RECRUITING

Adaptive Decision Support for Addiction Treatment Master

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 study refines and optimizes the EMBED\* clinical decision support (CDS; see NCT03658642) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. This study does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases. Optimization Phase: This phase has two stages. In stage 1, investigators will conduct a 2x2x2 factorial trial to expand EMBED is expanded to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompts to use the CDS along with individualized patient resources to promote equity and motivate readiness to start treatment. In Stage 2, investigators will improve CDS usability via serial randomized testing to inform iterative refinement of the CDS interface and workflow to minimize user errors, task disruption, and abandonment through identification of specific targets for improvement via application of novel CDS outcome measures in serial randomized tests. Evaluation phase: Investigators will conduct a randomized trial to compare the efficacy effectiveness of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD. \*EMBED is a user user-centered, clinician clinician-facing clinical decision support system integrated into the electronic health record workflow to facilitate initiating buprenorphine in the emergency department by: diagnosing opioid use disorder with a checklist based on the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition), assessing the severity of withdrawal with the Clinical Opioid Withdrawal Scale (COWS), motivating patients to accept treatment with a scripted brief negotiation interview, and automating the electronic health record workflow, including clinical and after visit documentation, order entry, prescribing, and referral for ongoing treatment in the community

Official Title

Adaptive Decision Support for Addiction Treatment (ADAPT)

Quick Facts

Study Start:2025-03-21
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06799117

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. * Emergency department patient
  2. * 18 years of age or older
  3. * Moderate to severe opioid use disorder
  1. * Under 18 years of age
  2. * Pregnant
  3. * Currently receiving medication for opioid use disorder

Contacts and Locations

Study Contact

Edward Melnick, MD, MHS
CONTACT
203-785-4363
edward.melnick@yale.edu
Laurel Buchanan
CONTACT
laurel.buchanan@yale.edu

Principal Investigator

Edward Melnick, MD, MHS
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale New Haven Shoreline Medical Center
Guilford, Connecticut, 06437
United States
Yale New Haven Hospital- St. Raphael
New Haven, Connecticut, 06510
United States
Yale New Haven Hospital
New Haven, Connecticut, 06510
United States

Collaborators and Investigators

Sponsor: Yale University

  • Edward Melnick, MD, MHS, PRINCIPAL_INVESTIGATOR, Yale University

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 Date2025-03-21
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2025-03-21
Study Completion Date2028-03-31

Terms related to this study

Keywords Provided by Researchers

  • Opioid use disorder
  • Clinical Decision Support

Additional Relevant MeSH Terms

  • Opioid Use Disorder