Daily Checklists and Outcome in the Intensive Care Unit

Study Overview
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Brief Summary
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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.

Official Title
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Daily Checklists and Outcome in the Intensive Care Unit

Conditions
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Critical Illness

Intervention / Treatment
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* Other: Electronic checklist
* Other: Verbal prompting


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic checklist<br>Electronic checklist | Other: Electronic checklist<br>* 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.<br>|
| Experimental: Verbal prompting<br>Verbal prompting with written checklist | Other: Verbal prompting<br>* Prompting by study investigators of physicians on the verbal prompting arm. Prompting will include questions related to antibiotic utilization and mechanical ventilation weaning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Empiric Antibiotic Duration |  | During intensive care unit admission, an average of 5 days per patient (although individual patients may vary) | 
| Proportion of Empiric Antibiotics | The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics). | ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Mortality |  | During hospitalization, an average of 2 weeks per patient (although individual patients may vary) | 
| Length of Stay |  | During hospitalization, an average of 2 weeks per patient (although individual patients may vary) | 
| Ventilator-free Days | Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation. | During hospitalization, an average of 2 weeks per patient (although individual patients may vary) | 
| Proportion of Successful Prompts | 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 | During ICU admission, an average of 5 days (although individual patients may vary) | 
| Proportion of Patients-days on Which Empirical Antibiotics Were Used | Proportion of patients-days on which empirical antibiotics were used | ICU admission | 
| Standardized Mortality Ratio |  | Hospital admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality improvement, Checklist, Critical care, Anti-bacterial agents, Mechanical ventilation