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| Name | Class |
|---|---|
| Parker B. Francis Fellowship Program | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic checklist | Experimental | Electronic checklist |
|
| Verbal prompting | Experimental | Verbal prompting with written checklist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Curtis H Weiss, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21616996 | Background | 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. |
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Patients were included only if they were treated with at least one day of empirical antibiotics.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Electronic Checklist | Electronic checklist |
| FG001 | Verbal Prompting | Verbal prompting with written checklist |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Electronic Checklist | Electronic checklist |
| BG001 | Verbal Prompting | Verbal prompting with written checklist |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Empiric Antibiotic Duration | All patients who received at least one day of empirical antibiotics during their ICU admission. | Posted | Median | Inter-Quartile Range | days | During intensive care unit admission, an average of 5 days per patient (although individual patients may vary) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electronic Checklist | Electronic checklist |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Curtis Weiss | Northwestern University | (312) 695-6439 | curtisweiss@northwestern.edu |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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. |
|
| 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 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Participants |
|
|
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| Primary | Proportion of Empiric Antibiotics | The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics). | All patients who received at least one day of empirical antibiotics during their ICU admission. | Posted | Mean | Standard Deviation | proportion of antibiotic-days | ICU admission |
|
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| Secondary | Hospital Mortality | All patients treated with at least one day of empirican antibiotics during ICU admission | Posted | Number | number of deaths | During hospitalization, an average of 2 weeks per patient (although individual patients may vary) |
|
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| Secondary | Length of Stay | All patients treated with at least one day of empirical antibiotics. | Posted | Median | Inter-Quartile Range | days | During hospitalization, an average of 2 weeks per patient (although individual patients may vary) |
|
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|
|
| Secondary | Ventilator-free Days | Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation. | All patients treated with at least one day of empirical antibiotics. | Posted | Median | Inter-Quartile Range | days | During hospitalization, an average of 2 weeks per patient (although individual patients may vary) |
|
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| Secondary | 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 | All patients treated with at least one day of empirical antibiotics. | Posted | Number | proportion of patient-days | During ICU admission, an average of 5 days (although individual patients may vary) |
|
|
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| Secondary | Proportion of Patients-days on Which Empirical Antibiotics Were Used | Proportion of patients-days on which empirical antibiotics were used | All patients who received at least one day of empirical antibiotics. | Posted | Number | Number of patient-days | ICU admission |
|
|
|
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| Secondary | Standardized Mortality Ratio | All patients treated with at least one day of empirical antibiotics. | Posted | Mean | 95% Confidence Interval | observed/expected deaths | Hospital admission |
|
|
|
| 0 |
| 125 |
| 0 |
| 125 |
| EG001 | Verbal Prompting | Verbal prompting with written checklist | 0 | 171 | 0 | 171 |
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