RECRUITING

Developing and Evaluating a Machine-Learning Opioid Overdose Prediction & Risk-Stratification Tool in Primary Care

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This clinical trial aims to evaluate the pilot implementation of a machine-learning (ML)-driven clinical decision support (CDS) tool designed to predict opioid overdose risk within the electronic health record (EHR) system at UF Health Internal Medicine and Family Medicine clinics in Gainesville, Florida. The study will use a pre- versus post-implementation design to compare outcomes within clinics, focusing on measures such as naloxone prescribing rates and opioid overdose occurrences. Researchers will also assess the usability, acceptability, and feasibility of the CDS tool through qualitative interviews with primary care clinicians (PCPs) in the participating clinics.

Official Title

Developing and Evaluating a Machine-Learning Opioid Prediction & Risk-Stratification E-Platform (DEMONSTRATE)

Quick Facts

Study Start:2025-04-08
Study Completion:2026-10-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06810076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PCPs
  2. * practicing in any of the 13 participating clinics (10 UF Health Family Medicine clinics and 3 UF Health Internal Medicine) in Gainesville, Florida.
  1. * had malignant cancer diagnosis or hospice care prior to study enrollment

Contacts and Locations

Study Contact

Wei-Hsuan Lo-Ciganic, PhD
CONTACT
412-383-2171
cp3@pitt.edu
Debbie L Wilson, PhD
CONTACT
352-273-6255
debbie.wilson@cop.ufl.edu

Principal Investigator

Wei-Hsuan Lo-Ciganic, PhD
PRINCIPAL_INVESTIGATOR
Division of General Internal Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA

Study Locations (Sites)

University of Florida Health Internal Medicine and Family Medicine
Gainesville, Florida, 32608
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Wei-Hsuan Lo-Ciganic, PhD, PRINCIPAL_INVESTIGATOR, Division of General Internal Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-08
Study Completion Date2026-10-02

Study Record Updates

Study Start Date2025-04-08
Study Completion Date2026-10-02

Terms related to this study

Keywords Provided by Researchers

  • Opiate overdose
  • Opioid-Related Disorders
  • Risk Evaluation and Mitigation
  • Machine Learning
  • Medical Order Entry Systems
  • Decision Support Systems, Clinical

Additional Relevant MeSH Terms

  • Opiate Overdose
  • Opioid-Related Disorders
  • Narcotic-Related Disorders
  • Substance-related Disorders
  • Chemically-Induced Disorders
  • Mental Disorders