Machine-Learning Prediction and Reducing Overdoses With EHR Nudges
NCT06806163 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1350
Last updated 2026-03-20
Summary
The goal of this cluster randomized clinical trial is to test a clinician-targeted behavioral nudge intervention in the Electronic Health Record (EHR) for patients who are identified by a machine-learning based risk prediction model as having an elevated risk for an opioid overdose.
The clinical trial will evaluate the effectiveness of providing a flag in the EHR to identify individuals at elevated risk with and without behavioral nudges/best practice alerts (BPAs) as compared to usual care by primary care clinicians.
The primary goals of the study are to improve opioid prescribing safety and reduce overdose risk.
Conditions
- Opioid Overdose
- Opioid Use
- Opioid Use Disorder
- Opioids
Interventions
- BEHAVIORAL
-
EHR-Embedded Elevated-Risk Flag
Clinicians seeing patients at elevated predicted risk will see a flag on the EHR 'storyboard' during in person or telephone encounters indicating the patient is at elevated predicted risk of opioid overdose. The clinician will have the option of including this information into their decision-making process when providing care. There will be no best practice alerts/behavioral nudges in this arm.
- BEHAVIORAL
-
EHR-Embedded Elevated-Risk Flag with Behavioral Nudges
Clinicians seeing patients at elevated predicted risk for opioid overdose will see a flag on the EHR storyboard indicating that the patient is at elevated predicted risk. Clinicians will also receive up to 4 best practice alerts/behavioral nudges during an in-person or telephone primary care encounter with elevated risk patients when certain requirements are met: 1) if the patient does not have an active naloxone prescription on their medication list, the clinicians will receive an active choice alert during any medication ordering to encourage naloxone prescription; 2) if the patient's opioid dosage is \>50 MME, OR they are ordered a new opioid prescription, OR they have an overlapping opioid and benzodiazepine prescription order, the clinicians will receive an accountable justification alert when the relevant order is entered.
- BEHAVIORAL
-
Usual Care
Patients in the practices randomized to the Usual Care arm will receive standard care practice without change.
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
University of Pittsburgh
lead OTHER
Principal Investigators
-
Walid F Gellad, MD, MPH · University of Pittsburgh Center for Pharmaceutical Policy and Prescribing
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-10
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
Countries
- United States
Study Locations
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