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

NCT05310786 | Completed DMC

• 1 other identifier: CTN-0116
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 4

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.

Conditions

Opioid Use Disorder; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Stages of Implementation Completion (SIC) Tool

  The SIC is a date-driven measure of implementation milestones spanning activities from the Pre-implementation through Competency stages of implementation.

  Up to 100 weeks

Secondary Outcomes (8)

• Applied Mental Health Research Dissemination & Implementation (AMHR) Tool

  3 months pre-model launch through 12 months post-model launch

• Clinical Sustainability Assessment Tool for PrIMO

  3 months pre-model launch through 12 months post-model launch

• Medical Conditions Regard Scale

  3 months pre-model launch through 12 months post-model launch

• Substance Use Stigma Mechanism Scale

  3 months pre-model launch through 12 months post-model launch

• Beliefs on MOUD Modified

  3 months pre-model launch through 12 months post-model launch

Study Arms (2)

Site Staff

OTHER

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

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

Patients

OTHER

Subset of patients receiving PrIMO care to receive survey assessments

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

Interventions

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

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

Patients; Site Staff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trustees of Dartmouth College: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

Harbor Health Care

Nashua, New Hampshire, 03062, United States

Location

UNM Truman Health Services

Albuquerque, New Mexico, 87102, United States

Location

Sugar House Health Center

Salt Lake City, Utah, 84106, United States

Location

Community Health Care

Tacoma, Washington, 98404, United States

Location

Related Publications (1)

• 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.

  PMID: 38500166 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lisa A Marsch, PhD

  Geisel School of Medicine at Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Technology and Behavioral Health; Andrew G. Wallace Professor of Psychiatry

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 5, 2022
• Study Start: August 18, 2022
• Primary Completion: August 31, 2024
• Study Completion: February 5, 2025
• Last Updated: February 25, 2025

Record last verified: 2024-10

Locations

US (4)