Clinical trial NCT04059016: Innovatively Increasing PCP Prescribing of Buprenorphine: Measurement Based Care and Integrated Electronic Solution
Official title: NIDA CTN Protocol 0090 Innovatively Increasing PCP Prescribing of Buprenorphine: Measurement Based Care and Integrated Electronic Solution (MBC4OUD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Abuse and Addiction
Keywords: opioid use disorder
buprenorphine waiver training
VitalSign6
measurement based care
primary care
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-08-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Providers and clinical staff from clinics in the University of Texas Southwestern Medical Center (UTSW) North Texas Community Based Primary Care Network that 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: % of primary care providers completing buprenorphine waiver training
timeFrame: 3 months
Secondary outcomes:
measure: Clinic Interest Rate
timeFrame: 3 months
measure: Provider Buprenorphine Waiver Training Completion Rate
timeFrame: 3 months
measure: OUD Module Training Completion Rate
timeFrame: 3 months
measure: Buprenorphine Treatment Acceptability Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Madhukar H Trivedi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dela Cruz AM, Walker R, Pipes R, Wakhlu S, Trivedi MH. Creation of an algorithm for clinical decision support for treatment of opioid use disorder with buprenorphine in primary care. Addict Sci Clin Pract. 2021 Feb 19;16(1):12. doi: 10.1186/s13722-021-00222-0.