Developing and Evaluating a Machine-Learning Opioid Overdose Prediction & Risk-Stratification Too… (NCT06810076) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Developing and Evaluating a Machine-Learning Opioid Overdose Prediction & Risk-Stratification Tool in Primary Care
United States674 participantsStarted 2025-04-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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:
Inclusion criteria: Patients who seen in any of the 9 participating UF Health clinics who
* are aged ≥18 years
* received any opioid prescription in the past year prior to their clinic visit.
* are identified as being at elevated risk for overdose by the ML algorithm. Exclusion Criteria: Patients who
* had malignant cancer diagnosis or hospice care prior to study enrollment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite patient-level outcomes related to opioids
Timeframe: From enrollment and up to 12 months (3, 6, 12 months) post implementation of the OPA
2
PCP's use feedback of the Overdose Prevention Alert (OPA)
Timeframe: From enrollment and up to 7 months post implementation of the OPA