COMPLETED

Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial

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 is stage 1 of a larger study which 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. In the current project, optimization phase, stage1 investigators will conduct a 2x2x2 factorial trial in which they expand EMBED to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompt to use the CDS along with patient resources to promote equity and motivate readiness to start treatment. Later study phases will include optimization phase, stage 2: rapid-cycle randomized testing, and evaluation phase: a randomized trial of the optimized package compared to the original EMBED and the evaluation phase in which investigators will compare the efficacy of the optimized, multicomponent CDS package to the original EMBED CDS on ED-initiation of buprenorphine rates in patients with OUD in a randomized trial. \*EMBED is a user centered, 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) Factorial Trial

Quick Facts

Study Start:2025-03-21
Study Completion:2025-10-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06793696

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

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 Date2025-10-14

Study Record Updates

Study Start Date2025-03-21
Study Completion Date2025-10-14

Terms related to this study

Keywords Provided by Researchers

  • Opioid use disorder
  • clinical decision support

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Clinical Decision Support