Daily Checklists and Outcome in the Intensive Care Unit

This study has been completed.
Sponsor:
Collaborator:
Parker B. Francis Fellowship Program
Information provided by (Responsible Party):
Curtis Weiss, Northwestern University
ClinicalTrials.gov Identifier:
NCT01396044
First received: July 13, 2011
Last updated: November 5, 2012
Last verified: November 2012
Results First Received: November 5, 2012  
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
Condition: Critical Illness
Interventions: Other: Electronic checklist
Other: Verbal prompting

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were included only if they were treated with at least one day of empirical antibiotics.

Reporting Groups
  Description
Electronic Checklist Electronic checklist
Verbal Prompting Verbal prompting with written checklist

Participant Flow:   Overall Study
    Electronic Checklist     Verbal Prompting  
STARTED     125     171  
COMPLETED     125     171  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Electronic Checklist Electronic checklist
Verbal Prompting Verbal prompting with written checklist
Total Total of all reporting groups

Baseline Measures
    Electronic Checklist     Verbal Prompting     Total  
Number of Participants  
[units: participants]
  125     171     296  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     64     101     165  
>=65 years     61     70     131  
Age  
[units: years]
Mean ± Standard Deviation
  62.6  ± 17.6     60.0  ± 17.8     61.1  ± 17.8  
Gender  
[units: participants]
     
Female     59     83     142  
Male     66     88     154  
Region of Enrollment  
[units: participants]
     
United States     125     171     296  



  Outcome Measures
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1.  Primary:   Empiric Antibiotic Duration   [ Time Frame: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary) ]

2.  Primary:   Proportion of Empiric Antibiotics   [ Time Frame: ICU admission ]

3.  Secondary:   Hospital Mortality   [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ]

4.  Secondary:   Length of Stay   [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ]

5.  Secondary:   Ventilator-free Days   [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ]

6.  Secondary:   Proportion of Successful Prompts   [ Time Frame: During ICU admission, an average of 5 days (although individual patients may vary) ]

7.  Secondary:   Proportion of Patients-days on Which Empirical Antibiotics Were Used   [ Time Frame: ICU admission ]

8.  Secondary:   Standardized Mortality Ratio   [ Time Frame: Hospital admission ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Curtis Weiss
Organization: Northwestern University
phone: (312) 695-6439
e-mail: curtisweiss@northwestern.edu


Publications:

Responsible Party: Curtis Weiss, 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