TY - JOUR AU - P. D. Wartko AU - J. F. Bobb AU - D. M. Boudreau AU - A. G. Matthews AU - J. McCormack AU - A. K. Lee AU - H. Qiu AU - O. Yu AU - N. Hyun AU - A. E. Idu AU - C. I. Campbell AU - A. J. Saxon AU - D. S. Liu AU - A. Altschuler AU - J. H. Samet AU - C. T. LaBelle AU - M. Zare-Mehrjerdi AU - A. L. Stotts AU - J. M. Braciszewski AU - M. T. Murphy AU - D. Dryden AU - J. H. Arnsten AU - C. O. Cunningham AU - V. E. Horigian AU - J. Szapocznik AU - J. E. Glass AU - R. M. Caldeiro AU - R. C. Phillips AU - M. Shea AU - G. Bart AU - R. P. Schwartz AU - J. McNeely AU - J. M. Liebschutz AU - J. I. Tsui AU - J. O. Merrill AU - G. T. Lapham AU - M. Addis AU - K. A. Bradley AU - M. M. Ghiroli AU - L. K. Hamilton AU - Y. Hu AU - J. S. LaHue AU - A. M. Loree AU - S. M. Murphy AU - T. F. Northrup AU - D. Shmueli-Blumberg AU - A. J. Silva AU - Z. M. Weinstein AU - M. T. Wong AU - R. P. Burganowski A1 - AB - 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. AD - Kaiser Permanente Washington Health Research Institute, Seattle.; Department of Biostatistics, School of Public Health, University of Washington, Seattle.; Now with Genentech Inc, South San Francisco, California.; The Emmes Company, Rockville, Maryland.; Now with Kaiser Permanente Washington, Renton.; Now with Department of Epidemiology and Biostatistics, Michigan State University, East Lansing.; Division of Research, Kaiser Permanente Northern California, Oakland.; Department of Psychiatry and Behavioral Sciences, University of California, San Francisco.; Center of Excellence in Substance Addiction Treatment and Education, VA Puget Sound Health Care System, Seattle, Washington.; National Institute on Drug Abuse Center for Clinical Trials Network, North Bethesda, Maryland.; Boston University Schools of Medicine and Public Health, Boston Medical Center, Boston, Massachusetts.; Department of Family and Community Medicine, UTHealth Houston McGovern Medical School, Houston, Texas.; Center for Health Policy and Health Services Research, Henry Ford Health, Detroit, Michigan.; MultiCare Health System, Tacoma, Washington.; Now with Mosaic Medical, Bend, Oregon.; Montefiore Medical Center, Bronx, New York.; Albert Einstein College of Medicine, Bronx, New York.; Now with New York State Office of Addiction Services and Supports, New York.; Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.; Mental Health and Wellness Department, Kaiser Permanente Washington, Renton.; Department of Medicine, Hennepin Healthcare, Minneapolis, Minnesota.; University of Minnesota Medical School, Minneapolis.; Friends Research Institute, Baltimore, Maryland.; Department of Population Health, Grossman School of Medicine, New York University, New York.; Center for Research on Health Care, Division of General Internal Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.; Division of General Internal Medicine, Department of Medicine, University of Washington School of Medicine, Seattle.; Department of Health Systems and Population Health, School of Public Health, University of Washington, Seattle.; Kaiser Permanente Bernard J Tyson School of Medicine, Pasadena, California.; Harris Health System, Bellaire, Texas.; Department of Population Health Sciences, Weill Cornell Medicine, New York, New York. AN - 37902748 BT - JAMA Intern Med C5 - Opioids & Substance Use CP - 12 DA - Dec 1 DO - 10.1001/jamainternmed.2023.5701 DP - NLM IS - 12 JF - JAMA Intern Med LA - eng N2 - 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. PY - 2023 SN - 2168-6106 (Print); 2168-6106 SP - 1343 EP - 1354+ ST - Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial T1 - Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial T2 - JAMA Intern Med TI - Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial U1 - Opioids & Substance Use U3 - 10.1001/jamainternmed.2023.5701 VL - 183 VO - 2168-6106 (Print); 2168-6106 Y1 - 2023 ER -