Innovatively Increasing PCP Prescribing of Buprenorphine: Measurement Based Care and Integrated Electronic Solution

Completed

• Conditions: Opioid Abuse and Addiction

• Registration Number: NCT04059016
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-07-16
• Study Start: 2019-08-01
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-16
• Primary Completion: 2024-05-02
• Study Completion: 2024-05-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% of primary care providers completing buprenorphine waiver training	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.

Secondary Outcome Measures

Name	Time	Method
Clinic Interest Rate	3 months	The number of Network clinics who accept the OUD module divided by the number of clinics that were approached.
OUD Module Training Completion Rate	3 months	The number of providers who complete the VS6 OUD module training divided by the number of providers who indicated desire/willingness to complete the VS6 OUD module training.
Provider Buprenorphine Waiver Training Completion Rate	3 months	The number of providers in Network clinics who complete buprenorphine waiver training divided by the number of providers who indicated desire/willingness to complete the buprenorphine waiver training.
Buprenorphine Treatment Acceptability Scale	3 months	The Buprenorphine Treatment Acceptability Scale has been created by the investigators for this study. It is a 29-item self report measure. Items 1-27 are assessed on 1-5 Likert scale, with 1=strongly disagree and 5=strongly agree. Items 28 and 29 are scored on a scale of 0-100, with higher scores indicating greater confidence. Items on the scale assess provider motivation for providing treatment for opioid use disorder, provider self-efficacy for the treatment of opioid use disorder, and challenges faced by providers in treating opioid use disorder.

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States