MBC2OTP Project (Measurement-Based Care Implementation in Community Opioid Treatment Programs)
MBC2OTP
Pilot Implementation of Measurement-Based Care in Community Opioid Treatment Programs
2 other identifiers
interventional
35
1 country
5
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness and implementation of measurement-based care, which involves the systematic use of client self-report data to inform and enhance treatment, in opioid treatment programs using a pilot hybrid effectiveness-implementation study design. The main questions this study aims to answer are: 1) is measurement based care effective for improving patient treatment attendance and opioid abstinence, and 2) can measurement based care be implemented with fidelity in opioid treatment programs? Participants in this study will be opioid treatment program leaders and treatment providers. Leaders and treatment providers will participate in measurement-based care implementation strategies such as training and consultation to help them use measurement-based care with their patients. There is no comparison group for this study, however researchers will compare effectiveness outcomes prior to and post measurement-based care implementation and will evaluate changes in measurement-based care use with fidelity post implementation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2024
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2024
CompletedFirst Posted
Study publicly available on registry
April 3, 2024
CompletedStudy Start
First participant enrolled
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2026
CompletedApril 27, 2026
April 1, 2026
2 years
March 21, 2024
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Patient treatment attendance (effectiveness outcome)
Treatment attendance will include both completion of medication for opioid use disorder (MOUD) dosing visits and attendance at treatment sessions. Data to be extracted from opioid treatment program electronic medical records include the number of treatment sessions/visits attended for each patient (e.g., MOUD dosing visits and individual/group counseling appointments) and the total number of treatment visits scheduled for each patient.
Assessed for 6 months for each patient both pre and post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Patient treatment attendance (effectiveness outcome)
Treatment attendance will include both completion of medication for opioid use disorder (MOUD) dosing visits and attendance at treatment sessions. Data to be extracted from opioid treatment program electronic medical records include the the total number of weeks each patient was retained in treatment after an initial intake appointment.
Assessed for 6 months for each patient both pre and post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Treatment provider measurement based care exposure (implementation outcome)
The total number of monthly completed counseling or treatment sessions delivered by treatment providers will be extracted from the opioid treatment program electronic medical record. The research team will compute monthly MBC exposure values by dividing the total number of sessions with MBC administration documentation by the total number of sessions completed for each patient.
Assessed for 6 months for each patient post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Secondary Outcomes (2)
Patient opioid abstinence (effectiveness outcome)
Assessed for 6 months for each patient both pre and post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Treatment provider measurement based care fidelity (implementation outcome)
Assessed for 6 months for each patient post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Study Arms (1)
Measurement Based Care Implementation
EXPERIMENTALAll participating opioid treatment programs will receive this arm.
Interventions
Participating opioid treatment program leaders and treatment providers will receive two measurement-based care implementation strategies: 1) didactic training including a total of four hours of workshop training led by a measurement-based care expert, and 2) monthly consultation calls led by a measurement-based care expert for 6 months.
Eligibility Criteria
You may qualify if:
- Provide supervision or oversight to treatment providers or provide administrative oversight at the OTP
- Conduct supervision or oversight primarily in English
- Are considered a treatment provider at the OTP providing direct patient care
- Conduct treatment primarily in English
You may not qualify if:
- Must be a new patient at the opioid treatment program in the 6 months pre or post measurement-based care implementation
- Younger than 18 years of age
- Does not have electronic medical records
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (5)
Family Guidance Centers, Inc.
Aurora, Illinois, 60505, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Family Guidance Centers, Inc.
Chicago, Illinois, 60654, United States
Family Guidance Centers, Inc.
Des Plaines, Illinois, 60016, United States
Family Guidance Centers, Inc.
Joliet, Illinois, 60435, United States
Related Publications (1)
Scott K, Guigayoma J, Palinkas LA, Beaudoin FL, Clark MA, Becker SJ. The measurement-based care to opioid treatment programs project (MBC2OTP): a study protocol using rapid assessment procedure informed clinical ethnography. Addict Sci Clin Pract. 2022 Aug 19;17(1):44. doi: 10.1186/s13722-022-00327-0.
PMID: 35986380BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 21, 2024
First Posted
April 3, 2024
Study Start
April 24, 2024
Primary Completion
April 14, 2026
Study Completion
April 14, 2026
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Study Protocol was published in 2022 in the Addiction Science and Clinical Practice Journal. Analytic code and participant-level data will be made ready for distribution within 12 months of study completion.
- Access Criteria
- Data will only be shared with external investigators when a data use agreement (DUA) is executed between Northwestern University and the requester's institution. The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project, and schedule for data destruction.
The study protocol and statistical analysis plan for this study was published in 2022 in the Addiction Science and Clinical Practice journal (https://doi.org/10.1186/s13722-022-00327-0). Additional data (analytic code, participant-level data) can be requested from the Principal Investigator. Analysis files will be constructed from the electronic data and will be stripped of identifying information. Specifically, participants will be identified with a numeric identifier that is not related to any element of their personal identifying information. No names, addresses, telephone numbers, email addresses, medical record numbers, etc. will be retained in the de-identified files.