- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04381260
RUrale forskelle i præhospital STEMI
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Opnåelse af PCI-tidsmål er påvirket af flere faktorer, såsom patientegenskaber, agentfaktorer og elementer i organisatorisk Emergency Medical Services (EMS) kultur. Organisationskultur er defineret som et sæt af fælles værdier, overbevisninger og antagelser i en organisation, der påvirker, hvordan mennesker i den pågældende organisation opfører sig. Forskelle i organisationskultur mellem hospitaler har været forbundet med både kardiovaskulær dødelighed og sygdomsspecifikke udfald. Selvom det endnu ikke er grundigt undersøgt i det præhospitale miljø, er det sandsynligt, at organisationskultur bidrager til forskelle i tempo og måde at gennemføre interventioner på. Præhospital præstationsansvarlighed og kultur er blevet diskuteret af eksperter i EMS-magasiner, men er aldrig blevet formelt undersøgt.
EMS STEMI-protokoller, der inkluderer direkte transport til et PCI-kompatibelt hospital og aktivering af et præhospitalt PCI-center, forbedrer patientresultaterne. Mislykket EKG-transmission, forsinket PCI-centeraktivering og kardiogent shock har vist sig at påvirke PCI-tidsmålinger og patientresultater negativt. Virkningen af PCI-forsinkelser i landdistrikterne er ikke blevet specifikt undersøgt. Derudover er der faktorer på agenturniveau, såsom ambulancer pr. indbygger, antal satellitstationer, miles af interstate, der sandsynligvis påvirker EMS-agenturets evne til at opnå kortere PCI-tider for de STEMI-patienter, de plejer. Dette forslag vil bruge blandede metoder til at identificere tidligere umålte komponenter i landdistrikternes EMS-agenturs organisationskultur, struktur, plejeprocesser og patientmiljø, der sandsynligvis påvirker PCI-tid og patientresultater. Derudover vil dette projekt identificere bedste praksis, der kan testes som nye interventioner og implementeres i landdistrikterne EMS-agenturer for at forbedre STEMI-tidsmålinger og derfor reducere patientmorbiditet og dødelighed.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University Health Sciences
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Register: Patienter, der er inkluderet i registerdataene, vil være en allemandspopulation af patienter, der lider af STEMI og transporteret til en primær PCI af et af 14 identificerede EMS-agenturer i landdistrikterne mellem 2016-2019.
Nøgleinformantinterviews: Deltagerne vil være EMS-direktører, EMS-medicinske direktører, EMS-træningsofficerer, paramedicinere eller EMT-besætningspartnere ved de højeste og lavest præsterende EMS-kontorer i landdistrikterne som bestemt af STEMI-registerdataene.
Interessentundersøgelser: Respondenter af undersøgelsen vil være EMS-direktører, EMS-medicinske direktører, EMS-uddannelsesofficerer, paramedicinere eller EMT-besætningspartnere på et af de 14 lokale EMS-agenturer, der er identificeret som landdistrikter.
Beskrivelse
STEMI register:
Inkludering:
- Alder ≥ 18 år
- Transporteret til et af fire primære PCI-centre (Wake Forest Baptist Medical Center (WFBMC), High Point Regional Medical Center (HPRMC), Novant Forsyth Medical Center (FMC) og Moses Cone) af landdistriktsagentur (amt identificeret landligt ved 2014 Census) ambulance fra 2016-2019
- STEMI identificeret før eller ved ankomst til hospitalet
Undtagelse:
- Ingen
Nøgleinformantinterviews:
Inkludering:
- Landdistriktsagentur (amt identificeret landdistrikt ved folketællingen 2014)
- Identificeret som de to øverste eller nederste udførende tjenester rangeret efter samlet PCI-tid af regionale STEMI-registerpatienter transporteret til primært PCI-center fra 2016-2019
- Hold stillingen som EMS Director, EMS Medical Director, EMS Training Officer, Paramedic (2), EMT Crew Partner (2) eller besidder en lignende nøgleinformantstilling hos et lokalt urban EMS-agentur (Forsyth county EMS) for at give interviewguiden mulighed for at blive testet i marken
Undtagelse:
- Ingen
Interessentundersøgelse:
Inkludering:
- Landdistriktsagentur (amt identificeret landdistrikt ved 2014 Census) transporteret til primært PCI-center fra 2016-2019
- Hold stillingen som EMS Director, EMS Medical Director eller EMS Training Officer eller vær en feltudbyder med en paramediciner eller EMT certificering
Undtagelse:
- Ingen
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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2016-2019 STEMI Registry
Retrospektive data vil blive indsamlet for at udvikle et velkarakteriseret register over patienter behandlet fra 2016-2019 af et hvilket som helst af 14 lokale EMS-agenturer i landdistrikterne og transporteret til en facilitet, der er i stand til at udføre perkutan koronar intervention.
Dette register vil blive brugt til at bestemme tiden til PCI-ydelse for hvert af EMS-bureauerne.
Tiden vil blive justeret for patientafstand fra et PCI-center ved hjælp af en lineær blandet model med en tilfældig effekt for centrum og en fast effekt for afstand.
Denne proces vil tillade kvalitative metoder til at identificere organisationskultur, struktur og kliniske processer, der påvirker STEMI-pleje fra de to højest og lavest præsterende EMS-agenturer i landdistrikterne.
(n=750)
|
Der er ingen intervention for patienter inkluderet i denne gruppe, da dette kun er et retrospektivt dataregister.
|
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Nøgleinformantinterviews
Efter at have identificeret de to højest og lavest præsterende EMS-bureauer i landdistrikterne i STEMI-registret for 2016-2019, vil nøglemedarbejdere fra hvert af disse agenturer blive rekrutteret til at deltage i semistrukturerede nøgleinformantinterviews.
Samtalerne vil vurdere den aktuelle kliniske pleje, organisationskultur og muligheder for forbedringer.
(n=32)
|
Nøgleinformantinterview
|
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Interessentundersøgelser
Medarbejdere på alle lokale EMS-bureauer vil blive inviteret til at deltage i interessentundersøgelser for at kvantificere hvert enkelt agenturs brug af de plejestrategier, der er identificeret under nøgleinformationsinterviews.
(n=240)
|
Interessentundersøgelse
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Sammenlign organisationskulturen, strukturen og de kliniske processer i høj- og lavtydende lokale EMS-bureauer i landdistrikterne ved hjælp af kvalitative metoder
Tidsramme: 1 dag
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Mål 1 vil blive opnået ved at udvikle et 2016-2019 STEMI-dataregister, som vil blive brugt til at identificere høj- og lavtydende EMS-agenturer i landdistrikter.
Efter at have identificeret disse bureauer, vil nøgleinformanter deltage i interviews designet til at vurdere facilitatorer og barrierer for at opnå STEMI-tidsmålinger.
|
1 dag
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Kvantificer sammenhængen mellem faktorer identificeret i mål 1 og PCI-tid blandt landdistrikterne EMS STEMI-patienter.
Tidsramme: 1 dag
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Interessentundersøgelser vil blive brugt til at kvantificere hvert agenturs brug af faktorer identificeret i mål 1
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1 dag
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jason M Stopyra, MD, Wake Forest Health Sciences
Publikationer og nyttige links
Generelle publikationer
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- IRB00064512
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