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NCT Number: NCT06806163

Machine-Learning Prediction and Reducing Overdoses With EHR Nudges

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.

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Key information

Conditions

Opioid Overdose Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Narcotic-Related Disorders Opiate Overdose Opioid Use Opioid Use Disorder Opioid-Related Disorders Opioids Prescription Drug Misuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Walid F Gellad, MD, MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 past year

Exclusion criteria

  • Diagnosis of malignant cancer within the past year
  • Enrollment in hospice care

Treatment and study plan

EHR-Embedded Elevated-Risk Flag

Behavioral

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.

EHR-Embedded Elevated-Risk Flag with Behavioral Nudges

Behavioral

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.

Other names: EHR-Embedded Elevated-Risk Flag with Best Practice Alerts (BPAs)

Usual Care

Behavioral

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

Primary outcomes

  1. Prescribing Practices Composite Score

    Time frame: Assessed at 4 months following study enrollment (i.e., at 4 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 outcome measures a composite of three prescribing practices associated with a reduced risk of opioid overdose. Each of the three is assigned a value of one point, with the composite score ranging from 0 to 3:

    • Naloxone prescription: Evidence of a prescription for naloxone.
    • Opioid dosage < 50 morphine milligram equivalents (MME) per day: No prescriptions exceeding 50 MME/day during the measurement period.
    • No opioid and benzodiazepine overlap: No concurrent prescriptions for opioids and benzodiazepines.

    The composite score will be treated as a 3-point ordinal measure reflecting adherence to these prescribing practices.

Secondary outcomes

  1. Prescribing Practices Composite Score--6 Month Measure

    Time frame: 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 outcome measures a composite of three prescribing practices associated with a reduced risk of opioid overdose. Each of the three is assigned a value of one point, with the composite score ranging from 0 to 3: 1. Naloxone prescription: Evidence of a prescription for naloxone. 2. Opioid dosage < 50 morphine milligram equivalents (MME) per day: No prescriptions exceeding 50 MME/day during the measurement period. 3. No opioid and benzodiazepine overlap: No concurrent prescriptions for opioids and benzodiazepines. The composite score will be treated as a 3-point ordinal measure reflecting adherence to these prescribing practices.

  2. Active Naloxone Prescription

    Time frame: Assessed at 4 & 6 months after study enrollment by reviewing data from 12 months preceding index date (i.e., at 4 & 6 months after enrollment). An active naloxone prescription is recorded if one exists at any point during the year before the index date.

    The presence of an active naloxone prescription, determined by evidence of a naloxone order, a naloxone fill, or both.

  3. Average Daily Opioid Dosage > 50 MME

    Time frame: Assessed at 4 and 6 months after study enrollment, based on the average daily MME calculated over the 7 days preceding the index date (i.e., 4 and 6 months after enrollment).

    The average daily opioid dosage, calculated in morphine milligram equivalents (MME), is evaluated using prescription fills data as the primary source. If fills data are unavailable, prescription orders data will be used. This measure reflects whether the average daily MME exceeds 50 during the specified time period.

  4. Overlapping Opioid Benzodiazepine Prescriptions

    Time frame: Assessed at 4 and 6 months after study enrollment, based on overlap occurring on the index date (i.e., 4 and 6 months after enrollment) or within the 28 days preceding the index date.

    This outcome evaluates overlapping opioid and benzodiazepine use, determined by the following criteria:

    (A) Active overlap on the index date: Both an opioid and a benzodiazepine prescription fill are active on the index date.

    (B) Historical overlap: At least one opioid and one benzodiazepine prescription order within the past 28 days.

    Overlap is defined as meeting any of the above.

  5. Overlapping Opioid Benzodiazepine Prescriptions Where Average Daily Opioid MME > 50

    Time frame: Assessed at 4 and 6 months after study enrollment, based on overlap occurring on the index date (i.e., 4 and 6 months after enrollment) or within the 28 days preceding the index date.

    This outcome evaluates the presence of overlapping opioid and benzodiazepine use where opioid MME is > 50, defined as above.

  6. Emergency Department or Inpatient Visits

    Time frame: Assessed at 4 and 6 months after study enrollment, based on visits occurring within the 30 days prior to the index date (i.e., 4 and 6 months after enrollment).

    This outcome measures the occurrence of any emergency department (ED) or inpatient visit during the specified time period.

  7. Emergency Department or Inpatient Visits for Overdose

    Time frame: Assessed at 4 and 6 months after study enrollment, based on visits occurring within the 30 days prior to the index date (i.e., 4 and 6 months after enrollment).

    This outcome measures the occurrence of any emergency department (ED) or inpatient visit specifically attributed to an overdose during the specified time period.

Study contacts

Contact information is provided by the study sponsor or research team.

Lead Research Program Coordinator, CP3

CONTACT

[email protected]

(412) 692-4889

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: mPROVEN

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 3, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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