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

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ClinicalTrials.gov Identifier: NCT04059016
Recruitment Status : Active, not recruiting
First Posted : August 16, 2019
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Madhukar H. Trivedi, MD, 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.

Condition or disease Intervention/treatment
Opioid Abuse and Addiction Other: MBC4OUD

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Other
Official Title: NIDA CTN Protocol 0090 Innovatively Increasing PCP Prescribing of Buprenorphine: Measurement Based Care and Integrated Electronic Solution (MBC4OUD)
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: MBC4OUD
    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.


Primary Outcome Measures :
  1. % of primary care providers completing buprenorphine waiver training [ Time Frame: 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 :
  1. Clinic Interest Rate [ Time Frame: 3 months ]
    The number of Network clinics who accept the OUD module divided by the number of clinics that were approached.

  2. Provider Buprenorphine Waiver Training Completion Rate [ Time Frame: 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.

  3. OUD Module Training Completion Rate [ Time Frame: 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.

  4. Buprenorphine Treatment Acceptability Scale [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059016


Locations
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United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Madhukar H Trivedi, MD UT Southwestern Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Madhukar H. Trivedi, MD, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04059016    
Other Study ID Numbers: STU-2019-0743
UG1DA020024 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center:
opioid use disorder
buprenorphine waiver training
VitalSign6
measurement based care
primary care
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders