Opioid Abuse and AddictionMBC4OUDNCT04059016
Innovatively Increasing PCP Prescribing of Buprenorphine: Measurement Based Care and Integrated Electronic Solution
An observational study of Opioid Abuse and Addiction, run by University of Texas Southwestern Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Abuse and Addiction
- What is being tested?
- MBC4OUD
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 2 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Providers and clinical staff from UTSW clinics currently utilizing the VitalSign6 software program
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
About this study
Official title: NIDA CTN Protocol 0090 Innovatively Increasing PCP Prescribing of Buprenorphine: Measurement Based Care and Integrated Electronic Solution (MBC4OUD)
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.
Read the 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.
- Conditions
- Opioid Abuse and Addiction
- Being tested
- MBC4OUD
- Keywords
- opioid use disorder, buprenorphine waiver training, VitalSign6, measurement based care, primary care
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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.
Measured: 3 months
Secondary outcomes (4)
Clinic Interest Rate
The number of Network clinics who accept the OUD module divided by the number of clinics that were approached.
Measured: 3 months
Provider Buprenorphine Waiver Training Completion Rate
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.
Measured: 3 months
OUD Module Training Completion Rate
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.
Measured: 3 months
Buprenorphine Treatment Acceptability Scale
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start1 Aug 2019
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid Abuse and AddictionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
- Investigators
- Madhukar H Trivedi, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059016
- Sponsor's protocol ID
- STU-2019-0743
- Other IDs
- UG1DA020024
- Acronym
- MBC4OUD
- Status last verified
- Jun 2024
- First submitted
- 16 Jul 2019
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37875835Dela 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.
PubMed 33608060
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIDA CTN Protocol 0090 Innovatively Increasing PCP Prescribing of Buprenorphine: Measurement Based Care and Integrated Electronic Solution (MBC4OUD)
- ClinicalTrials.gov ID
- NCT04059016
- Acronym / sponsor ID
- MBC4OUD / STU-2019-0743
- Conditions
- Opioid Abuse and Addiction
- Keywords
- opioid use disorder, buprenorphine waiver training, VitalSign6, measurement based care, primary care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Providers and clinical staff from UTSW clinics currently utilizing the VitalSign6 software program
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBC4OUDThis 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. | Other | – |
Primary outcome
% 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.
4 secondary outcomes
Clinic Interest Rate
Time frame: 3 months
Provider Buprenorphine Waiver Training Completion Rate
Time frame: 3 months
OUD Module Training Completion Rate
Time frame: 3 months
Buprenorphine Treatment Acceptability Scale
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Derived from this study: PubMed 37875835Dela 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.
- Derived from this study: PubMed 33608060Dela 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhukar H Trivedi, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Abuse and Addiction, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of primary care providers completing buprenorphine waiver training (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04059016, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.