Dynamic Treatment Regimes for Personalized Opioid Use Disorder Care
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- CAT-SUD severity scores
研究概览
简要总结
This study aims to develop and evaluate dynamic treatment regimes (DTRs) to improve personalized care for individuals with opioid use disorder (OUD). Using machine learning methods and longitudinal data from a national behavioral health provider, the investigators will identify optimal treatment sequences that minimize the risk of overdose and improve recovery outcomes. A pilot hybrid factorial SMART trial will be conducted to assess the feasibility and acceptability of implementing these personalized treatment decision rules in real-world clinical settings.
详细描述
This project supports the development and testing of dynamic treatment regimes (DTRs) for individuals with opioid use disorder (OUD), leveraging clinical and behavioral data from Discovery Behavioral Health and linked administrative records. In the first phase, multiple machine learning approaches (e.g., Q-learning, causal forests) will be used to estimate and validate DTRs that recommend tailored sequences of care based on patient characteristics and treatment response. The DTRs will be evaluated based on their ability to reduce fatal and non-fatal opioid overdose risk and hospital-based service use.
In the second phase, the investigators will conduct a pilot hybrid factorial Sequential Multiple Assignment Randomized Trial (SMART) to test the feasibility and acceptability of implementing the highest-performing DTR in a clinical setting. This pilot study will assess recruitment and retention, adherence to assigned treatment paths, and the practicality of integrating the DTR into routine care. The findings will inform a future full-scale trial aimed at improving personalized care for OUD and outcomes.
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
盲法说明
This is an open-label trial; no participants, providers, or investigators are masked to treatment assignment.
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
- •Age 18 or older
- •Diagnosed with opioid use disorder (OUD)
- •Receiving care at a participating Discovery Behavioral Health site
- •Able to provide informed consent
排除标准
- •Significant cognitive impairment or psychiatric instability that would prevent participation
- •Current incarceration or involuntary commitment
研究组 & 干预措施
Initial Intervention A + B
Participants randomized to receive the combination of Intervention A and Intervention B in Week 1. Additional weekly interventions in Weeks 2-4 will be assigned based on participant response and dynamic treatment algorithms derived in Aim 1.
干预措施: Medication for opioid use disorder (Drug)
Initial Intervention A + B
Participants randomized to receive the combination of Intervention A and Intervention B in Week 1. Additional weekly interventions in Weeks 2-4 will be assigned based on participant response and dynamic treatment algorithms derived in Aim 1.
干预措施: psychotherapy (Behavioral)
Initial Intervention A + D
Participants randomized to receive the combination of Intervention A and Intervention D in Week 1. Subsequent treatment assignments in Weeks 2-4 follow adaptive treatment decision rules.
干预措施: Medication for opioid use disorder (Drug)
Initial Intervention A + D
Participants randomized to receive the combination of Intervention A and Intervention D in Week 1. Subsequent treatment assignments in Weeks 2-4 follow adaptive treatment decision rules.
干预措施: psychotherapy (Behavioral)
Initial Intervention C + B
Participants randomized to receive the combination of Intervention C and Intervention B in Week 1. Adaptive treatment components are added weekly based on observed outcomes and predictive models.
干预措施: psychotherapy (Behavioral)
Initial Intervention C + D
Participants randomized to receive the combination of Intervention C and Intervention D in Week 1. Participants receive additional interventions in Weeks 2-4 based on dynamic treatment regimes developed in the modeling phase.
干预措施: psychotherapy (Behavioral)
结局指标
主要结局
CAT-SUD severity scores
时间窗: 4 weeks
Weekly Computerized Adaptive Test for Substance Use Disorder severity T-score. Scores range 0-100 (≈5-point precision). Higher scores indicate a greater SUD symptom burden/risk, while lower scores indicate fewer symptoms/lower risk. Prior validation studies have used \<50 = low, 50-70 = intermediate, \>70 = high severity/risk thresholds. Computerized Adaptive Test for Substance Use Disorder provides a dimensional severity score (not a diagnosis). Change is assessed week-to-week.
Retention in treatment
时间窗: 4 weeks
Whether participants remained engaged in behavioral health treatment through the end of the 4-week study period.
Patient and clinician satisfaction
时间窗: 4 weeks
Participant- and provider-reported satisfaction with the trial experience and procedures, assessed via standardized surveys.
Clinical fidelity to intervention protoco
时间窗: Weekly over 4-week study period
Fidelity of intervention delivery assessed via clinician checklists or independent fidelity ratings, evaluating adherence to protocol for each assigned treatment component.
Data completeness and consistency
时间窗: Throughout the 4-week trial
Proportion of participants for whom ethical standards are fully maintained (e.g., informed consent obtained, no reported violations). Proportion of participants for whom ethical standards are fully maintained (e.g., informed consent obtained, no reported violations). Proportion of EHR and survey data points with missing or inconsistent entries. Thresholds for success include \<5% missingness or inconsistency.
Timeliness of EHR data entry
时间窗: Weekly throughout the 4-week trial
Proportion of EHR entries recorded within 48 hours of patient interaction.
次要结局
未报告次要终点
研究者
Jason Brian Gibbons
Assistant Professor
Brigham and Women's Hospital