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OpenTrials
Completed

NCT Number: NCT01396044

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic checklist

Other

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.

Verbal prompting

Other

Prompting by study investigators of physicians on the verbal prompting arm. Prompting will include questions related to antibiotic utilization and mechanical ventilation weaning.

Primary outcomes

  1. Empiric Antibiotic Duration

    Time frame: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)

  2. Proportion of Empiric Antibiotics

    Time frame: ICU admission

    The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).

Secondary outcomes

  1. Hospital Mortality

    Time frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)

  2. Length of Stay

    Time frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)

  3. Ventilator-free Days

    Time frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)

    Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.

  4. Proportion of Successful Prompts

    Time frame: During ICU admission, an average of 5 days (although individual patients may vary)

    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

  5. Proportion of Patients-days on Which Empirical Antibiotics Were Used

    Time frame: ICU admission

    Proportion of patients-days on which empirical antibiotics were used

  6. Standardized Mortality Ratio

    Time frame: Hospital admission

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Parker B. Francis Fellowship Program

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 18, 2011
Registry last updated
Dec 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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