Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04059016 |
| Other study ID # |
STU-2019-0743 |
| Secondary ID |
UG1DA020024 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2019 |
| Est. completion date |
May 2, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
