- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03911687
(BEKYMRING) Clinical Decision Support (CDS) System
Kommunikation af narrative bekymringer indtastet af RNs (CONCERN) Clinical Decision Support (CDS) System
Der er patienter, der dør eller har et dårligt resultat på hospitalet, og dette kunne forebygges. Data i sygeplejerskernes notater kunne bruges af computere til at fortælle resten af plejeteamet, at en patient ikke har det godt, og at de bør handle hurtigere. Dette projekt skal bygge og evaluere et computersystem, der gør det nemmere for plejeteamet at se og forstå disse data og handle hurtigt for at redde patienterne. Formålet med denne undersøgelse er at besvare spørgsmålene, hvad er niveauet af udbyderens brug af CONCERN CDS notifikationssystemet (kaldet CONCERN SMARTapp) og den deraf følgende indvirkning på udvalgte patientresultater? Konkret har undersøgelsen 1) valideret ønskede tærskler for CONCERN CDS-systemet og 2) integreret CONCERN CDS-systemet til tidlig advarsel om risikable patienttilstande i CDS-værktøjer.
I denne del af undersøgelsen (mål 3) vil investigator implementere og evaluere CONCERN CDS-systemet om primære udfald af hospitalsdødelighed og liggetid og sekundære udfald af hjertestop, uventede overførsler til intensivafdelingen og 30 -genindlæggelsesrater på daghospital.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Årligt dør mere end 200.000 patienter på amerikanske hospitaler af hjertestop, og over 130.000 indlagte patienters dødsfald tilskrives sepsis. Disse dødsfald kan forebygges, hvis patienter, der er i fare, opdages tidligere. Tidligere arbejde fandt ud af, at sygeplejedokumentation inden for elektroniske sundhedsjournaler (EPJ'er) indeholder information, der kunne bidrage til tidlig opdagelse og behandling, men disse data bliver ikke analyseret og eksponeret af EPJ'er til klinikere for at igangsætte interventioner hurtigt nok til at redde patienter. En ny kilde til prædiktive data er defineret ved at analysere hyppigheden og typerne af sygeplejedokumentation, der indikerede sygeplejerskers øgede overvågning og niveau af bekymring for en patient. Disse data dokumenteret i de 48 timer forud for et hjertestop og hospitalsdødelighed var forudsigelige for hændelsen. Mens klinikere stræber efter at yde den bedste pleje, er der et systematisk problem inden for hospitalsmiljøer med ikke-optimal kommunikation mellem sygeplejersker og læger, hvilket fører til forsinkelser i behandlingen af patient i risikozonen. Veldesignede og testede EPJ'er er i stand til at trende data og understøtte kommunikation og beslutningstagning, men kommer for ofte til kort over disse mål og øger faktisk klinikerens kognitive belastning gennem fragmenterede informationsvisninger, "note bloat" og informationsoverbelastning. Substitutable Medical Applications & Reusable Technologies (SMARTapps) ved hjælp af Fast Health Interoperability Resource (FHIR) standard giver mulighed for åben deling og brug af innovationer på tværs af EPJ-systemer. Formålet med dette projekt er at designe og evaluere en SMART-app på FHIR, der bruges på tværs af to store akademiske medicinske centre, der eksponerer for læger og sygeplejersker vores nye forudsigende datakilde fra sygeplejedokumentation for at øge plejeteamets situationsbevidsthed om risikopatienter for at reducere forebyggelige uønskede resultater .
Kommunikation af narrative bekymringer indtastet af RNs (CONCERN) Clinical Decision Support (CDS) system er applikationen, der designes og evalueres. CONCERN Intervention Trial Design vil være en multipel tidsserieintervention. Baseline data vil blive indsamlet på alle undersøgelsessteder. Silent release-tilstand (ingen SMARTapp-meddelelse) vil blive brugt i ikke-ækvivalente kontrolenheder og som en post-intervention enhedskontrol til at evaluere, om underrettede klinikere kan reducere antallet af liggelængder på ikke-ICU-enheder og antallet af 30-dages hospitalsgenindlæggelser . Forskellige versioner af CDS-systemet (SMARTapp) vil blive inkorporeret for dynamisk, adaptiv funktionalitet og afgøre, om mønstret for sygeplejedokumentation har ændret sig. En "indbrændingsfase" er indbygget for at evaluere overtagelsen og tilpasningen til algoritmen og faserne for implementering af den stille frigivelsestilstand inden for interventionsforsøg med flere tidsserier for i alt 18 måneders dataindsamling, inklusive data før intervention opsamlings- og lydløs udløsningstilstande.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Brigham and Women's Hospital
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Newton, Massachusetts, Forenede Stater, 02462
- Newton-Wellesley Hospital
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New York
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New York, New York, Forenede Stater, 10032
- New York Presbyterian Columbia University Medical Center
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New York, New York, Forenede Stater, 10034
- New York Presbyterian Allen Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Undersøgelses inklusionskriterier for patienter:
- Indlagte patienter med et ophold på mindst 24 timer på en af vores studieenheder
Udelukkelseskriterier for undersøgelser for patienter:
- Indlagte patienter med mindre end 24 timer på en af vores studieenheder
- Patienter under 18 år
- Hospice patienter
- Havde ikke et hospitalsmøde, patienter ikke på en af vores undersøgelsesenheder.
Definition af studieenheder:
En klinisk enhed betragtes som en CONCERN-undersøgelsesenhed, hvis den opfylder følgende kriterier:
- En generel medicinsk eller kirurgisk akut- eller intensivafdeling
Følgende kliniske enheder betragtes IKKE som CONCERN-undersøgelsesenheder:
- Pædiatriske eller neonatale enheder
- Hospice enheder
- Skadestue
- Onkologiske enheder
- Fødselslæge (OB)/arbejds- og fødeafdelinger
- Adfærds-/psykiske enheder
- Observationsenheder
- Operationsstue
- Pre-op
- Post-op/post anesthesia Care Unit (PACU)
- Kirurgiske afdelinger samme dag
- Plast enheder
- Virtuelle afdelinger i EPJ-database.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Kontrolgruppe
Kontroldata vil blive indsamlet i CONCERN CDS-systemet, der vil være "live" i EPJ, men i silent release-tilstand (f.eks. ikke give besked til klinikere).
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Eksperimentel: Interventionsgruppe
Eksperimentelle data vil blive indsamlet i CONCERN CDS-systemet, der vil være "live" i EPJ i "aktiv" frigivelsestilstand (f.eks. give CONCERN CDS-systemunderretning til klinikere).
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CONCERN CDS vil udløse baseret på analyser af sygeplejedokumentation, der indikerer anerkendelse og bekymring for patientændringer. CONCERN CDS vil advare plejeteamet om patientens "risikofyldte tilstand" for at øge teambaseret situationsbevidsthed (dvs. delt forståelse af patientsituationen) hos patienter, der forudsiges at være i risiko for, at patienten dekompenserer med behov for hurtig intervention for at forhindre dødelighed og tilhørende skade. Version 1: Brænd i fase for at evaluere adoption og tilpasning til den algoritme, der undersøges. Forventet tidsramme - 3 måneder Version 2: Version 2 forfinet baseret på løbende overvågning af data. Forventet tidsramme - 3 måneder Version 3: Version 3 forfinet baseret på løbende overvågning af data. Forventet tidsramme - 3 måneder
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Dødeligheder på hospitalet
Tidsramme: Op til 24 måneder
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Antal patientdødsfald, der forekommer på hospitalet.
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Op til 24 måneder
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Gennemsnitlig længde af hospitalets ophold
Tidsramme: Op til 24 måneder
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Antallet af dage, hvor en patient var på hospitalet
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Op til 24 måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Antal hjertestop
Tidsramme: Op til 24 måneder
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Kardiopulmonale begivenheder under indlæggelse
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Op til 24 måneder
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Antal erhvervet sepsis
Tidsramme: Op til 24 måneder
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Sepsis, der forekommer under indlæggelse
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Op til 24 måneder
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Antal uventede overførsler til ICU
Tidsramme: Op til 24 måneder
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Overførsel til ICU fra akutte plejeundersøgelsesenheder under indlæggelse
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Op til 24 måneder
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Antal tilbagetagelser på hospitalet
Tidsramme: Op til 24 måneder
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Tilbagetagelse til hospitalet inden for 30 dage efter at de blev udskrevet i live.
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Op til 24 måneder
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Patricia Dykes, PhD, Brigham and Women's Hospital
- Ledende efterforsker: Sarah Collins Rossetti, PhD, Columbia University
- Ledende efterforsker: Kenrick Cato, PhD, Columbia University
Publikationer og nyttige links
Generelle publikationer
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