Opioid Use DisorderNCT06793696
Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial
A study testing Nurse prompt, Provider prompt and Patient facing materials in people with Opioid Use Disorder and Clinical Decision Support, run by Yale University at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Clinical Decision Support
- What is being tested?
- Nurse prompt, Provider prompt and Patient facing materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,129 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Mar 2025to 14 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
United States3 sites
Yale New Haven Shoreline Medical Center
Guilford, Connecticut, 06437
Yale New Haven Hospital- St. Raphael
New Haven, Connecticut, 06510
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
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.
Read more
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
- Conditions
- Opioid Use Disorder, Clinical Decision Support
- Being tested
- Nurse prompt, Provider prompt, Patient facing materials, EMBED
- Keywords
- Opioid use disorder, clinical decision support
- 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.
Nurse promptOther
Nurse prompt to complete COWS
Provider promptOther
Provider prompt to use EMBED CDS
Patient facing materialsOther
Patient materials provided at discharge from ED
EMBEDOther
Original EMBED CDS
| Study group | Role | What they receive |
|---|---|---|
| EMBED CDS | Active comparator | Provider receives EMBED CDS Receives: Other: EMBED |
| EMBED CDS and nurse prompt | Experimental | EMBED CDS and nurse receives prompt to complete COWS Receives: Other: Nurse prompt; Other: EMBED |
| EMBED CDS and provider prompt | Experimental | EMBED CDS and provider prompt for EMBED CDS Receives: Other: Provider prompt; Other: EMBED |
| EMBED CDS and patient facing materials | Experimental | EMBED CDS and patient materials at patient discharge from ED Receives: Other: Patient facing materials; Other: EMBED |
| EMBED CDS and nurse prompt and provider prompt | Experimental | EMBED CDS and nurse prompt to complete COWS and provider prompt for CDS Receives: Other: Nurse prompt; Other: Provider prompt; Other: EMBED |
| EMBED CDS and nurse prompt and patient facing materials | Experimental | EMBED CDS and nurse prompt to complete COWS and patient materials at discharge from ED Receives: Other: Nurse prompt; Other: Patient facing materials; Other: EMBED |
| EMBED CDS and provider prompt and patient facing materials | Experimental | EMBED CDS and provider prompt for EMBED and patient materials at discharge from ED Receives: Other: Provider prompt; Other: Patient facing materials; Other: EMBED |
| EMBED CDS and nurse prompt and provider prompt and patient facing materials | Experimental | EMBED CDS and nurse prompt to complete COWS and provider prompt to complete CDS and patient materials at discharge from ED Receives: Other: Nurse prompt; Other: Provider prompt; Other: Patient facing materials; Other: EMBED |
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: 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.
Measured: Trial start to end up to 18 months
Secondary outcomes (7)
Proportion of encounters with Naloxone prescription upon ED discharge
Proportion of eligible encounters with naloxone prescribed on discharge from the Emergency Department (ED). Obtained from EHR data.
Measured: Upon discharge from the ED, 1 day
Proportion of encounters with patient referral to ongoing MOUD treatment
Proportion of eligible encounters with referral for ongoing MOUD treatment received on discharge from the Emergency Department (ED). Obtained from EHR data.
Measured: Upon discharge from the ED, 1 day
Proportion of encounters with patient receipt of appropriate opioid related discharge instructions
Proportion of encounters with appropriate opioid related discharge instructions. Obtained from EHR data.
Measured: Upon discharge from the ED, 1 day
Proportion of attending physicians initiating BUP in the ED for at least one eligible patient
Proportion of attending physicians administered or prescribed Buprenorphine in the Emergency Department (ED) for at least one encounter. Obtained from EHR data.
Measured: Trial start to end up to 18 months
Proportion of attending physician prescribing naloxone upon ED discharge
Proportion of attending physicians prescribing naloxone in the Emergency Department (ED) for at least one encounter. Obtained from EHR data.
Measured: Trial start to end up to18 months
Proportion of attending physician referral to ongoing MOUD treatment
Proportion of attending physicians referring a patient to ongoing MOUD treatment on discharge from the Emergency Department (ED) for at least one encounter. Obtained from EHR data.
Measured: Trial start to end up to 18 months
Proportion of attending physicians giving appropriate opioid related discharge instructions
Proportion of attending physicians giving appropriate opioid related discharge instructions for at least one encounter. Obtained from EHR data.
Measured: Trial start to end up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start21 Mar 2025
- Primary completion14 Oct 2025
- Study completion14 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies 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
- Factorial
- 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
- 1,129 participants (actual)
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 Melnick, MD, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793696
- Sponsor's protocol ID
- 2000038624-A
- Other IDs
- 5R33DA059884-02
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2025
- Last updated
- 27 Jan 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial
- ClinicalTrials.gov ID
- NCT06793696
- Acronym / sponsor ID
- 2000038624-A
- Conditions
- Opioid Use Disorder, Clinical Decision Support
- Keywords
- Opioid use disorder, clinical decision support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,129 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 14 Oct 2025 (actual)
- Study completion
- 14 Oct 2025 (actual)
- First posted
- 27 Jan 2025 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- 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 |
|---|---|---|
| EMBED CDS | Active comparator | Other: EMBEDProvider receives EMBED CDS |
| EMBED CDS and nurse prompt | Experimental | Other: Nurse prompt, Other: EMBEDEMBED CDS and nurse receives prompt to complete COWS |
| EMBED CDS and provider prompt | Experimental | Other: Provider prompt, Other: EMBEDEMBED CDS and provider prompt for EMBED CDS |
| EMBED CDS and patient facing materials | Experimental | Other: Patient facing materials, Other: EMBEDEMBED CDS and patient materials at patient discharge from ED |
| EMBED CDS and nurse prompt and provider prompt | Experimental | Other: Nurse prompt, Other: Provider prompt, Other: EMBEDEMBED CDS and nurse prompt to complete COWS and provider prompt for CDS |
| EMBED CDS and nurse prompt and patient facing materials | Experimental | Other: Nurse prompt, Other: Patient facing materials, Other: EMBEDEMBED CDS and nurse prompt to complete COWS and patient materials at discharge from ED |
| EMBED CDS and provider prompt and patient facing materials | Experimental | Other: Provider prompt, Other: Patient facing materials, Other: EMBEDEMBED CDS and provider prompt for EMBED and patient materials at discharge from ED |
| EMBED CDS and nurse prompt and provider prompt and patient facing materials | Experimental | Other: Nurse prompt, Other: Provider prompt, Other: Patient facing materials, Other: EMBEDEMBED CDS and nurse prompt to complete COWS and provider prompt to complete CDS and patient materials at discharge from ED |
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 |
|---|---|---|
| Nurse promptNurse prompt to complete COWS | Other | EMBED CDS and nurse prompt, EMBED CDS and nurse prompt and patient facing materials, EMBED CDS and nurse prompt and provider prompt, EMBED CDS and nurse prompt and provider prompt and patient facing materials |
| Provider promptProvider prompt to use EMBED CDS | Other | EMBED CDS and nurse prompt and provider prompt, EMBED CDS and nurse prompt and provider prompt and patient facing materials, EMBED CDS and provider prompt, EMBED CDS and provider prompt and patient facing materials |
| Patient facing materialsPatient materials provided at discharge from ED | Other | EMBED CDS and nurse prompt and patient facing materials, EMBED CDS and nurse prompt and provider prompt and patient facing materials, EMBED CDS and patient facing materials, EMBED CDS and provider prompt and patient facing materials |
| EMBEDOriginal EMBED CDS | Other | EMBED CDS, EMBED CDS and nurse prompt, EMBED CDS and nurse prompt and patient facing materials, EMBED CDS and nurse prompt and provider prompt, EMBED CDS and nurse prompt and provider prompt and patient facing materials, EMBED CDS and patient facing materials, EMBED CDS and provider prompt, EMBED CDS and provider prompt and patient facing materials |
Primary outcome
Proportion of encounters with Buprenorphine initiation in the ED
Time frame: Upon discharge from the ED, 1 day
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.
Proportion of alerted encounters with CDS engagement
Time frame: Trial start to end up to 18 months
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.
7 secondary outcomes
Proportion of encounters with Naloxone prescription upon ED discharge
Time frame: Upon discharge from the ED, 1 day
Proportion of encounters with patient referral to ongoing MOUD treatment
Time frame: Upon discharge from the ED, 1 day
Proportion of encounters with patient receipt of appropriate opioid related discharge instructions
Time frame: Upon discharge from the ED, 1 day
Proportion of attending physicians initiating BUP in the ED for at least one eligible patient
Time frame: Trial start to end up to 18 months
Proportion of attending physician prescribing naloxone upon ED discharge
Time frame: Trial start to end up to18 months
Proportion of attending physician referral to ongoing MOUD treatment
Time frame: Trial start to end up to 18 months
Proportion of attending physicians giving appropriate opioid related discharge instructions
Time frame: Trial start to end up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 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. This study is not recruiting at the moment.
Edward Melnick, 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 Nurse prompt, Provider prompt and Patient facing materials in people with Opioid Use 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: finished, as of the sponsor's last update on 27 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: Upon discharge from the ED, 1 day). The study lists 2 primary outcomes in all. 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 27 Jan 2026.