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| ID | Type | Description | Link |
|---|---|---|---|
| 5R33DA059884-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study is stage 2, round 2 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 is stage 2, 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 we 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: Refined EMBED CDS | Active Comparator | EMBED CDS refined based on previous results |
|
| Refined EMBED plus provider alert in Epic to order a consult with an addiction counselor | Experimental | Provider alert in Epic to order a consult with an addiction counselor to assess for eligibility and initiation of MOUD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Refined EMBED CDS | Other | Refined EMBED CDS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of encounters with an order for an addiction counselor consult | Proportion of encounters with documentation of a clinician order for an addiction counselor consult specifically to assess for eligibility and initiation of MOUD. | Trial round start to end up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Trial round start to end up to 3 months |
| Proportion of eligible encounters with CDS engagement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward Melnick, MD, MHS | Contact | 203-785-4363 | edward.melnick@yale.edu | |
| Laurel Buchanan, MA | Contact | 203-785-4363 | laurel.buchanan@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Edward Edward, MD, MHS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Shoreline Medical Center | Guilford | Connecticut | 06437 | United States | ||
| Yale New Haven Hospital- St. Raphael |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39979056 | Background | 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. |
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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.
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.
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.
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Eligible patients are randomized to a study arm during Emergency Department encounters at study sites. There is no open enrollment.
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| Provider alert to order consultation with addiction counselor | Other | Provider alert to order consult with addiction counselor |
|
Proportion of eligible encounters in which any portion of the EMBED workflow was documented or completed. |
| 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) | Trial round start to end up to 3 months |
| Teamwork on ED initiation of buprenorphine | Proportion of encounters with multi-team-member use of EMBED for buprenorphine initiation, out of encounters with any team member use of EMBED for buprenorphine initiation | Trial round start to end up to 3 months |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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