Comparison of Collaborative Goal Setting With Enhanced Education for Managing Diabetes-Associated Distress and Hemoglobin A(1c) Levels: A Randomized Clinical Trial

IMPORTANCE: Type 2 diabetes is a prevalent and morbid condition. Poor engagement with self-management can contribute to diabetes-associated distress and hinder diabetes control. OBJECTIVE: To evaluate the implementation and effectiveness of Empowering Patients in Chronic Care (EPICC), an evidence-based intervention to improve diabetes-associated distress and hemoglobin A(1c) (HbA(1c)) levels after the intervention and after 6-month maintenance. DESIGN, SETTING, AND PARTICIPANTS: This hybrid (implementation-effectiveness) randomized clinical trial was performed in Veterans Affairs clinics across Illinois, Indiana, and Texas from July 1, 2015, to June 30, 2017. Participants included adults with uncontrolled type 2 diabetes (HbA(1c) level >8.0%) who received primary care during the prior year in participating clinics. Data collection was completed on November 30, 2018, and data analysis was completed on June 30, 2020. All analyses were based on intention to treat. INTERVENTIONS: Participants in EPICC attended 6 group sessions based on a collaborative goal-setting theory led by health care professionals. Clinicians conducted individual motivational interviewing sessions after each group. Usual care was enhanced (EUC) with diabetes education. MAIN OUTCOMES AND MEASURES: The primary outcome consisted of changes in HbA(1c) levels after the intervention and during maintenance. Secondary outcomes included the Diabetes Distress Scale (DDS), Morisky Medication Adherence Scale, and Lorig Self-efficacy Scale. Secondary implementation outcomes included reach, adoption, and implementation (number of sessions attended per patient). RESULTS: A total of 280 participants with type 2 diabetes (mean [SD] age, 67.2 [8.4] years; 264 men [94.3]; 134 non-Hispanic White individuals [47.9%]) were equally randomized to EPICC or EUC. Participants receiving EPICC had significant postintervention improvements in HbA(1c) levels (F(1, 252) = 9.12, Cohen d = 0.36 [95% CI, 0.12-0.59]; P = .003) and DDS (F(1, 245) = 9.06, Cohen d = 0.37 [95% CI, 0.13-0.60]; P = .003) compared with EUC. During maintenance, differences between the EUC and EPICC groups remained significant for DDS score (F(1, 245) = 8.94, Cohen d = 0.36 [95% CI, 0.12-0.59]; P = .003) but not for HbA(1c) levels (F(1, 252) = 0.29, Cohen d = 0.06 [95% CI, −0.17 to 0.30]; P = .60). Improvements in DDS scores were modest. There were no differences between EPICC and EUC in improvements after intervention or maintenance for either adherence or self-efficacy. Among all 4002 eligible patients, 280 (7.0%) enrolled in the study (reach). Each clinic conducted all planned EPICC sessions and cohorts (100% adoption). The EPICC group participants attended a mean (SD) of 4.34 (1.98) sessions, with 54 (38.6%) receiving all 6 sessions. CONCLUSIONS AND RELEVANCE: A patient-empowerment approach using longitudinal collaborative goal setting and motivational interviewing is feasible in primary care. Improvements in HbA(1c) levels after the intervention were not sustained after maintenance. Modest improvements in diabetes-associated distress after the intervention were sustained after maintenance. Innovations to expand reach (eg, telemedicine-enabled shared appointments) and sustainability are needed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01876485