Fortney John C, Ratzliff Anna D, Blanchard Brittany E, Ferro Lori, Chase Erin, Rouvere Julien, Duncan Mark H, Merrill Joseph O, Simpson Tracy, Williams Emily C, Austin Elizabeth J, Curran Geoffrey M, Schoenbaum Michael, Heagerty Patrick J, Saxon Andrew J
Department of Psychiatry and Behavioral Sciences, Division of Population Health, University of Washington School of Medicine, Seattle.
Advancing Integrated Mental Health Solutions (AIMS) Center, University of Washington, Seattle.
JAMA Psychiatry. 2025 Aug 20. doi: 10.1001/jamapsychiatry.2025.2126.
The criterion-standard treatment for opioid use disorder (OUD) is medications for OUD (MOUD). However, less than a quarter of people with OUD receive MOUD. The collaborative care model (CCM) is an evidence-based practice that integrates mental and physical health treatment in primary care settings. Expanding CCM to include patients with OUD could improve MOUD initiation.
To compare the effectiveness of CCM for OUD and co-occurring mental health symptoms (intervention) with CCM for mental health symptoms only (active control).
DESIGN, SETTING, AND PARTICIPANTS: This hybrid type 2a trial cluster-randomized 24 US primary care clinics to intervention or control. Participants included patients with OUD and mental health symptoms who were not receiving specialty mental health care or specialty substance use treatment. Study data were analyzed from February 2024 to January 2025.
The control care team included primary care practitioners, care managers, and psychiatric consultants. Primary care practitioners prescribed psychotropic medications with psychiatric consultation. Care manager activities included patient education, engagement and self-management, shared decision-making, measurement-based care for mental health symptoms, and brief psychotherapy for mental health. The intervention had the same components as the control, with additional MOUD training and psychiatric consultation for primary care practitioners, measurement-based care for OUD, and brief psychotherapy for OUD.
Participants completed research assessments at baseline, 3 months, and 6 months. The multiple primary outcomes were past-month number of days of using opioids and the Veterans RAND 12 Mental Health Component Summary score.
A total of 254 patients (mean [SD] age, 40.9 [12.4] years; 139 women [59.9%]) participated in the trial. Most participants (172 of 212 [81.1%]) were taking MOUD at baseline. Days using opioids decreased in both the control and intervention groups. The intervention significantly reduced opioid use more than the control with a medium effect size (adjusted ratio of odds ratio, 0.10; 95% CI, 0.03-0.38; Cohen d = -0.44; P < .001). Mental Health Component Summary scores improved slightly in both the control and intervention groups. The intervention did not significantly improve scores more than control (adjusted difference in change, -1.20; 95% CI, -4.97 to 2.57; Cohen d = -0.09; P = .53).
Findings of this cluster randomized clinical trial indicate that OUD can be successfully managed in primary care with CCM, especially CCM for OUD and mental health symptoms. Primary care clinics with MOUD prescribers should consider implementing CCM for OUD and mental health.
ClinicalTrials.gov Identifier: NCT04600414.
阿片类物质使用障碍（OUD）的标准治疗方法是使用阿片类物质使用障碍药物（MOUD）。然而，接受MOUD治疗的OUD患者不到四分之一。协作护理模式（CCM）是一种循证实践，可在初级保健环境中整合心理健康和身体健康治疗。将CCM扩展至包括OUD患者可能会提高MOUD的启动率。
比较针对OUD及并发心理健康症状的CCM（干预组）与仅针对心理健康症状的CCM（积极对照组）的有效性。
设计、设置和参与者：这项2a型混合试验将24家美国初级保健诊所进行整群随机分组，分为干预组或对照组。参与者包括患有OUD和心理健康症状但未接受专科心理健康护理或专科物质使用治疗的患者。研究数据于2024年2月至2025年1月进行分析。
对照护理团队包括初级保健医生、护理经理和精神科顾问。初级保健医生在精神科会诊的情况下开具精神药物。护理经理的活动包括患者教育、参与和自我管理、共同决策、基于测量的心理健康症状护理以及心理健康简短心理治疗。干预组与对照组有相同的组成部分，另外还包括针对初级保健医生的MOUD培训和精神科会诊、基于测量的OUD护理以及OUD简短心理治疗。
参与者在基线、3个月和6个月时完成研究评估。多个主要结局指标为过去一个月使用阿片类物质的天数以及退伍军人兰德12项心理健康分量表汇总得分。
共有254名患者（平均[标准差]年龄，40.9[12.4]岁；139名女性[59.9%]）参与试验。大多数参与者（212名中的172名[81.1%]）在基线时正在接受MOUD治疗。对照组和干预组使用阿片类物质的天数均有所减少。干预组比对照组更显著地减少了阿片类物质使用，效应量中等（调整后的比值比，0.10；95%置信区间，0.03 - 0.38；科恩d = -0.44；P <.001）。对照组和干预组的心理健康分量表汇总得分均略有改善。干预组在改善得分方面没有比对照组更显著（调整后的变化差异，-1.20；95%置信区间，-4.97至2.57；科恩d = -0.09；P = 0.53）。
这项整群随机临床试验的结果表明，使用CCM可在初级保健中成功管理OUD，尤其是针对OUD和心理健康症状的CCM。有MOUD处方医生的初级保健诊所应考虑实施针对OUD和心理健康的CCM。
ClinicalTrials.gov标识符：NCT04600414。
