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. 2023 Dec 1;183(12):1343-1354.
doi: 10.1001/jamainternmed.2023.5701.

Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial

Paige D Wartko  1 , Jennifer F Bobb  1   2 , Denise M Boudreau  1   3 , Abigail G Matthews  4 , Jennifer McCormack  4 , Amy K Lee  1   5 , Hongxiang Qiu  1   6 , Onchee Yu  1 , Noorie Hyun  1 , Abisola E Idu  1 , Cynthia I Campbell  7   8 , Andrew J Saxon  9 , David S Liu  10 , Andrea Altschuler  7 , Jeffrey H Samet  11 , Colleen T Labelle  11 , Mohammad Zare-Mehrjerdi  12 , Angela L Stotts  12 , Jordan M Braciszewski  13 , Mark T Murphy  14 , Douglas Dryden  14   15 , Julia H Arnsten  16   17 , Chinazo O Cunningham  17   18 , Viviana E Horigian  19 , José Szapocznik  19 , Joseph E Glass  1 , Ryan M Caldeiro  20 , Rebecca C Phillips  1 , Mary Shea  1 , Gavin Bart  21   22 , Robert P Schwartz  23 , Jennifer McNeely  24 , Jane M Liebschutz  25 , Judith I Tsui  26 , Joseph O Merrill  26 , Gwen T Lapham  1   27 , Megan Addis  1 , Katharine A Bradley  1   26   28 ; PROUD Trial Collaborators; Megan M Ghiroli  16   17 , Leah K Hamilton  1 , Yong Hu  13 , Jennifer S LaHue  29 , Amy M Loree  13 , Sean M Murphy  30 , Thomas F Northrup  12 , Dikla Shmueli-Blumberg  4 , Angela J Silva  14 , Zoe M Weinstein  11 , Mark TinFook Wong  29 , Rachael P Burganowski  1
Affiliations

Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial

Paige D Wartko et al. JAMA Intern Med. .

Abstract

Importance: Few primary care (PC) practices treat patients with medications for opioid use disorder (OUD) despite availability of effective treatments.

Objective: To assess whether implementation of the Massachusetts model of nurse care management for OUD in PC increases OUD treatment with buprenorphine or extended-release injectable naltrexone and secondarily decreases acute care utilization.

Design, setting, and participants: The Primary Care Opioid Use Disorders Treatment (PROUD) trial was a mixed-methods, implementation-effectiveness cluster randomized clinical trial conducted in 6 diverse health systems across 5 US states (New York, Florida, Michigan, Texas, and Washington). Two PC clinics in each system were randomized to intervention or usual care (UC) stratified by system (5 systems were notified on February 28, 2018, and 1 system with delayed data use agreement on August 31, 2018). Data were obtained from electronic health records and insurance claims. An implementation monitoring team collected qualitative data. Primary care patients were included if they were 16 to 90 years old and visited a participating clinic from up to 3 years before a system's randomization date through 2 years after.

Intervention: The PROUD intervention included 3 components: (1) salary for a full-time OUD nurse care manager; (2) training and technical assistance for nurse care managers; and (3) 3 or more PC clinicians agreeing to prescribe buprenorphine.

Main outcomes and measures: The primary outcome was a clinic-level measure of patient-years of OUD treatment (buprenorphine or extended-release injectable naltrexone) per 10 000 PC patients during the 2 years postrandomization (follow-up). The secondary outcome, among patients with OUD prerandomization, was a patient-level measure of the number of days of acute care utilization during follow-up.

Results: During the baseline period, a total of 130 623 patients were seen in intervention clinics (mean [SD] age, 48.6 [17.7] years; 59.7% female), and 159 459 patients were seen in UC clinics (mean [SD] age, 47.2 [17.5] years; 63.0% female). Intervention clinics provided 8.2 (95% CI, 5.4-∞) more patient-years of OUD treatment per 10 000 PC patients compared with UC clinics (P = .002). Most of the benefit accrued in 2 health systems and in patients new to clinics (5.8 [95% CI, 1.3-∞] more patient-years) or newly treated for OUD postrandomization (8.3 [95% CI, 4.3-∞] more patient-years). Qualitative data indicated that keys to successful implementation included broad commitment to treat OUD in PC from system leaders and PC teams, full financial coverage for OUD treatment, and straightforward pathways for patients to access nurse care managers. Acute care utilization did not differ between intervention and UC clinics (relative rate, 1.16; 95% CI, 0.47-2.92; P = .70).

Conclusions and relevance: The PROUD cluster randomized clinical trial intervention meaningfully increased PC OUD treatment, albeit unevenly across health systems; however, it did not decrease acute care utilization among patients with OUD.

Trial registration: ClinicalTrials.gov Identifier: NCT03407638.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Wartko reported grants from Syneos Health to conduct US Food and Drug Administration–mandated research from a consortium of pharmaceutical companies that manufacture long-acting opioids through a contract between Syneos Health and Kaiser Permanente Washington and grants from GlaxoSmithKline to study medications unrelated to the current work, both outside the submitted work. Dr Boudreau reported employment with Genentech Inc outside the submitted work. Dr Matthews reported salary from The Emmes Company, which was contracted with the National Institute on Drug Abuse to provide contract research services during the conduct of the study. Ms McCormack reported contract support from the National Institute on Drug Abuse during the conduct of the study. Ms Yu reported grants from Bayer outside the submitted work. Dr Campbell reported grants from the Opioid Post-Marketing Requirement Consortium, companies working together to conduct postmarketing studies required by the US Food and Drug Administration that assess risks related to opioid analgesic use; the US Food and Drug Administration; and the National Institute on Alcohol Abuse and Alcoholism outside the submitted work. Dr Saxon reported grants from the University of Washington during the conduct of the study. Dr M. Murphy reported personal fees from Indivior outside the submitted work. Dr Horigian reported grants from the National Institute on Drug Abuse outside the submitted work. Dr Glass reported in-kind support from Pear Therapeutics during a quality improvement pilot study conducted in the Kaiser Permanente Washington health care delivery system outside the submitted work. Dr Schwartz reported in-kind medication from Indivior for a National Institute on Drug Abuse–funded research study outside the submitted work. Dr Liebschutz reported personal fees from Biomotivate Inc outside the submitted work. Dr S. Murphy reported personal fees from Indivior outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Overview of Study Samples and Outcomes
Prerandomization samples include patients seen in intervention or usual care clinics prerandomization. Postrandomization samples include patients seen in intervention or usual care clinics postrandomization. OUD indicates opioid use disorder; PC, primary care; PROUD, Primary Care Opioid Use Disorders Treatment trial. aOutcomes could be measured anywhere in the health system.
Figure 2.
Figure 2.. Cumulative Number of Patients Treated for Opioid Use Disorder (OUD) During the 2 Years Postrandomization in Each Health System, Unadjusted for Baseline
The vertical dotted line in each panel represents when the nurse at each health system started seeing patients, and the vertical dashed line in each panel represents when the intervention was augmented. Health system 1 was notified of the clinics’ random assignment on August 31, 2018, and all other health systems were notified on February 28, 2018.
See this image and copyright information in PMC

Comment in

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