EHR Nudges for Opioid Overdose

(mPROVEN Trial)

Overseen By Lead Research Program Coordinator, CP3

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

1350 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Walid F Gellad, MD, MPH

Principal Investigator

University of Pittsburgh Center for Pharmaceutical Policy and Prescribing

Eligibility Criteria

This trial is for patients at high risk of opioid overdose as identified by a machine-learning model. It's not clear what specific inclusion or exclusion criteria are, but typically participants would have a history of opioid use disorder.

Inclusion Criteria

Received an opioid prescription within the past year

At least one visit to an internal medicine or family care practice within the past year

Exclusion Criteria

Enrollment in hospice care

I was diagnosed with cancer in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of EHR-embedded elevated-risk flags with or without behavioral nudges for patients identified as having elevated risk for opioid overdose

6 months

Ongoing monitoring during primary care visits

Follow-up

Participants are monitored for safety and effectiveness after intervention

6 months

Assessed at 6 months after study enrollment

Treatment Details

Interventions

• EHR-Embedded Elevated-Risk Flag with Behavioral Nudges

Trial Overview The study tests if adding a warning flag in doctors' electronic records helps prevent opioid overdoses. Some doctors will see just the flag, while others get extra reminders to follow best practices (nudges), compared to usual care without these tools.

Participant Groups

Group I: EHR-Embedded Elevated-Risk Flag with Behavioral Nudges Experimental Treatment 1 Intervention

An elevated-risk flag will be embedded in the EHR and prominently displayed in the chart during encounters for patients identified as having elevated-risk for opioid overdose. This flag will be combined with a set of best practice alerts/behavioral nudges that will trigger when certain conditions are met during encounters with elevated-risk patients.

Group II: EHR-Embedded Elevated-Risk Flag Experimental Treatment 1 Intervention

An elevated-risk flag will be embedded in the EHR and prominently displayed in the chart during encounters for patients identified as having elevated-risk for opioid overdose.

Group III: Usual Care Active Control 1 Intervention

Patients in the practices randomized to the Usual Care arm will receive standard care practice without change.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+