Clinical trial NCT06965010: Measurement Based Care in Opioid Treatment Programs
Official title: Hybrid Clinical Effectiveness Trial Type II of Measurement Based Care in Opioid Treatment Programs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-05-11
Enrollment: 3650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Patient Treatment Retention - Clinical Effectiveness Outcome
timeFrame: Continuous following new MOUD patient intake events during the 9-month periods prior to and during MBC+/Implementation Phase in an OTP
measure: Change in Patient's Perceived Recovery - Clinical Effectiveness Outcome
timeFrame: Monthly during the 9-month MBC+/Implementation Phase, sub-group of OTP sites during 9-month period pre-MBC+/Implementation Phase
measure: Change in Patient Quality of Life - Clinical Effectiveness Outcome
timeFrame: 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
measure: Sustainment of Measurement-Based Care Implementation
timeFrame: During the Sustainment Phase ~9 months post-Implementation
measure: Fidelity of Measurement-Based Care Implementation
timeFrame: Monthly during the 9-month MBC+/Implementation Phase
measure: Adoption of Measurement-Based Care Implementation as Assessed by Patient Surveys - Measure Implementation Outcome
timeFrame: Monthly during the 9-month MBC+/Implementation Phase
measure: Adoption of Measurement-Based Care Implementation as Assessed by Greenspace Mental Health tools - Measure Implementation Outcome
timeFrame: Monthly during the 9-month MBC+/Implementation Phase
Secondary outcomes:
Other outcomes:
measure: Net costs to Medicaid and cost-effectiveness
timeFrame: 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
Locations:
city: Pittsburgh
country: United States
facility: The University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Renee Cloutier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University Feinberg School of Medicine
name: Kelli S Scott, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: Arnie Aldridge, PhD
role: PRINCIPAL_INVESTIGATOR
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