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临床试验/NCT05310786
NCT05310786已完成不适用

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

Trustees of Dartmouth College8 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2022年8月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
8
主要终点
Stages of Implementation Completion (SIC) Tool

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.
  • 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

研究组 & 干预措施

Site Staff

Other

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

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

Patients

Other

Subset of patients receiving PrIMO care to receive survey assessments

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

结局指标

主要结局

Stages of Implementation Completion (SIC) Tool

时间窗: Up to 100 weeks

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

次要结局

  • 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)
  • Beliefs on MOUD Modified(3 months pre-model launch through 12 months post-model launch)
  • Implementation Citizenship Behavior Scale(3 months pre-model launch through 12 months post-model launch)
  • Electronic health record data(Model launch through up to 18 months post-launch)
  • Applied Mental Health Research Dissemination & Implementation (AMHR) Tool(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)
  • Qualitative interviews(3 months pre-model launch through 12 months post-model launch)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa A. Marsch

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

Trustees of Dartmouth College

研究点 (8)

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