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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: Electronic checklist; Other: Verbal prompting

• Study Type: Interventional
• Enrollment (Actual): 451
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Empiric Antibiotic Duration		During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Mortality		During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Length of Stay		During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
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)
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)
Proportion of Patients-days on Which Empirical Antibiotics Were Used	Proportion of patients-days on which empirical antibiotics were used	ICU admission
Standardized Mortality Ratio		Hospital admission

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Parker B. Francis Fellowship Program
• Investigators: Principal Investigator: Curtis H Weiss, MD, Northwestern University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: July 13, 2011
• First Submitted That Met QC Criteria: July 14, 2011
• First Posted (Estimate): July 18, 2011

Study Record Updates

• Last Update Posted (Estimate): December 4, 2012
• Last Update Submitted That Met QC Criteria: November 5, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Critical care; Quality improvement; Mechanical ventilation; Anti-bacterial agents; Checklist
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: NUIRBSTU00013313