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Machine-Learning Prediction and Reducing Overdoses With EHR Nudges

Study acronym: mPROVEN
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Primary completion date changed from estimate of Oct 2026 to May 31, 2026 · Completion pushed from Feb 2027 to May 2027 · Secondary endpoints: details revised at 5 of 7 entries · 3 more Show 6 more changesShow less
    • Primary completion date changed from estimate of Oct 2026 to May 31, 2026
    • Completion pushed from Feb 2027 to May 2027
    • Secondary endpoints: details revised at 5 of 7 entries
    • Site details revised
    • Publications: details revised at 10 of 10 entries
    • Eligibility criteria expanded, about 5 words
  2. Primary completion pushed from May 31, 2026 to Oct 2026 Completion pushed from May 31, 2026 to Feb 2027v5 Show 1 more changeShow less
    • Completion pushed from May 31, 2026 to Feb 2027
  3. Primary and study completion dates: Mar 2026 to May 31, 2026v4
  4. Secondary endpoints: 6 to 7v3 See this version in full on ClinicalTrials.gov ↗
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 2025 to Mar 10, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Feb 2025 to Mar 10, 2025
    • Site details revised
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06806163
Lead Sponsor University of Pittsburgh
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Opioid Overdose, Opioid Use, Opioid Use Disorder, Opioids
Enrollment 1,350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov