Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 3
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Edward Melnick, MD, MHS
- Telefonnummer: 203-785-4363
- E-post: edward.melnick@yale.edu
Studer Kontakt Backup
- Navn: Laurel Buchanan, MA
- Telefonnummer: 203-785-4363
- E-post: laurel.buchanan@yale.edu
Studiesteder
-
-
Connecticut
-
Guilford, Connecticut, Forente stater, 06437
- Yale New Haven Shoreline Medical Center
-
New Haven, Connecticut, Forente stater, 06520
- Yale New Haven Hospital
-
New Haven, Connecticut, Forente stater, 06510
- Yale New Haven Hospital- St. Raphael
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Raffinert EMBED CDS
EMBED CDS raffinert basert på tidligere resultater
|
Raffinert EMBED CDS
Provider alert that nurse completed COWS
|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Andel møter med Buprenorfin-start i akuttmottaket
Tidsramme: Prøverunde start til slutt opptil 3 måneder
|
Andel kvalifiserte konsultasjoner der buprenorfin ble administrert i akuttmottaket og/eller foreskrevet ved utskrivelse fra akuttmottaket.
Hentet fra EHR-data. |
Prøverunde start til slutt opptil 3 måneder
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Andel kvalifiserte konsultasjoner med CDS-engasjement
Tidsramme: Trial round start to end up to 3 months
|
Andel av kvalifiserte møter der noen del av EMBED-arbeidsflyten ble dokumentert eller fullført.
|
Trial round start to end up to 3 months
|
|
Tid brukt på EMBED
Tidsramme: Forsøkets oppstart til slutt varer opptil 3 måneder
|
Tid (i sekunder) brukt på EMBED totalt og per komponent.
|
Forsøkets oppstart til slutt varer opptil 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Edward Mel, MD, MHS, Yale University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2000038624-B3
- 5R33DA059884-02 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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