- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Illinois
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Chicago, Illinois, États-Unis, 60611
- Northwestern University
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Chicago, Illinois, États-Unis, 60611
- Northwestern Memorial Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Empiric Antibiotic Duration
Délai: 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
Délai: ICU admission
|
The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).
|
ICU admission
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hospital Mortality
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: ICU admission
|
Proportion of patients-days on which empirical antibiotics were used
|
ICU admission
|
|
Standardized Mortality Ratio
Délai: Hospital admission
|
Hospital admission
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Curtis H Weiss, MD, Northwestern University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NUIRBSTU00013313
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