Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial

NCT ID: NCT06793696

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-21

Study Completion Date

2025-10-14

Brief Summary

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This study is stage 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.

This study does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases. In the current project, optimization phase, stage1 investigators will conduct a 2x2x2 factorial trial in which they expand EMBED to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompt to use the CDS along with patient resources to promote equity and motivate readiness to start treatment.

Later study phases will include optimization phase, stage 2: rapid-cycle randomized testing, and evaluation phase: 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

Detailed Description

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Conditions

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Opioid Use Disorder Clinical Decision Support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Eligible patients are randomized to a study arm during Emergency Department encounters at study sites. There is no open enrollment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EMBED CDS

Provider receives EMBED CDS

Group Type ACTIVE_COMPARATOR

EMBED

Intervention Type OTHER

Original EMBED CDS

EMBED CDS and nurse prompt

EMBED CDS and nurse receives prompt to complete COWS

Group Type EXPERIMENTAL

Nurse prompt

Intervention Type OTHER

Nurse prompt to complete COWS

EMBED

Intervention Type OTHER

Original EMBED CDS

EMBED CDS and provider prompt

EMBED CDS and provider prompt for EMBED CDS

Group Type EXPERIMENTAL

Provider prompt

Intervention Type OTHER

Provider prompt to use EMBED CDS

EMBED

Intervention Type OTHER

Original EMBED CDS

EMBED CDS and patient facing materials

EMBED CDS and patient materials at patient discharge from ED

Group Type EXPERIMENTAL

Patient facing materials

Intervention Type OTHER

Patient materials provided at discharge from ED

EMBED

Intervention Type OTHER

Original EMBED CDS

EMBED CDS and nurse prompt and provider prompt

EMBED CDS and nurse prompt to complete COWS and provider prompt for CDS

Group Type EXPERIMENTAL

Nurse prompt

Intervention Type OTHER

Nurse prompt to complete COWS

Provider prompt

Intervention Type OTHER

Provider prompt to use EMBED CDS

EMBED

Intervention Type OTHER

Original EMBED CDS

EMBED CDS and nurse prompt and patient facing materials

EMBED CDS and nurse prompt to complete COWS and patient materials at discharge from ED

Group Type EXPERIMENTAL

Nurse prompt

Intervention Type OTHER

Nurse prompt to complete COWS

Patient facing materials

Intervention Type OTHER

Patient materials provided at discharge from ED

EMBED

Intervention Type OTHER

Original EMBED CDS

EMBED CDS and provider prompt and patient facing materials

EMBED CDS and provider prompt for EMBED and patient materials at discharge from ED

Group Type EXPERIMENTAL

Provider prompt

Intervention Type OTHER

Provider prompt to use EMBED CDS

Patient facing materials

Intervention Type OTHER

Patient materials provided at discharge from ED

EMBED

Intervention Type OTHER

Original EMBED CDS

EMBED CDS and nurse prompt and provider prompt and patient facing materials

EMBED CDS and nurse prompt to complete COWS and provider prompt to complete CDS and patient materials at discharge from ED

Group Type EXPERIMENTAL

Nurse prompt

Intervention Type OTHER

Nurse prompt to complete COWS

Provider prompt

Intervention Type OTHER

Provider prompt to use EMBED CDS

Patient facing materials

Intervention Type OTHER

Patient materials provided at discharge from ED

EMBED

Intervention Type OTHER

Original EMBED CDS

Interventions

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Nurse prompt

Nurse prompt to complete COWS

Intervention Type OTHER

Provider prompt

Provider prompt to use EMBED CDS

Intervention Type OTHER

Patient facing materials

Patient materials provided at discharge from ED

Intervention Type OTHER

EMBED

Original EMBED CDS

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward Melnick, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale New Haven Shoreline Medical Center

Guilford, Connecticut, United States

Site Status

Yale New Haven Hospital- St. Raphael

New Haven, Connecticut, United States

Site Status

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2000038624-A

Identifier Type: -

Identifier Source: org_study_id

5R33DA059884-02

Identifier Type: NIH

Identifier Source: secondary_id

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