Implementing a Pharmacist-Integrated Collaborative Model of Medication Treatment for Opioid Use Disorder

NCT ID: NCT05310786

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-18
• Study Completion Date: 2025-02-05

Brief Summary

This project will provide novel empirical information about how to optimally engage pharmacists and pharmacies as key partners in collaborative integrated care models designed to expand access to evidence-based medication treatment for OUD which may inform a larger experimental design that seeks to evaluate best ways to scale-up this model across the nation. This Phase 1 project seeks to evaluate the feasibility, acceptability, and impact of implementing a pharmacist-integrated model of MOUD into approximately four diverse outpatient clinical sites.

Detailed Description

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, integral part of a primary care team offering OUD care. In this Phase 1 project, the investigative team seeks to implement a Pharmacist-Integrated Medication Treatment for OUD (PrIMO) clinical model and will evaluate its feasibility and acceptability as well as its impact on clinical sites' capacity for MOUD care and on patient outcomes in OUD care.

This project will provide novel empirical information about how to optimally engage pharmacists and pharmacies as key partners in collaborative integrated care models designed to expand access to evidence-based medication treatment for OUD which may inform a larger experimental design that seeks to evaluate best ways to scale-up this model across the nation.

The PrIMO model is standard of care at a federally qualified health center in Maine and is based on the primary care pharmacist role utilized at health clinics around the US and internationally. This study will explore the implementation of this model at diverse clinics.

This Phase 1 project seeks to leverage the PrIMO model to:

Aim 1: Employ a mixed-methods approach to evaluate the feasibility of implementing a pharmacist-integrated model of MOUD into approximately four diverse outpatient clinical sites.

Aim 2: Evaluate the acceptability and impact of implementing the pharmacist-integrated model.

Primary Outcome Measure: The Stages of Implementation Completion (SIC) is a measure of implementation process and milestones. The SIC is the overarching measure used to assess progress towards successful implementation (i.e., extent to which each collaborating clinical site implements and sustains the numerous key activities within the PrIMO model).

Secondary Outcome Measures: The study's secondary outcomes are to explore the acceptability and impact of the PrIMO model. To assess acceptability, the study will utilize the Applied Mental Health Research Dissemination and Implementation (AMHR) tool, Clinical Sustainability Assessment Tool (CSAT), Medical Conditions Regard Scale, Substance Use Stigma Mechanism Scale, Beliefs on MOUD Survey, Implementation Citizenship Behavior Scale, PrIMO Fidelity Checklist, Cost of Implementing New Strategies (COINS) tool, and qualitative interviews. To assess impact, the study will explore treatment outcomes and capacity for MOUD via electronic health record (EHR) data extraction at each site.

The study will engage approximately four clinical outpatient sites. At each site, the study team will enroll participants in two subgroups: (1) site staff (including providers [may include MD, DO, PA, NP, nurse, behavioral health clinician, and/or social worker pending site variation], pharmacists, pharmacy technicians, administrators [may include CEO, CFO, CMO, medical assistants, front desk staff, clinic and/or team manager pending site variation]) and (2) patients.

Site Staff (range per site) Providers n=5-20 Pharmacists n=2-6 Pharmacy Technicians n=2-10 Administrators n=2-10

Patients (per site) n=12-40

Consented and enrolled participants will be 18 years or older, not considered prisoners at enrollment, and either employed by (site staff) or receiving MOUD (patients) from the site clinic implementing the PrIMO model.

Feasibility (Phase 1) Approximately four sites in the United States representing diverse patient populations (e.g., gender, race, ethnicity, geography) and at least one clinic-based pharmacist, at least one X-waivered primary care provider already providing MOUD treatment and a retail pharmacy (optimally employed by the clinic organization and/or co-located with the clinic) will be selected. The pharmacy and clinic staff must have shared access to each other's EHR systems, and sites must agree to provide clinic and pharmacy EHR data to the study team.

As the PrIMO model is considered standard of care in the originating clinic and is based on the national recognition of the role pharmacists play in collaboration with primary care, this is not a study evaluating an experimental intervention. And there is no experimental manipulation in this study. It is a study of the feasibility of implementing the PrIMO model of care in a diverse array of clinical sites.

As this is a minimal risk study examining the implementation of a standard of care clinical model, there will be no safety monitoring, and safety reporting will be limited to patient participant deaths.

Statistical methods will be largely descriptive, as this study is not testing a formal hypothesis. As a longitudinal mixed methods implementation feasibility study, analyses will include quantitative and qualitative analyses at the site, site staff, and patient levels. Analyses at the site level will be purely descriptive in nature and precision estimates for key secondary outcomes at the staff, provider and patient level will be conducted.

Data collection will begin approximately 3 months prior to sites launching the PrIMO model and will continue through 12-months post-launch. Patient participants will be enrolled beginning at implementation launch (after at least a 2-week exposure period to the PrIMO model) and will be asked to participate for 6 months' time, allowing for approximately 6 months of patient enrollment at each site (depending on actual date of launch). These timelines should ensure 15 months for collection of study outcome measures.

EHR data will be collected from each site for up to 12 months pre-launch and 12 months post-launch.

Site Staff participants will engage at approximately 3 months pre-launch, launch, and 3, 6, 9, and 12-months post-launch, totaling 15 months of study participation for those engaged throughout the full period.

Recruitment of patient participants will begin at launch. Patients will be enrolled after at least 2 weeks' exposure to the PrIMO model (whether new or existing prior to launch) and will follow-up at 3- and 6-months post-baseline, totaling up to 6 months of study participation.

Conditions

Opioid Use Disorder; Substance Use Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Site Staff

Providers, Pharmacists, Pharmacy Technicians, Administrators to receive survey assessments

Group Type: OTHER

Pharmacist-integrated Medication Treatment for Opioid Use Disorder (PrIMO)

Intervention Type: OTHER

This is not a true intervention, but rather a clinical model of care established at an FQHC in Maine.

Patients

Subset of patients receiving PrIMO care to receive survey assessments

Group Type: OTHER

Pharmacist-integrated Medication Treatment for Opioid Use Disorder (PrIMO)

Intervention Type: OTHER

This is not a true intervention, but rather a clinical model of care established at an FQHC in Maine.

Interventions

Pharmacist-integrated Medication Treatment for Opioid Use Disorder (PrIMO)

This is not a true intervention, but rather a clinical model of care established at an FQHC in Maine.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Site Staff

• 18 years of age and older.
• Employed at the clinic as an identified stakeholder role (provider, pharmacist, pharmacy technician, or administrator).

Patients

• 18 years of age or older.
• A patient of the participating clinic who is receiving or has received MOUD from a provider employed by the clinic.
• Exposed to the PrIMO model at the clinic site for at least 14 days.

Exclusion Criteria

Site Staff

• Unwilling or unable to provide consent
• Are currently in jail, prison, or other overnight facility as required by court of law; or have pending legal action that could prevent participation in study activities.

Patients

• Not able to speak English sufficiently to understand study procedures and provide written informed consent.
• Unable or unwilling to provide consent or to participate in study procedures.
• Are currently in jail, prison, or other overnight facility as required by court of law; or have pending legal action that could prevent participation in study activities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Trustees of Dartmouth College

OTHER

Sponsor Role: lead

Responsible Party

Lisa A. Marsch

Director, Center for Technology and Behavioral Health; Andrew G. Wallace Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa A Marsch, PhD

Role: PRINCIPAL_INVESTIGATOR

Geisel School of Medicine at Dartmouth College

Locations

Harbor Health Care

Nashua, New Hampshire, United States

UNM Truman Health Services

Albuquerque, New Mexico, United States

Sugar House Health Center

Salt Lake City, Utah, United States

Community Health Care

Tacoma, Washington, United States

Countries

United States

References

McLeman B, Gauthier P, Lester LS, Homsted F, Gardner V 3rd, Moore SK, Joudrey PJ, Saldana L, Cochran G, Harris JP, Hefner K, Chongsi E, Kramer K, Vena A, Ottesen RA, Gallant T, Boggis JS, Rao D, Page M, Cox N, Iandiorio M, Ambaah E, Ghitza U, Fiellin DA, Marsch LA. Implementing a pharmacist-integrated collaborative model of medication treatment for opioid use disorder in primary care: study design and methodological considerations. Addict Sci Clin Pract. 2024 Mar 18;19(1):18. doi: 10.1186/s13722-024-00452-y.

Reference Type: DERIVED

PMID: 38500166 (View on PubMed)

Other Identifiers

CTN-0116

Identifier Type: -

Identifier Source: org_study_id