Machine Learning Tool for Opioid Overdose
(DEMONSTRATE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byWei-Hsuan Lo-Ciganic, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pittsburgh

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for patients at UF Health Internal Medicine and Family Medicine clinics in Gainesville, Florida. It's focused on those who may be at risk of opioid overdose due to various conditions like drug abuse or mental disorders. Specific eligibility criteria are not provided.

Inclusion Criteria

For PCP level outcomes assessment: PCPs practicing in any of the 9 participating clinics (6 UF Health Family Medicine clinics and 3 UF Health Internal Medicine) in Gainesville, Florida.

I am over 18, got an opioid prescription last year, and am at high risk for overdose according to a special computer program.

Exclusion Criteria

Patients who had malignant cancer diagnosis or hospice care prior to study enrollment.

Participant Groups

The study tests a machine-learning tool that predicts opioid overdose risk within the electronic health record system. It compares outcomes before and after implementation, looking at naloxone prescriptions and overdose rates.

1Treatment groups

Experimental Treatment

Group I: Overdose Prevention Alert (OPA) Intervention ArmExperimental Treatment1 Intervention

The intervention arm will receive a ML CDS tool that provides interruptive alerts for patients at elevated risk of opioid overdose, triggered when a clinician signs an opioid order.