Machine-Learning Prediction and Reducing Overdoses With EHR Nudges

Last updated: October 8, 2025
Sponsor: University of Pittsburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Drug Use

Treatment

EHR-Embedded Elevated-Risk Flag

EHR-Embedded Elevated-Risk Flag with Behavioral Nudges

Usual Care

Clinical Study ID

NCT06806163
STUDY22040068
R01DA044985-04
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Received an opioid prescription within the past year

  • Age 18 years or older at the time of the opioid prescription

  • At least one visit to an internal medicine or family care practice within the pastyear

Exclusion

Exclusion Criteria:

  • Diagnosis of malignant cancer within the past year

  • Enrollment in hospice care

Study Design

Total Participants: 1350
Treatment Group(s): 3
Primary Treatment: EHR-Embedded Elevated-Risk Flag
Phase:
Study Start date:
March 10, 2025
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Active - Recruiting

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