Adaptive Decision Support for Addiction Treatment Master (ADAPT)
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About
This study 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 does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases.
Optimization Phase: This phase has two stages. In stage 1, investigators will conduct a 2x2x2 factorial trial to expand EMBED is expanded to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompts to use the CDS along with individualized patient resources to promote equity and motivate readiness to start treatment. In Stage 2, investigators will improve CDS usability via serial 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 in serial randomized tests.
Evaluation phase: Investigators will conduct a randomized trial to compare the efficacy effectiveness of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD.
*EMBED is a user user-centered, clinician 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
Full description
Computerized clinical decision support (CDS) is a scalable strategy to standardize evidence-
based practices and respond efficiently to the evolving operational demands of the opioid crisis.
Effective practice change requires CDS tools that are usable (easy to learn, efficient to navigate, support task completion with minimal errors, and provide a satisfactory user experience), well-
integrated into clinical workflows and supported by coordinated implementation strategies. We
will refine and evaluate the uptake, usability, and reach of a nationally disseminated multicomponent CDS intervention to improve treatment initiation during emergency care for individuals with opioid use disorder.
This study refines and optimizes the EMBED* clinical decision support (CDS; see NCT03658642) to increase the number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. This study does not have open enrollment.
Investigators will use a Multiphase Optimization Strategy (MOST) framework study with preparation, optimization, and confirmatory phases. Optimization Phases: This phase has two stages. In stage 1, investigators will conduct a 2x2x2 factorial trial to expand EMBED to include sustainable implementation strategies: nurse prompts for withdrawal assessment, and targeted clinician prompts to use the CDS along with individualized patient resources to promote equity and motivate readiness to start treatment. We will be randomizing these 3 strategies at the encounter level, resulting in these 8 arms:
Original EMBED
EMBED + nurse prompt
EMBED + clinician prompt
EMBED + patient facing materials
EMBED + nurse prompt + clinician prompt
EMBED + nurse prompt + patient facing materials
EMBED + clinician prompt + patient facing materials
EMBED + nurse prompt + clinician prompt + patient facing materials
In Stage 2, investigators will improve CDS usability via serial randomized testing to inform iterative refinement of the CDS interface and workflow to minimize user errors, task disruption, and abandonment. This will be done by identifying specific targets for improvement and applying novel CDS outcome measures in serial randomized tests.
Evaluation phase: In this confirmatory phase, investigators will conduct a randomized trial to compare the efficacy and effectiveness of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD. During this phase, the optimized treatment package will be tested in a fully powered 2-arm randomized trial comparing the efficacy of the optimized, multicomponent intervention package to the original EMBED CDS on rates of ED initiation of buprenorphine in patients with OUD. Based on the results of the optimization phase factorial trial in conjunction with findings from the rapid, serial randomized testing, the optimized treatment package will include individual components found to increase CDS uptake and all usability and workflow improvements found to decrease errors and increase efficiency in serial randomized testing.
*EMBED is a user user-centered, clinician 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.
Enrollment
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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
Trial design
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Allocation
Interventional model
Masking
1,912 participants in 3 patient groups
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Central trial contact
Laurel Buchanan; Edward Melnick, MD, MHS
Data sourced from clinicaltrials.gov
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