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

July 13, 2011
November 5, 2012
July 2011
April 2012   (final data collection date for primary outcome measure)
  • Empiric Antibiotic Duration [ Time Frame: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary) ] [ Designated as safety issue: No ]
  • Proportion of Empiric Antibiotics [ Time Frame: ICU admission ] [ Designated as safety issue: No ]
    The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).
Same as current
Complete list of historical versions of study NCT01396044 on ClinicalTrials.gov Archive Site
  • Hospital Mortality [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ] [ Designated as safety issue: No ]
  • Length of Stay [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ] [ Designated as safety issue: No ]
  • Ventilator-free Days [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ] [ Designated as safety issue: No ]
    Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.
  • Proportion of Successful Prompts [ Time Frame: During ICU admission, an average of 5 days (although individual patients may vary) ] [ Designated as safety issue: No ]

    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 [ Time Frame: ICU admission ] [ Designated as safety issue: No ]
    Proportion of patients-days on which empirical antibiotics were used
  • Standardized Mortality Ratio [ Time Frame: Hospital admission ] [ Designated as safety issue: No ]
  • Severity-adjusted mortality [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ] [ Designated as safety issue: No ]
  • Severity-adjusted length of stay [ Time Frame: During intensive care unit admission, an average of 5 days (although individual patients may vary) ] [ Designated as safety issue: No ]
  • Length of stay [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ] [ Designated as safety issue: No ]
  • Ventilator-free days [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ] [ Designated as safety issue: No ]
    Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.
  • Ventilator-associated pneumonia [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ] [ Designated as safety issue: No ]
    Presence of pneumonia associated with mechanical ventilation
  • Antibiotic resistance [ Time Frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary) ] [ Designated as safety issue: No ]
    Evidence of microbiologic organism resistance to administered antibiotics
  • Amount of prompting [ Time Frame: During ICU admission, an average of 5 days (although individual patients may vary) ] [ Designated as safety issue: No ]
    Amount of prompting required for each clinical practice under examination
Not Provided
Not Provided
 
Daily Checklists and Outcome in the Intensive Care Unit
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Critical Illness
  • 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.
  • 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.
  • Experimental: Electronic checklist
    Electronic checklist
    Intervention: Other: Electronic checklist
  • Experimental: Verbal prompting
    Verbal prompting with written checklist
    Intervention: Other: Verbal prompting
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
451
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01396044
NUIRBSTU00013313
No
Curtis Weiss, Northwestern University
Northwestern University
Parker B. Francis Fellowship Program
Principal Investigator: Curtis H Weiss, MD Northwestern University
Northwestern University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP