Daily Checklists and Outcome in the Intensive Care Unit

Critical Illness Clinical Trial

Official title:

Daily Checklists and Outcome in the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396044
• Other study ID #: NUIRBSTU00013313
• Status: Completed
• Phase: N/A
• First received: July 13, 2011
• Last updated: November 5, 2012
• Start date: July 2011
• Est. completion date: April 2012

Study information

• Verified date: November 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Critical Illness

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Parker B. Francis Fellowship Program

Country where clinical trial is conducted

United States, 

References & Publications (1)

Weiss CH, Moazed F, McEvoy CA, Singer BD, Szleifer I, Amaral LA, Kwasny M, Watts CM, Persell SD, Baker DW, Sznajder JI, Wunderink RG. Prompting physicians to address a daily checklist and process of care and clinical outcomes: a single-site study. Am J Respir Crit Care Med. 2011 Sep 15;184(6):680-6. doi: 10.1164/rccm.201101-0037OC. Epub 2011 May 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Empiric Antibiotic Duration		During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)	No
Primary	Proportion of Empiric Antibiotics	The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).	ICU admission	No
Secondary	Hospital Mortality		During hospitalization, an average of 2 weeks per patient (although individual patients may vary)	No
Secondary	Length of Stay		During hospitalization, an average of 2 weeks per patient (although individual patients may vary)	No
Secondary	Ventilator-free Days	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)	No
Secondary	Proportion of Successful Prompts	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)	No
Secondary	Proportion of Patients-days on Which Empirical Antibiotics Were Used	Proportion of patients-days on which empirical antibiotics were used	ICU admission	No
Secondary	Standardized Mortality Ratio		Hospital admission	No