Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 3
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is stage 3, 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 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 second round investigators will randomize an alert to providers to order a consult with addiction counselors. 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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Edward Melnick, MD, MHS
- Telefonnummer: 203-785-4363
- E-mail: edward.melnick@yale.edu
Undersøgelse Kontakt Backup
- Navn: Laurel Buchanan, MA
- Telefonnummer: 203-785-4363
- E-mail: laurel.buchanan@yale.edu
Studiesteder
-
-
Connecticut
-
Guilford, Connecticut, Forenede Stater, 06437
- Yale New Haven Shoreline Medical Center
-
New Haven, Connecticut, Forenede Stater, 06520
- Yale New Haven Hospital
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New Haven, Connecticut, Forenede Stater, 06510
- Yale New Haven Hospital- St. Raphael
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Forfinet EMBED CDS
EMBED CDS forbedret baseret på tidligere resultater
|
Raffineret EMBED CDS
Provider alert that nurse completed COWS
|
|
Eksperimentel: Refined EMBED plus provider alert the nurse completed COWS
Alert to provider in Epic that the nurse completed COWS
|
Provider alert that nurse completed COWS
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Andel af møder med buprenorphin-initiering på skadestuen
Tidsramme: Forsøgsrunde start til slut op til 3 måneder
|
Andel af kvalificerede konsultationer, hvor buprenorphin administreres på skadestuen (ED) og/eller ordineres buprenorphin ved udskrivning fra skadestuen.
Indhentet fra EHR-data. |
Forsøgsrunde start til slut op til 3 måneder
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Andel af berettigede konsultationer med CDS-engagement
Tidsramme: Forsøgsrundestart til slutning op til 3 måneder
|
Andel af berettigede møder, hvor en del af EMBED-arbejdsgangen blev dokumenteret eller afsluttet.
|
Forsøgsrundestart til slutning op til 3 måneder
|
|
Tid brugt på EMBED
Tidsramme: Forsøget runder start til slut op til 3 måneder
|
Tid (i sekunder) brugt på EMBED samlet set og efter komponent.
|
Forsøget runder start til slut op til 3 måneder
|
|
Task completion: Buprenorphine order or prescription placed
Tidsramme: 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.
|
Trial round start to end up to 3 months
|
|
Task Completion: Proportion of encounters with OUD diagnosis was recorded
Tidsramme: Trial round start to end up to 3 months
|
Proportion of encounters where EMBED was opened in which the OUD diagnosis was recorded.
|
Trial round start to end up to 3 months
|
|
Proportion of encounters in which buprenorphine was ordered through EMBED vs. externally
Tidsramme: 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).
|
Trial round start to end up to 3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Edward Mel, MD, MHS, Yale University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2000038624-B3
- 5R33DA059884-02 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
De-identified data sets used for analysis will be submitted to NAHDAP through the NIH HEAL Initiative and will be available for public use according to NAHDAP data sharing policies and restrictions set by our DUA with NAHDAP and our IRB. All data submissions to NAHDAP undergo confidentiality review to protect respondents' data from being re-identified.
Portions of the ADAPT intervention will be built for national distribution on the Epic EHR platform. Distribution of code that is proprietary to Epic may limit distribution of certain portions of software or code. In this situation, investigators will provide dashboards and visualizations of workflow diagrams as appropriate to disclose interface and workflow concepts to the broader scientific community These portions of the data will also be subject to restricted use access outside of organizations using Epic.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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