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Trial record 1 of 1 for:    21616996 [PUBMED-IDS]
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Daily Checklists and Outcome in the Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT01396044
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Collaborator:
Parker B. Francis Fellowship Program
Information provided by (Responsible Party):
Curtis Weiss, Northwestern University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Health Services Research
Condition Critical Illness
Interventions Other: Electronic checklist
Other: Verbal prompting
Enrollment 451
Recruitment Details All patients admitted to the MICU service at Northwestern Memorial Hospital on or after June 27, 2011 and discharged on or prior to October 7, 2011 were enrolled. Exclusion criteria: patients transferred to or from a different ICU service, and MICU re-admission without intervening hospital discharge.
Pre-assignment Details Patients were included only if they were treated with at least one day of empirical antibiotics.
Arm/Group Title Electronic Checklist Verbal Prompting
Hide Arm/Group Description Electronic checklist Verbal prompting with written checklist
Period Title: Overall Study
Started 125 171
Completed 125 171
Not Completed 0 0
Arm/Group Title Electronic Checklist Verbal Prompting Total
Hide Arm/Group Description Electronic checklist Verbal prompting with written checklist Total of all reporting groups
Overall Number of Baseline Participants 125 171 296
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 171 participants 296 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
64
  51.2%
101
  59.1%
165
  55.7%
>=65 years
61
  48.8%
70
  40.9%
131
  44.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants 171 participants 296 participants
62.6  (17.6) 60.0  (17.8) 61.1  (17.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 171 participants 296 participants
Female
59
  47.2%
83
  48.5%
142
  48.0%
Male
66
  52.8%
88
  51.5%
154
  52.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 125 participants 171 participants 296 participants
125 171 296
1.Primary Outcome
Title Empiric Antibiotic Duration
Hide Description [Not Specified]
Time Frame During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one day of empirical antibiotics during their ICU admission.
Arm/Group Title Electronic Checklist Verbal Prompting
Hide Arm/Group Description:
Electronic checklist
Verbal prompting with written checklist
Overall Number of Participants Analyzed 125 171
Median (Inter-Quartile Range)
Unit of Measure: days
3
(2 to 4)
3
(1 to 5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Electronic Checklist, Verbal Prompting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Proportion of Empiric Antibiotics
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one day of empirical antibiotics during their ICU admission.
Arm/Group Title Electronic Checklist Verbal Prompting
Hide Arm/Group Description:
Electronic checklist
Verbal prompting with written checklist
Overall Number of Participants Analyzed 125 171
Mean (Standard Deviation)
Unit of Measure: proportion of antibiotic-days
0.83  (0.27) 0.78  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Electronic Checklist, Verbal Prompting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Hospital Mortality
Hide Description [Not Specified]
Time Frame During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients treated with at least one day of empirican antibiotics during ICU admission
Arm/Group Title Electronic Checklist Verbal Prompting
Hide Arm/Group Description:
Electronic checklist
Verbal prompting with written checklist
Overall Number of Participants Analyzed 125 171
Measure Type: Number
Unit of Measure: number of deaths
30 30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Electronic Checklist, Verbal Prompting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Length of Stay
Hide Description [Not Specified]
Time Frame During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients treated with at least one day of empirical antibiotics.
Arm/Group Title Electronic Checklist Verbal Prompting
Hide Arm/Group Description:
Electronic checklist
Verbal prompting with written checklist
Overall Number of Participants Analyzed 125 171
Median (Inter-Quartile Range)
Unit of Measure: days
2.8
(1.7 to 6.5)
2.6
(1.5 to 6.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Electronic Checklist, Verbal Prompting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Ventilator-free Days
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients treated with at least one day of empirical antibiotics.
Arm/Group Title Electronic Checklist Verbal Prompting
Hide Arm/Group Description:
Electronic checklist
Verbal prompting with written checklist
Overall Number of Participants Analyzed 125 171
Median (Inter-Quartile Range)
Unit of Measure: days
20.3
(0 to 25.9)
21.9
(13.5 to 25.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Electronic Checklist, Verbal Prompting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Proportion of Successful Prompts
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients treated with at least one day of empirical antibiotics.
Arm/Group Title Electronic Checklist Verbal Prompting
Hide Arm/Group Description:
Electronic checklist
Verbal prompting with written checklist
Overall Number of Participants Analyzed 125 171
Measure Type: Number
Unit of Measure: proportion of patient-days
0.096 0.436
7.Secondary Outcome
Title Proportion of Patients-days on Which Empirical Antibiotics Were Used
Hide Description Proportion of patients-days on which empirical antibiotics were used
Time Frame ICU admission
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one day of empirical antibiotics.
Arm/Group Title Electronic Checklist Verbal Prompting
Hide Arm/Group Description:
Electronic checklist
Verbal prompting with written checklist
Overall Number of Participants Analyzed 125 171
Measure Type: Number
Unit of Measure: Number of patient-days
498 702
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Electronic Checklist, Verbal Prompting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Secondary Outcome
Title Standardized Mortality Ratio
Hide Description [Not Specified]
Time Frame Hospital admission
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients treated with at least one day of empirical antibiotics.
Arm/Group Title Electronic Checklist Verbal Prompting
Hide Arm/Group Description:
Electronic checklist
Verbal prompting with written checklist
Overall Number of Participants Analyzed 125 171
Mean (95% Confidence Interval)
Unit of Measure: observed/expected deaths
0.70
(0.47 to 1.0)
0.64
(0.43 to 0.92)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Electronic Checklist Verbal Prompting
Hide Arm/Group Description Electronic checklist Verbal prompting with written checklist
All-Cause Mortality
Electronic Checklist Verbal Prompting
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Electronic Checklist Verbal Prompting
Affected / at Risk (%) Affected / at Risk (%)
Total   0/125 (0.00%)   0/171 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Electronic Checklist Verbal Prompting
Affected / at Risk (%) Affected / at Risk (%)
Total   0/125 (0.00%)   0/171 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Curtis Weiss
Organization: Northwestern University
Phone: (312) 695-6439
Responsible Party: Curtis Weiss, Northwestern University
ClinicalTrials.gov Identifier: NCT01396044     History of Changes
Other Study ID Numbers: NUIRBSTU00013313
First Submitted: July 13, 2011
First Posted: July 18, 2011
Results First Submitted: November 5, 2012
Results First Posted: December 4, 2012
Last Update Posted: December 4, 2012