The PRimary Care Opioid Use Disorders Treatment (PROUD) Trial
Recommended Citation
Wartko P, Matthews A, Bobb J, Boudreau D, McCormack J, Qiu D, Yu O, Hyun N, Lee A, Campbell C, Saxon A, Liu D, Altschuler A, Samet J, Stotts A, Braciszewski J, Murphy M, Arnsten J, Horigian V, Szapocznik J, Glass J, Caldeiro R, Phillips R, Shea M, Bradley K. The PRimary Care Opioid Use Disorders Treatment (PROUD) Trial. Drug Alcohol Depend 2024; 260:110550.
Document Type
Conference Proceeding
Publication Date
7-1-2024
Publication Title
Drug Alcohol Depend
Abstract
Aim: Despite expert recommendations to treat OUD in primary care (PC), few PC practices do so. The PRimary Care Opioid Use Disorders treatment (PROUD) trial was a cluster-randomized, hybrid type III implementation trial that tested whether implementation of the Massachusetts Model of nurse care management for OUD in PC increased OUD treatment in 6 diverse health systems. Methods: Two PC clinics in each system were randomized to intervention or usual care. Data were obtained from electronic health records and insurance claims. Participants included patients visiting intervention or usual care clinics from up to 3 years before randomization, through 2 years after. The intervention included: salary for full-time OUD nurse care managers; training and technical assistance for nurses; and ≥3 PC providers waivered to prescribe buprenorphine. The main outcome was patient-years of OUD treatment (buprenorphine or extended-release naltrexone) per 10,000 PC patients during follow-up (up to 2 years post-randomization). Intent-to-treat clinic-level analyses compared intervention and usual care clinics in a mixed-effect model adjusted for baseline values of the outcome. An implementation monitoring team collected qualitative data. Results: The mean number of patients in intervention and usual care clinics were 18,485 and 22,557, respectively. Intervention clinics provided 8.2 more patient-years of OUD treatment per 10,000 PC patients post-randomization compared with usual care clinics (p=0.002). Most of the benefit accrued to patients new to PC clinics or newly treated for OUD post-randomization, and the main outcome varied widely across systems. Qualitative data indicated keys to successful implementation included: broad commitment to treat OUD in PC from health system leaders and PC teams, full financial coverage for OUD treatment, and structures that connected patients easily with nurses. Conclusions: The PROUD intervention significantly increased PC OUD treatment, albeit unevenly across health systems and largely in patients new to the clinics or newly treated for OUD. Financial Support: Research reported in this publication was supported by the National Institute On Drug Abuse of the National Institutes of Health under Award Numbers: Health Systems Node (UG1 DA040314), Pacific Northwest Node (UG1 DA013714), New England Consortium Node (UG1 DA015831), Big South-West Node (UG1 DA020024), New York Node (UG1 DA013035), Florida Node Alliance (UG1 DA013720), Northstar Node (UG1 DA040316), Mid-Atlantic Node (UG1 DA013034), Appalachian Node (UG1 DA049436), and The Emmes Company (HHSN271201400028C/75N95019D00013). The NIDA Center for Clinical Trials Network contributed to the design of the study, the protocol, and to the editing of the abstract. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Volume
260
First Page
110550
