Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT06806163

Conditions

Opioid Overdose

Opioid Use

Opioid Use Disorder

Opioids

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EHR-Embedded Elevated-Risk Flag

EHR-Embedded Elevated-Risk Flag with Behavioral Nudges

Usual Care

Study Details

Brief summary:

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.

Conditions

Opioid Overdose

Opioid Use

Opioid Use Disorder

Opioids

Study ID

NCT06806163

Start date

Mar 10, 2025

Status verified date

Jun, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

EHR-Embedded Elevated-Risk Flag

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

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

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

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 and Locations

Central contacts

Lead Research Program Coordinator, CP3

(412) 692-4889cp3@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Principal Investigator:

Walid F Gellad, MD, MPH

More Information

Sponsor

University of Pittsburgh

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • Machine learning
  • Risk prediction
  • Behavioral nudge
  • Best Practice Alert
  • Artificial intelligence
  • Primary care
  • Electronic Health Record Platforms
  • Opioid Overdose
  • Opioids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-06-17.