NCT06806163

Machine-Learning Prediction and Reducing Overdoses With EHR Nudges

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,350 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In response to the opioid overdose crisis, health systems have instituted multiple interventions to reduce patient risk, including decreasing unsafe opioid prescribing among high-risk patients and dispensing naloxone. However, these interventions face two key challenges. First, there are limited and poorly performing tools to identify who is truly at risk of overdose, leading to burdensome interventions targeting an overly broad population or missing key high-risk individuals. Second, even with more accurate identification of high-risk patients, highly effective strategies to change clinician behavior remain limited. Common cognitive biases may underlie clinicians' lack of response to risk factors for overdose. This project aims to address both of these limitations by combining more accurate risk prediction tools to identify those at elevated risk of opioid overdose with novel "nudge" interventions based on principles of behavioral economics that have been shown to address cognitive biases and change prescribing behavior. The primary hypothesis is that high-risk patients in primary care practices randomized to the elevated-risk flag + nudge intervention will have safer prescribing compared to usual care.

Conditions

• Opioid Overdose
• Opioid Use
• Opioid Use Disorder
• Opioids

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2025-02-03
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States