Refined EMBED CDS
OtherRefined EMBED CDS
NCT Number: NCT07602218
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Yale New Haven Shoreline Medical Center, Guilford, Connecticut, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Refined EMBED CDS
Provider alert to order consult with addiction counselor
Time frame: Trial round start to end up to 3 months
Proportion of encounters with documentation of a clinician order for an addiction counselor consult specifically to assess for eligibility and initiation of MOUD.
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.
Time frame: Trial round start to end up to 3 months
Proportion of eligible encounters in which any portion of the EMBED workflow was documented or completed.
Time frame: Trial round start to end up to 3 months
Proportion of eligible encounters in which buprenorphine order is placed through EMBED (i.e., using EMBED order set)
Time frame: Trial round start to end up to 3 months
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
Contact information is provided by the study sponsor or research team.
Edward Melnick, MD, MHS
CONTACT
Laurel Buchanan, MA
CONTACT
Yale University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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