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Behavioural Intervention

EHR Nudges for Opioid Overdose (mPROVEN Trial)

Pittsburgh, PA

N/A

Waitlist Available

Led By Walid F Gellad, MD, MPH

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Diagnosis of malignant cancer within the past year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at 6 months following study enrollment (i.e., at 6 months after the first encounter in the study period. an encounter refers to the 1st primary care visit for a patient enrolled in the study.)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new intervention in the Electronic Health Record for patients at risk of opioid overdose. It will compare the effectiveness of providing a flag in the EHR with behavioral nudges to usual

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Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves behavioral interventions rather than medications, traditional side effects aren't expected. However, there may be unintended consequences related to changes in prescribing practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was diagnosed with cancer in the last year.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 6 months following study enrollment (i.e., at 6 months after the first encounter in the study period. an encounter refers to the 1st primary care visit for a patient enrolled in the study.)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at 6 months following study enrollment (i.e., at 6 months after the first encounter in the study period. an encounter refers to the 1st primary care visit for a patient enrolled in the study.)

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 6 months following study enrollment (i.e., at 6 months after the first encounter in the study period. an encounter refers to the 1st primary care visit for a patient enrolled in the study.) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prescribing Practices Composite Score

Secondary study objectives

Active Naloxone Prescription

Average Daily Opioid Dosage > 50 MME

Emergency Department or Inpatient Visits

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: EHR-Embedded Elevated-Risk Flag with Behavioral NudgesExperimental Treatment1 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 FlagExperimental Treatment1 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 CareActive Control1 Intervention

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

0 / 2Eligibility criteria met