跳至主要内容
临床试验/NCT04059016
NCT04059016已完成不适用

NIDA CTN Protocol 0090 Innovatively Increasing PCP Prescribing of Buprenorphine: Measurement Based Care and Integrated Electronic Solution (MBC4OUD)

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
% of primary care providers completing buprenorphine waiver training

研究概览

简要总结

The objective of this observational feasibility project is to assess the feasibility and acceptability of universal screening and measurement based care for opioid use disorder (OUD) utilizing a computer software program in a network of primary care clinics currently utilizing this software for screening and measurement based care (MBC) for the treatment of depression. The primary objective of this project is to evaluate the feasibility of screening and MBC for OUD in our partner primary care clinics. The secondary objective of this project is to evaluate the acceptability of universal screening and measurement based care of OUD, including the barriers and facilitators of screening for OUD and providing buprenorphine treatment in primary care, changes in provider knowledge and beliefs regarding diagnosis and treatment of OUD, and treatment program outcomes.

详细描述

This is an observational feasibility project evaluating the impact of universal screening and enhanced access to care for patients with opioid use disorder via development and implementation of web-based software program that provides clinical decision support to primary care providers for the diagnosis and treatment of opioid use disorder (OUD) with buprenorphine. The key facets of measurement based care (MBC) for OUD will be supported by the software: (1) screening instrument used for all patients, (2) diagnostic instrument for patients who screen positive, and (3) buprenorphine treatment algorithm for those with diagnosed OUD. The MBC for OUD software will be offered to clinics in the University of Texas Southwestern Medical Center (UTSW) North Texas Community Based Primary Care Network. Clinics in the Network currently utilize VitalSign6, a software program that implements universal screening for depressive symptoms and provides electronic clinical decision support for measurement based care (MBC) for major depression. The VitalSign6 team provides training on how to clinically diagnose and manage major depression, training on the software, and expert clinical support during implementation.

Clinics in the Network will be offered the opportunity to utilize the newly developed VS6 OUD diagnosis and treatment module. Network clinics that take part in this project will be provided training in the diagnosis and management of OUD and federally-mandated training in the use of buprenorphine for OUD. The primary outcome will be the number of primary care providers trained to prescribe buprenorphine for OUD (i.e., complete waiver training). The providers and staff at clinics who choose to utilize the newly developed VS6 OUD module (i.e., MBC4OUD) will be invited to participate in a research project assessing acceptability of the diagnosis and treatment of OUD in primary care.. Focus groups will be utilized to assess stakeholder barriers to implementation of buprenorphine treatment for OUD and strategies for overcoming these barriers. Providers at clinics taking part in the project will be surveyed regarding their beliefs and comfort level with OUD diagnosis and treatment at 3 time-points: pre-training, post-training (i.e., prior to software dissemination to the clinic when the observation period begins), and at the end of the observation period. All data from providers will be collected anonymously. De-identified patient level data will be analyzed for the purpose of program evaluation.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Providers and clinical staff from UTSW clinics currently utilizing the VitalSign6 software program

排除标准

  • 未提供

结局指标

主要结局

% of primary care providers completing buprenorphine waiver training

时间窗: 3 months

The number of primary care providers who complete buprenorphine waiver training divided by the divided by the number of providers who indicate a desire/willingness to be trained will be computed.

次要结局

  • Clinic Interest Rate(3 months)
  • OUD Module Training Completion Rate(3 months)
  • Provider Buprenorphine Waiver Training Completion Rate(3 months)
  • Buprenorphine Treatment Acceptability Scale(3 months)

研究者

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

Madhukar H. Trivedi, MD

Professor

University of Texas Southwestern Medical Center

研究点 (1)

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