Hybrid Clinical Effectiveness Trial Type II of Measurement Based Care in Opioid Treatment Programs
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 3,650
- 试验地点
- 2
- 主要终点
- Change in Patient Treatment Retention - Clinical Effectiveness Outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Measurement Based Care
Monthly Use of Measurement-Based Care using Greenspace Mental Health tools
干预措施: Measurement-based care (Behavioral)
Measurement As Usual followed by Measurement Based Care
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
干预措施: Measurement-based care (Behavioral)
Measurement As Usual followed by Measurement Based Care
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
干预措施: Measurement As Usual (Behavioral)
Measurement As Usual
Participation in existing processes available within treatment sites including semi structured interviews
干预措施: Measurement As Usual (Behavioral)
结局指标
主要结局
Change in Patient Treatment Retention - Clinical Effectiveness Outcome
时间窗: 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 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).
Change in Patient's Perceived Recovery - Clinical Effectiveness Outcome
时间窗: Monthly during the 9-month MBC+/Implementation Phase, sub-group of OTP sites during 9-month period pre-MBC+/Implementation Phase
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.
Change in Patient Quality of Life - Clinical Effectiveness Outcome
时间窗: 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
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.
Sustainment of Measurement-Based Care Implementation
时间窗: During the Sustainment Phase ~9 months post-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
Fidelity of Measurement-Based Care Implementation
时间窗: Monthly during the 9-month MBC+/Implementation Phase
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
Adoption of Measurement-Based Care Implementation as Assessed by Patient Surveys - Measure Implementation Outcome
时间窗: Monthly during the 9-month MBC+/Implementation Phase
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.
Adoption of Measurement-Based Care Implementation as Assessed by Greenspace Mental Health tools - Measure Implementation Outcome
时间窗: Monthly during the 9-month MBC+/Implementation Phase
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.
次要结局
未报告次要终点
研究者
Renee Cloutier
Assistant Professor of Medicine
University of Pittsburgh