NCT06965010

Measurement Based Care in Opioid Treatment Programs

Hybrid Clinical Effectiveness Trial Type II of Measurement Based Care in Opioid Treatment Programs

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,650 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Opioid Use Disorder

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-11-01
• Completion: 2028-08-31
• First posted: 2025-05-11
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States