NCT04059016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

4.8 years

First QC Date

July 16, 2019

Last Update Submit

June 17, 2024

Conditions

Opioid Abuse and Addiction

Keywords

opioid use disorderbuprenorphine waiver trainingVitalSign6measurement based careprimary care

Outcome Measures

Primary Outcomes (1)

  • % of primary care providers completing buprenorphine waiver training

    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.

    3 months

Secondary Outcomes (4)

  • Clinic Interest Rate

    3 months

  • Provider Buprenorphine Waiver Training Completion Rate

    3 months

  • OUD Module Training Completion Rate

    3 months

  • Buprenorphine Treatment Acceptability Scale

    3 months

Interventions

MBC4OUDOTHER

This computer software program consists of patient-completed self reports for screening and diagnosis of opioid use disorder among primary care patients and provides web-based clinical decision support to primary care providers for provision of pharmacotherapy for opioid use disorder.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (2)

  • Dela Cruz AM, Karns-Wright T, Kahalnik F, Walker R, Lanham HJ, Potter JS, Trivedi MH. Stigma towards opioid use disorder in primary care remain a barrier to integrating software-based measurement based care. BMC Psychiatry. 2023 Oct 24;23(1):776. doi: 10.1186/s12888-023-05267-w.

    PMID: 37875835DERIVED

  • 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.

    PMID: 33608060DERIVED

MeSH Terms

Conditions

Opioid-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Madhukar H Trivedi, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2019

First Posted

August 16, 2019

Study Start

August 1, 2019

Primary Completion

May 2, 2024

Study Completion

May 2, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Data will be transmitted to the NIDA central data repository as requested by NIDA. The data management team will conduct final data quality assurance checks and "lock" the database from further modification. The final analysis dataset will be returned to NIDA, as requested, for storage and archive.

Shared Documents
STUDY PROTOCOL

Locations

US(1)