- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01396044
Daily Checklists and Outcome in the Intensive Care Unit
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60611
- Northwestern University
-
Chicago, Illinois, Stati Uniti, 60611
- Northwestern Memorial Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Empiric Antibiotic Duration
Lasso di tempo: 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
Lasso di tempo: ICU admission
|
The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).
|
ICU admission
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Hospital Mortality
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: ICU admission
|
Proportion of patients-days on which empirical antibiotics were used
|
ICU admission
|
|
Standardized Mortality Ratio
Lasso di tempo: Hospital admission
|
Hospital admission
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Curtis H Weiss, MD, Northwestern University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NUIRBSTU00013313
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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