Clinical trial NCT05310786: Implementing a Pharmacist-Integrated Collaborative Model of Medication Treatment for Opioid Use Disorder
Official title: Implementing a Pharmacist-Integrated Collaborative Model of Medication Treatment for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Substance Use Disorders
Lead sponsor: Trustees of Dartmouth College
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-04-05
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stages of Implementation Completion (SIC) Tool
timeFrame: Up to 100 weeks
Secondary outcomes:
measure: Applied Mental Health Research Dissemination & Implementation (AMHR) Tool
timeFrame: 3 months pre-model launch through 12 months post-model launch
measure: Clinical Sustainability Assessment Tool for PrIMO
timeFrame: 3 months pre-model launch through 12 months post-model launch
measure: Medical Conditions Regard Scale
timeFrame: 3 months pre-model launch through 12 months post-model launch
measure: Substance Use Stigma Mechanism Scale
timeFrame: 3 months pre-model launch through 12 months post-model launch
measure: Beliefs on MOUD Modified
timeFrame: 3 months pre-model launch through 12 months post-model launch
measure: Implementation Citizenship Behavior Scale
timeFrame: 3 months pre-model launch through 12 months post-model launch
measure: Qualitative interviews
timeFrame: 3 months pre-model launch through 12 months post-model launch
measure: Electronic health record data
timeFrame: Model launch through up to 18 months post-launch
Other outcomes:
Locations:
city: Nashua
country: United States
facility: Harbor Health Care
state: New Hampshire
city: Albuquerque
country: United States
facility: UNM Truman Health Services
state: New Mexico
city: Salt Lake City
country: United States
facility: Sugar House Health Center
state: Utah
city: Tacoma
country: United States
facility: Community Health Care
state: Washington
Study officials:
affiliation: Geisel School of Medicine at Dartmouth College
name: Lisa A Marsch, PhD
role: PRINCIPAL_INVESTIGATOR
References: