PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment

Addiction Science & Clinical Practice

Julia Arnsten¹  Jeffrey H. Samet²  Colleen T. LaBelle²  Andrew J. Saxon³  Zoe M. Weinstein⁴  Angela L. Stotts⁵  Jordan M. Braciszewski⁶  José Szapocznik⁷  Jane M. Liebschutz⁸  Andrea Altschuler⁹  Cynthia I. Campbell⁹  Robert P. Schwartz^1,10  Bobbi Jo H. Yarborough^1,11  Joseph E. Glass^1,12  Jennifer F. Bobb^1,12  Katharine A. Bradley^1,12  Denise M. Boudreau^1,12  Megan Addis^1,12  Amy K. Lee^1,12  Paige D. Wartko^1,12  Gwen T. Lapham^1,12  Ryan M. Caldeiro^1,13  Douglas T. Borst^1,14  Jennifer McNeely^1,15  David S. Liu^1,16  Abigail G. Matthews^1,17  Jennifer McCormack^1,17  Gavin Bart^1,18  Judith I. Tsui^1,19  Joseph O. Merrill^1,19  Sean M. Murphy^2,20 

[1] Albert Einstein College of Medicine, Montefiore Medical Center, 3300 Kossuth Avenue, 10467, Bronx, NY, USA;Boston Medical Center/Boston University School of Medicine: Clinical Addiction Research & Education (CARE) Unit Crosstown Center, 801 Massachusetts Ave., 2nd Floor, 02118, Boston, MA, USA;Center of Excellence in Substance Addiction Treatment and Education, VA Puget Sound Health Care System, 1660 S Columbian Way, 98108, Seattle, WA, USA;Clinical Addiction Research & Education (CARE) Unit, Boston University School of Medicine, Crosstown Center, 801 Massachusetts Ave., 2nd Floor, 02118, Boston, MA, USA;Department of Family & Community Medicine, McGovern Medical School, University of Texas Health Science Center at Houston School, 7000 Fannin Street, 77030, Houston, TX, USA;Department of Psychiatry, Center for Health Policy and Health Services Research, Henry Ford Health System, 2799 W Grand Blvd, 48202, Detroit, MI, USA;Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, 10th Floor, 33136, Miami, FL, USA;Division of General Internal Medicine, Center for Research On Health Care, University of Pittsburgh School of Medicine, 200 Lothrop Street, 933West, 15213, Pittsburgh, PA, USA;Division of Research, Kaiser Permanente Northern California, 2000 Broadway, 3rd Floor, 94612, Oakland, CA, USA;Friends Research Institute, 1040 Park Avenue, Suite 103, 21201, Baltimore, MD, USA;Kaiser Permanente Northwest, Center for Health Research, 3800 N. Interstate Avenue, 97227-1098, Portland, OR, USA;Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, 98101, Seattle, WA, USA;Kaiser Permanente Washington, 9800 4th Ave. N.E., 98115, Seattle, WA, USA;Kootenai Clinic Family Medicine, 1919 Lincoln Way, Suite 315, 83814, Coeur d Alene, ID, USA;NYU Grossman School of Medicine, 180 Madison Ave., 10016, New York, NY, USA;National Institute on Drug Abuse Center for Clinical Trials Network, Three White Flint North, 11601 Landsdown Street, 20852, North Bethesda, MD, USA;The Emmes Company, 401 N Washington St # 700, 20850, Rockville, MD, USA;University of Minnesota/Hennepin Healthcare, 701 Park Avenue, 55415, Minneapolis, MN, USA;University of Washington/Harborview Medical Center, 325 9th Ave, 98104, Seattle, WA, USA;Weill Cornell Medical College, 425 East 61st Street, Suite 301, 10065, New York, NY, USA;

关键词: Medication;    Buprenorphine;    Opioid use disorder;    Primary care;    Nurse care manager;    Collaborative care;    Pragmatic trial;   

DOI  :  10.1186/s13722-021-00218-w

来源: Springer

【 摘 要 】

BackgroundMost people with opioid use disorder (OUD) never receive treatment. Medication treatment of OUD in primary care is recommended as an approach to increase access to care. The PRimary Care Opioid Use Disorders treatment (PROUD) trial tests whether implementation of a collaborative care model (Massachusetts Model) using a nurse care manager (NCM) to support medication treatment of OUD in primary care increases OUD treatment and improves outcomes. Specifically, it tests whether implementation of collaborative care, compared to usual primary care, increases the number of days of medication for OUD (implementation objective) and reduces acute health care utilization (effectiveness objective). The protocol for the PROUD trial is presented here.MethodsPROUD is a hybrid type III cluster-randomized implementation trial in six health care systems. The intervention consists of three implementation strategies: salary for a full-time NCM, training and technical assistance for the NCM, and requiring that three primary care providers have DEA waivers to prescribe buprenorphine. Within each health system, two primary care clinics are randomized: one to the intervention and one to Usual Primary Care. The sample includes all patients age 16–90 who visited the randomized primary care clinics from 3 years before to 2 years after randomization (anticipated to be > 170,000). Quantitative data are derived from existing health system administrative data, electronic medical records, and/or health insurance claims (“electronic health records,” [EHRs]). Anonymous staff surveys, stakeholder debriefs, and observations from site visits, trainings and technical assistance provide qualitative data to assess barriers and facilitators to implementation. The outcome for the implementation objective (primary outcome) is a clinic-level measure of the number of patient days of medication treatment of OUD over the 2 years post-randomization. The patient-level outcome for the effectiveness objective (secondary outcome) is days of acute care utilization [e.g. urgent care, emergency department (ED) and/or hospitalizations] over 2 years post-randomization among patients with documented OUD prior to randomization.DiscussionThe PROUD trial provides information for clinical leaders and policy makers regarding potential benefits for patients and health systems of a collaborative care model for management of OUD in primary care, tested in real-world diverse primary care settings.Trial registration # NCT03407638 (February 28, 2018); CTN-0074 https://clinicaltrials.gov/ct2/show/NCT03407638?term=CTN-0074&draw=2&rank=1

【 授权许可】

CC BY