Machine-Learning Prediction and Reducing Overdoses With EHR Nudges

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT06806163
Status
Recruiting
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Conditions

  • Opioid Overdose
  • Opioid Use
  • Opioid Use Disorder
  • Opioids

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 10, 2025
Status verified
Oct 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
1,350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Usual Care
    Patients in the practices randomized to the Usual Care arm will receive standard care practice without change.
  • Experimental: EHR-Embedded Elevated-Risk Flag
    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.
  • Experimental: EHR-Embedded Elevated-Risk Flag with Behavioral Nudges
    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.

Primary Outcome Measure

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.) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213
Walid F Gellad, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
University of Pittsburgh· Pittsburgh, PA

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