study period, we will also have a pool of eligible patients whom we can use for untreated controls. 
We will randomly pull a sample of patients from each site to serve in this group. Thus, the trial will 
compare outcomes across three different treatment groups: (1) usual care without SMAs, (2) 
SMAs; and (3) SMAs + P2P. 
 
We will use a mixed methods approach to our data collection and analyses. Summative data for 
Aims 1 and the service utilization outcomes in Aim 2 will be obtained from VA databases and 
will include data on clinical outcomes and service utilization, which will be measured at 
baseline, at 6 months, and over a period of 12-18 months post-enrollment. Because this is an 
implementation study, we intend to use clinical data wherever possible, rather than add to staff 
burden with the imposition of additional collection of data solely for research purposes—
especially when data on the clinical measures of interest are already collected as part of patient 
care. For two of the arms (SMA, SMA+P2P), we expect labs to be drawn at baseline and 6 
months through SMA staff as part of usual care. In usual care without SMAs, we may have 
more missing values for A1cs, although guidelines recommending checking A1cs at least every 
6 months in patients with poor glycemic control. 
 
Data on patient-centered outcomes (Aim 2) will be obtained from surveys of all participants who are 
scheduled to participate in SMAs and agree to participate in the study at the five sites to allow for 
comparisons across the SMA and SMA + P2P groups. We will collect laboratory and service 
utilization data on patients in all three treatment groups. Qualitative data on organizational factors 
likely to affect P2P program implementation will be obtained via semi-structured interviews prior to 
implementation, mid-implementation (7-10 months following program implementation at each site), 
and post-implementation (18-24 months following program implementation at each site) as part of 
Aim 3. To further look into the SMA sustainment efforts in Ann Arbor, additional staff interviews, 
staff meeting observations, and SMA observations will be conducted in Ann Arbor only.  Data on 
staff time required for implementation of P2P will also be collected throughout the study to calculate 
the overall cost of program implementation (Aim 4). 
 
Patient enrollment will take place for 18 months at the five sites. Patients receiving P2P can stay 
in the P2P program as long as they wish (while the program is being funded). 
 
VA patient research procedures include completion of three surveys (baseline, 6 months post-
enrollment, and 12 months post-enrollment) and collection of medical record data from VA 
databases. Additionally, a subset of participants will be asked to participate in interviews as part of 
the program evaluation. 
 
As SMAs are being implemented as part of usual care, resources will not permit all patients 

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eligible for the program to be invited. Of those patients who are not invited to participate, a 
random sample will be identified from each site to serve as an untreated control (usual care 
without SMAs). We request a waiver of informed consent and HIPPA authorization for these 
patients in order to collect laboratory and service utilization data solely for research purposes. 
 
Semi-structured interviews with five to eight key informants (VA staff) at the participating sites will 
be conducted to obtain information on CFIR constructs likely to influence implementation success. 
These interviews will include the director of primary care, clinicians participating in the SMAs, P2P 
group facilitators, and other key staff involved in diabetes patient care (e.g., nurses, dieticians, 
pharmacists). 
 
 
5.1.2 Risks 
 
VA Patients 
Participants will be instructed to skip any survey or interview question they feel uncomfortable 
answering. Participants may also end an interview at any time. Participants will be told that they 
may withdraw from the study at any time without penalty. If a potential study participant does need 
support or wants further clarification of any issue, a study investigator will address the concern in a 
sensitive and professional manner (i.e., by calling the participant directly and/or recommending 
follow up with his primary care provider). 
 
We believe that risk of a breach of confidentiality is low. Throughout the study, IRB and HIPAA 
guidelines will be followed to ensure the privacy and integrity of the information we collect. To 
minimize the risk of a breach of confidentiality, we will perform the following steps. First, as soon 
as the cohort is defined by the data manager, each patient in the cohort will be assigned a unique 
study ID. All electronic data, including audio recordings, will be stored in an access-restricted folder 
on the HSR&D drive, which resides behind the VA firewall. All identifying data (e.g., names of other 
patients, providers, facilities) will be removed from transcripts of the audiofiles during the 
transcription process. At the study’s conclusion, all personally identifying information (PII) will be 
moved to an access restricted folder on the Ann Arbor VA OI&T network, accessible only to the 
HSR&D data manager. Members of the study team will no longer have access to these data. Data 
will be destroyed by the data manager 6 years following the end of the fiscal year after completion 
of the research project. All research data will be presented in aggregate form only. The data 
manager will also be responsible for creating analytic datasets for statisticians and investigators; 
these datasets will be de-identified per HIPAA guidelines. Furthermore, study staff members sign a 
pledge of confidentiality and understand that breach of confidentiality is grounds for dismissal. 
Study staff members are required to complete annual training on privacy and HIPAA, as well as 
biannual training on human subjects protection. All research findings will be presented in 
aggregate only. 
 
Minimization of risk to usual care 
A number of steps will be taken to ensure the safety and confidentiality of patients who participate 
in the P2P program. All patients participating in P2P will receive training for the peer support 
component of the study in order to prepare them for those interactions. Patients’ confidentiality will 
be protected via several mechanisms. Patients who are comfortable doing so will be asked to 
provide their name and phone number to their partner. All patients will be advised to not give out 
their address or other personal information. This will be explained to the participants during the 
initial face-to-face group visit, and on the "Do’s and Don'ts" card given to the participants to help 
guide the peer support calls. Finally, messages left on participants’ answering machines will not 
reference any information about their diabetes or other health problems. 
 
VA Employees 
There are no physical or psychological risks to study participation. The social/legal: risk to these 

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participants is potential loss of confidentiality from their interview responses and observational data 
(Ann Arbor only). The interviews will include questions about various characteristics of the VA 
medical center where they work, and respondents may provide negative comments about the 
organization. Linking these responses to a particular employee could result in adverse actions 
against that employee by other members of the organization, including the employee’s supervisor. 
 
Ann Arbor study staff will recruit the employees for all participating sites to reduce the risk of a 
breach of confidentiality. The same precautions for protecting the audiofiles and transcripts of 
Veteran participants will be used for protecting these data, along with observation notes, from VA 
employees. Data will be stored behind the VA firewall at the VAAAHS and minimal Ann Arbor 
study staff members will have access. 
 
VA Patients and VA employees 
There is no direct benefit to patients or VA employees as a result of participation. Patients may 
benefit indirectly, as this study may result in improvement in diabetes care at the VA. Findings 
from the study should provide information that will help with implementation of the P2P program, 
to facilitate its integration into existing clinic structures and processes and reduce the effort 
required by employees to implement and maintain the program. 
 
The study team will meet regularly during the recruitment period. These meetings will include 
discussion of the events of the week, particularly any problems/events that have come up. The PI 
and study team will work to address any problems/events to reduce the likelihood of occurrence in 
the future, to keep the risk to subjects as low as possible, and to maximize the potential study 
benefits. The research team will visit the sites in year 2 (approximately six months following 
implementation) to conduct an on-site assessment of program status, interview key staff members, 
and to problem-solve any issues that have come up. 
 
 
5.1.3 Study Population 
 
VA Patients 
We will enroll up to 1,100 VA patients to the SMA and SMA+P2P groups and 1,100 VA patients to 
the control group. Inclusion criteria are reflective of the criteria to participate in SMAs and P2P, with 
the addition of criteria to insure informed consent. Please see section 5.4 for a complete list of 
these criteria. 
 
VA Employees 
We will enroll up to 56 VA employees for the pre-, mid-, and post-implementation interviews. VA 
Employees will be asked to participate based on their role in the SMA and/or P2P programs. The 
director of primary care, clinicians participating in the SMAs, the P2P group facilitators, and other 
key staff involved in diabetes patient care (e.g., nurses, dieticians, pharmacists) will be asked to 
participate in semi-structured interviews. These employees, who may play a role in the SMA or 
P2P program (as a referring provider, or as someone facilitating the SMA or P2P group visits), will 
be targeted to obtain information on CFIR (Consolidated Framework for Implementation 
Research) constructs likely to influence implementation success. Additionally, in Ann Arbor, we 
will enroll up to an additional 25 VA employees in the sustainment assessments (i.e., interviews, 
meeting observations, SMA observations).  Employees will be asked to participate based on the 
teamlets who will be conducting upcoming SMAs.  All members of the involved teamlets (e.g., 
MD, PharmD, RD, RN, LPN, MSA, etc.) will be asked to participate in the sustainment 
assessments. 
 
 
5.1.4 Vulnerable Subjects 
 
Note: this study includes surveys and interviews only, no clinical interventions.) 

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VA Patients 
As this study is an effectiveness trial conducted under real-world implementation conditions, we 
will conduct the study in those who 1) are eligible to participate in SMAs, and 2) who can give 
informed consent. This excluded individuals with impaired decision-making capacity, those who 
do not speak English proficiently, and prisoners. It includes all other groups. There are no 
interventions as part of this study, so we will not exclude pregnant women. 
 
VA Employees 
Employees will be included for interviews and observations to gain knowledge regarding 
implementation of SMAs and the P2P program. 
 
 
 
5.2 
Recruitment Methods 
 
At a minimum, we will require 560 VA patients in the SMA and SMA+P2P groups and 560 VA 
patients in the control group (see power calculation in Section 5.6.1 below). We will also enroll up 
to 56 VA employees. 
 
VA Patients 
SMA and SMA+P2P groups – As usual care, some sites may only conduct one group at a time 
depending on variability of their resources over time, but all sites will conduct a number of groups 
over the study period and the two treatments will be offered in a random sequence within site. 
Patients are not assigned to groups, but are recruited from a population of eligible patients when 
the site is ready to run a new group. Thus patients will be randomly sampled for invitation from 
eligible patients and recruited for each wave of the group treatment with a standard script that is 
identical whether the group is SMA only or whether P2P will be offered as an additional optional 
part of the intervention. There will be two methods of recruitment: existing mechanisms and data 
pull.   
 
Existing Mechanisms 
During the start-up period of this project, many of the participating sites established a strong 
referral base and high participation rate in their SMAs. All patients referred to SMAs will be 
scheduled into the next available SMA; the scheduler will not be aware of which SMA groups 
will be offering P2P as an additional optional component. Once the patient is scheduled, the 
scheduler will communicate the patient’s information to the RC through encrypted email, 
CPRS alert, or a phone call.   
 
All patients scheduled for an SMA who meet our eligibility criteria will be mailed the Study 
Intro Letter, the Study Info Letter, a HIPAA authorization, and the baseline survey. 
Participants will be asked to return the baseline survey (with a waiver of written informed 
consent) prior to attending their first SMA, and the signed HIPAA authorization prior to the 
study team linking medical record data to the survey data. The RC may call participants who 
have not returned the baseline survey and/or HIPAA prior to the first SMA.  Whenever 
possible, the RC will attend the first SMA in order to administer/collect any outstanding 
baseline surveys and/or HIPAAs for those interested in the study, and distribute incentives 
for completion. Depending upon what type of group is starting at the time the participants are 
starting SMAs, they will become part of the SMA group or the SMA + P2P group. 
 
 
Data Pull 
Each quarter, the Data Manager will pull a list of all patients meeting the eligibility criteria 
outlined below. At our Ann Arbor site and Palo Alto site and subsites, the RC will provide 

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each newly eligible patient’s assigned provider (PCP or RN) the opportunity to opt that 
patient out of SMA recruitment. Providers will be asked to respond within 1 week and at that 
point, any patients who were not opted-out will be recruited.  
 
Eligible patients will be sent an SMA Info Letter explaining that they are being invited to 
participate in SMAs, provided a brief description of what the SMAs involve, and informed that 
some groups will also be offered an additional (optional) opportunity to participate in P2P as 
a supplement to the SMAs. This introductory letter will also explain that they will asked if 
they are interested in participating in a research study to evaluate this program, It will explain 
that they may participate in the SMAs regardless of their decision to participate in the 
research study. It will also include a phone number to call to opt-out of the invitation to 
participate in the research study, or to opt-out of both the invitation to participate in SMAs 
and the research study. Unless patients respond that they do not wish to participate, the 
letters will be followed with a phone call to further describe the program. If patients are 
interested in participating, they will also be asked a set of brief screening questions to 
screen out people with active substance abuse. Then the RC will schedule the patient to 
attend an upcoming SMA or SMA + P2P meeting. Veterans who do not wish to participate 
will be replaced with another Veteran randomly selected from the population of eligible 
Veterans, until the SMA group is filled. A full group will range from 10 – 14 patients 
depending upon the site resources. 
 
The patients who elect to participate in the SMAs will be asked if they are interested in 
participating in the study. If they are interested in the study, they will be asked to sign a 
HIPAA authorization to collect their medical record data and link it to survey information 
collected as part of the study in order to evaluate the SMA program. Even if they decide not 
to participate in the evaluation, they can still participate in the programs. Those who are 
interested in the study will be sent a BL Packet Letter, the Study Info Letter, a HIPAA 
authorization, and the baseline survey. Participants will be asked to return the baseline 
survey (with a waiver of written informed consent) prior to attending their first SMA, and the 
signed HIPAA authorization prior to the study team linking medical record data to the survey 
data. The RC may call participants who have not returned the baseline survey and/or HIPAA 
prior to the first SMA. Whenever possible, the RC will attend the first SMA in order to 
administer/collect any outstanding baseline surveys and/or HIPAAs and distribute incentives 
for completion. Depending upon what type of group is starting at the time the participants are 
starting SMAs, they will become part of the SMA group or the SMA + P2P group. 
 
Follow-up surveys, along with a pre-stamped business reply envelope, will be mailed to 
participants at 6-months and 12-months after their first SMA. Participants who not return a 
completed survey will be mailed a second survey 2 weeks after the initial mailing. RAs may follow 
up by phone with participants who have outstanding surveys. 
 
A random sample of the participants who participate in the P2P program, stratified by participation 
level, will be asked to participate in a semi-structured telephone interview to better understand their 
experiences with the program. At the end of the program, patients will be stratified by participation 
level: the low participation group (began the intervention but completed fewer than 25% of 
weekly phone calls/group sessions in 12 months of program participation); moderate 
participation group (completed approximately 50% of weekly phone calls/group sessions); and 
the significant participation group (completed greater than 75% of weekly phone calls/group 
sessions). Study staff will attempt to interview, by phone, an equal number of participants in each 
of these 3 groups. 
 
The patients who are invited but decline participation in the P2P (declined participation group) 
will be asked if they are willing to answer a few questions with a study team member. The 
responses will be recorded but there will be no link between the responses and the participant. 
 

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Of the patients receiving usual care who were randomly not selected for invitation SMAs (since in 
all the sites too many patients will be eligible for invitation than there are resources to 
accommodate over the study period), a random sample will be selected from each wave to be 
part of the no intervention control group under a waiver of informed consent. 
 
Patients will receive a $20 gift card upon completion of the baseline survey and a $10 gift card 
will be mailed with both the 6 and 12-month survey. Additionally, Patients who participate in an 
interview will receive a $10 gift card by mail. 
 
VA Employees 
Members of the Ann Arbor study team will send an introductory email with an attached information 
letter to these potential participants explaining the study. This email will give them an option to call 
to opt-out. Those who do not opt-out will be contacted by the RAs or Ms. Kowalski and will be 
asked if they are willing to participate. Employees who do not opt-out may also be approached in-
person at the time of an observation.  Verbal informed consent will be obtained from those willing 
to participate, and an appointment to complete the interview/observation will be scheduled. Verbal 
informed consent will also be captured at the beginning of recorded interviews. 
 
 
5.3 
Informed Consent Procedures 
 
Informed Consent will not be sought for 
 Veterans randomly selected from those who have not been asked to participate in SMAs 
(inactive controls). There will be no contact with this group. 
 
 Veterans who are invited to participate in SMA or P2P but elect not to (declined participation 
group). We would like to ask them a few questions at the time that they elect not to participate 
or soon after by telephone in order to better understand the barriers to participating in the 
program. (Appendix 3, Refuser Questions) 
 
Request Waiver of Documentation of informed consent 
 Veterans in the SMA and SMA+P2P groups. 
Veterans who are interested in the research study will be asked for verbal informed consent. 
Those who provide verbal informed consent will be sent a study survey by mail, as well as an 
information letter about the study, a HIPAA authorization request, and a postage paid return 
envelope. This will allow participants to complete the baseline study survey at home, 
eliminating the inconvenience of needing to come in early to a clinical appointment to complete 
the consent process and paper survey just prior to their first SMA.  
 
Until a signed HIPAA authorization is returned, survey/interview data will not be linked to PHI 
collected from administrative/medical record data. The RC may call participants who have not 
returned a signed HIPAA prior to the first SMA. The RC may also attend the first SMA to 
administer/collect any outstanding HIPAAs. If a signed HIPAA has not been returned at the time 
that the follow-up surveys are mailed, an additional HIPAA will be included in the mailing.  
 
 Employees. 
Employees will be e-mailed an introductory letter, including an information sheet about the 
study. Those who are interested in participating will be asked to provide verbal informed 
consent. 
 
Training will be conducted with each study team member approved to obtain informed consent at 
each recruiting site. This training will be conducted by telephone by the Ann Arbor project 
manager. In addition to this structured training, informed consent procedures will be reviewed 
with all study staff at the regularly study meetings, which will include discussion of the events of 

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the week where we will answer questions and address any problems/events to reduce the 
likelihood of occurrence in the future. 
 
 
 
5.4 
Inclusion/Exclusion Criteria 
 
VA Patients 
Inclusion criteria are reflective of the criteria to participate in SMAs and P2P, with the addition of 
criteria to insure informed consent: 
 
1. Meet at least one of the following criteria in the past 2 years: 
 
For data pull patients: 
a. At least one VA hospitalization with a type 2 diabetes-related ICD-9 or 10 code 
b. At least two VA outpatient visits with a type 2 diabetes-related ICD-9 or 10 code, or 
c. At least one VA prescription for a glucose control medication (insulin or oral agents) 
or monitoring supplies. 
 
For clinical referrals: 
a. Scheduled for diabetes SMA 
2. Poor glycemic control, indicated by a HbA1c in the past six months of: 
a. at least 7.5% if age < 70, or 
b. at least 8% if age 70+ 
3. No active substance abuse disorder (smoking cigarettes is not an exclusion) 
4. No serious psychiatric illness, including bipolar disorder, dementia, schizophrenia, or personality 
disorders (MDD and PTSD are not exclusions) 
5. Has a current address and telephone number listed in VA databases 
6. Is competent to provide informed consent 
7. Can communicate in English and by telephone 
8. Not terminally ill 
9. Able to participate in an outpatient program 
10. Not a prisoner 
 
VA Employees 
VA Employees will be asked to participate based on their role in the SMA and/or P2P programs. 
The director of primary care, clinicians participating in the SMAs, P2P group facilitators, and other 
key staff involved in diabetes patient care (e.g., nurses, dieticians, pharmacists) will be asked to 
participate in the pre-, mid-, and post-implementation semi-structured interviews. For the 
sustainment assessment, members of Ann Arbor teamlets who are involved in upcoming SMAs 
(e.g., MD, PharmD, RD, RN, LPN, MSA, etc.) will be asked to participate. 
 
 
 
5.5 
Study Evaluations 
 
Patient Research Participants 
VA patient research procedures include completion of three surveys (baseline, 6 months post 
enrollment, and 12 months post enrollment) and collection of medical record data from VA 
databases. Additionally, a subset of participants will be asked to participate in interviews as part of 
the program evaluation. 
 
Patient Inactive Controls 
Medical record information will be pulled from VA databases. The data will include A1c 
levels, blood pressures, insulin start dates, statin use, and number of admissions/bed days 
of care/outpatient visits. 

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Patient Refusers of SMAs and P2P 
Patients in the declined participation group will be asked to answer a few questions by the RC at 
the time of refusal or soon after refusal by telephone. 
 
Employee Research Participants 
Semi-structured interviews with five to eight key informants (VA staff) at the participating sites will 
be conducted to obtain information on CFIR constructs likely to influence implementation success. 
These interviews will include the director of primary care, clinicians participating in the SMAs, the 
P2P group facilitators, and other key staff involved in diabetes patient care (e.g., nurses, 
dieticians, pharmacists). Additionally, in Ann Arbor, up to an additional 25 VA employees will 
participate in sustainment assessments (i.e., interviews, meeting observations, SMA 
observations).  These employees will include all members of the teamlets involved in hosting 
upcoming SMAs.  
 
 
 
5.6 
Data Analysis 
 
This will be an effectiveness trial conducted under real-world implementation conditions in 
multiple sites and regions. The focus is on assessing the impacts of the P2P program on patient 
outcomes as well as optimization of the implementation strategy. 
 
5.6.1 Analysis Plans by Aim 
Aim 1 (Evaluation of the effect of SMAs and SMAs+P2P compared to usual care on diabetes 
patients’ glycemic control, blood pressure, statin use, and insulin starts at 6 and 12-18 months 
post-enrollment): The primary analysis will be an intention to treat analysis (ITT) comparing all 
participants scheduled for an SMA (regardless of whether an SMA was actually attended) and 
eligible patients randomized to usual care. We also will conduct analyses comparing outcomes 
between the usual care group and: 1) The SMA Attendee group, defined as a subset of those in 
the SMA ITT group who attended at least one SMA; and 2) the SMA Engagement group, defined 
as the subset of patients who attended at least half of the SMAs offered in the series. 
 
We will conduct a “difference-in-differences” (DID) analysis on our primary A1c outcome using a 
multilevel linear mixed effect model. The model will include an indicator or treatment, an indicator 
for time, the treatment-time interaction (DID estimator), and variables to adjust for baseline A1c, 
age, gender, and race. Random intercepts to include will be for patients (level-1) nested within site 
(level-2). An identical analysis will be used for the secondary SBP outcome. In the secondary 
analyses of insulin and statin starts, we will implement a multilevel logistic regression model, and 
for anti-hypertensive medication class changes, we will implement a multilevel Poisson regression 
model. To analyze the 6- and 12-month differences in utilization measures between treatment 
groups, we will use a two-sample Mann-Whitney U test.  Vargha and Delaney’s A statistic will be 
used to describe the effect size of the Mann-Whitney test. As a robustness check, we will repeat 
the above analyses on a subset of patients who will be matched 1:1 based on propensity scores. 
The propensity score model will be developed using a logistic regression on the patient 
demographics. Although our initial analyses will use observed data, because we are relying on 
data available in the EHR, we anticipate more missing values than if this were an efficacy trial. 
Accordingly, we will use logistic regression to model patients' likelihood of having outcome data 
and defined strata within which outcome values were missing at random. We will then stratify 
patients according to these propensities and randomly sample from the observed outcome 
distribution and impute these values for missing data within each stratum. As a sensitivity analysis 
for the primary A1c outcome, we will impute the missing data such that any missing A1c 
measurements at 6 or 12 months will match the value at baseline. 
 

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Aim 2 (Assessment of the impact of SMAs and SMAs+P2P on service utilization and patient-
centered outcomes, including patients’ satisfaction with VA care, diabetes-specific quality of life 
and social support at 6 and 12 months post-enrollment).  In our analysis of changes in patient-
centered outcomes as reported on patient surveys, we will conduct a paired Wilcoxon signed rank 
test to determine if there are significant changes between baseline and the 6- and 12-month post-
enrollment evaluation periods. We will use the Benjamini-Hochberg (BH) procedure to attempt to 
control the false discovery rate due to the multiple comparisons. There were very few participants 
in the SMA+P2P group chose to be formally matched with another participant in their SMA to give 
and receive peer support outside the SMA. If we do not have sufficient sample size of participants 
in P2P, we will be unable to compare outcomes between the SMA-only and SMA+P2P arms. In 
that case, will only conduct our primary analysis that combines the two SMA groups (SMA-only and 
SMA+P2P) into one active treatment group and compare clinical outcomes of participants 
participating in SMAs with those in usual care. 
 
Fidelity of the P2P Program. To collect data on fidelity, checklists of key content areas to cover and 
communication skills that should be used will be completed and forwarded to Ann Arbor. A HBC or 
another qualified health behaviorist will attend the first P2P visit (immediately following the first 
SMA) and will complete a fidelity assessment checklist. Additionally, they will provide feedback to 
the P2P facilitator immediately following the session. This feedback will be documented and shared 
with the Ann Arbor study team. An assessor will continue to attend drop-in sessions, completing 
fidelity assessments and providing feedback, until he/she feels the P2P facilitator is ready to 
continue without assistance. Then the fidelity assessments will be completed approximately every 
3rd drop-in session for the remainder of the study. Additionally, the P2P facilitators will be asked to 
complete self-assessment checklists after each session which will be forwarded to Ann Arbor. 
 
Process and Content Assessments of SMAs. A fidelity checklist of key content areas to cover and 
communication skills that should be used will be completed and forwarded to Ann Arbor. The 
intention of this assessment is for us to keep track of what is being covered during the SMAs, but 
we will not provide feedback to the facilitators. The goal is for the local sites to maintain local 
control over the content of their SMAs. The HBC or RC will attend all sessions of first and last 
SMA cohorts during the study period (and one in the middle if possible) and any cohorts following 
a significant change in SMA curriculum/protocol. A SMA facilitator will be asked to conduct a self-
assessment at all sessions, which are also to be forwarded to Ann Arbor. 
 
Aim 3: Staff interviews will be used to identify recommendations and develop a tool-kit for 
facilitating widespread dissemination efforts, and to contribute to the implementation science 
literature. The evaluation will include semi-structured interviews with five to eight key informants at 
the participating sites, including the director of primary care, clinicians participating in the SMAs, 
P2P group facilitators, and other key staff involved in diabetes patient care (e.g., nurses, dieticians, 
pharmacists). During the start-up period of this project, key stakeholders helped identify a subset of 
CFIR constructs that are likely to play a role in the effectiveness of the P2P program, such as: 
relative advantage, adaptability, complexity, and cost (intervention characteristics); patient needs 
and resources, external policies and incentives (outer setting); networks and communications, 
relative priority, goals and feedback, leadership engagement, available resources (inner setting); 
knowledge and beliefs (characteristics of individuals); and planning and engaging (process). These 
relevant constructs will be used to develop the semi-structured interview guides and to deductively 
code the interview responses. Interviews will be audiotaped and transcribed. Seven to ten months 
and eighteen months to two years following implementation of the SMA + P2P program at the 
participating sites, we will use this data collection procedure for collecting data on CFIR constructs 
from staff at the participating sites. 
 
Additionally, in Ann Arbor, semi-structured interviews, meeting observations, and SMA 
observations will be conducted to further evaluate clinical efforts to sustain SMAs.  The evaluation 
will include all members of teamlets involved in upcoming SMAs.  The interviews will be 
audiotaped and transcribed.  Teamlet planning meetings and SMAs will be observed by two 

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members of the Ann Arbor study team, who will take detailed notes.  The notes from the SMA 
observations will not include any patient data, but will rather focus on how the SMA is structured 
and how the facilitators run the session. 
 
In addition, we will conduct semi-structured interviews with a random sample of patients invited to 
participate in SMAs or SMAs + P2P, to better understand their experiences with the program 
(above and beyond their satisfaction with the program, determined as part of Aim 4). We will 
purposefully sample up to 140 Veterans, approximately 15-20 at each site (including of the four 
clinics within the Palo Alto site), approximately 12 months after enrollment, stratified into three 
groups according to level of participation in the intervention: low participation (began the 
intervention but completed fewer than 25% of weekly phone calls/group sessions in 12 months of 
program participation); moderate participation (completed approximately 50% of weekly phone 
calls/group sessions); and significant participation (completed greater than 75% of weekly phone 
calls/group sessions). By stratifying according to level of participation, we hope to understand both 
the barriers and facilitators patients experience in participating in the program. For the declined 
participation group, the RC at each site will ask patients who are contacted but do not enroll if they 
are willing to answer a few questions. These questions will be asked by the RC by phone at the 
time the patient declines participation in the SMA program. These questions will also be asked of 
those who participate in SMAs and are offered P2P as an optional add on but decline. The RC will 
ask these in person whenever possible; otherwise the RC will do this by phone. Those who agree 
to this short (expected to take less than 5 minutes) questionnaire will be asked questions about 
demographics, diabetes management and service utilization. The responses will be entered into a 
database, but there will be no patient identifiers. Interviews for the remaining groups will be 
conducted by telephone by Ann Arbor study staff and will last about 20 minutes. These interviews 
will be audio-recorded for transcription and analysis. We will continue to sample and interview 
patients until additional interviews no longer identify new themes in the areas of inquiry. 
 
Analysis of the qualitative data from the formative evaluations will begin with a deductive approach 
to coding interview data according to CFIR constructs. Once the data have been organized by 
constructs, an ordinal value (-2, -1, 0, 1, or 2) will be assigned to each construct at each site. These 
values represent the perceived magnitude and “role” of each construct in the implementation of the 
program—e.g., -2 for the construct of “relative priority” means there are a number of other high 
priority clinical programs competing for resources/attention, +2 means the proposed program has a 
high priority compared to other programs based on explicit facility goals related to improving the 
care of patients with diabetes. The data will also be coded inductively, to identify themes or issues 
not captured by the CFIR constructs that may deserve attention during the implementation process. 
In the post-implementation evaluation these data will then be used to construct a matrix for 
identifying potential correlations between each construct and program outcomes. Strong 
correlations will then form the basis of specific recommendations for program dissemination. 
 
Table 4 provides an example of what the matrix might look like for analyzing the staff interview 
data. Constructs A and B do not appear to be correlated to program outcomes, in that there is no 
orderly progression from low to high magnitude of the construct, consistent with the progression 
from small to large decrease in HbA1c. In contrast, constructs C and D do show a correlation, 
suggesting that these constructs might be important factors affecting successful implementation of 
the program. Thus, these findings can be used to develop recommendations for future efforts to 
disseminate the program, depending on what these factors are, and how they are manifested in the 
individual sites. We have used this rating process successfully to identify those constructs that 
appear to be most closely correlated with intervention outcomes in four different VA QUERI 
implementation studies, including an evaluation of VHA’s specialty care initiatives (E-consults and 
SCAN-ECHO). The process provides a more systematic means of linking constructs to 
implementation success than simply organizing qualitative data according to themes. 
 
 
Table 4: Example Findings from Qualitative Analyses of Staff Interviews 

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Sites (in order from least to biggest 
 
decrease in HbA1c) 
Co
1 
2 
3 
4 
A 
-2 
+
0 
+
B 
+
+
0 
+
C 
-1 
-2 
0 
+
D 
-2 
0 
+
+
 
 
Aim 4 (Obtain data throughout implementation on the staff effort required, to be used for 
calculating the costs of the program): Costs will be assessed from the VA perspective and will 
focus on the direct costs of the P2P program itself. We will ask the facilitators to record the 
number of group visits and duration of each, and the time spent in training and pre-visit 
preparation.  
 
5.6.2 Sample Size and Power Calculations 
We chose five VA health systems (8 sites, as one healthy system will implement the program in 4 
separate sites within the system) in which to implement SMAs + P2P based on our estimation of 
feasibility of implementation, given budget and time constraints. This number of health systems 
should also provide some variability in terms of the CFIR constructs (especially implementation 
context), which is important for investigating the role of these constructs in implementation 
success. We want to ensure that the study has a sample size sufficient to detect a clinically 
meaningful decline in A1c of 0.5% or a SBP decline of 5mm Hg between SMA and SMA+P2P. 
Based on discussions with clinical managers at a number of sites, both in relation to this project 
and others, they would be unlikely to undertake an addition of a new clinical management strategy 
unless it offered a benefit of this magnitude. 
 
The clustering induced by the treatment in small groups requires that we account for the intra-class 
correlation within clusters in our sample size calculation. An increasing number of publications 
have started to provide estimates of ICCs from practice-based interventions.82 83 84 85 86 However, 
there are not good sources for estimates of ICCs of clinical intermediate outcomes induced by 
shared medical appointments. In a previous RCT conducted by us of P2P alone, which given the 
intimate nature of the pairing may represent an upper limit of induced correlation that might be 
found in a larger SMA, we found that the ICC was estimated at 0.10 but it was not significantly 
different from 0. Thus we used a range of 0 to 0.10 for the estimate of ICC of the outcome a1c or 
SBP measurement. 
 
We present sample size calculations using Satterthwaite's approximate F test using modified 
degrees of freedom rather than a t-test to calculate the power for trials and the number of clusters 
and cluster sizes required for the difference of means in the presence of clustering or differential 
clustering effects between study arms as described by Roberts (2005) and implemented by 
Batistatou and Roberts (2011). We estimate that we can conduct 10 to 16 SMA groups per site 
(equally distributed between SMA and SMA+P2P) with 8-14 people per group. At our low estimate 
of 10 SMA groups per site, we can detect an effect size of 0.5% decline in A1c with a power of 0.8 
for all but the lowest number of participants per group (10) and highest ICC (0.1). 
 
For the comparison of both SMA groups to inactive control we must take into account the 
differential ICC between groups as the inactive controls will have no clustering induced by the 
treatment and therefore will have an ICC of 0. We continue to assume a worst case scenario of an 
ICC of 0.10 in the intervention group. In this case we examine our ability to detect a difference of 
5mm Hg in blood pressure between SMA groups and the inactive controls. 
 

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The standard deviation of a decline in A1c was estimated to be 1.45 from this same RCT 
mentioned in the paragraph above. The estimate of the standard error of the change in BP 
was estimated from a database of actual BPs obtained in routine clinical practice for 24,000 
patients with diabetes and hypertension in one large service network in the VA over a 24 
month period in FY 2004-2005. It depends on both the variation in BP change at the person 
level and variability within person between measurements. Increasing numbers of 
measurements in the 6 month window decreases the within person component of variance. 
Using the proposed 6 month pre- and post-intervention windows on either side of a 12-
month intervention period we estimated the standard error for the change in blood pressure 
as 17 mmHg for the mean of 3 BP measurements that was observed in the sample for each 
of the pre and post periods. 
 
Again, we assume that we can conduct 10 to 16 SMA groups per site (equally distributed 
between SMA and SMA+P2P) with 8-14 people per group. At the maximum, this would give 
us 1,568 people in active treatment and an equal number of inactive controls. At the 
minimum, this would give us 560 people in active treatment and an equal number of 
inactive controls. In this scenario, at our low estimate of 10 SMA groups per site, we can 
detect an effect size of 5mm decline in SBP with a power of 0.8 across all our ranges of 
group size and ICC. In this scenario, we also have a power at 0.8 at all estimated ICCs to 
detect a 0.5% difference in A1c between the active treatment groups and controls. 
 
Table 5 shows a snapshot of the number of eligible patients per site. Across all sites, we will 
recruit between 560 and 1,568 active treatment patients and an equal number of inactive 
controls. 
 
 
Table 5: Number of Patients with Diabetes* with qualifying A1c**, and Number of These 
Patients with and without Serious Mental Illness (SMI) or Substance Use Disorder (SUD) 
and with SBP>140 
 
Site 
No. of Diabetes 
Patients 
No. of Diabetes 
Patients without 
SMI or SUD 
No. of Diabetes Patients 
with Qualifying A1c** 
No. with Mean 
SBP>140 in Past 
6 months 
West Haven (Firm A) 
3,748 
306 
397 
187 
Providence 
5,466 
636 
794 
105 
Palo Alto 
3,877 
404 
534 
110 
Livermore 
1,212 
156 
168 
88 
Monterey 
3,736 
298 
381 
160 
Sacramento 
5,847 
858 
1,045 
210 
Ann Arbor 
11,020 
2,064 
2,576 
955 
*Source: VHA CWD (last updated 2015). 
**Patients less than 70 years old with A1c>7.5, for patients age 70 or above Ac1>8.0 
 
 
 
5.7 
Withdrawal of Subjects 
 
The interventions (SMAs and P2P) are usual care. Only the surveys, collection of medical record 
data, and interviews are research. Patients can elect to withdraw from the study and this does not 
change the usual care intervention in any way. 
 
 
 
6.0 
Privacy and Confidentiality 

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Throughout the study, IRB and HIPAA guidelines will be followed to ensure the privacy and integrity 
of the information we collect. To minimize the risk of a breach of confidentiality, we will perform the 
following steps. First, as soon as the cohort is defined by the data manager, each patient in the 
cohort will be assigned a unique study ID. All electronic data, including audio recordings, will be 
stored in an access-restricted folder on the HSR&D drive, which resides on the OI&T server behind 
the VA firewall.   All identifying data (e.g., names of other patients, providers, facilities) will be 
removed from transcripts of the audiofiles during the transcription process.  
 
In addition to transcription by study team members, audio files may also be transcribed by 
approved staff from the VA Salt Lake City (VASLC). The VASLC has a Centralized Transcription 
Service Center available to VA sites and monitored by their own IRB. The audio recordings to be 
transcribed by VASLC staff will be labeled by the subject's study ID number and saved behind the 
VA Firewall in the study’s secure shared project folder on Ann Arbor VA research drive. The 
VASLC transcription staff will be given access to the SLC Transcription sub-folder within the 
secure project folder. Approved study staff will place a copy of the audio files in this folder for an 
approved VASLC transcriptionist to access for the purposes of transcription. The VASLC 
transcriptionist will transcribe each interview and save the completed transcript in the sub-folder 
using the same study ID number. No data (audio files, in process transcripts, or completed 
transcripts) will leave the Ann Arbor VA secure research server. As completed transcripts become 
available, approved study staff will move these files from the transcription sub-folder into another 
sub-folder that is only accessible to study staff, where they will be stored and accessed for 
qualitative analyses.  
 
At the study’s conclusion, all personally identifying information (PII) will be moved to an access 
restricted folder on the Ann Arbor VA OI&T network, accessible only to the HSR&D data manager. 
Members of the study team will no longer have access to these data. Data will be destroyed by the 
data manager 6 years following the end of the fiscal year after completion of the research project. 
All research data will be presented in aggregate form only. The data manager will also be 
responsible for creating analytic datasets for statisticians and investigators; these datasets will be 
de-identified per HIPAA guidelines. Furthermore, study staff members sign a pledge of 
confidentiality and understand that breach of confidentiality is grounds for dismissal. Study staff 
members are required to complete annual training on privacy and HIPAA, as well as biannual 
training on human subjects protection. Patient HIPAA authorizations will be maintained in a locked 
filing cabinet at the patient’s study site in a restricted access office. Paper surveys (identified by 
study ID only) will be mailed to Ann Arbor and be maintained in a locked filing cabinet in a restricted 
access office. 
 
The research team will conduct patient recruitment and interviews in/from private offices. P2P and 
SMA visits will be held in conference rooms. Ground rules, specifically regarding confidentiality, 
will be discussed with the group at the first visit.  
 
All research findings will be presented in aggregate only. 
 
When study personnel are removed from the research team, their permissions to access the 
study files on the VA server will be removed. 
 
In the event of a breach of confidentiality, the ISO and Privacy Officer will be notified within one 
hour of discovery of the improper use or disclosure. 
 
 
7.0 
Communication Plan 
 
The project manager, Jennifer Burgess, will verify VA Central IRB approval and the local VA facility 

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approval before study recruitment can begin at that site. There are no facilities where the research 
is being conducted but the facility is not engaged in research. At the end of any individual site’s 
participation in this research, the CIRB local facility director and LSI will be notified by an email 
from an Ann Arbor study investigator. 
 
As P2P is being implemented, the research team will conduct regular conference calls 
(approximately biweekly) with the implementation team at each site, to track progress and address 
any questions that arise regarding implementation. These biweekly calls will continue for the first 
few months of patient enrollment and will decrease in frequency as appropriate, depending on the 
challenges (or lack thereof) associated with implementation. The research team will visit the sites 
in year 2 (approximately six months following implementation), to conduct an on-site assessment 
of program status and to problem-solve any issues that have arisen. These regular calls and site 
visits will be used as opportunities to ensure the study is conducted according to the IRB-approved 
protocol. These team calls will include discussion of any updates to the protocol, informed consent 
processes, and/or HIPAA authorizations. Minutes for these meetings, and any updated 
documentation, will be posted on the study SharePoint site, to which all study staff have access. 
 
Because this study has no medical intervention, and researchers have no contact with the 
participants, we do not expect any reportable medical adverse events, and other reportable events 
are unlikely. However, in the event that there is a breach of confidentiality, protocol deviation, or 
another UAP, reports will be made by the study team member who discovers the event to the VA 
Central IRB (CIRB). If the report is not made by the Ann Arbor project manager, she should be 
notified at the same time a report is made. Any UAPs meeting the definitions of serious and related 
to the research will be reported within 5 business days of discovery to the CIRB secure SharePoint 
site dedicated to this purpose. UAPs that do not meet these definitions will be reported to the Ann 
Arbor project manager as they are discovered, and will be reported to the CIRB in summary at the 
time of continuing review/project closure. Protocol deviations/violations that are likely to 
substantially adversely affect 1) the rights, safety, or welfare of a participant; 2) a participant’s 
willingness to continue participation; or 3) the integrity of the research data, including VA 
information security requirements will all be reported within 5 working days of being made aware of 
the occurrence. These will be reported through the secure SharePoint site dedicated to this 
purpose. Any UAPs and/or protocol deviations will be discussed at the regular study conference 
calls, and will be posted on the study SharePoint site. 
 
 

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3. Rosland AM, Heisler M, Janevic MR, et al. Current and potential support for chronic disease 
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5. Bodenheimer TS, Smith MD. Primary care: proposed solutions to the physician shortage without 
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32. Piette JD, Resnicow K, Choi H, et al. A diabetes peer support intervention that improved 
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33. Heisler M, Choi H, Palmisano G, et al. Comparison of community health worker-led diabetes 
medication decision-making support for low-income Latino and African American adults with 
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Med. 2014;161(10 Suppl):S13-22.  
34. Heisler M, Hofer TP, Schmittdiel JA, et al. Improving blood pressure control through a clinical 
pharmacist outreach program in patients with diabetes mellitus in 2 high-performing health 
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