- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06932341
Udnyttelse af elektroniske sundhedsrekordværktøjer til forbedring af den evidensbaserede behandling af børn, der er indlagt med bronchiolitis
Brug af en BPA til fremme af pleje af høj værdi i bronchiolitis: en randomiseret kontrolleret undersøgelse
Målet med denne eksperimentelle undersøgelse er at lære, om forskellige typer af bedste praksis-rådgivere (BPA'er), der direkte klinikere til at referere til kliniske retningslinjer, der er indlejret i den elektroniske sundhedsrekord (EHR), øger levering af evidensbaseret pleje hos børn, der præsenterer for hospitalet med bronchiolitis. De vigtigste spørgsmål, det sigter mod at besvare, er:
- Forbedrer BPA'er klinikernes levering af retningslinje-koncerts pleje i bronchiolitis?
- Forbedrer interruptive BPA'er retningslinjekoncordant pleje af bronchiolitis mere end ikke-interruptive BPA'er?
Forskere vil sammenligne behandlingen og resultaterne af patienter, hvis klinikere ikke modtog en BPA, med dem, hvis klinikere modtog en ikke-oprindiv BPA, til dem, hvis klinikere modtog en interruptive BPA.
Patienter vil fortsat modtage standard hospitalpleje for bronchiolitis.
Klinikere vil:
- Bevar adgang til en EHR-indlejret klinisk retningslinje for bronchiolitis-pleje
- Bliv udsat for enten ingen BPA, en ikke-interruptiv BPA eller en interruptive BPA, der fremmer den EHR-indlejrede kliniske retningslinje (randomiseret pr. Patientmøde)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Bronchiolitis, en viral luftvejssygdom, der påvirker spædbørn og småbørn, er den mest almindelige grund til, at børn, der er mindre end 2 år gamle, indlagt. Imidlertid får mange børn, der er indlagt med bronchiolitis, unødvendige behandlinger, der ikke fremskynder bedring og kan endda forårsage skade. På trods af bevis for, at den bedste behandling af bronchiolitis er støttende pleje (dvs. Oxygen- og hydratiseringsstøtte), klinikere fortsat overforbruger visse behandlinger, hvilket fører til længere hospitalophold, højere omkostninger og øget stress for familier.
Efterforskerne vil undersøge virkningerne af BPA'er, som er realtidsadvarsler inden for EHR. BPA'erne i denne undersøgelse fremmer brugen af en evidensbaseret pleje retningslinje for bronchiolitis, der er indlejret i EHR. Der er flere BPA -design, der ofte bruges i EHR'er: 1) interruptive BPA'er, som kræver, at klinikere interagerer med alarmen for at fortsætte klinikerens arbejdsgang; og 2) ikke-interruptive BPA'er, der vises som visuelle signaler, men ikke kræver, at klinikere ændrer arbejdsgange.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Benjamin E Bodnar, MD
- Telefonnummer: 410-614-4474
- E-mail: bbodnar2@jh.edu
Studiesteder
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Florida
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St. Petersburg, Florida, Forenede Stater, 33701
- Rekruttering
- Johns Hopkins All Children's Hospital
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Kontakt:
- Johns Hopkins IRB Office
- Telefonnummer: 410-502-2092
- E-mail: jhmeirb@jhmi.edu
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Maryland
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Baltimore, Maryland, Forenede Stater, 21224
- Rekruttering
- Johns Hopkins Bayview Medical Center
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Kontakt:
- Johns Hopkins IRB Office
- Telefonnummer: 410-502-2092
- E-mail: jhmeirb@jhmi.edu
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Baltimore, Maryland, Forenede Stater, 21287
- Rekruttering
- Johns Hopkins Children's Center
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Kontakt:
- Johns Hopkins IRB Office
- Telefonnummer: 410-502-2092
- E-mail: jhmeirb@jhmi.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
Kriterier for indeslutning af patient:
- Børn <= 24 måneders alder, der præsenterer for alarmrummet og/eller indlagt på hospitalet (under observation eller indpatientstatus) med bronchiolitis på et af tre undersøgelsessteder.
Kriterier for ekskludering af patient:
- Aktuelt møde er fødselsindhold
- I øjeblikket indlagt på en ICU
- Indlagt med opholdets længde> 14 dage
Kriterier for inkludering af kliniker:
- Læger og avancerede praksisudbydere, der kommer ind i patientens diagram eller ordrerindgangsaktivitet for akuttafdeling (ED) og indpatientmøder
Klinikernes ekskluderingskriterier:
- Læger og avancerede praksisudbydere, der ikke går ind i patientens diagram eller ordrer til indgangsaktivitet
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: No EHR-Alert
Clinicians will not be exposed to a any EHR-alert about the care of bronchiolitis.
The participants will still have access to the EHR-embedded, evidence-based clinical guideline.
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|
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Eksperimentel: Interruptive EHR-Alert
Clinicians will be exposed to an interruptive EHR-alert directing the clinician to reference the EHR-embedded, evidence-based clinical guideline for the care of bronchiolitis.
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The interruptive EHR alert requires clinicians to interact with the alert to continue the workflow.
The alert directs clinicians to reference the EHR-embedded, evidence-based clinical guideline for the care of bronchiolitis.
|
|
Eksperimentel: Non-interruptive EHR-Alert
Clinicians will be exposed to an non-interruptive EHR-Alert directing the clinician to reference the EHR-embedded, evidence-based clinical guideline for the care of bronchiolitis.
|
The non-interruptive EHR alert appears as a visual cue but does not require clinicians to alter workflows.
The alert directs clinicians to reference the EHR-embedded, evidence-based clinical guideline for the care of bronchiolitis.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of encounters provider utilizes EHR-integrated clinical decision support tool
Tidsramme: From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
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Use of the EHR-integrated Clinical Decision Support Guideline.
The proportion of encounters in which a provider utilizes the EHR-integrated clinical decision support tool for the care of bronchiolitis during a given encounter.
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From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of encounters providers utilize the EHR-integrated clinical decision support tool for the care of bronchiolitis
Tidsramme: From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
|
Multiple Use of the EHR-integrated clinical decision support guideline.
The proportion of encounters in which providers utilize the EHR-integrated clinical decision support tool for the care of bronchiolitis multiple times (2 or more times) during a given encounter.
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From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
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Proportion of encounters a provider enters orders via the EHR-integrated clinical decision support tool
Tidsramme: From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
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Order entry via the EHR-integrated clinical decision support guideline.
The proportion of encounters a provider enters orders via the EHR-integrated clinical decision support tool for the care of bronchiolitis during a given encounter.
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From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of patients who receive any subtherapeutic high flow nasal cannula (HFNC) treatment
Tidsramme: From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
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Post-randomization - Individual Clinical Outcome 1 - Subtherapeutic HFNC.
The proportion of patients who receive any subtherapeutic high flow nasal cannula (HFNC) treatment, defined as HFNC with a flow rate <1L/kg/min for patients <15kg or <15L/min for patients >15kg.
Comparator groups will be those in whom providers utilized the EHR-integrated clinical decision support guideline vs. those in whom the guideline was not accessed.
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From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
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|
The average number of hours during which a patient received subtherapeutic high flow nasal cannula (HFNC) treatment
Tidsramme: From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
|
Post Randomization - Individual Clinical Outcome 2 - Hours spent on subtherapeutic HFNC.
The average number of hours during which a patient received subtherapeutic high flow nasal cannula (HFNC) treatment, defined as HFNC with a flow rate <1L/kg/min for patients <15kg or <15L/min for patients >15kg.
Comparator groups will be those in whom providers utilized the EHR-integrated clinical decision support guideline vs. those in whom the guideline was not accessed.
|
From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
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Proportion of patients who receive any treatment with high flow nasal cannula
Tidsramme: From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
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Post Randomization - Systems Level Outcome 1 - Proportion Receiving any HFNC.
The proportion of patients who receive any treatment with high flow nasal cannula.
Comparator groups will be those in whom providers utilized the EHR-integrated clinical decision support guideline vs. those in whom the guideline was not accessed.
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From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
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The total time (in hours) during which patients received any treatment with high flow nasal cannula
Tidsramme: From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
|
Post Randomization - Systems Level Outcome 2 - Total time on HFNC.
The total time (in hours) during which patients received any treatment with high flow nasal cannula.
Comparator groups will be those in whom providers utilized the EHR-integrated clinical decision support guideline vs. those in whom the guideline was not accessed.
|
From enrollment to the end of ED encounter (approximately <24 hours) for non-hospitalized patients; End of hospital stay (approximately 2-4 days) for hospitalized patients
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Benjamin E Bodnar, MD, Johns Hopkins University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00456658
Plan for individuelle deltagerdata (IPD)
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