Diabetes mellitus is a highly prevalent chronic condition, affecting one in four Veterans who use the Veterans Affairs (VA) health care system. Patient self-management is critical for controlling diabetes and reducing its cardiovascular sequela. Providing diabetic patients with effective whole health training and self-management 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 can help patients set highly effective, evidence-based diabetes goals resulting in improved 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 PACT care in five VA facilities across two VISNs and to evaluate the effectiveness and patient-centeredness of this intervention relative to usual care.
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 functional health literacy (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.
In Phase 1 of the study, we implemented EPIC into routine PACT care. We conducted a mixed-methods formative evaluation that included 35 key informant interviews with VISN 12 leadership, clinicians, and staff and an assessment of organizational readiness for change. This evaluation identified how group and one-on-one sessions of EPIC can best be implemented into routine PACT workflows.
In Phase 2, we conducted a randomized clinical trial enrolling 280 Veterans, from a projected sample of 284, with poorly controlled diabetes (defined by average hemoglobin A1c of >= 8%). Veterans were randomized at the patient level to receive EPIC or enhanced usual care (EUC). Consented subjects were allocated evenly between EPIC and EUC. EPIC consisted of six 1-hour group sessions focusing on 1) Your Health, Your Values, 2) Diabetes ABCs, 3) Setting Goals and Making Action Plans, 4) Communication with Your Health Care Provider, 5) Staying Committed to Your Goals, and 6) Reviewing and Planning for the Future. After each group session, a one-on-one goal-coaching session between an EPIC clinician, drawn from the local PACT staff, and Veteran participants focused on collaborative goal-setting. EPIC coaches were trained to personalize goal-setting using patient-reported activation and health literacy data.
We collected laboratory and survey data at baseline, post-intervention, and post-maintenance phase. We evaluated 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.
In the Phase 1 formative evaluation of implementation, we conducted 35 in-depth, qualitative interviews from a snowball sample of staff actively engaged in VISN 12 diabetes management (PACT members and Health Promotion Disease Prevention staff) and facility leadership. Consistent with the PARIHS framework, interviews elicited information about participants' existing knowledge regarding group education programs (Evidence); physical and social climate at each target facility (Context); and clinicians' preparedness and intentions to participate (Facilitation). Analysis was dictated by thematic saturation.
We identified consistent implementation needs across five VISN 12 facilities. All facilities desired a collaborative culture, but differed in their actual level of existing collaborations. Participants' concerns involved lack of leadership support for diabetes-related programs, inadequate staffing, difficulty balancing EPIC with existing responsibilities, and overlap between the intervention and ongoing diabetes programs. Some participants raised concerns about the intensity of the intervention, given the health literacy and activation of the target patient population.
We addressed implementation needs through open, ongoing communication, partnership building, and engagement with diabetes care staff and leadership at target facilities. We promoted successful collaboration by identifying mechanisms to meet participants' goals while simultaneously meeting EPIC project goals. We used the shared medical appointment mechanism to address staffing and workload issues, and incentivized participation with CEU credits to meet existing training responsibilities for intervention staff. Based on partner feedback, we modified patient training materials and expanded the intervention dose from 4 to 6 sessions to meet the needs of the low health literacy patient population.
In the Phase 2 randomized-controlled trial of EPIC implementation, a total of five sites actively participated in the intervention delivery: the Hines VA Hospital in Hines, IL, and the associated Joliet Community-Based Outpatient Clinic in Joliet, IL, the Jesse Brown VAMC in downtown Chicago, and the associated Adam Benjamin, Jr. community-based outpatient clinic in Crown Point, IN, as well as the Michael E. DeBakey VAMC in Houston, TX. Sites implemented 100% of expected groups; a total of 25 group cohorts were delivered between the sites during the intervention window from July 2015-July 2017. Groups ranged in size from 2-10 Veterans, with an average group size of 6 Veterans. Overall, 280 Veterans were recruited to participate, meeting 99% of the target sample of 284 Veterans. Allocation between the treatment and control groups was exactly even at 140 Veterans each. Baseline characteristics of our patient participants suggest that participants randomized to the EPIC and EUC arms of the study were statistically not significantly different from each other on key characteristics such as their baseline HbA1C, DDS, and potential co-variates (e.g., demographics). The only exception is that the number of participants with prior diabetes education was greater for participants in the EUC arm compared to the EPIC arm (X2(1) = 8.44, p = 0.004). Those assigned to the EPIC arm had significantly greater improvement in HbA1c levels from baseline to post-intervention, relative to those assigned to the EUC arm (F = 9.12, p = 0.003, d = 0.36 (95% CI = 0.12, 0.59)). However, this difference was not maintained at the post-maintenance time point (F = 0.29, p = 0.60, d = 0.06 (95% CI = -0.17, 0.30). We found statistically significant improvements in Diabetes Distress Scale scores among EPIC Veterans relative to controls at both the post-intervention (F = 9.06, p = 0.003, d = 0.37 (95% CI = 0.13, 0.60) and post-maintenance time points (F = 8.94, p = 0.003, d = 0.36 (95% CI = 0.12, 0.59). The significant improvements all reflect mild to moderate effect sizes that build on the effectiveness of usual care. Data from qualitative analyses demonstrated that both Veterans and clinicians endorsed participation in the EPIC intervention, with Veterans citing approval for the peer support and personalized approach to goal setting incumbent to the intervention. Clinicians endorsed the exposure and practical application of clinical skills, like motivational interviewing, interprofessional collaboration and shared-decision making.
Integration of patient-reported measures into routine care should aid PACT providers in personalizing goals and action plans for Veterans with treated but uncontrolled diabetes. Having PACT members conduct the personalized goal-setting will improve clinical and patient-centered outcomes because patient goals/action plans can better align with the PACT treatment plan. PACT personnel will gain a greater understanding of patients' challenges and problems related to diabetes self-care, and patients will likely gain a deeper appreciation of diabetes self-management through collaborative goal-setting. Information gained from this work will provide greater understanding of the role of collaborative goal-setting in targeting high-risk patient populations within the PACT setting and could be extended to other chronic conditions. The profile of clinicians delivering the intervention varies by clinical site. Nation-wide adoption of this intervention is possible because of widespread implementation of PACT in the VA and the flexibility in the staffing patterns of delivery. Furthermore, deliberate efforts to engage PACT personnel in the planning and implementation of the effectiveness study will enhance the potential impact and feasibility of adoption across VA PACTs. We have concluded the interventional phase of the project and are conducting data analysis currently that will further elucidate the project impact. Given that our findings support EPIC's effectiveness, we are currently exploring different potential funding opportunities that will enable us to implement and disseminate the program more broadly. To date, we have secured funding from our partners in VISN 12 to disseminate the project more broadly throughout the VISN. This funding has enabled us to create an EPIC toolkit to insure the program is embedded long-term, accounting for products and processes traditionally accomplished by members of the research staff. These elements include: 1) A sustainable process map for Veteran identification and scheduling; 2) A decision tree for EPIC coach identification; 3) EES-accredited E-learning platform for EPIC coach training; 4) A clinic profile request form to insure creation of an EPIC clinic; 5) Revised and updated EPIC manuals; 6) Frequently Asked Question guide for facilitators; and 7) a SharePoint site to house EPIC materials and instructions. Our partners in Crown Point, IN have utilized the EPIC toolkit and are currently running a cohort of Veterans without support from any research staff.
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