Measurement Based Care in Opioid Treatment Programs

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Change in Patient Treatment Retention - Clinical Effectiveness Outcome [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: During the Sustainment Phase ~9 months post-Implementation]
• Fidelity of Measurement-Based Care Implementation [Срок оценки: Monthly during the 9-month MBC+/Implementation Phase]
• Adoption of Measurement-Based Care Implementation as Assessed by Patient Surveys - Measure Implementation Outcome [Срок оценки: Monthly during the 9-month MBC+/Implementation Phase]
• Adoption of Measurement-Based Care Implementation as Assessed by Greenspace Mental Health tools - Measure Implementation Outcome [Срок оценки: Monthly during the 9-month MBC+/Implementation Phase]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Pittsburgh — Pittsburgh

Публикации

• Cloutier RM, Aldridge A, Lessley A, Loveland D, Sedlock R, Scott K. The HEALing Measurement Center: a stepped wedge cluster randomized study protocol to enhance opioid use disorder recovery through measurement based care. Implement Sci. 2026 Feb 21;21(1):25. doi: 10.1186/s13012-026-01492-5. PMID 41723468

Идентификаторы

NCT: NCT06965010 · STUDY24080133 · 1RM1DA059395-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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