Critical Illness
Conditions
Keywords
Quality improvement, Checklist, Critical care, Anti-bacterial agents, Mechanical ventilation
Brief summary
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.
Interventions
OTHERElectronic 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.
OTHERVerbal prompting
Prompting by study investigators of physicians on the verbal prompting arm. Prompting will include questions related to antibiotic utilization and mechanical ventilation weaning.
Sponsors
Parker B. Francis Fellowship Program
Northwestern University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Empiric Antibiotic Duration | During intensive care unit admission, an average of 5 days per patient (although individual patients may vary) | — |
| Proportion of Empiric Antibiotics | ICU admission | The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free Days | 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. |
| Proportion of Successful Prompts | 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 |
| Hospital Mortality | During hospitalization, an average of 2 weeks per patient (although individual patients may vary) | — |
| Standardized Mortality Ratio | Hospital admission | — |
| Proportion of Patients-days on Which Empirical Antibiotics Were Used | ICU admission | Proportion of patients-days on which empirical antibiotics were used |
| Length of Stay | During hospitalization, an average of 2 weeks per patient (although individual patients may vary) | — |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Patients were included only if they were treated with at least one day of empirical antibiotics.
Participants by arm
| Arm | Count |
|---|---|
| Electronic Checklist Electronic checklist | 125 |
| Verbal Prompting Verbal prompting with written checklist | 171 |
| Total | 296 |
Baseline characteristics
| Characteristic | Verbal Prompting | Electronic Checklist | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 70 Participants | 61 Participants | 131 Participants |
| Age, Categorical Between 18 and 65 years | 101 Participants | 64 Participants | 165 Participants |
| Age Continuous | 60.0 years STANDARD_DEVIATION 17.8 | 62.6 years STANDARD_DEVIATION 17.6 | 61.1 years STANDARD_DEVIATION 17.8 |
| Region of Enrollment United States | 171 participants | 125 participants | 296 participants |
| Sex: Female, Male Female | 83 Participants | 59 Participants | 142 Participants |
| Sex: Female, Male Male | 88 Participants | 66 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 125 | 0 / 171 |
| serious Total, serious adverse events | 0 / 125 | 0 / 171 |
Outcome results
Primary
Empiric Antibiotic Duration
Time frame: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
Population: All patients who received at least one day of empirical antibiotics during their ICU admission.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Electronic Checklist | Empiric Antibiotic Duration | 3 days |
| Verbal Prompting | Empiric Antibiotic Duration | 3 days |
p-value: 0.27Wilcoxon (Mann-Whitney)
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).
Time frame: ICU admission
Population: All patients who received at least one day of empirical antibiotics during their ICU admission.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electronic Checklist | Proportion of Empiric Antibiotics | 0.83 proportion of antibiotic-days | Standard Deviation 0.27 |
| Verbal Prompting | Proportion of Empiric Antibiotics | 0.78 proportion of antibiotic-days | Standard Deviation 0.27 |
p-value: 0.093t-test, 2 sided
Secondary
Hospital Mortality
Time frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Population: All patients treated with at least one day of empirican antibiotics during ICU admission
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electronic Checklist | Hospital Mortality | 30 number of deaths |
| Verbal Prompting | Hospital Mortality | 30 number of deaths |
p-value: 0.17Chi-squared
Secondary
Length of Stay
Time frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Population: All patients treated with at least one day of empirical antibiotics.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Electronic Checklist | Length of Stay | 2.8 days |
| Verbal Prompting | Length of Stay | 2.6 days |
p-value: 0.27Wilcoxon (Mann-Whitney)
Secondary
Proportion of Patients-days on Which Empirical Antibiotics Were Used
Proportion of patients-days on which empirical antibiotics were used
Time frame: ICU admission
Population: All patients who received at least one day of empirical antibiotics.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electronic Checklist | Proportion of Patients-days on Which Empirical Antibiotics Were Used | 498 Number of patient-days |
| Verbal Prompting | Proportion of Patients-days on Which Empirical Antibiotics Were Used | 702 Number of patient-days |
p-value: 0.002Chi-squared
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
Time frame: During ICU admission, an average of 5 days (although individual patients may vary)
Population: All patients treated with at least one day of empirical antibiotics.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electronic Checklist | Proportion of Successful Prompts | 0.096 proportion of patient-days |
| Verbal Prompting | Proportion of Successful Prompts | 0.436 proportion of patient-days |
Secondary
Standardized Mortality Ratio
Time frame: Hospital admission
Population: All patients treated with at least one day of empirical antibiotics.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Electronic Checklist | Standardized Mortality Ratio | 0.70 observed/expected deaths |
| Verbal Prompting | Standardized Mortality Ratio | 0.64 observed/expected deaths |
Secondary
Ventilator-free Days
Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.
Time frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Population: All patients treated with at least one day of empirical antibiotics.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Electronic Checklist | Ventilator-free Days | 20.3 days |
| Verbal Prompting | Ventilator-free Days | 21.9 days |
p-value: 0.36Wilcoxon (Mann-Whitney)