- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07793383
Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 3
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Edward Melnick, MD, MHS
- Telefonnummer: 203-785-4363
- E-post: edward.melnick@yale.edu
Studera Kontakt Backup
- Namn: Laurel Buchanan, MA
- Telefonnummer: 203-785-4363
- E-post: laurel.buchanan@yale.edu
Studieorter
-
-
Connecticut
-
Guilford, Connecticut, Förenta staterna, 06437
- Yale New Haven Shoreline Medical Center
-
New Haven, Connecticut, Förenta staterna, 06520
- Yale New Haven Hospital
-
New Haven, Connecticut, Förenta staterna, 06510
- Yale New Haven Hospital- St. Raphael
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Förfinad EMBED CDS
Förfinat CDS-inbäddning baserat på tidigare resultat
|
Förfinad EMBED CDS
Provider alert that nurse completed COWS
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Andel möten med Buprenorfininledning på akutmottagningen
Tidsram: Testomgångs start till slut upp till 3 månader
|
Andelen berättigade möten där buprenorfin administrerats på akutmottagningen (ED) och/eller ordinerats buprenorfin vid utskrivning från ED.
Hämtat från EHR-data.
|
Testomgångs start till slut upp till 3 månader
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Andel berättigade möten med CDS-engagemang
Tidsram: PRövningsperiodens start till slut upp till 3 månader
|
Andel av berättigade möten där någon del av EMBED-arbetsflödet dokumenterades eller slutfördes.
|
PRövningsperiodens start till slut upp till 3 månader
|
|
Tid som spenderats på EMBED
Tidsram: Prövningsomgångens start till slut upp till 3 månader
|
Tid (i sekunder) tillbringad på EMBED totalt och per komponent.
|
Prövningsomgångens start till slut upp till 3 månader
|
|
Task completion: Buprenorphine order or prescription placed
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Edward Mel, MD, MHS, Yale University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2000038624-B3
- 5R33DA059884-02 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ANALYTIC_CODE
Läkemedels- och apparatinformation, studiedokument
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