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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
A medication treatment component delivered in Week 1 as part of a 2×2 factorial SMART design. The exact content (e.g., treatment modality or intensity) will be finalized based on model results from Aim 1, which identifies optimal dynamic treatment regimes.
A behavioral treatment component delivered in Week 1 as part of a 2×2 factorial SMART design. The exact content (e.g., treatment modality or intensity) will be finalized based on model results from Aim 1, which identifies optimal dynamic treatment regimes.
Discovery Behavioral Health
Irvine, California, United States
CAT-SUD severity scores
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.
Time frame: 4 weeks
Retention in treatment
Whether participants remained engaged in behavioral health treatment through the end of the 4-week study period.
Time frame: 4 weeks
Patient and clinician satisfaction
Participant- and provider-reported satisfaction with the trial experience and procedures, assessed via standardized surveys.
Time frame: 4 weeks
Clinical fidelity to intervention protoco
Fidelity of intervention delivery assessed via clinician checklists or independent fidelity ratings, evaluating adherence to protocol for each assigned treatment component.
Time frame: Weekly over 4-week study period
Data completeness and consistency
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.
Time frame: Throughout the 4-week trial
Timeliness of EHR data entry
Proportion of EHR entries recorded within 48 hours of patient interaction.
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Time frame: Weekly throughout the 4-week trial