Engaging Veterans and Family Supporters in PACT to Improve Diabetes Management
Phase: NA
Conditions: Diabetes
Sponsor: VA Office of Research and Development

CO-IMPACT Study Protocol approved 9.8.17 
 
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STUDY PROTOCOL 
Title: Engaging Veterans and Family Supporters in PACT to Improve Diabetes Management 
Funding Source: VA Health Services Research and Development 
Principal Investigator: Ann-Marie Rosland 
Protocol Version: September 29, 2016 
 
 
This version approved by IRB on 9.8.17 
 
 
 
 
 
 

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Table of Contents 
List of Terms and Abbreviations .............................................................................................................. 4 
1. Abstract ................................................................................................................................................. 5 
2. Study Personnel .................................................................................................................................... 6 
3. Rationale ............................................................................................................................................... 8 
4. Research Problem or Question .............................................................................................................. 8 
5. Specific Aims and Primary Measures ................................................................................................... 8 
6. Background ........................................................................................................................................... 9 
7. Preliminary Data ................................................................................................................................. 11 
8. Overview of Study Design: ................................................................................................................. 12 
9. Experimental Plan ............................................................................................................................... 13 
9.1 Study Inclusion and Exclusion Criteria ........................................................................................ 13 
9.2 Recruitment ................................................................................................................................... 16 
9.3 Enrollment ..................................................................................................................................... 17 
9.4 Randomization Procedures ........................................................................................................... 17 
9.5 Single-Blinding Procedures .......................................................................................................... 18 
9.6 Subject Withdrawal ....................................................................................................................... 18 
9.7  Procedures to Maintain Study Enrollment ................................................................................... 18 
10.  Intervention ...................................................................................................................................... 19 
10.1 Preparation .................................................................................................................................. 19 
10.2 Primary Care Staff Orientation ................................................................................................... 19 
10.3  Initial Session with the Dyad Engagement Coach (DEC) .......................................................... 19 
10.4 IVR Component .......................................................................................................................... 21 
10.5 Patient-Care Partner Regular Discussions .................................................................................. 21 
10.6 Visit Preparation ......................................................................................................................... 21 
10.7  After Visit Summary .................................................................................................................. 22 
Fidelity ................................................................................................................................................ 22 
11.  Control Condition ............................................................................................................................ 22 
12. Data Collection Procedures ............................................................................................................... 23 
12.1 Patient ......................................................................................................................................... 23 
12.2 Care Partner ................................................................................................................................ 24 
12.3 Dyads .......................................................................................................................................... 25 
12.4 Intervention Processes................................................................................................................. 25 
12.5 DEC Experiences and Feedback ................................................................................................. 25 

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13. Study Measures ................................................................................................................................. 25 
13.1 Patient Outcomes ........................................................................................................................ 25 
13.2 Care Partner Outcomes ............................................................................................................... 27 
13.3 Patient and Supporter Moderators of Effect................................................................................ 28 
13.4 Provider Behavior and Impact on PACT Teamlet ...................................................................... 29 
13.5 Intervention and Control Processes ............................................................................................. 29 
14. Data analysis/Interpretation .............................................................................................................. 29 
14.1 Overall Approach ........................................................................................................................ 29 
14.2 Unit of Analysis and Sample Size Calculation ........................................................................... 30 
14.3 Primary and Secondary Outcomes (Aims 1 and 2) ..................................................................... 30 
14.4 Mediators and Moderators of Intervention Effect (Aim 3) ......................................................... 32 
14.5 Qualitative Analysis .................................................................................................................... 33 
14.6 Process Evaluation ...................................................................................................................... 33 
15. Study Oversight, Quality Control ..................................................................................................... 33 
16. Timeline ............................................................................................................................................ 33 
17. Ethics/Protection of Human Subjects ............................................................................................... 34 
17.1 Risks to Subjects ......................................................................................................................... 34 
17.2 Adequacy of protections against risks......................................................................................... 35 
17.3 Protection against Risk................................................................................................................ 36 
17.4 Potential Benefits ........................................................................................................................ 43 
18. Data and Safety Monitoring Plan ...................................................................................................... 44 
19. Inclusion of Women, Minorities and/or Children ............................................................................. 45 
 
 
 
 
 

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List of Terms and Abbreviations 
 
AAVA-Ann Arbor VA 
ADL – Activities of Daily Living 
AE- Adverse Events 
BMI – Body Mass Index 
BP – Blood pressure 
Care Partner (CP)– Unpaid family member or friend who is involved in the patient’s health care 
CBOC – Community Based Outpatient Clinic 
CO-IMPACT - Caring Others Increasing EngageMent in PACT intervention 
CPRS – Computerized Patient Record System 
DEC – Dyad Engagement Coach 
ED – Emergency Department 
HbA1C – Glycated hemoglobin (hemoglobin A1c) 
HIPAA - Health Insurance Portability and Accountability Act 
IVR- Interactive Voice Response 
LDL – low-density lipoprotein 
PACE - Patient and Caregiver Experiences with Diabetes Study 
PACT- Patient Aligned Care Teams 
Patient Partner – Patient participants who are paired with a Care Partner 
PCP – Primary Care Physician 
PHI - Protected Health Information 
RCT – Randomized Controlled Trial 
SAS - Statistical Analysis Software 
SBP – systolic blood pressure 
SD - Standard Deviation 
UKPDS – United Kingdom Prospective Diabetes Study 
VA – Veterans Affairs 
VAAAHS - VA Ann Arbor Healthcare System (Ann Arbor VA + CBOCs)  
VHA – Veterans Health Administration 
 
 
 
 

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1. Abstract 
BACKGROUND: Veterans with diabetes must control cardiovascular risk factors in order to prevent 
disabling and life-threatening complications. The VA PACT initiative seeks to provide patients 
comprehensive support for following diabetes care regimens, but Veterans must effectively engage in and 
navigate care to obtain the most benefit from PACT. One relatively untapped resource for supporting 
engagement in PACT is patients’ family and friends (“Care Partners”).   
 
OBJECTIVES: The overall objective of this randomized trial is to test a strategy to strengthen the 
capacity of supporters to help patients with high-risk diabetes engage in PACT care and successfully 
enact care plans. The central hypothesis is that providing health care engagement tools to both Care 
Partners and patients will increase patient activation and improve management of diabetes complication 
risks. 
 
RESEARCH PLAN: This will be a randomized controlled trial evaluating an intervention (Caring Others 
Increasing EngageMent in PACT, or CO-IMPACT) designed to structure and facilitate Care Partner 
involvement in PACT so that patients can become more actively engaged in PACT care, and improve 
their diabetes treatment processes and outcomes. 
 
METHODS: 240 patients with diabetes receiving PACT primary care who 1) are at high risk for diabetes 
complications due to hyperglycemia OR high blood pressure and 2) have a Care Partner involved in their 
care will be recruited along with their Care Partner.  Patient-supporter dyads will be randomized to the 
CO-IMPACT intervention or usual PACT care for high-risk diabetes, for 12 months. The CO-IMPACT 
protocol provides patient-supporter dyads: one coaching session on action planning, communicating with 
providers, navigation skills and support skills; preparation by phone before patients’ primary care visits; 
after-visit summaries for both patients and Care Partners; and biweekly automated phone calls to prompt 
action on new patient health concerns. CO-IMPACT builds on medical record-integrated patient 
activation tools in the PACT toolkit and is designed to be implementable within existing PACT nurse 
encounters. Primary outcomes for this study include a validated measure of patient activation (Patient 
Activation Measure-13) and a cardiac event 5-year risk score designed for patients with diabetes (UKPDS 
Risk Engine). Secondary outcomes include patients’ self-efficacy for diabetes self-care; diabetes self-
management behaviors including medication adherence; diabetes distress; and glycemic and blood 
pressure control. Measures among supporters will include supporter activation, use of effective support 
techniques, distress about patient’s diabetes care, and Care Partner burden. We will also measure patient-
supporter and patient-provider relationship quality, patient safety (e.g. hypoglycemia), and utilization. We 
will measure potential moderators of intervention effect, such as patient health literacy level, and 
facilitators and barriers to wider implementation among participants and staff. 
 
 

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2. Study Personnel 
Principal Investigator/Study Chair: 
Ann-Marie Rosland, MD, MS 
Research Investigator, VA Ann Arbor Healthcare System 
Address: NCRC (152), 2800 Plymouth Rd., Bldg 16, 3rd Floor, Ann Arbor, MI 48105 
Phone: (734) 845-3504 
Email: ann-marie.rosland@va.gov  
 
Co-Investigators: 
Michele Heisler, MD, MPA 
Research Investigator, VA Ann Arbor Healthcare System 
Address: NCRC (152), 2800 Plymouth Rd., Bldg 16, 3rd Floor, Ann Arbor, MI 48105 
Email: mheisler@umich.edu 
 
Eve Kerr, MD, MPH 
Research Investigator, VA Ann Arbor Healthcare System; 
Address: NCRC (152), 2800 Plymouth Rd., Bldg 16, 3rd Floor, Ann Arbor, MI 48105 
Email: Eve.Kerr@va.gov 
 
John Piette, PhD, MSc 
Research Investigator, VA Ann Arbor Healthcare System 
Address: NCRC (152), 2800 Plymouth Rd., Bldg 16, 3rd Floor, Ann Arbor, MI 48105 
Email: jpiette@umich.edu 
 
Ranak Trivedi, PhD, MA, MS 
Research Investigator, VA Palo Alto Healthcare System 
Address: VA Palo Alto Health Care System, Menlo Park Division, 795 Willow Road, Menlo Park, CA 
94025 
Email: Ranak.Trivedi@va.gov 
 
Study Staff: 
 
Shelley Stoll MPH 
Project Manager, Center for Clinical Management Research 
Address: NCRC (152), 2800 Plymouth Rd., Bldg 16, 3rd Floor, Ann Arbor, MI 48105 
Email: Shelley.Stoll@va.gov 
 
Caroline Keep 
Research Associate, Center for Clinical Management Research 
Address:  NCRC (152), 2800 Plymouth Rd., Bldg 16, 3rd Floor, Ann Arbor, MI 48105 
Email:  Caroline.Keep@va.gov 
 
Dana Horowitz 
Research Associate, Center for Clinical Management Research 
Address:  NCRC (152), 2800 Plymouth Rd., Bldg 16, 3rd Floor, Ann Arbor, MI 48105 
Email:  dana.horowitz@va.gov 
 
Jenny Davis MHSA 
Data Manager, Center for Clinical Management Research 
Address: NCRC (152), 2800 Plymouth Rd., Bldg 16, 3rd Floor, Ann Arbor, MI 48105 
Email:  Jennifer.Davis@va.gov 

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3. Rationale 
Despite system wide advances in diabetes quality of care, over 30% of VHA patients with diabetes have 
high blood pressure, hyperglycemia, and hyperlipidemia and thus are at high-risk for disabling diabetes 
complications. To reduce diabetes complications, these ‘high-risk’ veterans are advised to follow 
treatment regimens that are complicated and often difficult to follow. PACT (Patient-Aligned Care 
Teams) seeks to provide patients comprehensive, team-based support for following diabetes care 
regimens. PACT’s success, however, hinges on its ability to effectively engage patients in care. It is 
widely appreciated that patients who are more engaged in their health care have better health outcomes.1 
To fully engage in PACT, veterans must effectively communicate with multiple PACT team members 
and proficiently navigate the health care system. High-risk patients, with more complex care needs, often 
need more support to engage in what PACT has to offer. 
 
One relatively untapped resource for this support is patients’ family and friends.  Three out of four adults 
with diabetes reach out to an unpaid family member or friend (a Care Partner) for ongoing help with 
diabetes managemen.2,3 Half regularly bring a Care Partner to their medical appointments.4,5 Chronically 
ill patients with Care Partners have better self-management and long-term health outcomes.6–9 However, 
while PACT emphasizes the importance of family members as part of the care team, PACT does not have 
formal mechanisms to involve Care Partners in PACT care. This is unfortunate as these supporters could 
play a crucial role in helping patients effectively engage in PACT care.  Our preliminary work shows that 
25-50% of Care Partners already regularly talk with PACT providers on the phone, try to help patients 
prepare for PACT appointments, and try to help patients carry out plans made at their medical visit.  
However, studies indicate that Care Partners are currently less effective at influencing patients’ medical 
self-management tasks (e.g., medication adherence or blood glucose monitoring) than healthy lifestyles 
(e.g., healthy eating).10 Care Partners tell us they need more information on patient’s medical care plans, 
clear channels for communicating with PACT team members, and information on navigating PACT 
resources. 
 
4. Research Problem or Question 
Our long-term goal is to provide VA clinical teams with evidence-based structured approaches to 
communicating with Care Partners that improve patient health outcomes and satisfaction with care.  The 
objective of this randomized trial is to test a strategy to strengthen the capacity of supporters to help 
patients with high-risk diabetes engage in PACT care and successfully enact care plans. Our central 
hypothesis is that providing health care engagement tools to both Care Partners and patients will increase 
patient activation and improve management of diabetes complication risks. 
 
5. Specific Aims and Primary Measures 
The study will address the following specific aims: 
 
1) Determine the effect of the CO-IMPACT intervention on engagement in treatment and health 
behaviors among patients at high-risk for diabetes complications. We hypothesize that CO-
IMPACT will significantly increase patient activation, as measured by the PAM-13, 
compared to usual PACT care. 
 
2) Determine the effect of the CO-IMPACT intervention on health risks among patients at high-
risk for diabetes complications. We hypothesize that CO-IMPACT will significantly decrease 
patients’ 5-year cardiovascular event risk, as measured by the UKPDS cardiac risk score 
(which includes HbA1C,non-fasting lipid levels and blood pressure), compared to usual 
PACT care.  

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3) Evaluate how the characteristics of patients, family supporters, and their relationships 
mediate and moderate the effects of CO-IMPACT. We hypothesize that higher levels of 
family supporter participation in CO-IMPACT will lead to greater improvements in patient 
activation and patient cardiac risk. 
 
6. Background 
Many VHA Patients With Diabetes Are At High Risk For Diabetes Complications: 
Twenty-five percent of VHA patients have diabetes, representing about 1.5 million Veterans.  While the 
quality of diabetes care is high when measured by processes such as HbA1c monitoring and lipid testing, 
20-30% of VHA diabetes patients have poor glycemic control (HbA1c >8%), poor blood pressure control 
(>140/90), or high lipid levels (LDL >130 mg/dl). 
 
Increasing Patient Activation Can Improve Diabetes Management: 
“Activated” patients are those who have the “skills and confidence to become less activated in their health 
and healthcare.”11 Activation includes the ability to share in decision-making with health care providers, 
monitor and self-manage symptoms, and access care in an appropriate and timely way.  Patient activation 
encompasses several more specific health behavior concepts, including locus of control and self-efficacy 
for executing self-managing behaviors.12 The main result of patient activation is patient engagement, or 
“actions that people take for their health and to benefit from care.”13 
 
Highly activated patients have better health behaviors (including adherence to medications, regular self-
monitoring at home, physical activity, and healthy eating) and health outcomes (including lower BMI, 
HbA1C, blood pressure, and cholesterol).1 Increases in activation over time are linked to improvements in 
similar health behaviors and outcomes.14 Less activated patients are unengaged in their care, delay care 
seeking and have poorly coordinated outpatient follow-up, including in the VHA.15–17 Less activated 
patients also have higher rates of hospitalizations and ED visits,1 and higher costs of care.11 
 
Intervention studies have shown that coaching or prompting patients to ask questions immediately prior to 
a medical visit can increase patient activation during and just after the visit.18,19 Most of these studies have 
been done in oncology clinics, but one RCT of pre-visit coaching to increase diabetes patients’ 
information gathering led to improved glycemic control and less reported functional limitations compared 
to control patients.20  How best to increase global patient activation among patients with chronic illness is 
still uncertain.   
 
Full Patient Engagement in PACT Diabetes Management Requires High Activation: 
The VA Patient Aligned Care Teams (PACT) model for primary care is designed to provide multiple, 
coordinated mechanisms for supporting patients with complex chronic disease. These include visits with 
nurse care managers and clinical pharmacists that complement primary care provider (PCP) visits, 
telephone visits between in-person visits, health psychology programs to support self-management 
behavior change, group diabetes education, the MOVE! weight management program, and telehealth 
monitoring.  To make the most of this complex array of new services, patients must identify resources 
that can best meet their needs, make appointments or enroll in programs, actively participate, implement 
care plan changes, and maintain ongoing communication with clinical teams.  Uptake of PACT chronic 
disease management programs has been slow,21 and it is uncertain what approach is best to help complex 
patients obtain the full benefit of PACT chronic disease care. In our CO-IMPACT (Caring Others 
Increasing EngageMent in PACT) intervention, we will mobilize patients’ family members and friends to 
help increase patient engagement in PACT care. 
 

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Most VA Patients with Diabetes Have Family Members or Friends Who Are Involved in Their Health 
Care: 
As many as 75% of VA patients with diabetes have a family member or friend who is regularly involved 
in their diabetes care (a ‘Care Partner’).2,3 These supporters assist patients in engaging in activities 
directly related to successful diabetes management, including medication management and adherence, 
tracking home glucose and blood pressure measurements, maintaining a healthy eating plan, and being 
physically active.2,3,22 Care Partners often help patients make key decisions about their diabetes 
management, such as how to address medication side effects.23 Typically, 50-60% of Care Partners are 
spouses, and most of the rest are family members who do not live with the patient (such as adult 
children).2,24,25 
 
 
Care Partners Can Affect Chronic Disease Management and Outcomes: 
Family and friend support can lead to better glycemic control and lower mortality among patients with 
diabetes.6 In other chronic conditions that require significant self-management, such as cardiac disease 
and heart failure, social support is linked to lower rates of recurrent cardiac events and hospitalizations.7,8 
There is strong evidence that social support acts on chronic disease outcomes largely through improved 
patient self-management behaviors.10 
 
There is little direct evidence that Care Partner engagement can increase overall patient activation, but we 
have several reasons to hypothesize that this is the case. There are very strong links between social 
support and improved patient self-efficacy for self-care, 26–30a concept closely related to patient activation. 
Higher social support is linked to activated self-management behaviors, such as increased self-
monitoring.31,32 When supporters accompany patients to medical visits, patients exhibit more activated 
behavior, including increased participation in decision making with providers.4,5,25 In one pre-visit 
preparation intervention delivered to patients with cancer and their visit companions, both patient and 
companion question asking increased.33 We found in prior work that patients participating with a Care 
Partner in an interactive voice response self-management intervention were more engaged in the 
intervention than those who participated alone.34,35 
 
Previous interventions aiming to leverage family support to improve disease management have generally 
engaged supporters in patients’ day-to-day health management through counseling or coaching.36,37 Such 
interventions have demonstrated improvements in dietary behavior among heart failure patients,38 and 
physical activity among obese patients.39 However no published interventions or known clinical programs 
have focused on helping Care Partners boost chronically ill patients’ engagement in clinical care and 
medical self-care (i.e. medication adherence).  
 
Significance of Proposed Research: 
Veterans with high-risk diabetes are highly vulnerable to disabling complications and death. These 
patients often remain at high risk for poor outcomes and frequently use emergency care. Innovative and 
sustainable approaches that increase engagement of patients’ and their supporters in primary care could 
improve patients’ risk factor control, and reduce emergency utilization and morbidity. 
The VA has recently expanded its commitment to engaging family caregivers in medical care. The 
Caregivers and Veterans Health Services Act of 2010 provides Veterans’ caregivers with substantial 
support through several means, including increased training and financial support; a telephone support 
line; a VA website with caregiving tools and resources, and full-time Caregiving Program Coordinators at 
each VA facility nationwide. 
 
An overarching goal of the nationwide VA PACT initiative is to engage the patient, and all those helping 
to care for the patient, in a coordinated, team-based approach.40 The PACT model specifically includes 
family members as part of the care team. Structured and implementable approaches to identifying Care 

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Partners and including them in the flow of health care information are needed for PACT to achieve this 
goal. If successful, this study will produce a scalable protocol that can be used by VA PACT teams across 
the VHA to engage Veterans’ Care Partners and caregivers in diabetes care. The lessons learned in this 
study can be used to evaluate and enhance Care Partner and caregiver engagement for patients with other 
complex conditions, or patients in vulnerable situations such as transitions from hospital to home. 
 
 
7. Preliminary Data 
Ann Arbor VA Patients with High-Risk Diabetes Have Involved Care Partners: In our prior studies, 
including our preliminary VA observational studies of Patient and Caregiver Experiences (PACE) with 
Veterans with high-risk diabetes and their Care Partners, we found that 40% of out-of-home supporters 
live within 20 miles of the patient’s home, and 78% talk with the patient by phone at least weekly.24 Prior 
research, including our own, has shown that chronically ill patients with low health literacy, multiple 
comorbidities, and comorbid depression involve Care Partners in their care more often.4,5,26 
Our prior studies also indicate that Care Partners are highly involved in patients’ interactions with the 
health care system. About half of patients with diabetes are regularly accompanied by a supporter into the 
exam room for primary care visits,4,5 and 25% have had a supporter talk on the phone with their clinician 
in the last year.4 Importantly, (Table 1) we found that Care Partners often help patients prepare questions 
before visits, assist patients in processing visit information and plans (‘debriefing’), and help patients 
navigate VA services such as pharmacy fills and diabetes class enrollment. Thus, there is significant 
potential to increase patient engagement in PACT care by enhancing the effectiveness of these 
interactions among Care Partners, patients, and PACT team members at key points in medical care. 
 
Care Partners are Limited By Lack of Patient-Specific and VA-Specific Information, and Structured 
Support Opportunities:  In our national survey of 760 family supporters of patients with chronic disease,41 
and in our 12 VA PACE supporter interviews, supporters reported feeling limited by a lack of patient-
specific information, such as changes in medication regimens or test results, as well as a lack of health 
system-specific information, such as the roles of PACT teamlet members or available diabetes programs. 
Supporters also face significant challenges when helping patients prepare for, and debrief after, clinical 
visits. For example, as shown in Table 1, patients often do not bring written questions for the doctor, and 
many are not confident they are reporting accurate visit information back to their supporter. Twenty-eight 
percent of supporters reported that their patient-partner regularly discusses being confused about health 
care provider instructions.23 In PACE interviews, many supporters requested printed summaries after 
patient visits with a clear way to follow-up with questions. Importantly, few patients (9%) in PACE 
surveys felt that privacy should be a barrier to information sharing between supporters and patients’ 
clinicians.  However in interviews, several supporters reported feeling intimidated by perceived 
complexity in VA primary care clinic structure and privacy rules. 
Supporter effectiveness could also be boosted through more structured and action-oriented between-visit 
discussions with patients.  In our national Care Partner survey, we found that supporters discuss health 
with their patient-partners almost every time they talk, but approximately 30% were unsure what 
questions to ask or what advice to give about diabetes. Supporters can make the most of these discussions 
when they have patient-specific information and when they use evidence-based support techniques,42 such 
as positive and autonomy-supportive statements, and collaborative action planning and coping.  
 
Pilot of CO-IMPACT Shows Feasibility and Perceived Benefit: In preparation for the current trial, we 
developed the CO-IMPACT intervention protocol, patient and supporter materials, and assessment 
instruments, and delivered CO-IMPACT (see Section 8, Table 1) to 19 patient-supporter dyads over a 4-
month period. Patient participants were recruited from a VAAAHS registry of patients with high-risk 
diabetes with similar criteria to section D3. 18/19 patients were men, with a mean age of 66 years (range 
47-89). Patients chose a Care Partner to participate with them, who was assessed for eligibility as 
described in D4. Eighteen of 19 supporters were women; mean age of supporters was 54 years (range 22-

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71). Most supporters were spouses (N 11) and lived with the patient. The other 8 supporters did not live 
with the patient (7/8 lived ≤20 miles apart) and included 3 daughters, 1 son, 3 friends, and 1 other family 
member. All patient-supporter dyads completed an initial session with a Dyad Engagement Coach(DEC). 
Among the 19 patients, 21 pre-visit preparation phone calls were completed (out of 25 eligible visits), and 
25 after-visit summaries were mailed to dyads. Patients completed 82% of attempted weekly automated 
IVR telephone assessments, with 18/19 patients continuing to complete IVR calls for the entire 4 months. 
At follow-up, 95% of patients and 89% of supporters said they were satisfied with the program. 84% of 
patients felt CO-IMPACT helped them more effectively manage diabetes, and 84% of supporters felt the 
program helped them more effectively support the patient’s health care. 100% of patients would 
recommend the program to another Veteran. In post-intervention interviews, both patients and supporters 
reported that CO-IMPACT was helpful in promoting patient engagement and changing patient-supporter 
communication about care: “She [supporter] reminded me [patient] to call my doctor with problems”, “He 
[patient] brought our questions with him to his appointment and asked them to the doctor and nurse”, “I 
[supporter] am more aware of what questions to ask him [patient] and what to say about diabetes”. 
Extensive interviews with participants and their PACT teamlets have informed intervention refinement.  
 
 
8. Overview of Study Design: 
This will be a randomized controlled trial evaluating an intervention (CO-IMPACT) designed to activate 
dyads of Care Partners and Veterans with diabetes.  240 patients with diabetes receiving PACT primary 
care who are at high risk for diabetes complications and who have a Care Partner involved in their care 
will be recruited along with a Care Partner.   
 
The overarching goal of this intervention is to structure and facilitate Care Partner involvement in PACT 
so that patients can become more actively engaged in PACT care, and improve their diabetes treatment 
processes and outcomes. CO-IMPACT will address key limitations to supporter effectiveness by 
providing supporters with information about their patient-partner’s health status and treatment plan, ways 
to effectively identify and engage in PACT-related services, structured pre, post, and between visit 
information that can improve supporter-patient discussions about diabetes plans, and guidance to 
supporters on evidence-based communication techniques. Patient-supporter dyads will be identified via a 
VAAAHS registry of patients with high-risk diabetes and randomized to CO-IMPACT or usual PACT 
care. Main outcomes will be measured at baseline, six months and 12 months post-enrollment via patient 
and supporter surveys, and patient laboratory tests, vital signs, and medical records.  The below chart is a 
depiction of the overall study design.   
 
 

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Table 1:  Study Design 
 
Study Contact 1 
Prior to  
Enrollment 
 
Study Contact 2 
0 Months 
 
 
 
 
 
 
 
 
 
 
 
Intervention Contacts 
0-1 month 
 
 
 
Intervention Contacts 
0-12 months 
 
 
 
Study Contact 3  
6 months 
 
 
 
 
Study Contact 4 
12 months 
 
 
 
 
 
9. Experimental Plan 
9.1 Study Inclusion and Exclusion Criteria 
9.1.1 Participant Inclusion Criteria 
Patient Inclusion criteria: 
• 
Provide signed and dated informed consent form 
• 
Willing to comply with all study procedures and plan to be available for the duration of the 
study 
Recruit N = 240 VHA Patients with high-risk diabetes and 240 Care Partners:   
Screen potential subjects by inclusion and exclusion criteria and obtain informed consent  
6-Month Assessments 
Patients:  Brief (15 min) survey by phone or mail 
Care Partners: Brief (15 min) survey by phone or mail 
Randomize by Patient-Care Partner Dyad 
Control 
N = 120 Dyads 
Intervention 
N = 120 Dyads 
DEC Initial Coaching Session 
In-person for patient; CP can call in if can’t be present 
Baseline Assessments 
Patients In-Person: Survey, blood pressure measurement, venipuncture for HbA1c and lipid levels 
Care Partners Telephone survey 
Patient 
• visit planning phone calls 
• Visit Summaries by mail 
• IVR calls, 2/month 
12-Month Assessments 
Patients In-Person: Survey, blood pressure measurement, venipuncture for HbA1c and lipids 
Care Partners by phone: survey  
Care Partner 
• visit planning reminder emails 
• Visit Summary email reminders, on website 
• Email summary of IVR calls, 2/month 

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• 
Validated though completion of patient study screener: 
o Plan to use Ann Arbor VA Healthcare System (including CBOCs) primary care as 
their main source of diabetes care over the subsequent 12 months 
o Able to use telephone to respond to twice monthly automated IVR calls 
o Be able to identify an eligible adult family member or friend who is regularly 
involved in their health management or health care (get involved with medications, 
managing sugars, coming to appointments, etc) who consents to participate in the 
study 
• 
Validated through patient medical record: 
o Male or female, age 30-70 years old 
o Have a diagnosis of diabetes, defined as:   
o (1) a diagnosis of diabetes based on encounter diagnoses from 1 inpatient or 2 
outpatient encounters (ICD9 code of 250.xx, 357.2x, 362.xx, 366.41, 962.3 or E932.3 
OR ICD10 code of  E08.xx, E09.xx, E10.xx, E11xx, E13.xx, O24.0xx, or O24.1xx) 
OR a diabetes medication (at least one >3 month prescription from VA drug classes 
HS501 (insulin) or HS502, other than metformin),  
o Have an assigned NON-RESIDENT and NON-GeriPACT VAAAHS (all 4 sites) 
primary care provider 
o Have 2 or more qualifying in-person primary care visits at VAAAHS in the last 12 
months: 
 
• 
Be at high-risk for diabetes complications, defined as: 
o Poor glycemic control, defined as last HbA1C >8  within the last 9 months 
 
OR 
 
o Poor blood pressure control, defined as:  
o (If they have >1 BP in last 9 months) Most recent SBP>=150 and mean SBP over 
9 months >=150 
o (If only 1 BP in last 9 months) Last SBP in last 6 months >=160 and no other BP 
measures 
o AND exclude from poor BP control group if last BP diastolic or mean diastolic is 
<=65 
o Notes on BP data to use: 
• 
If multiple BPs on one day, use the lowest one. 
• 
Exclude BPs done on days with these encounters: ED, urgent care, 
procedure or surgery department encounters; inpatient days.   
Specific Stop codes for BPs to EXCLUDE from the data: 
102 ADMITTING/SCREENING; 110 Interventional Radiology; 130 
(ER); 131 (Urgent Care); 158 Brachytherapy; 321 GI Endoscopy 
327 THROUGH 333 Procedures including Cardiac Catheterization; 
401 (gen surg); 402 (cardiac surgery); 403 (ENT); 405 (hand surg); 
406 (neurosurg); 407 (Opth); 409 (orthopedics) 
410 (plastic surg); 412 (proctology); 413 (thoracic surg); 414 
(urology); 415 (dialysis access, vascular surg); 418 (amputation); 
419 (anethsesia pre-op); 426 (women’s surgery); 427 Anethsesia 

CO-IMPACT Study Protocol approved 9.8.17 
 
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Special Procedures in operating room suite; 429 (patient care in OR); 
430 (cysto room); 431 (chemotherapy); 434 (non-OR anesthesia 
procedures); 435 (surgical procedure unit) 
 
 
Care Partner Inclusion Criteria: 
• 
Validated through completion of Care Partner study screener 
o Discusses patient’s health issues at least twice monthly 
o At least 21 years of age 
o Fluent in English 
o Expect to have either continuous postal mail service or internet access 
o Live in the United States 
 
 
Patient Exclusion Criteria: 
• 
Validated through completion of patient study screener 
o Expect to have >1 month gap in VAAAHS care in the 12 months following 
enrollment (e.g. snowbird travel). 
o Plan to receive the majority of their care for diabetes mainly from a non-PACT 
provider (either VA specialist or nonVA provider)  in the 12 months following 
enrollment 
o Live in a nursing home OR assisted living  
o Have significant cognitive impairment as measured by more than 2 of 6 possible 
errors on the Callahan Six-item Screener to Identify Cognitive Impairment 
o Need help with more than 1 of the 6 basic ADLs as measured by the Katz Basic 
Activities of Daily Living Scale 
o Do not speak English 
o Have a life-limiting severe illness (such as ESRD requiring dialysis, COPD requiring 
oxygen, cancer undergoing active treatment, receiving palliative/hospice care) 
o Are concurrently enrolled in another research study, at time of enrollment, that could 
conflict with CO-IMPACT’s protocol (e.g. another diabetes management research 
intervention) 
o Concurrently enrolled in Diabetes TeleHealth (CCHT) 
o Do not have a working phone or are not able to use a telephone to respond to 
automated IVR calls 
o Currently Pregnant or planning to become pregnant in the next 12 months 
• 
Validated through patient medical record: 
• 
Have a serious mental illness, dementia, or active substance abuse issue as determined by the 
following encounter codes in a single inpatient or outpatient encounter in the last two years. 
 
ICD9 Codes 
ICD10 Codes 
Schizophrenia/Delusional 
Disorders/Other 
Psychoses 
295.0x, 295.1x, 295.2x, 295.3x, 295.4x, 
295.6x,295.7x,295.8x,295.9x, 
297.0x,297.1x,297.2x,297.3x,297.8x,297.9x, 
298.0x, 298.1x, 298.2x, 298.3x, 298.4x, 
298.8x,298.9x, 
F20.xx-F29.xx 
F06.0x, F06.1x, 
F06.2x 
Bipolar: 
296.0x, 296.1x, 296.4x, 296.5x, 296.6x, 
296.7x, 296.8x 
F30.xx, F31.xx, 
F44.xx, F45.xx 
Substance abuse 
303.xx (alcohol dependence syndrome), 
304.xx (drug dependence), 305.xx 
F10.xx, F11.xx, 
F13.xx, F14.xx, 

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(excluding 305.1 – tobacco use disorder), 
291.xx (alcohol induced mental disorders), 
292.xx (drug induced mental disorders) 
F15.xx, F16.xx, 
F18.xx, F19.xx 
Dementia 
'0461x', '0463x', '2900x', '2903x', '2912x', 
'3310x', '3311x', ’29010', '29011', '29012', 
'29013', '29020',29021', 
'29040','29041','29042','29043', '29410', 
'29411', '33111', '33119', '33182' 
F01.xx, F02.xx, 
F03.xx, G30.xx, 
G31.0x, G31.1x, 
G31.2x, G31.81, 
G31.82, G31.83, 
G31.85 
Moderate, severe, and 
profound intellectual 
disability 
 
F71.xx, F72.xx, 
F73.xx 
 
Care Partner Exclusion: 
• 
Validated through completion of Care partner study screener 
o Receive pay for caring for the patient 
o Have significant cognitive impairment as measured by more than 2 of 6 possible 
errors on the Callahan Six-item Screener to Identify Cognitive Impairment 
o A self-report of a physician diagnosis of dementia, Alzheimer’s, schizophrenia, or 
manic depression  
o Need help with basic ADLs as measured by the Katz Basic Activities of Daily Living 
Scale (score less than 5) 
o Have a life-limiting severe illness (such as end-stage renal disease requiring dialysis, 
chronic lung disease requiring oxygen, cancer undergoing active treatment, receiving 
palliative/hospice care) 
 
 
 
9.2 Recruitment  
We will recruit 240 pairs, or dyads, of Care Partners and patients receiving care for diabetes, who are 
also at high-risk for diabetes complications, in the one parent facility and three CBOCs affiliated with 
the VA Ann Arbor Healthcare System (VAAAHS).  
 
Prior to commencing recruitment activities in a site (Ann Arbor VA Hospital or one of three CBOCs), 
study team members will attend a staff meeting of PACT primary care providers at the site during 
which they describe the study and how their patients may be involved.  Time will be given for 
providers to ask questions, and providers will be given the option to make the patients assigned to 
their primary care panel ineligible for the study.  Following these meetings, providers will receive via 
email a summary of the study information provided at the staff meeting and the ability to opt their 
patients out of the study by replying to the email within one week of its receipt. 
9.2.1 Patient Recruitment 
Following the provider “opt-out” window, potentially eligible patients will be identified using the VA 
patient database (Corporate Data Warehouse), with the specific criteria noted above.  They will be 
sent an introductory letter informing them about the study and inviting them to learn more about 
participating. The letter will include a study phone number and language indicating that they can opt 
out of further contact by calling study staff via a toll-free number or by mailing a form that is printed 

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on the back of the letter in a postage-paid, addressed envelope that is included with the letter.  The 
outside of the envelope will not contain anything that indicates the nature of the research.  In the 
absence of such notification, 7-10 days after the letter is expected to arrive, study staff will call 
patients to explain the study in more detail, conduct initial screening and if eligible, ask if they wish 
to participate.  During the initial contact call, the study will be described and patients will have ample 
and repeated opportunities to ask questions.  
 
9.2.2 Care Partner Recruitment 
During the initial screening phone call to the patient, willing and eligible patients will be asked to 
identify a Care Partner to participate in the study with them. Eligible patients will be encouraged to 
contact the potential Care Partner to explain their interest in the study, and concurrently, the RA will 
send a letter to the potential Care Partner that includes a study information sheet.   After about a 
week, the RA will call the potential Care Partner to screen for interest and eligibility.  If the 
individual is interested and eligible, they will be asked for verbal consent following a clear protocol.  
We anticipate that in some rare cases, the patient will not have the potential Care Partner’s mailing 
address or email address; in such cases, study staff will send the materials to the patient and ask that 
they deliver them to the prospective Care Partner. After a waiting period determined by the patient, 
the study staff will call the potential Care Partner. 
9.3 Enrollment 
9.3.1 Patient Participants 
At in-person enrollment, study staff will describe the content of the study in detail, including that 
patients and Care Partners can decline participation in the study at any time or decline Care Partner 
participation in the patient’s health care at any time.  Patients will also be told in detail the type of 
clinical information that Care Partners may have access to should they be randomized to the 
intervention group.  After any and all patient questions are encouraged and answered, and  informed 
consent  and HIPAA is obtained via signature, the RA will conduct the baseline assessment, including 
survey and BP measurement.  The RA will ensure that each patient has a glucometer, glucometer 
supplies, and home blood pressure cuff, if desired by the patient. 
The RA will also enter the order for lab work at the VA clinical laboratory to assess HbA1c and non-
fasting lipid panel.  Details on baseline assessments can be found in Section 12, Data Collection 
Procedures.   
 
9.3.2 Care Partner Participants 
Oral informed consent via phone will be obtained from Care Partner participants.  The Care Partner 
will have received a written study information sheet, and the RA will follow a script to go over all 
key points in the consent form, answer any questions, and request oral consent.  The RA will 
document the process, as specified in the script.  After informed consent is obtained, he/she will be 
asked to complete a baseline survey assessment by phone.  
 
9.4 Randomization Procedures 
After both baseline assessments are completed for the dyad, the dyad will be randomly assigned, 
within blocks of dyads that live together versus those that live apart, in equal numbers to the two 
study conditions.  Allocation will be concealed, with the RA randomizing participants to study arms 
using a computer-generated randomization series.   
 

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9.5 Single-Blinding Procedures 
Study analysts and the study PIs and Co-Is will be blind to study assignment of the dyads.  The 
Project Manager, RA and DEC will by necessity be aware of which participants are assigned to the 
intervention group.  To ensure study analysts are blinded to study assignment, the DEC and IVR 
databases tracking intervention participation will be kept separate from study assessment databases 
until main outcome analyses have been completed. 
 
9.6 Subject Withdrawal 
9.6.1 Reasons for Withdrawal 
Subjects may choose to stop participating for any reason at any time. 
 
If a subject becomes newly ineligible during the study, according to eligibility/ineligibility criteria 
listed in section 5 above (i.e. develops a terminal illness), they will be notified that their eligibility has 
changed and will be withdrawn from the study by study staff.  Based on signed HIPAA, study data up 
to that point will be retained for Intention to Treat analysis purposes. 
 
9.6.2 Handling of Subject Withdrawals or Subject Discontinuation of Study Intervention 
 
Subjects may choose to stop participating at any time. We will record the date and reason for 
withdrawal. For patient participants who wish to stop participating in the intervention or in primary 
data collection (surveys, study-related lab measurements), we will ask if they are willing to remain in 
the study for purposes of secondary data collection only (data available in the subjects’ medical 
record, collected per study protocol). 
 
If a subject stops responding to study contacts (DEC calls, assessment calls, IVR contacts), study staff 
will contact them directly to determine whether they would like to continue with the study.  In the 
absence of any response, participants will be considered enrolled in the study.  Patients who are 
unable to be reached for their 12 month follow up survey will be considered ‘lost to follow up’ for 
analysis purposes.   
 
If a Care Partner becomes ineligible, or elects to withdraw from the study, patient-partners assigned to 
the intervention group will be offered the option to continue with patient-focused IVR calls and DEC 
contacts for the remaining duration of the study period. The patient will be instructed to ignore any 
IVR references to the Care Partner.  All patient participants who remain enrolled but whose Care 
Partners drop out will be contacted for the 12 month assessment and be included in the intervention 
group in intent-to-treat analyses. 
 
9.7  Procedures to Maintain Study Enrollment 
Participants in the intervention group will receive contact at least every two weeks in the form of IVR 
calls (for patients) and summaries of the IVR calls (for Care Partners).  We anticipate that this 
frequent contact and provision of helpful information, in addition to other intervention contacts with 
incentives provided at 6 months and 12 months, will encourage sustained enrollment.   
 
Participants in the control group will receive contact at baseline, 6 months, and 12 months, and at 
each time point, they will receive incentives for completion of assessments.  At these points of 
contact, participants will be thanked for their contributions and reminded of the value of their 
contributions.   
 

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Additionally, at enrollment, patients will be offered a tote bag with the study logo, and with the 
mailed reminder of the 6 month survey, participants will receive a magnet with the study logo that is a 
mini dry-erase board and a pen.  We anticipate that these actions will maintain study enrollment. 
 
10.  Intervention  
 
10.1 Preparation 
10.1.1 Training of Dyad Engagement Coach  
The Dyad Engagement Coach will be trained in all study protocols, and ability to extract clinical data 
for initial visit and post-visit summaries and ability to follow DEC contact scripts will be evaluated 
before the start of the trial.  
 
10.2 Primary Care Staff Orientation 
Prior to intervention start, primary care staff (primary care providers, nurses, and clerks) will be 
oriented to the intervention during regularly scheduled provider & staff meetings.  At these meetings 
we will: 
• 
Describe the study process for screening patients and Care Partners  
• 
Share the protocol and fax template for contacting primary care teams if an urgent clinical issue is 
detected  
• 
Share clinically related forms used in the intervention:  the form completed during the initial 
session, the clinical visits planning worksheet, and the template for the Visit Summaries.   
• 
Ask providers to notify study staff if they do not wish for their patients to participate in general 
• 
Ask primary care staff to report to study staff any Care Partners that they feel are interfering with 
patient well-being or clinical care.   
 
At another provider and staff meeting, staff will be given a brief training and reference materials on 
positive and productive communication with patients’ family members. 
 
10.3  Initial Session with the Dyad Engagement Coach (DEC)  
This session will take place within 2 weeks of enrollment whenever possible. The patient will meet 
in-person with the DEC at VAAAHS.  The Care Partner will either be present in person or on 
speakerphone during the visit.  Care Partners who participate by phone will be pre-mailed printed 
materials and guided to the intervention website during the session if possible. This visit is anticipated 
to take about 45 minutes. 
 
10.3.1 Agenda of the Initial Session   
• 
Explain the role of the coach 
• 
Discuss the Care Partner’s role /ice breaker 
• 
Discuss patient’s diabetes-related health information 
• 
Provide program informational resources:  website and binder 
• 
Patient Engagement 
o Communicating with Health Care Providers 
o Action Planning 
• 
Effective Supporter Techniques 
• 
Navigating VA Resources 
o Explain what the PACT team is and how to reach them 

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o Point out list of Ann Arbor VA Diabetes-Related Programs 
• 
The CO-IMPACT Program (what’s next) 
o Describe automated calls and determine call day and time 
o Weekly talks / action planning 
o Before and after primary care appointments 
• 
Wrap-up 
 
A written summary of this session will be given to patients and Care Partners and an initial session 
medical record note placed in the patients’ medical record for their PACT teamlet to view and co-
sign.    
 
10.3.2 Initial DEC Session Materials 
After the initial session, patients and Care Partners will be able to review the session’s 
educational content, strategies, and talking points via a study website and a binder of printed 
material. Both Care Partner and patient will be given login information to access the website, and 
the patient will receive a binder with same content.  If the Care Partner prefers to receive a 
personal copy of the binder, the Care Partner will also receive a binder. 
 
These materials, both on the website and in the binder, will include: 
• 
General information about diabetes management (similar to that which patients receive 
in VA diabetes and PACT education)  
• 
Tips for patient-clinician communication and visit preparation (based on VA brochures 
such as “TEAM UP For Your Care”) 
• 
Referred to VA website for care partners.  
• 
Care Partners program guidelines  
• 
General ways Care Partners/family can facilitate diabetes management in day-to-day life 
and limits of Care Partner roles 
• 
How Care Partners can provide autonomy-supportive encouragement 
• 
Importance of patient/Care Partner engagement  between visits and active participation 
in encounter 
• 
Tips on best Care Partner communication with patient’s doctors/nurses 
• 
Steps in effective action planning and setting SMART goals 
• 
Info on PACT teamlet members and their roles and how to access PACT services (based 
on standard PACT orientation brochures) 
• 
Info on navigating the AAVA (e.g. information on obtaining medications and making 
appointments) 
• 
Info on VA diabetes programs available and on MyHealtheVet (standard brochures 
available to patients at AAVA) 
• 
Steps to take if patient receives care in a non-VA facility 
• 
Logs 
• 
Glucose and Blood Pressure Home Testing Log  
• 
Medication Log - to record medication regimen, medications taken 
• 
Events Log – to record illnesses, ED visits, hospitalizations 
• 
Care Partner-Patient Talk Log 
• 
Worksheets 
• 
Visit planning worksheets for primary care appointments 
o Questions for provider  
o Information to bring from home 
o Information to bring from outside providers 
• 
SMART Goal/Action Planning Worksheet 

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o Current goal(s) and progress towards/barriers against them 
 
 
-------- 
10.4 IVR Component 
Patients will receive automated IVR assessment calls once every two weeks. The goal of these calls 
will be to prompt continued progress towards diabetes goals and Care Partner involvement between 
PACT visits.   
 
Patient calls will consist of statements and queries recorded in a human voice, to which they can 
respond by selecting a number on their touch-tone pad. During each call, patients will be asked 
whether they are experiencing any diabetes management concerns for which taking action within the 
next weeks would be prudent. These topics include more high sugars, low sugars, bothersome 
medication side effects, or running short on medication supply. After a patient completes an IVR call, 
the Care Partner will receive an automated summary, via structured email or mailed letter (if Care 
Partner does not use email), with any identified action issues and whether or not the patient plans to 
address the issue over the next two weeks. Supporter messages following each completed patient call 
will include reminders to discuss diabetes care with the patient, using the talking-points and 
guidelines provided at the initial session, and more detailed information on those issues the patient 
identified as potentially requiring action. The patient’s PACT nurse care manager will receive an 
automated fax alert when patients identify the following clinically urgent issues:   
• 
a blood sugar level below 70 more than twice in the past two weeks 
• 
a blood sugar level below 80 more than twice in the past two weeks and symptoms of low 
blood sugar such as sweating or trembling, plus feeling irritable, confused or weak. 
• 
a fasting blood sugar level above 300 more than twice in the past two weeks 
• 
a systolic blood pressure less than 90 more than once in the last two weeks 
• 
a systolic blood pressure less than 100 more than once in the last two weeks and symptoms of 
low blood pressure such as feeling dizzy, confused or weak 
• 
a systolic blood pressure over 170 at least once in the last two weeks 
 
 
10.5 Patient-Care Partner Regular Discussions 
Participant guidelines specify several parameters for Care Partner-patient discussions about diabetes 
care. These are to:  
a) talk approximately once per week about diabetes management for at least 10 minutes per 
occasion to review recent assessments and trends 
b) use supportive comments and avoid criticism 
c) collaboratively approach problem solving 
d) review progress and barriers to achieving past diabetes management plans 
e) discuss any recent or upcoming primary care appointments.    
f) the Care Partner will encourage the patient to contact his or her clinical team in appropriate 
situations. 
 
10.6 Visit Preparation 
After the initial coaching session, the study team will monitor VISTA appointment files for enrolled 
patients to identify upcoming PACT visits. A qualifying visit will be an in-person visit to a PACT 

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PCP, nurse, or clinical pharmacist. Approximately one week before each qualifying visit, the Dyad 
Engagement Coach (DEC) will conduct a visit planning session with the patient via telephone. During 
that call, the DEC will use a visit planning worksheet (included in the binder) to help the patient 
identify any diabetes risk-related questions or concerns they would like to address during their visit, 
as well as diabetes-related information, such as home monitoring logs, they will bring to the visit. The 
DEC will help patients role-play asking the one or two questions most important to them. Patients 
will be free to add non-diabetes related questions or information to their visit planning worksheet, but 
these will not be specifically elicited by the DEC. If the enrolled Care Partner is present with the 
patient at the time of the call and can join using speakerphone or another phone on the same line, they 
will be invited to participate in the call. The DEC will document this call in CPRS and add the 
teamlet LPN as co-signer.  Thus, the teamlet LPN will not need to conduct their usual visit reminder 
phone call for this patient. 
 
Care Partners will receive an email notifying them that their patient-partner has an upcoming primary 
care visit.  It will contain a website link to the visit planning worksheet, and the message will 
encourage Care Partners to use the worksheet with their patient-partner and add questions and 
concerns for the patient’s visit. Care Partners who do not have access to email will be mailed a letter 
with similar content and a referral to the same worksheet in their binder. 
 
10.7  After Visit Summary 
We will be using a slightly modified version of the AviTracks medication reconciliation program 
currently used in clinical care in VAAAHS that will generate and print a patient-friendly Visit 
Summary from Vista/CPRS.  Within three days of a completed, qualifying PACT visit, the Dyad 
Engagement Coach will mail to the patient their visit summary. Three business days following the 
mailing (to allow time for the Visit Summary to be delivered to the patient), the Dyad Engagement 
Coach will post the Visit Summary to the study’s secure website.  The posting will trigger an 
immediate email to the Care Partner that notifies them that the summary is available on the website. If 
the Care Partner does not use email, the Visit Summary will be mailed to them. 
 
10.8 Fidelity  
A predetermined sequence (the first 10, then 10% of the remaining) of visit planning calls will be 
recorded for review by study investigators to assess intervention fidelity, quality of interactions, and 
to provide feedback to coaches.  DEC-created documents will also be reviewed.  Patient appointment 
and IVR call records will be monitored regularly by study staff for level of missed contact 
opportunities. 
 
Audiorecording of these calls is not required for the intervention, and participants who decline to be 
recorded will still be able to fully participate in calls. These files will be not be labeled with 
participant IDs and will be moved to the HSR&D data repository only accessible by the HSR&D data 
manager and will be destroyed when the new records control schedule is published. 
 
11.  Control Condition 
Patients assigned to the control condition will receive usual PACT care for diabetes at VAAAHS facilities 
that are at an advanced stage of PACT implementation. PACT care for diabetes is expected to follow 

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VA/DoD diabetes management guidelines. These patients are then eligible for PACT services at the 
teamlet’s discretion.  
 
Study staff will also provide control group patients with access to the study website pages that contain 
educational information on general diabetes management; patients will receive the same educational 
information in hard copy, and Care Partners may also receive the same binder if they prefer.  Study staff 
will ensure that patients have home glucometers and blood pressure monitors, if desired by the patient. 
Patients in the control condition will not be precluded from involving Care Partners in medical visits or 
VA health programs. 
 
12. Data Collection Procedures 
12.1 Patient 
Baseline: 
Immediately after in-person informed consent is obtained by study staff, the study staff will 
administer an assessment consisting of self-reported survey items, blood pressure measurement, and a 
lab order so that patients provide venous samples for Hemoglobin A1c (HbA1c) tests and non-fasting 
Lipid Panels through the VA lab. The RA will read each survey question and record the patient’s 
answer on the paper survey.  The patient will complete the survey in a private room while their Care 
Partner, if present, will be asked to wait outside of the room.  Patients will be informed that they can 
ask questions of the RA if they have trouble with any part of the survey. If patients have had an 
HbA1c performed at a VAAAHS facility as part of routine care 4 or fewer weeks prior, or if they had 
a lipid panel performed 4 or fewer weeks before, that test result will be used for the study assessment 
and an additional study-associated venipuncture will not be performed.  Prior to the enrollment 
meeting, RAs will go into CPRS to determine if the labs were conducted within the four week 
window. Patients do not need to pay any fees for the bloodwork.  We anticipate this assessment will 
take about 45 minutes to complete, exclusive of time required to complete bloodwork at the VA 
Laboratory. Patient participants will receive a $50 gift certificate upon completing the baseline 
assessment. 
 
6 months: 
At 6 months after baseline assessment, the patient will complete a short survey of self-reported items 
including the PAM-13, how their Care Partner is involved in their health care, and diabetes self-
management adherence. Study staff will conduct a medical record review of patient participants to 
obtain HbA1c, lipids, blood pressure, and smoking status at this time point. The patient will complete 
the survey by one of two options:   
1. a hard copy of the survey is mailed to participant, completed, and mailed back in a postage-
paid envelope 
2. the survey is administered via telephone interview by study staff 
 
The patient will asked their preferred option at the end of the baseline assessment.  If the patient does 
not complete the mailed version within two weeks, study staff will call to remind the patient and give 
them the option of scheduling a telephone interview instead.  We anticipate this assessment will take 
about 15 minutes to complete. Patient participants will receive a $15 gift certificate upon completing 
the 6-month assessment.  

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12 Months: 
At 12 months after the baseline assessment, study staff will measure the patient’s blood pressure and 
administer a survey of self-reported items using the same methods described above for the baseline 
assessment. In addition, study staff will ask a few open-ended questions on the participant’s 
experience of and impressions of the intervention, or control materials.  HbA1c tests and non-fasting 
Lipid Panels will be obtained through the VA lab. If patients have had an HbA1c performed at a 
VAAAHS facility as part of routine care 2 weeks before, or if they had a lipid panel performed within 
4 weeks before the assessment date, that test result will be used for the study assessment and an 
additional study-associated venipuncture will not be performed. We anticipate this assessment will 
take about 45 minutes to complete, exclusive of time required to complete bloodwork at the VA 
Laboratory. Patient participants will receive a $50  gift certificate upon completing the 12-month 
follow-up assessment.   
 
Patient pharmacy (medication fills) and encounter data will be collected from the following time 
periods: 
• 
12 months prior to baseline for calculating baseline measures 
• 
from baseline to 24-month post-baseline to calculate follow-up measures.  
 
12.2 Care Partner 
Baseline: 
A baseline assessment consisting of self-reported survey items will be conducted over the phone by 
study staff after Care Partner consent.  Assessment should take a little less than 45 minutes to 
complete. Care Partner participants will receive a $20 gift card to following completion of the 
baseline assessment.    
 
6 months:  
An assessment consisting of self-reported survey items for Care Partner participants will be 
conducted. The Care Partner will complete the survey by one of two options:   
1. a hard copy of the survey is mailed to participant, completed, and mailed back in a postage-
paid envelope 
2. the survey is administered via telephone interview by study staff 
 
The participant will be asked their preferred option at the end of the baseline assessment.  If the 
patient does not complete the mailed version within two weeks, study staff will call to remind the 
patient and give them the option of scheduling a telephone interview instead. We anticipate this 
assessment will take about 15 minutes to complete. Care Partner participants will receive a $15 gift 
certificate upon completing the 6-month assessment.  
12 months: 
At 12 months after the baseline assessment, the Care Partner will complete an assessment consisting 
of self-reported survey items that is very similar to the baseline assessment. In addition, study staff 
will ask a few open-ended questions on the participant’s experience of and impressions of the 
intervention, or control materials. Study staff will administer the full assessment over the phone.  We 

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anticipate this assessment will take about 45 minutes to complete.  Care Partner participants will 
receive a $20 gift certificate upon completing the 12-month follow-up assessment. 
 
12.3 Dyads 
Sixteen Dyads will be purposively sampled for more extensive semi-structured qualitative interviews 
at 12-15 months after baseline (see section 13.6 below) 
12.4 Intervention Processes  
The CO-IMPACT automated IVR system will capture patient participants’ responses to questions 
about symptoms, medication adherence, and home glucose and blood pressure readings. The system 
will automatically track dates and times of all assessment attempts and whether they are completed.  
The CO-IMPACT website will automatically collect data on access to various parts of the website. 
Data from coach initial session and visit planning call session logs will be also be captured (e.g., 
length of session, attempts made to schedule session, etc.). 
 
12.5 DEC Experiences and Feedback 
After all 240 patients have completed the study period, study staff will conduct a semi-structured 
interview with the DECs. 
 
13. Study Measures 
13.1 Patient Outcomes 
Health Behaviors and Behavioral Determinants: The study’s main outcome measure will be the 
Patient Activation Measure-13 (PAM-13). The PAM-13 has been widely used to measure patient 
activation in longitudinal studies, and in clinical trials as a primary outcome measure, and scores have 
been responsive to intervention. The PAM-13 is reliable (Cronbach alpha 0.87), and improvement in 
PAM-13 scores has been linked to improvement in self-management behavior. A 4-6 point change in 
the PAM is considered clinically significant. We will also measure patient activation in medical visits 
with the Perceived Efficacy in Patient-Physician Interactions (PEPPI-5). Items include “I am 
confident in my ability…to get a doctor to answer all of my questions” and “to get a doctor to take 
my chief health concern seriously”. The PEPPI-5 has been validated against other self-efficacy and 
patient satisfaction scales, and is reliable (Cronbach alpha 0.92). 
 
Health Risks: To address the effect of CO-IMPACT on patient health risks, our main measure will be 
the 5-year UKPDS Risk Engine. This score estimates the risk of a coronary heart disease (CHD) 
event (fatal or non-fatal MI, or sudden death) specifically among people with diabetes. The score 
components include factors we hypothesize could be improved by the intervention, including HbA1C, 
systolic blood pressure (SBP), total cholesterol/HDL cholesterol ratio, and smoking status. The score 
also includes age, sex, race/ethnicity, and length of time since diabetes diagnosis. The UKPDS Risk 
Engine has been validated in multiple populations. Using a cardiac risk score to measure risk factor 
changes offers the advantage of quantifying the cumulative impact of changes in multiple risk factors, 
and translating changes in physiologic parameters to a risk estimate that is meaningful to patients and 
policy makers. For similar reasons, cardiac risk scores, including the UKPDS Risk Engine and the 
Framingham Risk Score, have been successfully used as outcomes in multiple clinical trials.43–47 The 
UKPDS Risk Engine has been validated in multiple populations.48 A 1-2% change in risk is 
considered clinically significant at a population level. In preparation for this study, we measured 

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UKPDS risk among 434 VAAAHS patients randomly selected from a high-risk diabetes registry with 
similar inclusion criteria to this study. Mean 5-year UKPDS risk in this population was 18%, SD 
12%.  We then simulated the changes in risk that would result from changes in individual score 
components. We found that an average 0.5% decrease in HbA1c over 1 year led to an average 1.3% 
decrease in UKPDS risk over that of the same population with no change in HbA1c.  Similarly, a 
10mmHg decrease in SBP led to a 1.3% risk decrease, and a 30% decrease in total cholesterol among 
those with total cholesterol >160mg/dL (to simulate new adherence to a statin) led to a 3% risk 
decrease.  
 
HbA1C, lipid levels, blood pressure, and smoking status will be analyzed independently as secondary 
health outcomes. We will measure, via survey, patients’ frequency of hypoglycemia, and diabetes 
distress. Patients’ use of VA urgent care will be extracted from the EMR for the period 12 months 
prior to intervention start and during the 12 month study period, supplemented by patient report of 
non-VA urgent care. 
 
Table 2: Details on Selected Patient Measures 
Construct 
Source 
Instrument(s) 
BL 
6M 12M 
Health Behaviors and Determinants 
Activation 
Survey 
PAM-13 
X 
X 
X 
Activation in Health 
Encounters 
Survey 
PEPPI-5 
X 
X 
X 
Diabetes Self-Efficacy 
Survey 
Stanford Chronic Disease  
Self-Efficacy Scale41  
X 
X 
X 
Diabetes Self-Management  
Behavior (self-monitoring, 
healthy eating, physical 
activity) 
Survey 
Summary of Diabetes Self-Care  
Activities49 
X 
X 
X 
Diabetes Medication 
Adherence 
EMR x12 
months 
Cumulative Medication Gaps 
<20%50 
X 
 
X 
Health Outcomes 
5-Year Cardiac Event Risk 
 
UKPDS 5 year cardiac risk score 
X 
 
X 
Glycemic Control 
Venous 
Sample 
HbA1C 
X 
 
X 
Blood Pressure 
Direct 
measure 
Systolic Blood Pressure, Mean  
Arterial Pressure 
X 
 
X 
Non-fasting Lipid Levels 
Venous 
Sample 
Total Cholesterol/HDL  
X 
 
X 
Smoking Status 
Survey 
 
X 
X 
X 
Diabetes Distress 
Survey 
Problem Areas in Diabetes Scale51 X 
 
X 
Patient-Supporter Relationship and Support Quality 
Patient-Supporter  
Relationship Quality 
Survey 
Relationship Rating Form –  
Respect Subscale52 
X 
 
X 
Patient Satisfaction with  
Diabetes Social Support 
Survey 
Diabetes Care Profile –  
Support Subscale53 
X 
X 
X 
Supporter use of Autonomy  
Supportive Communication 
Survey 
Important Other Climate  
Questionnaire54 
X 
 
X 
Patient-Partner Closeness 
Survey 
Subjective Closeness Index55 
 
X 
 
X 
Patient-Provider Relationship 

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Patient-provider trust 
Survey 
Primary Care Assessment Survey-
Trust Subscale56 
X 
 
X 
Patient-provider  
shared decision making 
Survey 
Provider Participatory Decision-
Making Style57 
X 
 
X 
Potential Moderators 
Time with Diabetes  
Survey 
 
X 
 
 
Patient Comorbidities 
EMR x12 
months  
Charlson Comorbidity Index58 
X 
 
 
Health Literacy 
Survey 
Brief Health Literacy Screen59 
X 
 
 
 
 
 
 
 
 
Current PTSD symptoms 
Survey 
Primary Care-PTSD Screen for 
DSM560 
X 
 
 
Depression and Anxiety 
Survey 
Patient Health Questionnaire-461,62 X 
 
 
 
Patient-Supporter Relationship and Support Quality: We will measure overall relationship quality for 
both patients and supporters (see Tables 2 and 3). Patient satisfaction with overall quality of diabetes 
support received and supporter use of autonomy-supportive communication will be assessed via 
patient survey. Supporters and patients will be surveyed about concerns about health privacy 
breaches. The Subjective Closeness Index (SCI)46,47 will be used to assess patient and Care Partners 
perceived closeness to each other. We are interested in examining the effect of the intervention on 
patient-Care Partner closeness. The SCI is comprised of two items and has demonstrated convergent 
validity with other measures of inter-personal closeness.47 Further, prior research indicates that SCI 
measures interpersonal closeness irrespective of gender and relationship type (e.g., romantic 
relationship vs. friendships).46 
 
Patient-Provider Relationship and Patient Satisfaction with VA Health Care: We will measure 
patient-provider communication, trust, and level of shared decision-making via patient survey (Table 
2). We will measure patient satisfaction with PACT care using a question from the VA Consumer 
Assessment of Healthcare Providers and Systems (CAHPS)-PCMH, and patient satisfaction with 
PACT engagement of Care Partners using questions developed in our pilot. 
 
13.2 Care Partner Outcomes 
We will measure changes in Care Partner roles (e.g. help track patient medication use at home) via 
surveys at baseline, 6 and 12 months. Care Partners’ self-efficacy for helping patients with diabetes, 
supporter distress about the patient’s diabetes, and supporter distress about patient hypoglycemia, will 
be measured with adaptations from similar validated patient measures. These supporter-adapted 
measures were used in our pilot intervention assessment. In this study, we will calculate psychometric 
properties of these measures, and associations with validated supporter measures, among our 240 
Care Partners. Caregiving burden will be assessed with the reliable and validated Multidimensional 
Caregiver Strain Index. See Table 3. 
 

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13.3 Patient and Supporter Moderators of Effect 
 
Theoretical patient moderators of intervention effects include (also see Table 2): sociodemographics 
(sex, age, education), baseline diabetes medication regimen, distance from VA site, comorbidities, 
health literacy level, and co-morbid depressive symptoms. Additional moderators include: whether 
the patient and supporter live together, whether the supporter has diabetes, supporter depressive 
symptoms, baseline patient-supporter and patient-physician relationship quality, and whether Care 
Partners attend patient visits in person.  
 
The Primary Care PTSD screen for DSM5 (PC-PTSD-5)62  will be used to identify Veterans with 
probable PTSD at baseline. PTSD is relatively common (estimated prevalence: 11.5-32.6%) among 
VA primary care patients.65 Existing research suggests that adults with PTSD have lower levels of 
physical activity,66 poorer dietary behaviors,67,68 and are at elevated risk for weight gain and 
cardiometabolic conditions69,70. Some evidence suggests that Veterans with PTSD do not benefit from 
health behavior programs (e.g., VA MOVE!) to the same extent as Veteran without PTSD.71,72 
Accordingly, we would like to compare the interventions effects of the current study among Veterans 
with and without probable PTSD at baseline. The PC-PTSD-5 is comprised of six “yes” or “no” items 
and was designed to screen for PTSD within the primary care patient populations and has been 
validated among a large sample of Veteran primary care patients.60 The PC-PTSD-5 has a very high 
level of diagnostic accuracy for identifying primary care patients PTSD.60 Scores ≥3 have a high level 
of sensitivity and specificity (0.85) for identifying primary care patients PTSD.60 VA/DoD PTSD 
Management Guidelines recommend screening all VA primary care patients, using the PC-PTSD-5 or 
other brief instrument, on an annual basis.72 Consequently, study participants (i.e., VA primary care 
patients) are likely familiar with the PC-PTSD-5. We are interested in assessing participants’ current 
PTSD status which, unfortunately, cannot be ascertained using prior PC-PTSD-5 screen results with 
participants’ electronic medical records. Results from the initial validation study indicate that 
Veterans feel comfortable completing the PC-PTSD-5 and find the measures easy to understand.60 
 
Table 3: Details on Selected Supporter Measures 
Construct 
Source 
Instrument(s) 
BL 6
M 
 
12
M 
 
Behaviors and  
Determinants 
Supporter Self-Efficacy for Helping 
Patient With DM Care 
Survey Adapted Stanford Chronic 
Disease Self-Efficacy Scale 41 X 
X 
X 
Health and Relationship Outcomes 
Caregiver Burden 
Survey Caregiver Strain Index63 
X 
 
X 
Supporter Distress About 
Patient’s Diabetes 
Survey 
Adapted Problem Areas in  
Diabetes Scale51 
Adapted Fear of 
Hypoglycemia – Worry 
Subscale64 
X 
 
X 
X 
 
X 
X 
 
X 
Patient-Supporter  
Relationship Quality 
Survey Relationship Rating Form –  
Respect Subscale52 
X 
 
X 
Patient-Partner Closeness 
Survey Subjective Closeness Index55 X 
 
X 
Potential Moderators 
 
 
 
 
 
 
Depression and Anxiety 
Survey Patient Health Questionnaire-
4 61,62 
X 
 
 

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The PHQ-462which is an ultra-brief screen for depression and anxiety. The PHQ-4 is comprised of a 
two-item depression scree (i.e., PHQ-2) and a two-item anxiety screen (i.e., GAD-2). PHQ-4 total 
scores can be used to measure of general psychological distress.61 Scores greater ≥6 screen positive 
for significant psychological distress and will be referred to Primary Care Mental Health.  
 
 
13.4 Provider Behavior and Impact on PACT Teamlet  
A theoretical mediator of intervention effect, medication intensification, will be measured via EMR 
similarly to methods used by Dr. Kerr previously. 73 In interviews with PACT clinical staff, we will 
assess whether clinicians perceived changes in:  effectiveness or efficiency of patient-clinician 
communication; any unintended consequences on privacy or clinician comfort; clinician awareness of 
supporter roles at home; and relationships with patient supporters. 
 
13.5 Intervention and Control Processes   
We will record the frequency of each type of DEC contact with intervention-assigned participants, 
and time spent in preparation and execution of each contact. We will automatically capture outcomes 
of all IVR call attempts, and number of page visits and downloads from the study website. For 
participants in both arms we will capture via the EMR the number of completed PACT PCP, nurse, 
and clinical pharmacist encounters, occurring in-person or by phone. We will ask participants via 
survey whether they received after-visit summaries after PACT in-person visits. We will tally 
consults entered by PACT teamlets to diabetes risk related programs, and patient (via EMR) and 
supporter (via survey) rate of attendance. Finally, we will ask all patients and supporters about the 
frequency of general discussions about diabetes, clinical visit preparation discussions, and post-visit 
debriefing.  
 
13.6 Facilitators and Barriers to Future Implementation  
We will ask eligible patients and Care Partners who decline participation to provide consent for a 
brief survey including reasons for not enrolling.  We will conduct semi-structured interviews of 
selected participants and clinicians to evaluate facilitators and barriers to intervention 
implementation. Eight dyads will be purposely sampled from those with high vs. low engagement in 
the intervention (as measured by rate of pre-visit and IVR call completions), and eight from those 
with high vs. low level of improvement in cardiac risk score.  
 
 
14. Data analysis/Interpretation 
14.1 Overall Approach  
We will follow international guidelines for analysis and reporting of clinical trials. We will examine 
baseline data for prognostically important differences across the two study groups, such as patients’ 
age, race, comorbidities, and baseline use of services. Although we do not anticipate any imbalances, 
any baseline differences between experimental arms will be included as covariates in analyses 
comparing outcomes. Missing data will be imputed for non-outcome measures, using multiple 
imputation methods. If we find baseline variables to be associated with the loss to follow-up, we will 
include those baseline variables as covariates in models evaluating the intervention effect. 
 

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14.2 Unit of Analysis and Sample Size Calculation  
Our main aims are to evaluate effects at the patient level. Our sample size calculations are based 
on our primary outcome of patient activation, measured by the PAM-13. Assuming that PAM-13 
was highly correlated between baseline and 1 year (r = .70), we calculated our sample size to 
provide a minimum of 80% power to detect a between group difference in PAM-13 change of 
4.0, with a standard deviation of change of 13, and a two-tailed alpha of 0.05. To achieve 80% 
power, a minimum of 102 patients is needed in each group, for a total sample size of 204. To 
allow for 15% attrition, we will enroll 120 patients in each group, for a total of 240 patients.  
This sample size will also be sufficient for detecting clinically-significant differences in the 
secondary outcome of change in 5-year UKPDS cardiac risk score.  Assuming the underlying 
correlation between UKPDS at baseline and 1 year later is .90,  our sample size of 102 per group 
will provide more than 80% power for detecting between group differences in predicted cardiac 
risk of 2.0% (SD=12), which is considered clinically significant on a population level.. Based on 
estimates from our pilot study and other observational research, a 2.0% or greater change in 
intervention patients is achievable in the CO-IMPACT intervention. 
 
14.3 Primary and Secondary Outcomes (Aims 1 and 2)   
Preliminary analyses.  We will construct trajectory plots of all three PAM-13 measurements to 
understand general trends over the study period. Although baseline differences between groups are 
not expected due to randomization, this will be validated for key sociodemographic and health 
characteristics of participants via a series of independent samples t-tests and chi-square analyses.  
Missing data will be examined for randomness. We expect that key variables such as the scaled PAM-
13 will be normally distributed, but highly skewed measures will be transformed if needed.   
 
PAM-13 will be administered by a research assistant in person or over the phone at baseline and 12-
months. In addition, 6 months following the start of the study, PAM-13 will be given to all 
participants via internet or mail survey. The raw PAM-13 score will be transformed according to a 
formula established by the creators of the PAM and its licensee Insignia Health.  Transformed PAM-
13 scores range from 0-100 where higher values indicate greater degree of activation.  Due to the 
different modes of administration, there is the potential for notable differences in reliability and 
disproportionate missing data between the 6 month collection and the other collection time points.  
Consequently, PAM-13 measured at 6 months will be used only in supplemental analyses to assess 
the possible curvilinear trajectory of patient activation as well as the dependence of this trajectory on 
treatment group. 
 
We will first evaluate bivariate associations between the study group condition (by intention to treat 
principles) and outcomes using two-sided, two-sample t–tests for continuous measures and Pearson’s 
chi-square tests for categorical measures. We expect that key outcomes such as the PAM-13 will be 
normally distributed, but measures will be transformed if needed. We will then use multivariable 
regression models, taking into account baseline score of the outcome, to identify main effects.  
 
Main analyses:   All main analyses will be conducted using Intention to Treat principles.  Main 
analyses for both Aims 1 and 2 will be performed using hierarchical linear models (HLM) with scaled 
PAM scores (at baseline and 1 year) and UKPDS scores (baseline and 1 year) respectively as the 
outcomes. HLM, or mixed models, incorporates both fixed and random effects.  A fixed effect 
indicates that only specific levels of a variable are studied and inference is made only to the measured 
levels, consequently no variance parameter is estimated for these effects.  In this study fixed effects 

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include treatment group, time, and whether the Care Partner and participant lived together. All are 
dichotomous predictors: time is coded as 0 = baseline and 1 = the 1 year point; treatment group is 
indicated by 0 = control (PACT only) and 1 = treatment (PACT + CO-IMPACT); living situation is 0 
= living apart and 1 = living together.  Random effects on the other hand imply that not all levels of a 
variable are represented but indeed exist.  In this study where a longitudinal model is used, a random 
variable representing differences in mean outcome scores is represented by a random component 
(𝑢0𝑗) that captures information about the outcome not explained by the fixed effects (time, treatment, 
etc.).   
 
Basic model.  The fundamental model for Aims 1 and 2 is represented by the respective outcome at 
time point (i) for person (j) as a function of time, treatment group, the interaction between them, and a 
person-level effect indicating whether the Care Partner lives with the participant (1) or lives apart (0): 
 
eq. 1: 
𝑠𝑐𝑜𝑟𝑒𝑖𝑗= 𝛾00 + 𝛾10(𝑡𝑖𝑚𝑒)𝑖𝑗+ 𝛾20(𝑡𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡)𝑗+ 𝛾11[(𝑡𝑖𝑚𝑒)𝑖𝑗(𝑡𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡)𝑗]
+ 𝛾30(𝑙𝑖𝑣𝑒𝑠 𝑤𝑖𝑡ℎ 𝐶𝑃)𝑗+ 𝑢0𝑗+ 𝑟𝑖𝑗 
 
 
 
 
where: 
 
 
 
 
𝑢𝑜𝑗~𝑁(0, 𝜏00)  
 
 
 
 
𝑟𝑖𝑗~𝑁(0, 𝜎2) 
 
Aim-Specific Models 
 
Aim 1 primary analysis.  In this model the fixed effects are as follows: 𝛾̂00 is the mean of PAM-13 
scores at baseline for the control group who were not living with their Care Partner; the significance 
test assesses if this mean is 0 (cf. eq. 1).  The change in PAM-13 scores across time is described via 
the  𝛾̂10 and 𝛾̂11 parameter estimates; if there is a significant interaction of time and treatment, the 
change in PAM scores differs depending on treatment group.  The change in PAM score for the 
control group is revealed in the 𝛾̂10estimate; how much PAM differs across time for the treatment 
group will be captured in the 𝛾̂11estimate.  Similarly, the treatment effect is modified by the 
interaction term -- 𝛾̂20 captures the mean difference in PAM scores for the groups at baseline, while 
the mean difference at the final observation period must be interpreted through both 𝛾̂20 and 𝛾̂11.  In 
other words, the differential change over time based on treatment group is indicated by the  𝛾̂11 effect; 
here, a significant test reveals that the change in PAM over time is different depending on treatment 
group.  This is the primary effect of interest for Aim 1. Further, participants will be randomly 
assigned to treatment condition within the stratum of whether the Care Partner lives with the patient 
or lives apart; this effect is represented by 𝛾̂30 which tests for the mean difference in PAM scores 
between these groups after adjusting scores for treatment, time, and the time × treatment interaction.   
 
The random component includes 𝑢0𝑗 which represents the how much a person’s average PAM score 
differs from the rest of the sample after controlling for the other effects in the model.  Stated another 
way, the variance component of this effect (𝜏̂00) captures the average deviation between participants’ 
PAM scores and the baseline mean for the control group after controlling for treatment, time, and 
living status effects.  If this is different from 0 then it supports the idea that something is driving PAM 
scores beyond time, treatment, and living situation.  As more fixed effects are included in the model 
this parameter estimate approaches 0. If 𝜏̂00 is not statistically different from 0, the result is a fixed 
(not random or mixed) effects model and the remaining variability in PAM scores is from truly 
random, idiosyncratic sources (𝑟𝑖𝑗). This other random effect (𝑟𝑖𝑗) captures the variation in PAM 
scores at a particular time point for a particular person that is not explained by the other effects.   
 

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Aim 1 auxiliary analyses.  As a supplementary analysis, we will analyze differences in PAM score by 
interacting with four baseline PAM strata, as a priori defined by the PAM scale developer. 
 
As another supplemental analysis, the curvilinear trajectory of PAM-13 over time will be tested with 
growth curve modeling using the PAM-13 score at 6 months in addition to PAM-13 at baseline and 1-
year. Further, random effects models will be used to examine differences in this trajectory based on 
treatment group can be examined.  This is represented as: 
 
𝑃𝐴𝑀𝑖𝑗= 𝛾00 + 𝛾10(𝑡𝑖𝑚𝑒)𝑖𝑗+ 𝛾20(𝑡𝑖𝑚𝑒2)𝑖𝑗+ 𝛾30(𝑡𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡)𝑗+ 𝛾11[(𝑡𝑖𝑚𝑒)𝑖𝑗(𝑡𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡)𝑗]
+ 𝛾40(𝑙𝑖𝑣𝑒𝑠 𝑤𝑖𝑡ℎ 𝐶𝑃)𝑗+ 𝑢0𝑗+ 𝑟𝑖𝑗 
 
Aim 2 primary analysis.  Consistent with the statistical model for Aim 1, the fixed effects for Aim 2 
is represented by 5-year UKPDS score at time point (i) for person (j) as a function of time, treatment 
group, the interaction between them, and living situation of the Care Partner.  Specifically, 𝛾̂00 is the 
mean cardiac risk at baseline for the control group who live apart from their care partner.  The overall 
change in risk across time for all people is seen in 𝛾̂10 – the test of this parameter asks whether risk 
changes across time after adjustment for treatment influences and CP living status.  The mean 
difference in risk scores between treatment and control groups, regardless of time, is measured by 
𝛾̂20; namely, this is how much the average risk score for treatment group deviates from the control 
group so that a significant  𝛾̂20 indicates a significant mean difference in PAM scores as a function of 
treatment group.  The differential change over time based on treatment group is indicated by the  𝛾̂11 
effect; here, a significant test reveals that the change over time in cardiac risk is different depending 
on treatment group.  Mean difference in UKPDS score between those who live with their Care 
Partners and those who don’t after adjusting scores for treatment, time, and the time × treatment 
interaction is measured via 𝛾̂30.   
 
The random component includes 𝑢0𝑗 which represents the how much a person’s average risk score 
differs from the rest of the sample after controlling for the other effects in the model; the variance 
component of this effect (𝜏̂00) captures the average deviation between participants’ risk scores and the 
grand mean.  If this is different from 0 then it supports the idea that something is driving risk scores 
beyond time, treatment group, and living situation.   
 
Aim 2 auxiliary analyses.  The same fixed effects of the fundamental model will be retained, but the 
outcomes will be selected individual components of the UKPDS analyzed independently as secondary 
health outcomes:  HbA1c, systolic blood pressure (SBP), total cholesterol/HDL cholesterol ratio, and 
smoking status.   
 
14.4 Mediators and Moderators of Intervention Effect (Aim 3)    
We will use multivariable regression models to examine potential mediators and moderators of 
intervention effects. We will introduce potential mediators to models linking intervention condition to 
outcomes, examining changes in the magnitude of the relationship between the intervention and the 
outcomes before and after the covariates are introduced. We will also use the Preacher and Hayes 
bootstrapping method to examine potential mediators to determine whether the mediation effect is 
significant. This is a non-parametric method that can be used when the outcome violates assumptions 
of normality. Potential mediators are specified in our theoretical model (Figure 1), and include an 
index of Care Partner engagement in the intervention, composed of measures of supporter 
participation in intervention sessions, and reported use of pre-visit preparation and debriefing tools.  
Analyses of potential moderators (as in section 13.3) will use standard approaches to evaluate 
interactions between these covariates and the intervention, which will include plotting regression lines 
for high and low values of the moderator variable using Stata routines74 Independent variables and 

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moderators will be centered before testing interactions, so that multicollinearity between first order 
and higher-order terms will be minimized. 
 
14.5 Qualitative Analysis   
We will conduct a thematic analysis of interview transcripts using the “Editing Analysis Style,”75  
which contains both deductive and inductive elements. Following this approach, Drs. Rosland and 
Heisler will independently read interview transcripts, break down responses into individual segments 
that express a single idea or theme (e.g., ways participants found pre-visit calls useful or not useful) 
and label these phrases with appropriate codes. An iterative process will be used to compare results 
until agreement is reached on the codes and their definitions, after which we will apply the codes to 
the remaining transcripts. Emerging themes will be compared across patients and compared to 
patterns in survey responses. 
 
14.6 Process Evaluation   
We will use the RE-AIM framework76 to guide this analysis. To analyze the potential reach of the 
intervention, we will calculate the proportion of patients with diabetes who meet inclusion criteria and 
compare characteristics of eligible and non-eligible dyads. Effectiveness will be measured via our 
main outcomes and differences in outcomes among key patient groups. We will evaluate adoption by 
examining the characteristics of patients and supporters who decline enrollment and their reasons for 
declining. We will also examine retention/dropout from the study and reasons, length/frequency of 
DEC sessions, % of potential DEC sessions completed, and IVR call adherence (% attempted calls 
completed, # weeks adherent to calls). We will analyze facilitators and barriers to implementation 
among dyad and staff interview themes using the Consolidated Framework for Implementation 
Research (CFIR). The CFIR’s five major domains are the intervention, inner and outer setting, the 
individuals involved and the implementation process. 
 
 
15. Study Oversight, Quality Control 
Study investigators and staff will be responsible for study oversight and maintaining the highest standards 
of intervention delivery throughout the study period.  The principal investigator, Dr. Rosland, will 
maintain appropriate oversight of this research protocol and study staff, including recruitment, selection 
of study participants, study conduct, and delegation of research responsibilities.  Bi-weekly meetings will 
be conducted throughout the study period to review all study activities.  All study investigators will 
review study materials and protocols prior to the start of the intervention in order to provide input on best 
practices for managing patient safety and privacy.  Additionally, the intervention will undergo annual and 
continuing review through the Ann Arbor IRB and comply with all yearly consent form audits as well as 
3 year full regulatory audits.  To remain prepared for regulatory audits, the project will maintain a 
regulatory binder which meets all regulatory requirements and is kept up to date throughout the study 
period.   
 
 
16. Timeline 
 
 
Year 1 
Year 2 
Year 3 
Year 4 
 
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 
 
JJ
A 
SO
N 
DJ
F 
MA
M 
JJ
A 
SO
N 
DJ
F 
MA
M 
JJ
A 
SO
N 
DJ
F 
MA
M 
JJ
A 
SO
N 
DJ
F 
MA
M 

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IRB Review 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hire/Train 
Research 
Assistants 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hire/Train Dyad 
Engagement Coach 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Refine and Finalize 
Study and 
Intervention 
Materials 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participant 
Recruitment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participant 
Enrollment/Assess
ment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12 Month 
Participant 
Assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Qualitative Data 
Collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Write 
Reports/Manuscrip
ts 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dissemination 
Planning 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
17. Ethics/Protection of Human Subjects 
 
17.1 Risks to Subjects 
17.1.1 Patient and Care Partner Participants 
Physical risks: Patient participants will undergo venipuncture for HbA1C and lipid panels two times 
over 12 months.  If patients have had an HbA1C performed at a VAAAHS facility as part of routine 
care within 4 weeks prior their baseline study assessment date or 2 weeks before their 12-month study 
assessment date, or if they had a lipid panel performed within 4 weeks before an assessment date, that 
test result will be used for the study assessment and an additional study-associated venipuncture will 
not be performed. However, we estimate that at least 80% of patient participants will undergo a 
venipuncture that would not be required by routine clinical care. Risks of this minor procedure 
include brief pain, bruising, and minor bleeding.  This study does not involve pharmacotherapy. Care 
Partner participants will not undergo venipuncture or blood pressure measurement. 
 
Psychological risks:  It is possible that some participants may find that being interviewed or audio-
recorded is stressful.  However, almost all the survey questions (and all of the questions that are 
related to sensitive issues such as depressive symptoms) have been used in multiple prior studies 
conducted by our team, and our participants have not reported that the questions increase their burden 
or anxiety.   
 

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Patients in the intervention group will receive biweekly automated tele-monitoring concerning their 
health.  Although it is possible that automated calls would become burdensome or annoying, our 
preliminary studies suggest otherwise.  This probability assessment is based upon the high rates of 
retention and call completion, very high user satisfaction, and the fact that most patients desire that 
the automated calls become part of their standard care.   
 
It is possible that participation in the CO-IMPACT intervention may cause participant discomfort, 
strain patient-supporter relationships, strain patient-clinician relationships, or increase Care Partner 
burden.  However, the intent of the intervention is to better support patients and family members, 
decrease their diabetes and caregiving related stress, and improve the quality of diabetes-related 
communication between the patient and the supporter and between the patient and their clinicians.  
There was no indication in the CO-IMPACT pilot study, or in multiple previous studies of patient-
supporter IVR interventions, that burden was increased or relationships were strained. 
 
There is a small risk that patients will regret sharing certain medical or personal information with 
their Care Partner. However, we are stipulating that the supporter should be someone who is already 
regularly involved in the patient’s health care.  In our pilot studies with VAAAHS patients with high-
risk diabetes, there was minimal concern about sharing health information with a close family 
member or friend who was already involved in the patient’s health care. 
 
 
In the baseline and 12-month assessments, both patients and Care Partners will be assessed for 
depression using the Patient Health Questionnaire (PHQ-4).61,62 Those who score 6 or above will be 
referred to a primary care doctor.  If the participant is a Care Partner and does not have a primary care 
provider, they will be given contact information for mental health providers or referral services that 
are located near the participant’s home.  In the baseline for patients, patients will be assessed for 
PTSD using the Primary Care PTSD Screen for DSM5 (PC-PTSD-5)60, and those who endorse a prior 
traumatic event and at least 3 of the 6 symptoms in the last month will be referred to their primary 
care provider, who can refer the patient to Primary Care Mental Health or the PTSD Clinic Team, 
according to VA clinical guidelines.72 Project staff will also be trained to follow standard protocols if 
they detect a patient is a high suicide risk, including a warm handoff to the VA Suicide Prevention 
Hotline. 
 
Social and Legal:  These risks include potential breach of confidentiality, inadvertent release of 
sensitive information, and the risk of participation due to potential coercion.   
 
17.2 Adequacy of protections against risks 
Recruitment and Informed Consent 
We will request a HIPAA informed consent waiver to perform searches to identify potential 
participants based on: “38 CFR 16.116 (d) (2): This research presents no more than minimal risk of 
harm to the subjects, the waiver will not adversely affect the rights and welfare of the subjects, and 
this research could not be practicably carried out without a waiver.” This search protocol involves no 
more than minimal risk and use of secondary data will not adversely affect patients’ rights. The 
research could not be carried out without the waiver because without access to the electronic medical 
record data, we will have no way of identifying patients with high-risk diabetes that might benefit 
from participating in the trial. We have obtained waivers successfully for similar screening and 
recruitment approaches in several previous and ongoing studies. We will seek informed consent from 
any potential participants prior to baseline assessment and randomization. 
 

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Identified patients will be sent an introductory letter informing them about the study and inviting 
them to participate. The letter will include a study phone number and language indicating that they 
can opt out of further contact by calling study staff via a toll-free number or by mailing a form that is 
printed on the back of the letter in a postage-paid, addressed envelope that is included with the letter.  
The outside of the envelope will not contain anything that indicates the nature of the research.  In the 
absence of such notification, 7-10 days after the letter is expected to arrive, study staff will call 
patients to explain the study in more detail, conduct initial screening and if eligible, ask if they wish 
to learn more about participating.  During the initial contact call, the study will be described and 
patients will have ample and repeated opportunities to ask questions. 
 
Patients who are deemed eligible and continue to express interest in the study after screening will be 
invited to an in-person informed consent and enrollment visit at the AAVA.  At that time, study staff 
will describe the content of the study in detail, including that patients and Care Partners can decline 
participation in the study at any time or decline Care Partner participation in the patient’s health care 
at any time.  Patients will also be told in detail the type of clinical information that Care Partners may 
have access to should they be randomized to the intervention group.  After any and all patient 
questions are encouraged and answered, patients will be invited to sign an informed consent form and 
HIPAA form consenting to release their PHI to study staff.  If randomized to the intervention, patients 
will be invited to sign a standard AAVA Release of Information form to give permission for VA staff 
to share personal health information with their Care Partner. 
 
During the initial screening phone call to the patient, willing and eligible patients will be asked to 
identify a Care Partner to participate in the study with them. Eligible patients will be encouraged to 
contact the potential Care Partner to explain their interest in the study, and concurrently, the RA will 
send a letter to the potential Care Partner that briefly introduces the study.  After about a week, the 
RA will call the potential Care Partner to screen for interest and eligibility.  If the individual is 
interested and eligible, they will be asked for verbal consent following a clear protocol.  We 
anticipate that in some rare cases, the patient will not have the potential Care Partner’s mailing 
address or email address; in such cases, study staff will send the materials to the patient and ask that 
they deliver them to the prospective Care Partner. After a waiting period determined by the patient, 
the study staff will call the potential Care Partner.  We received IRB approval to verbally consent 
Care Partners in the CO-IMPACT pilot and other previous studies involving Veterans’ Care Partners 
based on the following: 1) in the control arm, Care Partners will undergo only limited assessment, 2) 
in the intervention arm, Care Partner involvement will be limited to receiving information about 
patient’s diabetes status and care plans, and guidelines to discussing diabetes care with patients. We 
have used this same process in prior studies and have found that it is an efficient and effective way to 
recruit large samples of Veterans and their Care Partners. 
 
Because our outcome evaluation is guided by the RE-AIM framework, it is important for us to assess 
the intervention's “reach” among potentially eligible Patients or Care Partners.  Thus, Patients and 
Care Partners who decline to participate will be asked to volunteer to answer 3-4 questions over the 
phone about their sociodemographics (age, race/ethnicity, distance from the VA) and reasons for not 
participating. 
 
 
17.3 Protection against Risk  
 
17.3.1 Patient and Care Partner Participants 
 

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Physical Risks:  
To minimize risk, venipuncture will be performed by VAAAHS trained laboratory phlebotomists 
in VAAAHS facilities. Patient participants who have recently had the relevant laboratory test done 
as part of routine care will not be asked to repeat it for the study assessment.  If patients have had 
an HbA1c performed at a VAAAHS facility as part of routine care within 4 weeks prior their 
baseline study assessment date, or 2 weeks before their 12-month study assessment date, or if they 
had a lipid panel performed within 4 weeks before an assessment date, that test result will be used 
for the study assessment and an additional study-associated venipuncture will not be performed.  
Blood work ordered at baseline and 12-month follow-up will be ordered under the Principal 
Investigator’s name, a practicing primary care physician at AAVA.  She will review all results and 
alert the patient’s assigned primary care physician if there are any unexpected results.  
The RAs will be trained by the PI, a practicing primary care physician, on blood pressure 
measurement using an automatic cuff.  If either number of the patient’s blood pressure is <90/50 
or >180/110, the RA will escort the patient to the (on-site) VA urgent care provider.  If either 
number of the patient’s blood pressure is >140/90 but <180/110, the RA will recommend that the 
patient call his or her primary care doctor, and the RA will also contact the patient’s team the same 
day by adding a note in the patient’s chart and adding their PACT RN as a cosigner. 
Psychological Risks: 
Assessment Burden:  Patients and Care Partners will be informed as part of their informed consent 
process and immediately prior to each interview that they can refuse to answer any questions in the 
assessments, or drop out of the study at any time.   
In the baseline assessments, both patients and Care Partners will be assessed for depression using 
the Patient Health Questionnaire (PHQ-4).  Those who score 6 or above will be referred to a 
primary care doctor.  If the participant is a Care Partner and does not have a primary care provider, 
they will be given contact information for mental health providers or referral services that are 
located near the participant’s home.  Project staff will also be trained to follow standard protocols 
if they detect a patient is a high suicide risk, including a warm handoff to the VA Suicide 
Prevention Hotline.  
Patient-Care Partner Relationship:  
We will reduce the risk of patient-Care Partner conflicts through several strategies.  These include 
the following:  
We specifically structure the Care Partner’s role as assistive to the patient. This is conveyed 
repeatedly in study contacts. For example, Care Partners are instructed to discuss any concerns 
with patients in a non-judgmental manner, and to offer choices.  They are instructed to encourage 
the patient to be the main contact for the patient’s health care providers whenever possible. Our 
pilot study experiences suggest that under these arrangements, patients welcome the supporter’s 
instrumental and emotional support. Clear and redundant presentation through printed participant 
guidelines for patients and Care Partners to structure their roles encourage effective 
communication.  This information is repeated in smaller chunks throughout the study timeline. 

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Patient willingness to share their health information with their Care Partner will be explicitly 
confirmed in their written consent. We will thoroughly explain to patients the type of information 
that will be included in Dyad Engagement Coach contacts with Care Partners. To minimize risk of 
patient regret over sharing health information, we are stipulating that the Care Partner should be 
someone whom is already regularly involved in the patient’s health care.  The study team will not 
share information with a Care Partner before it is shared directly with the patient. Information that 
is directly related to diabetes management and management of risk of diabetes complications will 
be emphasized in communications between the study team and Care Partners.  However, we will 
inform patient participants that standard VA clinic printouts of medication lists or appointments 
may contain information related to potentially sensitive topics, such as psychiatric care or sexual 
health.  The Dyad Engagement Coach will be thoroughly trained by the PI in protocols for 
extracting diabetes-relevant data from the medical record, and extraction will be tested prior to 
intervention start, and monitored by the PI throughout the intervention through a random sample 
of DEC documents (sampled more frequently at the beginning of the study). Patients and Care 
Partners will be reminded at every study contact that they can decline participation at any time and 
that the patient can terminate Care Partner participation in care at any time. 
Care Partner Caregiving Burden: 
A standard measure to assess Care Partner burden will be administered to each Care Partner 
participant at study baseline and endpoint. Prior studies involving chronically ill Veterans and family 
supporters, including the pilot study of this intervention, show that Care Partner burden does not 
increase, and often decreases, as the result of intervention. We will include on our study website a 
link to the National VA Caregiver’s Program page on reducing caregiver stress. 
 
Patient-Clinician Relationship and Clinical Care: 
One of the goals of our intervention is to relieve busy clinicians from some of the day-to-day 
problem-solving that some patients request and require. Nevertheless, it is critical that patients and 
Care Partners understand that the intervention is not intended to be a substitute for professional-level 
formal caregiving, and that they should not attempt to address every problem identified via the 
assessments without input from the patient’s clinical team. We will employ several strategies to 
ensure timely and appropriate use of formal health services when indicated: 
• 
individual patient assessment calls will include explicit reminders about the importance of 
contacting their clinician if their health deteriorates.   
• 
We included an option for patients to hear the number for their VA clinician’s clinic call 
center at the end of each call.  
• 
Content for Care Partners will emphasize the importance of the patient’s health care 
relationship with their VA clinicians, and supporters will be instructed to encourage the 
patient to contact clinicians directly rather than having the supporter serve as a 
communication intermediary.  However, supporters will also receive the clinicians’ name and 
phone numbers.   
• 
The binder and website will also emphasize that chronic illness care is most effective when 
patients take an active role in their care, and we will provide concrete guidance regarding 
effective patient - provider communication.   
 
The study will be described to all provider and clinical staff at staff meetings.  Providers will be 
allowed to opt out of the study, thus making patients assigned to their primary care panel ineligible 
for the study. 
 

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Although risks of worsening symptoms will be minimal, patients will receive additional clinical 
monitoring than would be provided as part of routine clinical care. Therefore, any potential adverse 
effects of the intervention will likely be detectable through the increased monitoring and contact 
provided by the intervention. All study staff will be thoroughly trained on how to address patients 
found to be experiencing worsening diabetes outcomes or psychological distress during study-related 
contacts. Patients will continue to have access to all usually available health care services. 
 
If patients or Care Partners discuss non-urgent health concerns with the Dyad Engagement Coach, the 
coach will encourage them to discuss their concerns with their patient partner and record the concerns 
for discussion with their provider at their next appointment. If patients or supporters discuss urgent 
health concerns, the health educator will recommend that they call their health care provider 
immediately, and, for VA patients, offer to connect them directly by phone to the appropriate primary 
care team, if during usual business hours. Dyad Engagement Coach will be trained to call 911 for any 
emergency situations they encounter. 
 
During IVR phone assessments, an automated fax alert to the patient’s PACT nurse care manager will 
be generated if clinically urgent issues are identified. IVR assessments will not ask about symptoms 
that constitute medical emergencies (i.e. chest pain, loss of consciousness), but patients will be 
reminded in relevant calls and in study printed materials to hang up and call 911 if they experience a 
medical emergency. 
 
Coercion: 
Staff training will be employed to minimize risk of potential coercion.  
 
Social and Economic Risks:  Multiple, stringent measures to protect confidentiality and prevent 
inadvertent release of sensitive information will be implemented.   
 
We will obtain written informed consent from each study participant.  As part of that consent, 
participants will be adequately informed about the small risk of a breach of confidentiality and they 
will be given the option of opting out of participation. Throughout the study, IRB and HIPAA 
guidelines will be followed to ensure the privacy and integrity of the information we collect.  All study 
staff will have signed a pledge of confidentiality and are trained annually in secure handling of VA 
research data according to HIPAA and human subjects guidelines. Any breach of confidentiality will 
be immediately reported to the PI and to the VA Ann Arbor Healthcare System Human Subjects 
Committees (and as required to any other IRBs).  In addition, any complaints or concerns expressed to 
the study staff by participants, providers, or anyone else affected by this study will be immediately 
reported to the PI and the IRB.   
 
For individuals who decide to not be screened for the study, express interest but decide not to consent, or 
are lost to follow-up prior to providing written informed consent, we will retain only the screening data for 
these individuals using an unlinkable identifier so that we can characterize non-participants for scientific 
reasons.  Essentially, no screening data will be linkable to other research or clinical data unless the 
participant provides written informed consent, and no additional data will be collected on participants who 
provide informed consent but are later determined to be ineligible to participate, with the exception of a 
coded identifier on a “do not contact” list maintained only for the duration of the recruitment phase in order 
to prevent such individuals from being re-solicited.   

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To protect against confidentiality breach, we will follow confidentiality procedures throughout the study 
and afterwards. The database linking participants’ unique study identification numbers with their 
Personally Identifying information will be kept  in a study-specific, access-restricted folder on the OI&T 
server behind the VA firewall. HSR&D will maintain all research records containing VA sensitive 
information (VASI) in accordance with 36 CFR 1228, Subpart D, until instructions on when to destroy 
them are approved by the National Archives and Records Administration and are published in VHA's 
Records Control Schedule (RCS 10-1). Until that time, records will be kept on the HSR&D drive on the 
OI&T server behind the VA firewall and will be destroyed according to the new Records Control 
Schedule once it is published. 
Some Dyad Engagement Coach documentation might become part of patients' medical records, and 
therefore subject to current clinical data confidentiality regulations.  No participant-level data, including 
identifiers and individual data points, will be published. PII of those participants who do not enroll will be 
moved to an access restricted folder on the Ann Arbor VA OI&T network.  
Confidentiality of the Intervention Website 
The public website hosted at Amazon Web Services (AWS) GovCloud will be used by patient participants, 
Care Partners and study staff to access pre-visit worksheets, after-visit summaries, reports, and health 
education resources.  The only personalized information available on the website will be PDFs of Visit 
Summaries--short summaries of any diabetes-related test results and what happened during a patient’s 
clinical visit to their provider at the VA.  These visit summaries do not contain any personally identifying 
information about the patient or care partner. Information that is related to diabetes management and 
management of the risk of diabetes complications will be emphasized in the Visit Summary.  However 
information shared with Care Partners may include medication or appointments lists that pertain to 
potentially sensitive topics such as psychiatric care or sexual health.  
 
The program website is separate from any electronic medical records or other data storage devices, and 
there will be no access to other patient-level PHI via the website or server. All patient data will be de-
identified. Patients in the research project will sign an informed consent document which details how their 
data will be transmitted and stored.  
 
Server Software 
InterVision Media (IVM) will manage and support the software infrastructure. 
Datacenter Infrastructure 
The server will be hosted at the Amazon Web Services (AWS) GovCloud 
AWS GovCloud (US) is an isolated AWS region designed to host sensitive data and regulated 
workloads in the cloud, helping customers support their U.S. government compliance 
requirements, including the International Traffic in Arms Regulations (ITAR) and Federal Risk 
and Authorization Management Program (FedRAMP). AWS GovCloud (US) is operated by 
employees who are vetted "U.S. Persons" and root account holders of AWS accounts must 
confirm they are U.S. Persons before being granted access credentials to the region. 
AWS’ data centers are state of the art, utilizing innovative architectural and engineering 
approaches. AWS has many years of experience in designing, constructing, and operating large-
scale data centers. This experience has been applied to the AWS platform and infrastructure. 

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AWS data centers are housed in nondescript facilities. Physical access is strictly controlled both 
at the perimeter and at building ingress points by professional security staff utilizing video 
surveillance, intrusion detection systems, and other electronic means. Authorized staff must pass 
two-factor authentication a minimum of two times to access data center floors. All visitors and 
contractors are required to present identification and are signed in and continually escorted by 
authorized staff. 
Data Transmission Security 
In this project, a public website is used by CarePartners and study staff.  AWS GovCloud (US) is 
configured with multiple virtualized hosting environments. A firewall isolates each environment from all 
others. All data transmissions are protected by an SSL (Secure Sockets Layer) certificate using AES 256-
bit encryption. 
Data storage security and backup 
All data is encrypted at rest by the application—using an AES-256 cipher—before it is saved to the 
storage partition. Furthermore, partition encryption is provided at the OS level using a FIPS 140-2 kernel-
level disk volume encryption method. All system data is encrypted and backed up nightly to a separate 
server within the isolated network. 
Firewall 
An Internet firewall provides monitors and controls incoming and outgoing network traffic, providing 
protection from intrusions, attacks and other unauthorized access. 
Confidentiality of the IVR System 
The IVR system, an automated phone system, is separate from any electronic medical records or other 
data storage devices, and separate from the Intervention Website described above, and there will be no 
access to other outside patient-level PHI via the website or server.  Patients in the research project will 
sign an informed consent document which details how their data will be transmitted and stored. The 
portal hosted at the Amazon Web Services (AWS) GovCloud will be used to manage the IVR system, 
including patient registration, scheduling, monitoring, and reporting. Access to the portal is password 
protected, using unique ‘strong’ passwords. Data stored on the site will be limited to patients’ first and 
last names, year of birth, telephone numbers, and Care Partners’ email address, which will be entered 
through a web interface by study personnel only. All patient responses to IVR call questions will be 
stored as numerical data, further limiting the patient-level data on the system.  
Server Software 
InterVision Media (IVM) will manage and support the software infrastructure. 
Datacenter Infrastructure 
The server will be hosted at AWS GovCloud (US).  AWS GovCloud (US) is an isolated AWS 
region designed to host sensitive data and regulated workloads in the cloud, helping customers 
support their U.S. government compliance requirements, including the International Traffic in 
Arms Regulations (ITAR) and Federal Risk and Authorization Management Program 
(FedRAMP). AWS GovCloud (US) is operated by employees who are vetted "U.S. Persons" and 
root account holders of AWS accounts must confirm they are U.S. Persons before being granted 
access credentials to the region. 
AWS’ data centers are state of the art, utilizing innovative architectural and engineering 
approaches. AWS has many years of experience in designing, constructing, and operating large-

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scale data centers. This experience has been applied to the AWS platform and infrastructure. 
AWS data centers are housed in nondescript facilities. Physical access is strictly controlled both 
at the perimeter and at building ingress points by professional security staff utilizing video 
surveillance, intrusion detection systems, and other electronic means. Authorized staff must pass 
two-factor authentication a minimum of two times to access data center floors. All visitors and 
contractors are required to present identification and are signed in and continually escorted by 
authorized staff. 
Data Transmission Security 
In this project, a private portal will facilitate patient IVR calls and is accessed only by the study staff. No 
public access is permitted to the private website portal. It can only be accessed after an authorized user 
first establishes a FIPS 140-2 compliant Virtual Private Network (VPN) connection. All subsequent data 
transmissions, including all data collected by the IVR system, are further protected by an SSL (Secure 
Sockets Layer) certificate using AES 256-bit encryption. 
Telecommunications 
IVM’s telecommunications provider, NexVortex, provisions and supports the SIP trunks that carry all 
VoIP traffic.  NexVortex’s Service Assurance Manager (SAM) allows monitoring, analysis, and response 
to IP network changes in real time. The system provides both outgoing as well as toll-free incoming 
phone calls, and supports cell phones and fax machines both domestically and internationally.  
Data storage security and backup 
All data is encrypted at rest by the application—using an AES-256 cipher—before it is saved to the 
storage partition. Furthermore, partition encryption is provided at the OS level using a FIPS 140-2 kernel-
level disk volume encryption method. All system data is encrypted and backed up nightly to a separate 
server within the isolated network.  
Firewall 
An Internet firewall monitors and controls incoming and outgoing network traffic, providing protection 
from intrusions, attacks and other unauthorized access. Connections between authorized VA personnel 
and AWS GovCloud (US) are available only via the firewall’s VPN, configured with a validated FIPS 
140-2 crytographic module. 
 
Confidentiality of Assessment Data 
It will be made clear to participants that no information gathered through study baseline, 6-month and 12-
month assessments will be shared with the other member of the dyad (i.e. patient assessment information 
will not be shared with the patient’s Care Partner and vice versa). None of the information provided to 
research assistants will be shared with participants’ clinicians unless the patient appears to be in danger (in 
cases of suicidality, for example) and Dr. Rosland deems it necessary to contact the participant’s physician.  
 
Assessment data collected face-to-face or by mail will be collected by paper survey and then entered into 
a study assessment database on the VA restricted sever.  When assessments take place by phone 
interview, the study staff will enter the data directly into a study assessment database on the VA restricted 
sever.  Assessment data will be linked to the participant’s study ID number but not to PII.  Data captured 
on paper will be stored in secure, locked cabinets in the research office space.   
After data collection is complete, de-identified data from the patient participants (not the Care Partner 
participants) will be shared with Insignia, the company that holds the rights to the Patient Activation 

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Measure (PAM).  (Insignia normally requires an annual fee $7,500 for a license, which is not within our 
study's budget. However, Insignia provides a reduced or waived fee for organizations that are willing to 
share deidentified data.)  This de-identified data includes, but is not limited to the same dataset in which 
the PAM is used.  Jenny Davis, HSR&D's data manager, will de-identify the dataset, write the data on an 
encrypted CD rom disc, and send to Insignia.  Its contents will be only accessible by the intended 
recipient.  
Confidentiality of Audio Recordings for Quality Assurance 
Audio-recording of selected coaching sessions is necessary to ensure the fidelity of the coaching sessions.  
Participants, including Care Partners, will be asked to provide to verbal consent to the audiorecording 
immediately prior to the session.  They will explain to participants that the recordings are made for 
quality assurance purposes, notified that they may participate in the study even if they do not wish to be 
audio recorded, and that the audio recording will be stopped at any time they wish.  They will then state 
their consent to being recorded, as they are recorded. Participants who decline to be audio-recorded will 
complete the scheduled coaching session as usual without audio-recording. Each digital audio file will be 
labeled only with the participant’s study ID#.  Recording devices will be kept physically secure in a 
locked drawer or locked transport case at all times, and once audio files are uploaded to the secure servers 
behind the VA firewalls, they will be deleted from the DVRs.  
 
 
17.4 Potential Benefits 
 
Potential benefits of the proposed research to the subjects and others  
This study will evaluate an innovative method for improving informal care support through engaging 
patients’ Care Partners and enhancing the effectiveness of their support. We expect this study to 
produce an evidence-based protocol and tools that engage VA patients with high-risk diabetes and 
their Care Partners in PACT to help PACT achieve the best diabetes outcomes. This protocol could 
then be implemented in PACT encounters with high-risk patients throughout the VA. 
Many intervention-assigned participants are likely to experience direct benefits from participation in 
this study: 
• 
All intervention-assigned patient participants will receive twice-monthly automated telephone 
assessment of their diabetes symptoms and self-care.  This may improve the quality of their 
diabetes care, and their diabetes outcomes.   
• 
Patient participants may experience additional benefits to their health and well-being as a 
result of feedback also being sent to the Care Partner whom they nominate.   
• 
Coaching on patient activation skills may improve patient communication with their PACT 
clinicians, and result in improved diabetes clinical care.  
• 
Control-assigned participants will receive physician-approved information on diabetes 
management. 
 
We expect that this study will contribute to the growing body of knowledge on how VA can most 
effectively engage family supporters and Care Partners in patients’ care to optimize health 
management and outcomes. By improving informal care support for Veterans with diabetes, this 
research may indicate new ways to improve their health, health-related quality of life, health 
behaviors, and reduce diabetes-related distress.  Diabetes is prevalent among Veterans and often 
results in substantial morbidity, distress, disability, and health care costs.  We feel the potential 
knowledge to be gained outweighs the low risk of minimal harm to participants. 

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Because diabetes is prevalent among Veterans and results in substantial morbidity, health care 
utilization and costs, we feel the study's potential benefits outweigh the low risk of minimal harm to 
participants. 
 
18. Data and Safety Monitoring Plan 
Institutional Review Board (IRB) approvals will be obtained at the Ann Arbor VAMC.  The PI, Dr. 
Ann-Marie Rosland, will take ultimate responsibility for ensuring the safety of the participants.  
Regular study team meetings will be used to ensure that all study protocols and IRB policies and 
procedures are being followed. This will include ensuring that; 
1. All participants understand, agree to, and sign a written consent form before participating 
2. Strict adherence is maintained to communication regarding the participants’ right to withdraw 
or refuse to answer questions 
3. Staff maintain confidentiality both by protecting hard-copy and electronic data collection 
forms and also by avoiding all unauthorized conversations about individual patients 
4. Consent forms and identifying information are kept separately from study related information 
about patients’ sociodemographics, clinical characteristics, disease self-care, service use, and 
outcomes 
5. All hard copies containing identifying information is kept locked at all times, and sensitive 
computer files are maintained on a secured VA server with access limited to approved study 
staff 
6. Coding for ambiguous responses is handled in a way that is consistent and clear across data 
collectors and over time 
7. Participants are informed in writing how to contact the study PI, the study coordinator, and 
the relevant IRB office with any questions or concerns.  
 
All AEs, problems, and protocol deviations/violations will be brought to the immediate attention of 
Dr. Rosland.  Dr. Rosland will be responsible for reporting all serious adverse events (SAEs), adverse 
events (AEs), and serious problems, as defined in the policy entitled VA IRB policy, analysis, and 
reporting form for serious adverse events, serious problems, protocol deviations, and other 
reportable events to participants and others in human subjects research (last updated 9.8.16).  Such 
events or problems may be identified through participant report via the study toll-free number, or 
research staff viewing in medical records in the course of planned study activities. Specifically, death 
and life-threatening SAEs will be reported to the VAAAHS IRB by phone immediately following the 
discovery of the event, with a completed Serious Adverse Event, Serious Problem, Protocol 
Deviation, and Other Reportable Event Investigator Reporting Form VA Ann Arbor Healthcare 
System Subcommittee on Human Studies (151) form submitted within 5 business days following the 
discovery of the event, problem or information that involves VA research.  Other SAEs, AEs, and 
serious problems that are possibly related to research and unanticipated will be reported to the 
VAAAHS IRB within 5 business days of the discovery via the form named above.  This includes 
suspension or termination of research activities.  Protocol deviations will be reported to the VA IRB 
within 30 days, in memo format.   
 
Reports of non-serious unanticipated events, problems and protocol deviations will be submitted in 
tabular form at each annual continuation review, and other events reported immediately, within 5 
days, and within 30 days will be included.  If any uncertainty exists regarding reporting, the PI will 
consult with the IRB coordinator. 

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19. Inclusion of Women, Minorities and/or Children 
Children will not be eligible for this study, as either patients or Care Partners. We will recruit eligible 
patients and Care Partners who give informed consent, regardless of their gender, race, or ethnicity. 
We expect the study to reflect the racial, ethnic, and gender distribution of the study sites. 
Representation of racial minority groups and women will be monitored throughout the project, and if 
it appears that they are underrepresented among participants, significant efforts will be made to boost 
their enrollment. These efforts will include qualitative interviews with women and minorities who are 
and are not participating to understand barriers to participation and to learn new strategies for 
increasing representation of those groups. 
 
 
 
 

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