Project Background: Diabetes mellitus is a highly prevalent chronic condition, affecting one in five Veterans who use the Veterans Affairs (VA) health care system. Self-management skills are critical for controlling diabetes and reducing its cardiovascular sequela. Providing diabetic patients with effective self-management training and support can be challenging due to time constraints at primary care encounters and limited clinician training with behavior change. We have previously demonstrated that a group-based, VA primary care intervention to help patients set highly effective, evidence-based diabetes goals had a positive impact on both diabetes self-efficacy and hemoglobin (Hb) A1c levels. This study aims to evaluate the process of implementing a collaborative goal-setting intervention personalized to patient activation and health literacy levels (i.e. Empowering Patients in Chronic Care [EPIC]) into routine VISN 12 PACT care and to evaluate the effectiveness this intervention relative to usual care. Project Objectives:
Specific Aim 1 : Assess effective processes for and costs associated with implementing a collaborative diabetes goal-setting intervention personalized to patient activation and FHL (i.e., EPIC) into the routine workflows of VISN 12 PACTs. H1: Formative measures within the PARIHS framework (evidence, context, facilitation) will be associated with implementation of EPIC (defined by reach, adoption, cost effectiveness, and fidelity measures) into routine PACT care.
Specific Aim 2 : Evaluate the effectiveness of delivering collaborative goal-setting personalized to patient activation and FHL on clinical (HbA1c) and patient- centered (Diabetes Distress Scale) outcomes among eligible patients in enrolled PACTs. H2: Patients receiving collaborative goal-setting personalized to activation and FHL levels will have significant improvements in a) HbA1c and b) Diabetes Distress Scale levels, respectively, at 6-months (post-intervention) compared with patients receiving enhanced usual care. H3: Patients receiving collaborative goal-setting personalized to activation and FHL levels will maintain significant improvements in a) HbA1c and b) Diabetes Distress Scale levels at 1-year follow-up, respectively, compared with patients receiving enhanced usual care. Project Methods: In Phase 1 of the study, we will implement EPIC into routine PACT care. We will conduct a mixed-methods formative evaluation that includes 33-48 key informant interviews with VISN 12 leadership, clinicians, and staff and an assessment of organizational readiness for change. This evaluation will identify how group and one-on-one sessions of EPIC can best be implemented into routine workflows of VISN 12 PACT. In Phase 2, we will conduct a randomized clinical trial enrolling 32 designated PACT members and 260 of their patients with poorly controlled diabetes defined by average hemoglobin A1c of e 8% to receive EPIC or enhanced usual care. The PACT teamlet will serve as the unit of randomization. EPIC consists of four 1-hour group sessions focusing on 1) The ABCs of Diabetes Care, 2) How to Make Goals and Action Plans, 3) Communication with Your Provider, and 4) Staying Committed to Your Goals &Action Plans. After each group, a one-on-one session between a designated PACT member and patient participants will focus on collaborative goal-setting. Designated PACT members will be trained to personalize goal-setting using patient- reported activation and health literacy data. We will collect laboratory and survey data at baseline, six months, and one year. We will evaluate the effectiveness of personalized goal-setting compared to enhanced usual care on clinical (e.g., hemoglobin A1c) and patient-centered (e.g., Diabetes Distress Scale) outcomes.
Patients with diabetes, a highly prevalent condition in the VA, are at increased risk for cardiovascular disease and disability. Self-management skills are critical for reducing this risk. Collaborative goal-setting improves diabetes self-management and is influenced by patient activation and health literacy. We have previously demonstrated that a group-based, VA primary care intervention to help patients set highly effective, evidence- based diabetes goals had a positive impact on diabetes self-efficacy and hemoglobin (Hb) A1c levels. This study aims to evaluate the process of implementing a collaborative goal-setting intervention personalized to patient activation and health literacy levels into routine VISN 12 PACT care and to evaluate the effectiveness this intervention relative to usual care on clinical (e.g., HbA1c) and patient-centered (e.g., Diabetes Distress Scale) outcomes. Information gained from this work will provide insight into the role of personalized goal- setting within PACT for high-risk patients with other chronic conditions.
