Opioid Abuse (Disorder)NCT07793383
Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 3
A study testing Refined EMBED CDS and Provider alert that nurse completed COWS in people with Opioid Abuse (Disorder) and Clinical Decision Support, run by Yale University at 3 sites in United States.
Trial summary
This study is stage 2, round 3 of a larger study which refines and optimizes the EMBED clinical decision support (CDS) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. See NCT03658642 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Abuse (Disorder), Clinical Decision Support
- What is being tested?
- Refined EMBED CDS and Provider alert that nurse completed COWS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Aug 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emergency department patient
- 18 years of age or older
- Moderate to severe opioid use disorder
Who cannot join
- Under 18 years of age
- Pregnant
- Currently receiving medication for opioid use disorder
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Yale New Haven Shoreline Medical Center
Guilford, Connecticut, 06437
- Recruiting
Yale New Haven Hospital- St. Raphael
New Haven, Connecticut, 06510
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
This study is stage 2, round 3 of a larger study which refines and optimizes the EMBED clinical decision support (CDS) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. See NCT03658642
Read the detailed description
This study is stage 3, rapid response testing (RRT), of the optimization phase 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. Investigators will use a Multiphase Optimization Strategy (MOST) framework with preparation, optimization, and confirmatory phases.
In stage 2, optimization phase, investigators will conduct serial rapid-cycle 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 with the goal of improving CDS usability.
Five rounds of A-B testing are expected. The more successful condition will be tested in the subsequent round against a novel test condition. In this second round investigators will randomize an alert to providers to order a consult with addiction counselors. Future rounds will be planned, with arms and interventions added, as the project progresses in order to build on insights gained in each round.
Phase 3, the evaluation phase will consist of 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
This study does not have open enrollment.
- Conditions
- Opioid Abuse (Disorder), Clinical Decision Support
- Being tested
- Refined EMBED CDS, Provider alert that nurse completed COWS
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refined EMBED CDSOther
Refined EMBED CDS
Provider alert that nurse completed COWSOther
Provider alert that nurse completed COWS
| Study group | Role | What they receive |
|---|---|---|
| Refined EMBED CDS | Active comparator | EMBED CDS refined based on previous results Receives: Other: Refined EMBED CDS; Other: Provider alert that nurse completed COWS |
| Refined EMBED plus provider alert the nurse completed COWS | Experimental | Alert to provider in Epic that the nurse completed COWS Receives: Other: Provider alert that nurse completed COWS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Trial round start to end up to 3 months
Secondary outcomes (5)
Proportion of eligible encounters with CDS engagement
Proportion of eligible encounters in which any portion of the EMBED workflow was documented or completed.
Measured: Trial round start to end up to 3 months
Proportion of encounters in which buprenorphine was ordered through EMBED vs. externally
Proportion of eligible encounters in which buprenorphine order is placed through EMBED (i.e., using EMBED order set).
Measured: Trial round start to end up to 3 months
Time spent on EMBED
Time (in seconds) spent on EMBED overall and by component.
Measured: Trial round start to end up to 3 months
Task Completion: Proportion of encounters with OUD diagnosis was recorded
Proportion of encounters where EMBED was opened in which the OUD diagnosis was recorded.
Measured: Trial round start to end up to 3 months
Task completion: Buprenorphine order or prescription placed
Proportion of encounters where EMBED was opened in which a buprenorphine order or prescription was placed.
Measured: Trial round start to end up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start17 Aug 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Abuse (Disorder)Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Eligible patients are randomized to a study arm during Emergency Department encounters at study sites. There is no open enrollment.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Edward Mel, MD, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793383
- Sponsor's protocol ID
- 2000038624-B3
- Other IDs
- 5R33DA059884-02
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 3
- ClinicalTrials.gov ID
- NCT07793383
- Acronym / sponsor ID
- 2000038624-B3
- Conditions
- Opioid Abuse (Disorder), Clinical Decision Support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is stage 2, round 3 of a larger study which refines and optimizes the EMBED clinical decision support (CDS) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. See NCT03658642
Detailed description
This study is stage 3, rapid response testing (RRT), of the optimization phase 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. Investigators will use a Multiphase Optimization Strategy (MOST) framework with preparation, optimization, and confirmatory phases.
In stage 2, optimization phase, investigators will conduct serial rapid-cycle 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 with the goal of improving CDS usability.
Five rounds of A-B testing are expected. The more successful condition will be tested in the subsequent round against a novel test condition. In this second round investigators will randomize an alert to providers to order a consult with addiction counselors. Future rounds will be planned, with arms and interventions added, as the project progresses in order to build on insights gained in each round.
Phase 3, the evaluation phase will consist of 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
This study does not have open enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients are randomized to a study arm during Emergency Department encounters at study sites. There is no open enrollment.
| Arm | Type | Receives |
|---|---|---|
| Refined EMBED CDS | Active comparator | Other: Refined EMBED CDS, Other: Provider alert that nurse completed COWSEMBED CDS refined based on previous results |
| Refined EMBED plus provider alert the nurse completed COWS | Experimental | Other: Provider alert that nurse completed COWSAlert to provider in Epic that the nurse completed COWS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Emergency department patient
- 18 years of age or older
- Moderate to severe opioid use disorder
Key exclusion criteria (3 listed)
- Under 18 years of age
- Pregnant
- Currently receiving medication for opioid use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Refined EMBED CDSRefined EMBED CDS | Other | Refined EMBED CDS |
| Provider alert that nurse completed COWSProvider alert that nurse completed COWS | Other | Refined EMBED CDS, Refined EMBED plus provider alert the nurse completed COWS |
Primary outcome
Proportion of encounters with Buprenorphine initiation in the ED
Time frame: Trial round start to end up to 3 months
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.
5 secondary outcomes
Proportion of eligible encounters with CDS engagement
Time frame: Trial round start to end up to 3 months
Proportion of encounters in which buprenorphine was ordered through EMBED vs. externally
Time frame: Trial round start to end up to 3 months
Time spent on EMBED
Time frame: Trial round start to end up to 3 months
Task Completion: Proportion of encounters with OUD diagnosis was recorded
Time frame: Trial round start to end up to 3 months
Task completion: Buprenorphine order or prescription placed
Time frame: Trial round start to end up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward Mel, MD, MHS principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Refined EMBED CDS and Provider alert that nurse completed COWS in people with Opioid Abuse (Disorder) and Clinical Decision Support, run by Yale University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward Melnick, MD, MHS (203-785-4363, edward.melnick@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of encounters with Buprenorphine initiation in the ED (time frame: Trial round start to end up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.