Clinical Decision Support, Opioid Use Disorder
Conditions
Keywords
Opioid Use Disorder, Clinical Decision Support
Brief summary
This study is stage 2, round 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.
Detailed description
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 study 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 first round we will test the placement of the nurse prompt to complete COWS randomizing encounters to place the prompt under either required or optional documentation. 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.
Interventions
Nurse receives prompt to complete COWS under required documentation
Refined EMBED CDS
Sponsors
Study design
Intervention model description
Eligible patients are randomized to a study arm during Emergency Department encounters at study sites. There is no open enrollment.
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of encounters with COWS completed | Trial round start to end up to 3 months | Proportion of eligible encounters with a COWS competed, by any team member and via any workflow (internal and external of EMBED). Obtained from EHR data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Teamwork on CDS Engagement | Trial round start to end up to 3 months | Proportion of eligible encounters in which more than one team member (regardless of role) helped complete the EMBED workflow. |
| Proportion of eligible users who used EMBED | Trial round start to end up to 3 months | Proportion of EM staff members (Attendings, Residents and APPS) who cared for at least patient for whom the alert fired during the study period who used EMBED at least once during the study period. |
| 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: Proportion of Encounters with COWS Score Entered | Trial round start to end up to 3 months | Proportion of encounters where EMBED was opened in which a COWS score was entered. |
| 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. |
Countries
United States
Contacts
Yale University