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

Disqualifiers: Malignant cancer, Hospice care

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

Compensation: Varies

Number of Visits: 6

1350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if electronic health records (EHR) with special alerts can help doctors manage opioid prescriptions more effectively and reduce overdose risk. The study targets patients identified by a computer model as having a higher likelihood of opioid overdose. It will compare three groups: usual care, an EHR flag indicating risk, and an EHR-Embedded Elevated-Risk Flag with Behavioral Nudges, which includes additional reminders for doctors. Candidates include those who have received an opioid prescription in the last year and visited a family or internal medicine doctor. As an unphased trial, this study offers the chance to contribute to innovative research that could enhance patient safety and care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving opioid prescribing safety, so it's best to discuss your medications with the trial team.

What prior data suggests that this EHR-Embedded Elevated-Risk Flag with Behavioral Nudges is safe for patients?

In this trial, researchers are testing a tool in electronic health records (EHR) to identify patients at high risk for opioid overdose. This tool includes gentle reminders, known as behavioral nudges, to encourage doctors to follow best practices. Studies have shown that these nudges can help doctors make safer prescribing decisions. Importantly, this trial does not involve any new drugs or medical procedures. Instead, it focuses on changing how information is presented and used in doctors' records.

Since this trial involves software changes rather than new medicines, the safety concerns differ. The tool itself is not expected to cause harm. It is designed to help doctors better identify and manage risks. There are no direct negative effects from the tool, as it primarily aims to improve communication and decision-making. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to prevent opioid overdoses using technology. Unlike traditional approaches that rely on prescribing practices and patient education, this trial uses electronic health records (EHR) in innovative ways. One treatment arm features an elevated-risk flag embedded in the EHR, which alerts healthcare providers when a patient is at high risk for an opioid overdose. Another arm adds behavioral nudges to these alerts, prompting providers to take specific actions during patient encounters. These tech-driven strategies aim to enhance clinical decision-making and potentially reduce the rate of opioid overdoses, offering a fresh approach to a critical public health issue.

What evidence suggests that the EHR-Embedded Elevated-Risk Flag with Behavioral Nudges is effective for reducing opioid overdose risk?

Studies have shown that alerts in electronic health records (EHR) can help reduce opioid overdoses. In this trial, one group will use an EHR-Embedded Elevated-Risk Flag to identify high-risk patients, guiding doctors toward safer prescribing choices. Another group will combine this alert with behavioral nudges, which remind doctors to follow best practices during patient visits. Early findings suggest that these combined tools could lower overdose risk by encouraging better prescribing habits. This approach employs advanced computer programs to predict which patients might be at higher risk, enabling more focused and preventative care. ^{1 2 3 4 5}

Who Is on the Research Team?

Walid F Gellad, MD, MPH

Principal Investigator

University of Pittsburgh Center for Pharmaceutical Policy and Prescribing

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06806163

Machine-Learning Prediction and Reducing Overdoses ... 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/ ...

2. reporter.nih.gov reporter.nih.gov/search/EaC3BhVN6USBfOMuTswDVQ/project-details/10520478

Project Details - NIH RePORTER In this project, we propose to reduce opioid overdose risk by bringing together machine-learning based overdose risk prediction and behavioral nudges through a ...

3. withpower.com withpower.com/trial/ehr-nudges-for-opioid-overdose-25ffb

EHR Nudges for Opioid Overdose (mPROVEN Trial) 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/ ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06806163/machine-learning-prediction-and-reducing-overdoses-with-ehr-nudges

Machine-Learning Prediction and Reducing Overdoses ... The clinical trial will evaluate the effectiveness of providing a flag in the EHR to identify individuals at elevated risk with and without ...

5. researchprotocols.org researchprotocols.org/2024/1/e52882/

Decreasing Opioid Addiction and Diversion Using ... The primary goal of this project is to evaluate the effect of the 3 versions of the Opioid Management for You (OPY) tool on measures of opioid use relative to ...