Caring Others Increasing EngageMent in PACT — CO-IMPACT  

Diabetes Clinical Trial

Official title: Engaging Veterans and Family Supporters in PACT to Improve Diabetes Management

Status Completed

Clinical Trial Summary

This trial will compare two methods of increasing engagement in care and success in diabetes management, among patients with diabetes with high-risk features, who also have family members involved in their care.

Clinical Trial Description

Background:

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.

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.

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. ;

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

• NCT number: NCT02328326
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: N/A
• Start date: November 16, 2016
• Completion date: June 6, 2020