Measurement Based Care in Opioid Treatment Programs

NCT06965010 | Enrolling By Invitation DMC

• 2 other identifiers: STUDY240801331RM1DA059395-01
• Study Type: interventional
• Target: 3,650
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (7)

• Change in Patient Treatment Retention - Clinical Effectiveness Outcome

  Change in Patient Treatment Retention: clinic-level outcome measure that tracks the duration of OUD treatment based on medications, counseling and related services, as recorded in the claims data. Specific measures are the (1) % of patients still in treatment 6 months after initiating MOUD and (2) the average number of months new MOUD patients remain in treatment (12-month follow-up window).

  Continuous following new MOUD patient intake events during the 9-month periods prior to and during MBC+/Implementation Phase in an OTP

• Change in Patient's Perceived Recovery - Clinical Effectiveness Outcome

  Change in Patient Recovery: patient-level outcome measure that evaluates progress in patient recovery obtained from survey data. The Brief Addiction Monitoring assessment question will be administered monthly to monitor substance use.

  Monthly during the 9-month MBC+/Implementation Phase, sub-group of OTP sites during 9-month period pre-MBC+/Implementation Phase

• Change in Patient Quality of Life - Clinical Effectiveness Outcome

  Change in Patient Quality of Life: patient-level outcome measure that evaluates progress in patient quality of life. The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Instrument will be administered at baseline and at every 3 months to evaluate and monitor physical, mental, and social health via The Greenspace Mental Health tool.

  At baseline and every 3 months during the 9-month MBC+/Implementation Phase, sub-group of OTP sites during 9-month period pre-MBC+/Implementation Phase

• Sustainment of Measurement-Based Care Implementation

  The sustainment of MBC implementation is defined as the extent to which providers continue to use MBC tools with fidelity following the removal of active implementation support, based on data sourced from Greenspace and/or provider surveys. Each treatment session will continue to receive a score of "1" for documentation of MBC data collection, a "2" for documented data sharing, and a "3" for documented action informed by data. Sessions without MBC documentation will receive a "0." Sustainability is assessed by examining whether fidelity to core MBC components is maintained over time. Potential metrics include: Percentage of sessions with completed MBC assessments during Sustainment Percentage of sessions where MBC results were reviewed with patients during Sustainment Percentage of sessions with documented action taken during Sustainment Percentage of providers meeting a predefined threshold for sustained fidelity (e.g., 80% of sessions scoring ≥2) during Sustainment

  During the Sustainment Phase ~9 months post-Implementation

• Fidelity of Measurement-Based Care Implementation

  The Fidelity of MBC Implementation is defined as the extent to which providers administer and use MBC tools as intended based on data sourced from Greenspace and/or provider surveys during the Implementation Phase. MBC fidelity will be a single outcome measure that ranges from 0-3. Each treatment session will receive a "1" for documentation of MBC data collection, a "2" for documented data sharing, and a "3" for documented action informed by data. All attended appointments without MBC documentation will receive a "0." Potential metrics include: Percentage of sessions with completed MBC assessments Percentage of sessions where MBC results were reviewed with patients Percentage of sessions with documented action taken

  Monthly during the 9-month MBC+/Implementation Phase

• Adoption of Measurement-Based Care Implementation as Assessed by Patient Surveys - Measure Implementation Outcome

  The adoption of MBC implementation will be assessed based on the percentage of OTP treatment providers who use MBC during and after active implementation. Adoption will be measured using patient surveys during the Implementation Phase.

  Monthly during the 9-month MBC+/Implementation Phase

• Adoption of Measurement-Based Care Implementation as Assessed by Greenspace Mental Health tools - Measure Implementation Outcome

  The adoption of MBC implementation will be assessed based on the percentage of OTP treatment providers who use MBC during and after active implementation. Adoption will be measured using Greenspace Mental Health tools during the Implementation Phase.

  Monthly during the 9-month MBC+/Implementation Phase

Other Outcomes (1)

• Net costs to Medicaid and cost-effectiveness

  From the beginning of 36 Month stepped wedge trial timeline and 9-month MBC+/Implementation Phase through the completion of the 6-month Sustainability Phase

Study Arms (3)

Measurement Based Care

EXPERIMENTAL

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

Behavioral: Measurement-based care

Measurement As Usual followed by Measurement Based Care

EXPERIMENTAL

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

Behavioral: Measurement-based care; Behavioral: Measurement As Usual

Measurement As Usual

ACTIVE COMPARATOR

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

Behavioral: Measurement As Usual

Interventions

Measurement-based care 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; Measurement Based Care

Measurement As Usual 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; Measurement As Usual followed by Measurement Based Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OTP patients will be eligible to participate if they:
• are adults (aged 18 years or older);
• are initiating MOUD at the OTP, as a new patient (as defined by OTP guidelines); and
• speak primarily English or Spanish.

You may not qualify if:

• OTP patients will be excluded from participation if they:
• are under the age of 18;
• are not a new MOUD patient at the OTP
• do not speak primarily English or Spanish.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Renee Cloutier, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Kelli S Scott, PhD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

• Arnie Aldridge, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 11, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Raw data will be deposited to NAHDAP throughout the study as it is received. Cleaned analytic data files will be deposited to NAHDAP within 12 months of receiving the final assessment for the final participant.
• Access Criteria: Authorized research personnel who are trained in the ethical conduct of research (e.g., Collaborative Institutional Training Initiative, National Institutes of Health tutorials) will have access to the research laboratory and participant data.

Locations

US (1)