Developing and Evaluating a Machine-Learning Opioid Overdose Prediction & Risk-Stratification Tool in Primary Care
Developing and Evaluating a Machine-Learning Opioid Prediction & Risk-Stratification E-Platform (DEMONSTRATE)
University of Pittsburgh
2,000 participants
Apr 8, 2025
INTERVENTIONAL
Conditions
Summary
This clinical trial aims to evaluate the pilot implementation of a machine-learning (ML)-driven clinical decision support (CDS) tool designed to predict opioid overdose risk within the electronic health record (EHR) system at UF Health Internal Medicine and Family Medicine clinics in Gainesville, Florida. The study will use a pre- versus post-implementation design to compare outcomes within clinics, focusing on measures such as naloxone prescribing rates and opioid overdose occurrences. Researchers will also assess the usability, acceptability, and feasibility of the CDS tool through qualitative interviews with primary care clinicians (PCPs) in the participating clinics.
Eligibility
Inclusion Criteria6
- For PCP level outcomes assessment
- PCPs
- practicing in any of the 13 participating clinics (10 UF Health Family Medicine clinics and 3 UF Health Internal Medicine) in Gainesville, Florida.
- For patient level outcomes assessment:
- are aged ≥18 years
- received any opioid prescription in the past year prior to their clinic visit.
Exclusion Criteria1
- had malignant cancer diagnosis or hospice care prior to study enrollment
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Interventions
In this study, researchers will pilot test an interruptive, ML CDS tool for opioid overdose risk across thirteen primary care clinics at the UF Health in Gainesville, FL. When a patient is identified by the ML algorithm as having an elevated overdose risk and a PCP signs an opioid prescription for the patient, an Opioid Prevention Alert (OPA) will be triggered. The alert will include the rationale for the patient's elevated risk status and provide three risk mitigation recommendations: optimizing pain treatment and mental health support, reviewing and discussing risks with the patient, and offering naloxone annually if no prior naloxone order is found in the patient's record. PCPs can also select an override reason, such as the patient already has naloxone, declined the intervention, is not present/it is not the right time, or the alert is not relevant/other comments, when appropriate.
Locations(1)
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NCT06810076