Daily Checklists and Outcome in the Intensive Care Unit
Primary Purpose
Critical Illness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic checklist
Verbal prompting
Sponsored by
About this trial
This is an interventional health services research trial for Critical Illness focused on measuring Quality improvement, Checklist, Critical care, Anti-bacterial agents, Mechanical ventilation
Eligibility Criteria
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
Sites / Locations
- Northwestern Memorial Hospital
- Northwestern University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Electronic checklist
Verbal prompting
Arm Description
Electronic checklist
Verbal prompting with written checklist
Outcomes
Primary Outcome Measures
Empiric Antibiotic Duration
Proportion of Empiric Antibiotics
The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).
Secondary Outcome Measures
Hospital Mortality
Length of Stay
Ventilator-free Days
Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.
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
Proportion of Patients-days on Which Empirical Antibiotics Were Used
Proportion of patients-days on which empirical antibiotics were used
Standardized Mortality Ratio
Full Information
NCT ID
NCT01396044
First Posted
July 13, 2011
Last Updated
November 5, 2012
Sponsor
Northwestern University
Collaborators
Parker B. Francis Fellowship Program
1. Study Identification
Unique Protocol Identification Number
NCT01396044
Brief Title
Daily Checklists and Outcome in the Intensive Care Unit
Official Title
Daily Checklists and Outcome in the Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Parker B. Francis Fellowship Program
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Quality improvement, Checklist, Critical care, Anti-bacterial agents, Mechanical ventilation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
451 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electronic checklist
Arm Type
Experimental
Arm Description
Electronic checklist
Arm Title
Verbal prompting
Arm Type
Experimental
Arm Description
Verbal prompting with written checklist
Intervention Type
Other
Intervention Name(s)
Electronic checklist
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Verbal prompting
Intervention Description
Prompting by study investigators of physicians on the verbal prompting arm. Prompting will include questions related to antibiotic utilization and mechanical ventilation weaning.
Primary Outcome Measure Information:
Title
Empiric Antibiotic Duration
Time Frame
During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
Title
Proportion of Empiric Antibiotics
Description
The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).
Time Frame
ICU admission
Secondary Outcome Measure Information:
Title
Hospital Mortality
Time Frame
During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Title
Length of Stay
Time Frame
During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Title
Ventilator-free Days
Description
Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.
Time Frame
During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Title
Proportion of Successful Prompts
Description
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
Time Frame
During ICU admission, an average of 5 days (although individual patients may vary)
Title
Proportion of Patients-days on Which Empirical Antibiotics Were Used
Description
Proportion of patients-days on which empirical antibiotics were used
Time Frame
ICU admission
Title
Standardized Mortality Ratio
Time Frame
Hospital admission
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis H Weiss, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21616996
Citation
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.
Results Reference
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Daily Checklists and Outcome in the Intensive Care Unit
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