Measurement-Based Care for Opioid Use Disorder

Overseen By Kelli Scott, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must be taking: MOUD

Disqualifiers: Under 18, Not new MOUD, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for people with opioid use disorder by using tools that help track symptoms and facilitate discussions with healthcare providers. It will test whether these tools, known as measurement-based care, lead to better treatment outcomes compared to usual care. The trial seeks new patients at opioid treatment programs who speak English or Spanish. Participants will either use the new tools or continue with current care methods, with some switching to the new tools later. As an unphased trial, this study offers participants the opportunity to contribute to innovative care approaches that could enhance treatment outcomes for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that measurement-based care tools are safe for use in opioid treatment programs?

Research has shown that measurement-based care (MBC) is generally well-received by patients. MBC uses tools to track symptoms and help patients better understand their health. Studies have found that MBC can improve treatment results by increasing patient involvement and reducing early treatment discontinuation. Reports of negative effects from using MBC tools are absent.

The Greenspace Mental Health tools, used in this trial as part of the MBC approach, allow patients to see their symptoms and how they change over time. This involvement helps them play an active role in their treatment. Evidence does not indicate that these tools cause harm or discomfort. Overall, using MBC tools appears safe based on current data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing opioid use disorder using measurement-based care. Unlike standard treatments that rely primarily on medication and counseling, this method uses Greenspace Mental Health tools to provide personalized care through regular assessments and feedback. This approach could lead to more tailored and effective interventions by continuously adjusting treatments based on individual progress. By integrating technology and data-driven insights, researchers hope to improve outcomes for individuals struggling with opioid use disorder.

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

Research has shown that measurement-based care (MBC) tools can enhance the treatment of opioid use disorder (OUD). These tools track symptoms and engage patients more actively in their treatment. In this trial, participants may be assigned to different arms, including one that uses Measurement-Based Care with Greenspace Mental Health tools. One study found that 47% of patients using MBC remained in treatment for at least six months, compared to only 2.9% of those who did not use these tools. This suggests that MBC can lead to better outcomes, such as reduced opioid use and improved overall health. By regularly monitoring key health factors, MBC tailors treatment to each person's needs, making care more effective. ^{6 7 8 9 10}

Who Is on the Research Team?

Kelli S Scott, PhD

Principal Investigator

Northwestern University Feinberg School of Medicine

Renee Cloutier, PhD

Principal Investigator

University of Pittsburgh

Arnie Aldridge, PhD

Principal Investigator

RTI International

Are You a Good Fit for This Trial?

This trial is for adults over 18 starting Medication for Opioid Use Disorder (MOUD) at participating treatment programs. Participants must speak English or Spanish. It's not open to current MOUD patients or those who don't speak these languages.

Inclusion Criteria

I am 18 or older and starting medication-assisted treatment for opioid use as a new patient.

Exclusion Criteria

Patients who are not new MOUD patients at the OTP

I primarily speak a language other than English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of Measurement-Based Care (MBC) tools and systems in opioid treatment programs

9 months

Monthly visits

Sustainment

Sustainment of MBC implementation to assess continued use and fidelity of MBC tools

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Measurement As Usual
• Measurement-based care

Trial Overview The study tests a new approach called Measurement-Based Care (MBC) in opioid treatment programs. MBC involves using tools to track patient symptoms and outcomes, aiming to improve the quality and equity of care.

How Is the Trial Designed?

Group I: Measurement Based Care Experimental Treatment 1 Intervention

Monthly Use of Measurement-Based Care using Greenspace Mental Health tools

Group II: Measurement As Usual followed by Measurement Based Care Experimental Treatment 2 Interventions

Participation in existing processes available within treatment sites including semi structured interviews followed by monthly use of Measurement-Based Care using Greenspace Mental Health tools

Group III: Measurement As Usual Active Control 1 Intervention

Participation in existing processes available within treatment sites including semi structured interviews

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12367799/

Research agenda evaluating measurement-based care for ... MBC relies on brief, validated measures assessing clinically relevant parameters related to OUD. These parameters encompass the level of opioid use, withdrawal ...

2. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-024-00446-w

Tools to implement measurement-based care (MBC) in the ... An effectiveness-implementation trial, the measurement-based care to opioid treatment programs project (MBC2OTP), has been launched to inform ...

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

MBC2OTP - Feinberg School of Medicine Pilot Implementation of Measurement-Based Care in Community Opioid Treatment Programs ... MBC effectiveness and implementation data will be collected.

4. pew.org pew.org/en/research-and-analysis/issue-briefs/2022/10/states-should-measure-opioid-use-disorder-treatment-to-improve-outcomes

States Should Measure Opioid Use Disorder Treatment to ... Studies have shown that long-term treatment can lead to better outcomes in employment, health, and criminal justice involvement.28 In addition, ...

5. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.20220456

Performance Measurement for Opioid Use Disorder ... Among those successfully engaging in care, 47.0% remained in care for a minimum of 6 months versus 2.9% of those who did not meet measurement ...

6. greenspacehealth.com greenspacehealth.com/en-us/measurement-based-care/

A Best-In-Class Measurement-Based Care Platform Measurement-Based Care is proven to increase client engagement, reduce drop-out rates, and improve treatment outcomes.

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

Tools to implement measurement-based care (MBC) in the ... The prevalence and associated overdose death rates from opioid use disorder (OUD) have dramatically increased in the last decade.

8. greenspacehealth.com greenspacehealth.com/en-us/

Greenspace Mental Health Measurement-Based Care Solutions Our solutions allow clients, patients and people to track symptom changes and visualize their results, empowering them to better understand their mental health.

9. library.samhsa.gov library.samhsa.gov/product/financing-measurement-based-care-community-behavioral-health-settings/pep24-01-007

Financing Measurement-Based Care in Community ... Measurement based care (MBC) for behavioral health care is a clinical process that uses standardized measurements to track a client's ...

10. ictp.uw.edu ictp.uw.edu/wp-content/uploads/2024/03/UWPACC_2020_06_18_Measurement_Based_Care_Navmoon_Mann_MD.pdf

Measurement Based Care (MBC) for Substance use Disorder Based Care regarding: -Usefulness of MBC in treatment of Substance Use Disorders. -Available tools to provide MBC for Substance Use Disorders. Page 7. UW PACC.