Caring Others Increasing EngageMent in PACT
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): CO-IMPACT; PACT
Intervention type(s): Other; Other
Intervention description(s): Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter; participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Diabetes; diabetes self-management; patient activation; social support