Measurement-Based Care for Opioid Use Disorder

(MBC2OTP Trial)

Recruiting at 4 trial locations

Overseen By Kelli Scott, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Non-English speakers, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Measurement-Based Care for Opioid Use Disorder?

Measurement-based care (MBC) is shown to be effective in improving treatment outcomes by regularly tracking patient progress and adjusting care as needed. It has been recommended as a flexible and low-cost intervention to enhance patient engagement and retention in opioid treatment programs. ^{1 2 3 4 5}

Is measurement-based care safe for treating opioid use disorder?

The research does not provide specific safety data for measurement-based care in treating opioid use disorder, but it is described as a flexible and low-cost intervention that supports clinical decision-making and treatment monitoring. ^{1 2 3 4 5}

How is the Measurement-Based Care Training and Monthly Consultation treatment different from other treatments for opioid use disorder?

This treatment is unique because it uses a systematic approach called measurement-based care (MBC) to track patient progress and adjust treatment plans based on real-time data, which can improve treatment retention and effectiveness. Unlike traditional methods, MBC provides ongoing feedback to both patients and clinicians, helping to make more informed decisions about care. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for leaders and providers in opioid treatment programs. It's designed to see if a specific approach called measurement-based care, which uses patient feedback to guide treatment, can improve attendance and opioid abstinence when implemented with proper training and consultation.

Inclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Measurement-based care is implemented in opioid treatment programs, integrating MBC assessment protocols into electronic medical records.

6 months

Regular sessions as per treatment protocol

Follow-up

Participants are monitored for treatment attendance and opioid abstinence post-implementation.

6 months

Treatment Details

Interventions

• Measurement Based Care Training and Monthly Consultation

Trial Overview The MBC2OTP Project tests the effectiveness of measurement-based care (MBC) in enhancing opioid addiction treatments. The study involves training program leaders and providers on how to implement MBC, without a comparison group but comparing outcomes before and after its implementation.

Participant Groups

Group I: Measurement Based Care Implementation Experimental Treatment 1 Intervention

All participating opioid treatment programs will receive this arm.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

A new set of measurement-based care (MBC) tools, including the TAPS tool for universal screening and the OUD Symptom Checklist for symptom tracking, has been developed to support primary care physicians in treating opioid use disorder (OUD) with buprenorphine.

These tools aim to enhance treatment capacity for OUD by providing structured guidance during the first 12 weeks of buprenorphine treatment, although further testing is needed to evaluate their feasibility and acceptability in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creation of an algorithm for clinical decision support for treatment of opioid use disorder with buprenorphine in primary care. Dela Cruz, AM., Walker, R., Pipes, R., et al.[2021]

Measurement-based care (MBC) could enhance clinical outcomes in substance use disorder (SUD) treatment by improving communication between patients and providers, as well as among clinicians, according to insights from 15 clinicians interviewed.

To increase the adoption of MBC in SUD settings, it should be designed to fit existing workflows, track clinically relevant outcomes like coping skills and motivation, and be presented as a supportive tool rather than a replacement for current practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do clinicians want? Understanding frontline addiction treatment clinicians' preferences and priorities to improve the design of measurement-based care technology. Tauscher, JS., Cohn, EB., Johnson, TR., et al.[2023]

The MBC2OTP Project aims to implement Measurement-based Care (MBC) in opioid treatment programs to improve patient engagement and retention, using a two-phase pilot study involving qualitative and quantitative data collection from 32-48 staff interviews and 64-80 surveys across eight programs.

The study will evaluate the effectiveness of MBC by analyzing patient outcomes, such as opioid abstinence and treatment engagement, through chart reviews of 160 patient records before and after MBC integration, highlighting its potential to enhance treatment for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The measurement-based care to opioid treatment programs project (MBC2OTP): a study protocol using rapid assessment procedure informed clinical ethnography. Scott, K., Guigayoma, J., Palinkas, LA., et al.[2022]

A measurement-based care (MBC) approach for opioid use disorder (OUD) can enhance treatment retention and effectiveness by tracking the 11 symptoms of OUD as defined by DSM-5, allowing for tailored medication delivery and evaluation.

Implementing MBC involves assessing patient responses to medications for opioid use disorder (like methadone and buprenorphine) at specific intervals (2 weeks, 3, 6, and 12 months), which helps in personalizing treatment and improving patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement-based care using DSM-5 for opioid use disorder: can we make opioid medication treatment more effective? Marsden, J., Tai, B., Ali, R., et al.[2021]

A review identified seven quality measures for treating opioid use disorder (OUD), all of which focus on the processes of service delivery, highlighting the need for better assessment of treatment outcomes and patient experiences.

There is a significant gap in quality measures specifically tailored for OUD, indicating that a unified framework, like an OUD Treatment Cascade, is necessary to improve care access and reduce opioid-related deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an opioid use disorder treatment cascade: A review of quality measures. Williams, AR., Nunes, EV., Bisaga, A., et al.[2022]

A focus group study with 33 clinicians revealed that systemic and attitudinal barriers still hinder the screening, diagnosis, and treatment of opioid use disorder (OUD), despite the availability of effective treatments.

Clinicians responded positively to a software-delivered measurement-based care (MBC) model, suggesting it could enhance access to OUD treatment, but emphasized the need for additional efforts to address stigma before such tools can be effectively implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stigma towards opioid use disorder in primary care remain a barrier to integrating software-based measurement based care. Dela Cruz, AM., Karns-Wright, T., Kahalnik, F., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Creation of an algorithm for clinical decision support for treatment of opioid use disorder with buprenorphine in primary care. [2021]

2. England pubmed.ncbi.nlm.nih.gov

What do clinicians want? Understanding frontline addiction treatment clinicians' preferences and priorities to improve the design of measurement-based care technology. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The measurement-based care to opioid treatment programs project (MBC2OTP): a study protocol using rapid assessment procedure informed clinical ethnography. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Measurement-based care using DSM-5 for opioid use disorder: can we make opioid medication treatment more effective? [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Developing an opioid use disorder treatment cascade: A review of quality measures. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Stigma towards opioid use disorder in primary care remain a barrier to integrating software-based measurement based care. [2023]