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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether patient feedback can enhance treatment for opioid use disorder. The aim is to determine if this approach encourages patients to attend sessions more consistently and remain opioid-free. The trial focuses on training program leaders and providers in a new method called Measurement-Based Care Training and Monthly Consultation. This method suits leaders and providers at opioid treatment programs who primarily work in English and seek to improve patient care. As an unphased trial, it offers patients a unique opportunity to contribute to innovative care improvements.

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 prior data suggests that this measurement-based care is safe for opioid treatment programs?

Research has shown that measurement-based care (MBC) is a new method being tested in opioid treatment programs. Although specific data on MBC's safety in these settings is limited, MBC generally uses patient-reported information to guide and improve treatment. This method has been applied in other healthcare areas without major safety concerns.

The trial is labeled "Not Applicable" in terms of phase, indicating that MBC is not a drug or device with typical risks. Instead, it serves as a strategy to enhance communication between patients and healthcare providers. MBC itself poses no known direct safety risks, as it primarily involves training and consultation for healthcare providers.

In summary, while specific safety data for MBC in opioid treatment is not yet widely available, the approach is considered safe because it does not involve changing medications or direct physical interventions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Measurement Based Care for opioid use disorder because it offers a new approach by focusing on personalized treatment plans. Unlike traditional methods that often rely on a one-size-fits-all strategy, this approach involves ongoing assessments and tailored adjustments to treatment, ensuring that each patient receives the most effective care for their specific needs. By integrating regular measurements and feedback into the care process, this method aims to enhance treatment outcomes and provide more responsive and effective support for those battling opioid addiction.

What evidence suggests that measurement-based care is effective for opioid use disorder?

Research shows that measurement-based care (MBC) can help people with opioid use disorder recover more effectively. Studies have found that MBC works by regularly checking patients' progress and adjusting their treatment as needed. This method has been linked to better attendance at treatment sessions and higher rates of staying off opioids. In this trial, all participating opioid treatment programs will implement MBC. Early results suggest that when treatment providers receive training and ongoing support in MBC, they can successfully use it in opioid treatment programs. This approach may offer patients more personalized care that directly meets their needs, potentially leading to better recovery outcomes. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10902994/

Tools to implement measurement-based care (MBC) in the ... The opioid use disorder core outcomes set (OUD-COS) for treatment research: findings from a Delphi consensus study. Addiction. 2022;117(9): ...

2. feinberg.northwestern.edu feinberg.northwestern.edu/sites/cdis/research/mbc2otp.html

MBC2OTP - Feinberg School of Medicine Treatment providers will also receive MBC training and ongoing support, and preliminary MBC effectiveness and implementation data will be collected. Results ...

3. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-022-00327-0

The measurement-based care to opioid treatment programs ... This study is among the first to take forward recommendations to implement and evaluate MBC in opioid treatment programs.

4. withpower.com withpower.com/trial/phase-opioid-use-disorder-oud-3-2024-67ac5

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 ...

5. trial.medpath.com trial.medpath.com/clinical-trial/5589a0b93da192b8/nct06965010-hybrid-clinical-effectiveness-opioid-treatment

Measurement Based Care in Opioid Treatment Programs This data will be collected over the course of the study to evaluate the effectiveness of MBC in improving patient care and treatment outcomes. Detailed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9389829/

The measurement-based care to opioid treatment ... This study is among the first to take forward recommendations to implement and evaluate MBC in opioid treatment programs.

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/76/NCT05122676/Prot_003.pdf

PATIENT-CENTERED TEAM-BASED PRIMARY CARE TO ... primary care-based collaborative care (CC) model can increase opioid use disorder. (OUD) treatment and improve depression outcomes among ...

8. cce.upmc.com cce.upmc.com/content/measurement-based-care-mbc-opioid-treatment-programs-session-1-10825

Measurement-Based Care (MBC) in Opioid Treatment ... This training session will serve as a first step in addressing these barriers and enhancing OTP implementation of MBC by enhancing treatment provider ...