Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 1
Purpose
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.
Conditions
- Opioid Use Disorder
- Clinical Decision Support
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Eligible patients are randomized to a study arm during Emergency Department encounters at study sites. There is no open enrollment.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Refined EMBED plus nurse prompt to complete COWS placed under required documentation in Epic |
Nurse prompt to complete COWS placed under optional documentation in Epic |
|
|
Active Comparator Refined EMBED CDS |
EMBED CDS refined based on previous results |
|
Recruiting Locations
Guilford, Connecticut 06437
New Haven, Connecticut 06510
New Haven, Connecticut 06510
More Details
- Status
- Recruiting
- Sponsor
- Yale University
Detailed Description
Investigators will use a Multiphase Optimization Strategy (MOST) framework study with preparation, optimization, and confirmatory phases. In the current stage, optimization phase, stage 2 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 planned. The more successful condition will be tested in the subsequent round against a novel test condition. In the 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. The last study phase, 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.