BACKGROUND/RATIONALE:
Veterans with diabetes must control cardiovascular risk factors in order to prevent disabling and life-threatening complications. However, despite system wide advances in diabetes quality of care, over 30% of VHA patients with diabetes continue to have uncontrolled blood pressure, hyperglycemia, or hyperlipidemia. The nationwide VA PACT (Patient-Aligned Care Teams) initiative 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. One relatively untapped resource for supporting engagement in PACT 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 management. These supporters help patients with medication adherence, tracking home glucose measurements, maintaining a healthy eating plan, and often accompany patients to their medical visits. However, while PACT emphasizes the importance of family members as part of the care team, PACT does not have formal mechanisms to involve health supporters in PACT care. Health supporters report that, in order to be more effective, they need more information on patient's medical care plans, clear channels for communicating with PACT team members, and information on navigating PACT resources.

OBJECTIVE(S):
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.

METHODS:
This is a randomized controlled trial evaluating an intervention (Caring Others Increasing EngageMent in PACT, or CO-IMPACT) designed to structure and facilitate health supporter involvement in PACT so that patients can become more actively engaged in PACT care. 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 health supporter involved in their care will be recruited along with their health supporter. Patient-supporter dyads are randomized to the CO-IMPACT intervention or usual PACT care for high-risk diabetes, for 12 months.

The intervention 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 by mail; 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 include supporter activation, use of effective support techniques, distress about patient's diabetes care, and caregiver burden. We are also measuring patient-supporter and patient-provider relationship quality, patient safety (e.g. hypoglycemia), utilization, potential moderators of intervention effect such as patient health literacy level, and facilitators and barriers to wider implementation.

FINDINGS/RESULTS:
This study began recruitment in November 2016. Recruitment is expected to be complete mid-year of 2018. Outcomes data currently are being collected.

IMPACT:
If successful, the study will establish a new approach for involving patients' supporters in VA care, in ways that could avert devastating consequences of uncontrolled diabetes.

Similar methods could be used by the VA and others to better support Veterans' family caregivers, and to improve health management for Veterans with other high-risk conditions.

---

External Links for this Project

NIH Reporter

Grant Number: I01HX001618-01
Link: https://reporter.nih.gov/project-details/8785155

---

PUBLICATIONS:

Journal Articles

1. Lee AA, Heisler M, Trivedi R, Leukel P, Mor MK, Rosland AM. Autonomy support from informal health supporters: links with self-care activities, healthcare engagement, metabolic outcomes, and cardiac risk among Veterans with type 2 diabetes. Journal of behavioral medicine. 2021 Apr 1; 44(2):241-252. [view]
2. Rosland AM, Piette JD, Trivedi R, Lee A, Stoll S, Youk AO, Obrosky DS, Deverts D, Kerr EA, Heisler M. Effectiveness of a Health Coaching Intervention for Patient-Family Dyads to Improve Outcomes Among Adults With Diabetes: A Randomized Clinical Trial. JAMA Network Open. 2022 Nov 1; 5(11):e2237960. [view]
3. Rosland AM, Piette JD, Trivedi R, Kerr EA, Stoll S, Tremblay A, Heisler M. Engaging family supporters of adult patients with diabetes to improve clinical and patient-centered outcomes: study protocol for a randomized controlled trial. Trials. 2018 Jul 24; 19(1):394. [view]
4. Zupa MF, Lee A, Piette JD, Trivedi R, Youk A, Heisler M, Rosland AM. Impact of a Dyadic Intervention on Family Supporter Involvement in Helping Adults Manage Type 2 Diabetes. Journal of general internal medicine. 2022 Mar 1; 37(4):761-768. [view]
5. Zupa MF, Piette JD, Stoll SC, Obrosky DS, Boudreaux-Kelly M, Youk AO, Overholt L, Trivedi R, Heisler M, Rosland AM. Patient and supporter factors affecting engagement with diabetes telehealth. The American journal of managed care. 2021 Oct 1; 27(10):409-414. [view]
6. Fields B, Lee A, Piette JD, Trivedi R, Mor MK, Obrosky DS, Heisler M, Rosland AM. Relationship between adult and family supporter health literacy levels and supporter roles in diabetes management. Families, systems & health : the journal of collaborative family healthcare. 2021 Jun 1; 39(2):224-233. [view]

Conference Presentations

1. Rosland A, Wong E, Zulman DM, Piegari R, Prenovost K, Fihn S, Nelson K. Higher Level of Patient-Centered Medical Home Implementation Associated with Improvements in Clinical Quality of Care in the Nation-Wide VHA PACT Initiative. Paper presented at: AcademyHealth Annual Research Meeting; 2015 Jun 14; Minneapolis, MN. [view]
2. Rosland A, Wong ES, Zulman D, Piegari R, Prenovost K, Fihn SD, Nelson KM. Higher Level of Patient-Centered Medical Home Implementation Associated with Larger Improvements in Clinical Quality in the PACT Initiative. Paper presented at: VA HSR&D / QUERI National Meeting; 2015 Jul 10; Philadelphia, PA. [view]
3. Rosland A, Heisler MM, Trivedi RB, Gaudioso S, Fennelly J, Piette JD. Improving Diabetes Management by Engaging Family Supporters in the Patient-Centered Medical Home: A Pilot Intervention Study. Poster session presented at: AcademyHealth Annual Research Meeting; 2015 Jun 15; Minneapolis, MN. [view]
4. Rosland A, Heisler MM, Trivedi RB, Gaudioso S, Fennelly J, Piette JD. Improving Diabetes Management by Engaging Family Supporters in the Patient-Centered Medical Home: A Pilot Intervention Study. Poster session presented at: Society of General Internal Medicine Annual Meeting; 2015 Apr 23; Toronto, Canada. [view]
5. Rosland A, Heisler MM, Trivedi R, Gaudioso S, Fennelly J, Piette JD. Improving Diabetes Management by Engaging Family Supporters in the Patient-Centered Medical Home: A Pilot Intervention. Paper presented at: VA HSR&D / QUERI National Meeting; 2015 Jul 9; Philadelphia, PA. [view]

DRA: Health Systems, Diabetes and Other Endocrine Disorders, Aging, Older Veterans' Health and Care
DRE: Treatment - Comparative Effectiveness
Keywords: Adherence, Comparative Effectiveness, Diabetes, Outcomes - Patient
MeSH Terms: none