Adaptive Decision Support for Addiction Treatment Master

Official title

Adaptive Decision Support for Addiction Treatment (ADAPT)

Overview

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

Detailed 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.

Interventions

• Other EMBED CDS
  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 t
• Other Nurse prompt to complete COWS
  Nurse prompt to complete COWS
• Other Provider Prompt
  Provider Prompt to use EMBED: 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), m
• Other Patient facing materials
  Provider prompt to give patient customized discharge instructions directing patient to resources matched to their needs.
• Other Optimized EMBED
  CDS following Optimization Phase, Stage 2: Rapid serialized testing
• Other Name of Intervention
  Intervention to be informed by results during Evaluation Phase, Stage 1 and will involve refinement of user interface and workflows for the EMBED CDS: 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 M

Primary outcome measures

• Proportion of encounters with Buprenorphine initiation in the ED [Time frame: Upon discharge from the ED, 1 day]
• Proportion of alerted encounters with CDS engagement [Time frame: From ED visit through end of trial stage/cycle, up to 18 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 3 centers

• Yale New Haven Shoreline Medical Center — Guilford
• Yale New Haven Hospital- St. Raphael — New Haven
• Yale New Haven Hospital — New Haven

Publications

• Iscoe MS, Diniz Hooper C, Levy DR, Buchanan L, Dziura J, Meeker D, Taylor RA, D'Onofrio G, Oladele C, Sarpong DF, Paek H, Wilson FP, Heagerty PJ, Delgado MK, Hoppe J, Melnick ER. Adaptive decision support for addiction treatment to implement initiation of buprenorphine for opioid use disorder in the emergency department: protocol for the ADAPT Multiphase Optimization Strategy trial. BMJ Open. 2025 PMID 39979056

Identifiers

NCT: NCT06799117 · 2000038624 · 5R33DA059884-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗