Measurement Based Care in Opioid Treatment Programs

NCT ID: NCT06965010

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

3650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2028-08-31

Brief Summary

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The goal of this HEAL Initiative study is to enhance the measurement, quality, and equity of care delivered in 20 community opioid treatment programs (OTPs) by creating and using measurement-based care (MBC) tools and systems. Patients will use MBC tools to track their symptoms and discuss with their providers. 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 Description

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Opioid use disorder (OUD) remains a critical public health crisis in Pennsylvania. Measurement-based care (MBC) is the systematic use of client self-report data to inform treatment and is an evidence-based intervention that is uniquely well suited to complement opioid use disorder (OUD) pharmacotherapy that occurs within opioid treatment programs (OTPs). The study aims to enhance the measurement, quality, and equity of care delivered in 20 community OTPs by co-designing and implementing MBC tools and systems. Using a Hybrid Implementation Effectiveness Type II trial with a stepped-wedge design, MBC implementation (e.g., fidelity) and clinical (e.g., patient retention, improved quality of life) effectiveness will be evaluated simultaneously with quantitative and qualitative data. This study aims to provide: (1) preliminary evidence regarding the role and significance of capitalizing on MBC in opioid use disorder (OUD) treatments (including evidence on potential mechanisms underlying MBC's effects); (2) enhanced adoption of MBC via implementation strategies that are co-designed with stakeholders (policymaker, payer, and OTP); and (3) alternative avenues to potentially enhance symptom-related outcomes and treatment retention of OUD interventions with downstream societal, psychological, and public health benefits.

Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This study is a hybrid implementation effectiveness type II trial with a stepped wedge design. Each cohort of OTP sites (\~5 sites per cohort; 4 cohorts or 20 OTP sites total) will begin in the Measurement as Usual condition (MAU) and then cross over to a 9-month MBC+ Implementation Phase followed by a Sustainability Phase to monitor ongoing MBC implementation. Individual participant may experience one or the other or both interventions
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Measurement Based Care

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

Group Type EXPERIMENTAL

Measurement-based care

Intervention Type BEHAVIORAL

Patients will complete MBC measures with their treatment provider and follow-up surveys conducted at baseline and monthly intervals. Both providers and patients will use the Greenspace Mental Health tools to regularly assess patient-reported symptoms, review results together, and collaboratively design individualized treatment plans. Providers will implement MBC to guide treatment adjustments based on these assessments.

Measurement As Usual followed by Measurement Based Care

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 Type EXPERIMENTAL

Measurement-based care

Intervention Type BEHAVIORAL

Patients will complete MBC measures with their treatment provider and follow-up surveys conducted at baseline and monthly intervals. Both providers and patients will use the Greenspace Mental Health tools to regularly assess patient-reported symptoms, review results together, and collaboratively design individualized treatment plans. Providers will implement MBC to guide treatment adjustments based on these assessments.

Measurement As Usual

Intervention Type BEHAVIORAL

Patients will participate in Measurement As Usual (MAU) via the existing processes available within treatment sites. Currently, patients are assessed and participate in semi-structured interviews at 6-month increments to assess progress and appropriateness of level of care.

Measurement As Usual

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

Group Type ACTIVE_COMPARATOR

Measurement As Usual

Intervention Type BEHAVIORAL

Patients will participate in Measurement As Usual (MAU) via the existing processes available within treatment sites. Currently, patients are assessed and participate in semi-structured interviews at 6-month increments to assess progress and appropriateness of level of care.

Interventions

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Measurement-based care

Patients will complete MBC measures with their treatment provider and follow-up surveys conducted at baseline and monthly intervals. Both providers and patients will use the Greenspace Mental Health tools to regularly assess patient-reported symptoms, review results together, and collaboratively design individualized treatment plans. Providers will implement MBC to guide treatment adjustments based on these assessments.

Intervention Type BEHAVIORAL

Measurement As Usual

Patients will participate in Measurement As Usual (MAU) via the existing processes available within treatment sites. Currently, patients are assessed and participate in semi-structured interviews at 6-month increments to assess progress and appropriateness of level of care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

OTP patients will be eligible to participate if they:

1. are adults (aged 18 years or older);
2. are initiating MOUD at the OTP, as a new patient (as defined by OTP guidelines); and
3. speak primarily English or Spanish.

Exclusion Criteria

OTP patients will be excluded from participation if they:

1. are under the age of 18;
2. are not a new MOUD patient at the OTP
3. do not speak primarily English or Spanish.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Renee Cloutier

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Renee Cloutier, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Kelli S Scott, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Arnie Aldridge, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

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The University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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1RM1DA059395-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY24080133

Identifier Type: -

Identifier Source: org_study_id