Trial Outcomes & Findings for Daily Checklists and Outcome in the Intensive Care Unit (NCT NCT01396044)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

451 participants

Primary outcome timeframe

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

Results posted on

2012-12-04

Participant Flow

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.

Patients were included only if they were treated with at least one day of empirical antibiotics.

Participant milestones

Participant milestones
Measure	Electronic Checklist Electronic checklist	Verbal Prompting Verbal prompting with written checklist
Overall Study STARTED	125	171
Overall Study COMPLETED	125	171
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Daily Checklists and Outcome in the Intensive Care Unit

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electronic Checklist n=125 Participants Electronic checklist	Verbal Prompting n=171 Participants Verbal prompting with written checklist	Total n=296 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=5 Participants	101 Participants n=7 Participants	165 Participants n=5 Participants
Age, Categorical >=65 years	61 Participants n=5 Participants	70 Participants n=7 Participants	131 Participants n=5 Participants
Age Continuous	62.6 years STANDARD_DEVIATION 17.6 • n=5 Participants	60.0 years STANDARD_DEVIATION 17.8 • n=7 Participants	61.1 years STANDARD_DEVIATION 17.8 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	83 Participants n=7 Participants	142 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	88 Participants n=7 Participants	154 Participants n=5 Participants
Region of Enrollment United States	125 participants n=5 Participants	171 participants n=7 Participants	296 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Electronic Checklist n=125 Participants Electronic checklist	Verbal Prompting n=171 Participants Verbal prompting with written checklist
Empiric Antibiotic Duration	3 days Interval 2.0 to 4.0	3 days Interval 1.0 to 5.0

PRIMARY outcome

Timeframe: ICU admission

Population: All patients who received at least one day of empirical antibiotics during their ICU admission.

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

Outcome measures

Outcome measures
Measure	Electronic Checklist n=125 Participants Electronic checklist	Verbal Prompting n=171 Participants Verbal prompting with written checklist
Proportion of Empiric Antibiotics	0.83 proportion of antibiotic-days Standard Deviation 0.27	0.78 proportion of antibiotic-days Standard Deviation 0.27

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Electronic Checklist n=125 Participants Electronic checklist	Verbal Prompting n=171 Participants Verbal prompting with written checklist
Hospital Mortality	30 number of deaths	30 number of deaths

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Electronic Checklist n=125 Participants Electronic checklist	Verbal Prompting n=171 Participants Verbal prompting with written checklist
Length of Stay	2.8 days Interval 1.7 to 6.5	2.6 days Interval 1.5 to 6.9

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Electronic Checklist n=125 Participants Electronic checklist	Verbal Prompting n=171 Participants Verbal prompting with written checklist
Ventilator-free Days	20.3 days Interval 0.0 to 25.9	21.9 days Interval 13.5 to 25.7

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Electronic Checklist n=125 Participants Electronic checklist	Verbal Prompting n=171 Participants Verbal prompting with written checklist
Proportion of Successful Prompts	0.096 proportion of patient-days	0.436 proportion of patient-days

SECONDARY outcome

Timeframe: ICU admission

Population: All patients who received at least one day of empirical antibiotics.

Proportion of patients-days on which empirical antibiotics were used

Outcome measures

Outcome measures
Measure	Electronic Checklist n=125 Participants Electronic checklist	Verbal Prompting n=171 Participants Verbal prompting with written checklist
Proportion of Patients-days on Which Empirical Antibiotics Were Used	498 Number of patient-days	702 Number of patient-days

SECONDARY outcome

Timeframe: Hospital admission

Population: All patients treated with at least one day of empirical antibiotics.

Outcome measures

Outcome measures
Measure	Electronic Checklist n=125 Participants Electronic checklist	Verbal Prompting n=171 Participants Verbal prompting with written checklist
Standardized Mortality Ratio	0.70 observed/expected deaths Interval 0.47 to 1.0	0.64 observed/expected deaths Interval 0.43 to 0.92

Adverse Events

Electronic Checklist

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Verbal Prompting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Curtis Weiss

Northwestern University

Phone: (312) 695-6439

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place