Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 3

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.

• Refined EMBED CDS (Other): Refined EMBED CDS
• Provider alert that nurse completed COWS (Other): Provider alert that nurse completed COWS

Primary outcomes

• Proportion of encounters with Buprenorphine initiation in the ED [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.

Secondary outcomes

• Proportion of eligible encounters with CDS engagement [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.
• Proportion of encounters in which buprenorphine was ordered through EMBED vs. externally [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 spent on EMBED [Trial round start to end up to 3 months]: Time (in seconds) spent on EMBED overall and by component.
• Task Completion: Proportion of encounters with OUD diagnosis was recorded [Trial round start to end up to 3 months]: Proportion of encounters where EMBED was opened in which the OUD diagnosis was recorded.
• Task completion: Buprenorphine order or prescription placed [Trial round start to end up to 3 months]: Proportion of encounters where EMBED was opened in which a buprenorphine order or prescription was placed.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Emergency department patient
* 18 years of age or older
* Moderate to severe opioid use disorder

Exclusion Criteria:

* Under 18 years of age
* Pregnant
* Currently receiving medication for opioid use disorder

• Edward Mel, MD, MHS, Principal investigator, Yale University

NIH grants: R33DA059884