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
  Purpose

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.


Condition Intervention
Critical Illness
Other: Electronic checklist
Other: Verbal prompting

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
Official Title: Daily Checklists and Outcome in the Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 451
Study Start Date: July 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electronic checklist
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396044

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Parker B. Francis Fellowship Program
Investigators
Principal Investigator: Curtis H Weiss, MD Northwestern University
  More Information

Publications:
Responsible Party: Curtis Weiss, Instructor of Medicine, 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

Keywords provided by Northwestern University:
Quality improvement
Checklist
Critical care
Anti-bacterial agents
Mechanical ventilation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014