Adaptive Decision Support for Addiction Treatment Master
ADAPT
2 other identifiers
interventional
1,912
1 country
3
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2025
CompletedFirst Posted
Study publicly available on registry
January 29, 2025
CompletedStudy Start
First participant enrolled
March 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
June 25, 2025
June 1, 2025
3 years
January 23, 2025
June 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of encounters with Buprenorphine initiation in the ED
Proportion of eligible encounters with buprenorphine administered in the Emergency Department (ED) and/or prescribed buprenorphine on discharge from the ED. Obtained from EHR data.
Upon discharge from the ED, 1 day
Proportion of alerted encounters with CDS engagement
Proportion of eligible encounters in the Emergency Department with an alert fired (silent or active) with CDS engagement. CDS engagement is defined as: OUD diagnosis entered via CDS, withdrawal assessment, readiness assessment, buprenorphine order/prescription placed, referral placed, or any flowsheet item completed.
From ED visit through end of trial stage/cycle, up to 18 months
Study Arms (3)
Optimization Phase, Stage1: Factorial Trial
EXPERIMENTALSuccessful completion of Optimization Phase, Stage 1 Successful completion of the 2x2x2 factorial trial in which investigators 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.
Optimization Phase, Stage 2: Rapid serialized testing
EXPERIMENTALSuccessful completion of Optimization Phase, Stage 2: 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
EXPERIMENTALSuccessful completion of the Evaluation phase: Investigators will conduct a randomized trial to compare the efficacy of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD.
Interventions
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. Intervention to be informed by CDS measurement and user feedback during the factorial trial phase (Optimization Phase, Stage 1)
Nurse prompt to complete COWS
Provider Prompt to use EMBED: 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. Intervention to be informed by CDS measurement and user feedback during the factorial trial phase (Optimization Phase, Stage 1)
Provider prompt to give patient customized discharge instructions directing patient to resources matched to their needs.
CDS following Optimization Phase, Stage 2: Rapid serialized testing
Intervention to be informed by results during Evaluation Phase, Stage 1 and will involve refinement of user interface and workflows for the EMBED CDS: 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.
Eligibility Criteria
You may qualify if:
- Emergency department patient
- years of age or older
- Moderate to severe opioid use disorder
You may not qualify if:
- Under 18 years of age
- Pregnant
- Currently receiving medication for opioid use disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (3)
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
Related Publications (1)
Iscoe MS, Diniz Hooper C, Levy DR, Buchanan L, Dziura J, Meeker D, Taylor RA, D'Onofrio G, Oladele C, Sarpong DF, Paek H, Wilson FP, Heagerty PJ, Delgado MK, Hoppe J, Melnick ER. Adaptive decision support for addiction treatment to implement initiation of buprenorphine for opioid use disorder in the emergency department: protocol for the ADAPT Multiphase Optimization Strategy trial. BMJ Open. 2025 Feb 20;15(2):e098072. doi: 10.1136/bmjopen-2024-098072.
PMID: 39979056DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Melnick, MD, MHS
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2025
First Posted
January 29, 2025
Study Start
March 21, 2025
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2028
Last Updated
June 25, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- De-identified data will be shared with NAHDAP as soon as possible upon completion of quality control procedures, analysis, and at the time of associated publication or end of performance period. Data will be released by NAHDAP at the time of receipt and will be available indefinitely.
- Access Criteria
- De-identified data sets used for analysis will be submitted to NAHDAP through the NIH HEAL Initiative and will be available for public use according to NAHDAP data sharing policies and restrictions set by our DUA with NAHDAP and our IRB. All data submissions to NAHDAP undergo confidentiality review to protect respondents' data from being re-identified. Portions of the ADAPT intervention will be built for national distribution on the Epic EHR platform. Distribution of code that is proprietary to Epic may limit distribution of certain portions of software or code. In this situation, investigators will provide dashboards and visualizations of workflow diagrams as appropriate to disclose interface and workflow concepts to the broader scientific community These portions of the data will also be subject to restricted use access outside of organizations using Epic.
De-identified data related to EHR use measurements in various levels of aggregation. e.g., time spent on the CDS or threshold outcomes such as dismissal of the CDS without action under a specific amount of time or the time spent on CDS that exceeds what was expected based on the patient's clinical opioid withdrawal (COWS) score, time in the ED, or level of acuity, patient acuity, chief complaints or diagnoses, clinician, interruptions (such as orders started but not finished), task switching, seasonality, and variation in shift timing (such as nights and weekends). Data shared will include variables relating to patient demographics, medical history, prescription information, clinician facing clinical decision support (CDS) firing and clinician action information, and clinician prescribing decisions and historical prescribing