- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07602218
Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 2
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is stage 2, 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 we 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, 06510
- Yale New Haven Hospital
-
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: Active Comparator: Refined EMBED CDS
EMBED CDS refined based on previous results
|
Raffineret EMBED CDS
|
|
Eksperimentel: Refined EMBED plus provider alert in Epic to order a consult with an addiction counselor
Provider alert in Epic to order a consult with an addiction counselor to assess for eligibility and initiation of MOUD
|
Raffineret EMBED CDS
Provider alert to order consult with addiction counselor
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of encounters with an order for an addiction counselor consult
Tidsramme: Trial round start to end up to 3 months
|
Proportion of encounters with documentation of a clinician order for an addiction counselor consult specifically to assess for eligibility and initiation of MOUD.
|
Trial round start to end up to 3 months
|
Sekundære 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
|
|
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
|
|
Andel af møder, hvor buprenorphin blev ordineret via EMBED vs. eksternt.
Tidsramme: Forsøgets runde starter til slutter op til 3 måneder
|
Andel af berettigede møder, hvor buprenorphin ordren placeres via EMBED (dvs. ved brug af EMBED ordresæt)
|
Forsøgets runde starter til slutter op til 3 måneder
|
|
Teamwork on ED initiation of buprenorphine
Tidsramme: Trial round start to end up to 3 months
|
Proportion of encounters with multi-team-member use of EMBED for buprenorphine initiation, out of encounters with any team member use of EMBED for buprenorphine initiation
|
Trial round start to end up to 3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Edward Edward, MD, MHS, Yale University
Publikationer og nyttige links
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-B2
- 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
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Opioidbrugsforstyrrelse
-
University of North Carolina, Chapel HillIkke rekrutterer endnuOpioid ordinationForenede Stater
-
Montefiore Medical CenterRekrutteringOpioid tilspidsendeForenede Stater
-
University of MichiganThe Benter FoundationAfsluttetOpioid ordinationForenede Stater
-
matthieu clanetAfsluttet
-
University of MichiganNational Institute on Drug Abuse (NIDA)AfsluttetOpioid ordinationForenede Stater
-
University of North Carolina, Chapel HillNorth Carolina Department of Health and Human ServicesAfsluttetAnalgetika OpioidForenede Stater
-
Purdue Pharma LPAfsluttetOpioid analgesiForenede Stater, Australien, Finland, New Zealand
-
St. Louis UniversityAfsluttetOpioid-vedligeholdte gravide kvinder
-
Frederiksberg University HospitalAfsluttet
-
Second Hospital of Shanxi Medical UniversityRekrutteringOpioid analgetisk bivirkningKina
Kliniske forsøg med Refined EMBED CDS
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... og andre samarbejdspartnereAfsluttetKronisk nyresygdom | Kronisk nyreinsufficiens | Kronisk nyreinsufficiens | Kroniske nyresygdomme | Nyreinsufficiens, kroniskForenede Stater
-
New York City Department of Health and Mental HygieneAgency for Healthcare Research and Quality (AHRQ); NYUAfsluttetForhøjet blodtrykForenede Stater
-
Children's Hospital of PhiladelphiaAfsluttetSøvn | Obstruktiv søvnapnø | Søvnforstyrret vejrtrækningForenede Stater
-
Vanderbilt University Medical CenterAfsluttetSelvmordstanker | Selvmord, ForsøgForenede Stater
-
Children's Hospital of PhiladelphiaNational Heart, Lung, and Blood Institute (NHLBI)Rekruttering
-
Intermountain Health Care, Inc.AfsluttetLungebetændelseForenede Stater
-
Ann & Robert H Lurie Children's Hospital of ChicagoNational Institute of Allergy and Infectious Diseases (NIAID)AfsluttetFødevareallergi Peanut | Fødevareallergi hos spædbørnForenede Stater
-
Academisch Medisch Centrum - Universiteit van Amsterdam...VU University of AmsterdamRekrutteringPancreas Neoplasma | Distalt cholangiocarcinom | Biliær obstruktionHolland
-
Kaiser PermanenteUniversity of California, San Francisco; OCHIN, Inc.AfsluttetForhøjet blodtryk | Diabetes mellitus, type 2Forenede Stater
-
HealthPartners InstituteKaiser Permanente; Children's Hospitals and Clinics of MinnesotaAfsluttetBlindtarmsbetændelseForenede Stater