BACKGROUND: Pharmacists remain an underutilized resource in the treatment of opioid use disorder (OUD). Although studies have engaged pharmacists in dispensing medications for OUD (MOUD), few studies have evaluated collaborative care models in which pharmacists are an active, integrated part of a primary care team offering OUD care. METHODS: This study seeks to implement a pharmacist integrated MOUD clinical model (called PrIMO) and evaluate its feasibility, acceptability, and impact across four diverse primary care sites. The Consolidated Framework for Implementation Research is used as an organizing framework for study development and interpretation of findings. Implementation Facilitation is used to support PrIMO adoption. We assess the primary outcome, the feasibility of implementing PrIMO, using the Stages of Implementation Completion (SIC). We evaluate the acceptability and impact of the PrIMO model at the sites using mixed-methods and combine survey and interview data from providers, pharmacists, pharmacy technicians, administrators, and patients receiving MOUD at the primary care sites with patient electronic health record data. We hypothesize that it is feasible to launch delivery of the PrIMO model (reach SIC Stage 6), and that it is acceptable, will positively impact patient outcomes 1 year post model launch (e.g., increased MOUD treatment retention, medication regimen adherence, service utilization for co-morbid conditions, and decreased substance use), and will increase each site's capacity to care for patients with MOUD (e.g., increased number of patients, number of prescribers, and rate of patients per prescriber). DISCUSSION: This study will provide data on a pharmacist-integrated collaborative model of care for the treatment of OUD that may be feasible, acceptable to both site staff and patients and may favorably impact patients' access to MOUD and treatment outcomes. TRIAL REGISTRATION: The study was registered on Clinicaltrials.gov (NCT05310786) on April 5, 2022, https://www.clinicaltrials.gov/study/NCT05310786?id=NCT05310786&rank=1
AD - Northeast Node, NIDA Drug Abuse Treatment Clinical Trials Network, Hanover, NH, USA. Bethany.m.mcleman@dartmouth.edu.; Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA. Bethany.m.mcleman@dartmouth.edu.; Northeast Node, NIDA Drug Abuse Treatment Clinical Trials Network, Hanover, NH, USA.; Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA.; FQHC 340B Compliance, Lebanon, TN, USA.; University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.; Lighthouse Institute, Chestnut Health Systems, Eugene, OR, USA.; University of Utah, Salt Lake City, UT, USA.; Greater Intermountain Node, NIDA Drug Abuse Treatment Clinical Trials Network, Salt Lake City, UT, USA.; The Emmes Company, LLC, Rockville, MD, USA.; Community Health Care, Tacoma, WA, USA.; University of Utah College of Pharmacy, Salt Lake City, UT, USA.; University of New Mexico School of Medicine, Albuquerque, NM, USA.; Harbor Care Health & Wellness, Nashua, NH, USA.; National Institute on Drug Abuse, North Bethesda, MD, USA.; New England Consortium Node, NIDA Drug Abuse Treatment Clinical Trials Network, New Haven, CT, USA.; Program in Addiction Medicine, Department of Medicine, Yale School of Medicine, New Haven, CT, USA. AN - 38500166 BT - Addict Sci Clin Pract C5 - Opioids & Substance Use; Education & Workforce CP - 1 DA - Mar 18 DO - 10.1186/s13722-024-00452-y DP - NLM ET - 20240318 IS - 1 JF - Addict Sci Clin Pract LA - eng N2 -BACKGROUND: Pharmacists remain an underutilized resource in the treatment of opioid use disorder (OUD). Although studies have engaged pharmacists in dispensing medications for OUD (MOUD), few studies have evaluated collaborative care models in which pharmacists are an active, integrated part of a primary care team offering OUD care. METHODS: This study seeks to implement a pharmacist integrated MOUD clinical model (called PrIMO) and evaluate its feasibility, acceptability, and impact across four diverse primary care sites. The Consolidated Framework for Implementation Research is used as an organizing framework for study development and interpretation of findings. Implementation Facilitation is used to support PrIMO adoption. We assess the primary outcome, the feasibility of implementing PrIMO, using the Stages of Implementation Completion (SIC). We evaluate the acceptability and impact of the PrIMO model at the sites using mixed-methods and combine survey and interview data from providers, pharmacists, pharmacy technicians, administrators, and patients receiving MOUD at the primary care sites with patient electronic health record data. We hypothesize that it is feasible to launch delivery of the PrIMO model (reach SIC Stage 6), and that it is acceptable, will positively impact patient outcomes 1 year post model launch (e.g., increased MOUD treatment retention, medication regimen adherence, service utilization for co-morbid conditions, and decreased substance use), and will increase each site's capacity to care for patients with MOUD (e.g., increased number of patients, number of prescribers, and rate of patients per prescriber). DISCUSSION: This study will provide data on a pharmacist-integrated collaborative model of care for the treatment of OUD that may be feasible, acceptable to both site staff and patients and may favorably impact patients' access to MOUD and treatment outcomes. TRIAL REGISTRATION: The study was registered on Clinicaltrials.gov (NCT05310786) on April 5, 2022, https://www.clinicaltrials.gov/study/NCT05310786?id=NCT05310786&rank=1
PY - 2024 SN - 1940-0632 (Print); 1940-0632 SP - 18 ST - Implementing a pharmacist-integrated collaborative model of medication treatment for opioid use disorder in primary care: study design and methodological considerations T1 - Implementing a pharmacist-integrated collaborative model of medication treatment for opioid use disorder in primary care: study design and methodological considerations T2 - Addict Sci Clin Pract TI - Implementing a pharmacist-integrated collaborative model of medication treatment for opioid use disorder in primary care: study design and methodological considerations U1 - Opioids & Substance Use; Education & Workforce U3 - 10.1186/s13722-024-00452-y VL - 19 VO - 1940-0632 (Print); 1940-0632 Y1 - 2024 ER -