Daily Checklists and Outcome in the Intensive Care Unit
|ClinicalTrials.gov Identifier: NCT01396044|
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : December 4, 2012
Last Update Posted : December 4, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness||Other: Electronic checklist Other: Verbal prompting||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||451 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Daily Checklists and Outcome in the Intensive Care Unit|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Experimental: Electronic checklist
Other: 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.
Experimental: Verbal prompting
Verbal prompting with written checklist
Other: Verbal prompting
Prompting by study investigators of physicians on the verbal prompting arm. Prompting will include questions related to antibiotic utilization and mechanical ventilation weaning.
- Empiric Antibiotic Duration [ Time Frame: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary) ]
- Proportion of Empiric Antibiotics [ Time Frame: ICU admission ]The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).
- Hospital Mortality [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ]
- Length of Stay [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ]
- Ventilator-free Days [ Time Frame: 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.
- Proportion of Successful Prompts [ Time Frame: 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
- Proportion of Patients-days on Which Empirical Antibiotics Were Used [ Time Frame: ICU admission ]Proportion of patients-days on which empirical antibiotics were used
- Standardized Mortality Ratio [ Time Frame: Hospital admission ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396044
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Curtis H Weiss, MD||Northwestern University|