Measurement Based Care in Opioid Treatment Programs

University of Pittsburgh

Status: Invitation-only

Conditions: Opioid Use Disorder

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06965010

1RM1DA059395-01 (U.S. NIH Grant/Contract)

STUDY24080133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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3,650 participants in 3 patient groups

Measurement Based Care

Experimental group

Description:

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

Treatment:

Behavioral: Measurement-based care

Measurement As Usual followed by Measurement Based Care

Experimental group

Description:

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

Treatment:

Behavioral: Measurement-based care

Behavioral: Measurement As Usual

Measurement As Usual

Active Comparator group

Description:

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

Treatment:

Behavioral: Measurement As Usual