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Daily Checklists and Outcome in the Intensive Care Unit

5. november 2012 opdateret af: Curtis Weiss, Northwestern University

Medical errors account for tens of thousands of deaths and tens of billions of dollars in healthcare costs in the United States every year. One field that has seen the strongest push toward quality improvement has been critical care medicine, likely because its particularly high degree of medical complexity makes it a practice area prone to high error rates with serious consequences. One of the most commonly used interventions used to help reduce errors in the intensive care unit (ICU) has been the implementation of checklists.

The investigators propose a clinical trial in a University critical care setting to determine whether an electronic checklist versus verbal prompting to use a written checklist improves clinical practice and patient outcomes. The investigators also plan to compare these data with a time period prior to the study to determine if the electronic checklist or verbal prompting are better than usual care. The investigators hypothesize that both the electronic checklist and verbal prompting to use a written checklist will be better for clinical practice and patient outcomes than usual care, and that verbal prompting will lead to better outcomes compared to the electronic checklist.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

451

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Admission to a medical intensive care unit (MICU) team during the study timeframe

Exclusion Criteria:

  • Transfer from MICU team to a separate ICU team within 12 hours of admission
  • Transfer to MICU team from a separate ICU team after more than 72 hours on the separate ICU team

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Electronic checklist
Electronic checklist for process of care issues implemented in our institution. Training on a regular basis of the electronic checklist arm to use the electronic checklist. Process of care issues on the electronic checklist include several that are under investigation: antibiotics and mechanical ventilation.
Eksperimentel: Verbal prompting
Verbal prompting with written checklist
Prompting by study investigators of physicians on the verbal prompting arm. Prompting will include questions related to antibiotic utilization and mechanical ventilation weaning.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Empiric Antibiotic Duration
Tidsramme: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
Proportion of Empiric Antibiotics
Tidsramme: ICU admission
The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).
ICU admission

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hospital Mortality
Tidsramme: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Length of Stay
Tidsramme: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Ventilator-free Days
Tidsramme: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.
During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Proportion of Successful Prompts
Tidsramme: During ICU admission, an average of 5 days (although individual patients may vary)

Prompting group: number of patient-days that prompting led to empirical antibiotics being discontinued or narrowed/number of patient-days prompting occurred

Electronic checklist group: number of patient-days that electronic checklist led to empirical antibiotics being discontinued or narrowed/number of patient-days electronic checklist was completed

During ICU admission, an average of 5 days (although individual patients may vary)
Proportion of Patients-days on Which Empirical Antibiotics Were Used
Tidsramme: ICU admission
Proportion of patients-days on which empirical antibiotics were used
ICU admission
Standardized Mortality Ratio
Tidsramme: Hospital admission
Hospital admission

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Curtis H Weiss, MD, Northwestern University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2011

Primær færdiggørelse (Faktiske)

1. april 2012

Studieafslutning (Faktiske)

1. april 2012

Datoer for studieregistrering

Først indsendt

13. juli 2011

Først indsendt, der opfyldte QC-kriterier

14. juli 2011

Først opslået (Skøn)

18. juli 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. december 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2012

Sidst verificeret

1. november 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NUIRBSTU00013313

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kritisk sygdom

Kliniske forsøg med Electronic checklist

Abonner