Daily Checklists and Outcome in the Intensive Care Unit
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Critical Illness |
Other: Electronic checklist Other: Verbal prompting |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
| Official Title: | Daily Checklists and Outcome in the Intensive Care Unit |
- Empiric Antibiotic Duration [ Time Frame: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary) ] [ Designated as safety issue: No ]
- Proportion of Empiric Antibiotics [ Time Frame: ICU admission ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]
- Length of Stay [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ] [ Designated as safety issue: No ]
- Ventilator-free Days [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]Proportion of patients-days on which empirical antibiotics were used
- Standardized Mortality Ratio [ Time Frame: Hospital admission ] [ Designated as safety issue: No ]
| Enrollment: | 451 |
| Study Start Date: | July 2011 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Electronic checklist
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.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Curtis H Weiss, MD | Northwestern University |
More Information
Publications:
| Responsible Party: | Curtis Weiss, Instructor of Medicine, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01396044 History of Changes |
| Other Study ID Numbers: | NUIRBSTU00013313 |
| Study First Received: | July 13, 2011 |
| Results First Received: | November 5, 2012 |
| Last Updated: | November 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
Quality improvement Checklist Critical care Anti-bacterial agents Mechanical ventilation |
Additional relevant MeSH terms:
|
Critical Illness Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013