MBC2OTP Project (Measurement-Based Care Implementation in Community Opioid Treatment Programs) (NCT06345274) | Clinical Trial Compass
CompletedNot Applicable
MBC2OTP Project (Measurement-Based Care Implementation in Community Opioid Treatment Programs)
United States35 participantsStarted 2024-04-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (Opioid Treatment Program Leaders):
* Provide supervision or oversight to treatment providers or provide administrative oversight at the OTP
* Conduct supervision or oversight primarily in English
Inclusion Criteria (Opioid Treatment Program Providers):
* Are considered a treatment provider at the OTP providing direct patient care
* Conduct treatment primarily in English
Exclusion Criteria (Opioid Treatment Program Leaders and Providers):
* Exclusion criteria are minimal to enhance generalizability and enable participation of all leaders and treatment providers overseeing or delivering care at each opioid treatment program. Providers and leaders will be excluded if they do not conduct treatment in English, as the measurement-based care assessment tool is written in the English language.
Inclusion Criteria (Persons receiving treatment at Opioid Treatment Programs \[Not recruited, via electronic medical records only\]):
* Must be a new patient at the opioid treatment program in the 6 months pre or post measurement-based care implementation
Exclusion Criteria (Persons receiving treatment at Opioid Treatment Programs \[Not recruited, via electronic medical records only\]):
* Younger than 18 years of age
* Does not have electronic medical records
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Timeframe: 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.
Timeframe: 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.
3
Treatment provider measurement based care exposure (implementation outcome)
Timeframe: Assessed for 6 months for each patient post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.