Houston Center for Innovations in Quality, Effectiveness, and Safety, Michael E. Debakey Veterans Affairs (VA) Medical Center, Houston, Texas.
Department of Medicine, Baylor College of Medicine, Houston, Texas.
JAMA Netw Open. 2022 May 2;5(5):e229975. doi: 10.1001/jamanetworkopen.2022.9975.
Type 2 diabetes is a prevalent and morbid condition. Poor engagement with self-management can contribute to diabetes-associated distress and hinder diabetes control.
To evaluate the implementation and effectiveness of Empowering Patients in Chronic Care (EPICC), an evidence-based intervention to improve diabetes-associated distress and hemoglobin A1c (HbA1c) 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 (HbA1c 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.
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.
The primary outcome consisted of changes in HbA1c 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).
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 HbA1c levels (F1, 252 = 9.12, Cohen d = 0.36 [95% CI, 0.12-0.59]; P = .003) and DDS (F1, 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 (F1, 245 = 8.94, Cohen d = 0.36 [95% CI, 0.12-0.59]; P = .003) but not for HbA1c levels (F1, 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.
A patient-empowerment approach using longitudinal collaborative goal setting and motivational interviewing is feasible in primary care. Improvements in HbA1c 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.
ClinicalTrials.gov Identifier: NCT01876485.
重要性：2 型糖尿病是一种普遍且严重的疾病。自我管理参与度低可能导致与糖尿病相关的痛苦，并阻碍糖尿病控制。
目的：评估基于证据的 EPICC 干预措施（Empowering Patients in Chronic Care）的实施和效果，该干预措施可改善糖尿病相关痛苦和血红蛋白 A1c（HbA1c）水平，实施后和 6 个月维持后。
设计、设置和参与者：这是一项在伊利诺伊州、印第安纳州和德克萨斯州的退伍军人事务诊所进行的混合（实施-效果）随机临床试验，从 2015 年 7 月 1 日至 2017 年 6 月 30 日。参与者包括在参与诊所接受过过去一年初级保健的未控制 2 型糖尿病（HbA1c 水平>8.0%）成年人。数据收集于 2018 年 11 月 30 日完成，数据分析于 2020 年 6 月 30 日完成。所有分析均基于意向治疗。
干预措施：EPICC 组的参与者参加了由卫生保健专业人员主导的基于合作目标设定理论的 6 次小组会议。临床医生在每次小组会议后进行单独的动机访谈。常规护理（EUC）增加了糖尿病教育。
主要结果和措施：主要结果是干预后和维持期间的 HbA1c 水平变化。次要结果包括糖尿病困扰量表（DDS）、莫瑞斯药物依从性量表和洛里格自我效能量表。次要实施结果包括覆盖率、采用率和实施率（每位患者参加的课程数）。
结果：共有 280 名 2 型糖尿病患者（平均[标准差]年龄，67.2[8.4]岁；264 名男性[94.3%]；134 名非西班牙裔白人个体[47.9%]）被平均随机分配到 EPICC 或 EUC。接受 EPICC 的患者在 HbA1c 水平（F1,252=9.12，Cohen d=0.36[95%CI，0.12-0.59]；P=0.003）和 DDS（F1,245=9.06，Cohen d=0.37[95%CI，0.13-0.60]；P=0.003）方面均有显著改善，与 EUC 相比。在维持期间，EUC 和 EPICC 组之间的 DDS 评分差异仍然显著（F1,245=8.94，Cohen d=0.36[95%CI，0.12-0.59]；P=0.003），但 HbA1c 水平差异不显著（F1,252=0.29，Cohen d=0.06[95%CI，-0.17 至 0.30]；P=0.60）。DDS 评分的改善幅度较小。在干预或维持后，EPICC 和 EUC 在依从性或自我效能方面均无改善。在所有 4002 名合格患者中，有 280 名（7.0%）参加了该研究（覆盖率）。每个诊所都进行了所有计划的 EPICC 课程和队列（100%的采用率）。EPICC 组的参与者平均参加了 4.34（1.98）次课程，其中 54 人（38.6%）接受了所有 6 次课程。
结论和相关性：使用纵向合作目标设定和动机访谈的患者赋权方法在初级保健中是可行的。干预后 HbA1c 水平的改善在维持后并未持续。干预后糖尿病相关痛苦的适度改善在维持后得以持续。需要创新措施来扩大覆盖面（例如，远程医疗支持的共享预约）和可持续性。
试验注册：ClinicalTrials.gov 标识符：NCT01876485。
