Clinical trial NCT01396044: Daily Checklists and Outcome in the Intensive Care Unit
Official title: Daily Checklists and Outcome in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Quality improvement
Checklist
Critical care
Anti-bacterial agents
Mechanical ventilation
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Parker B. Francis Fellowship Program
First posted: 2011-07-18
Enrollment: 451
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Empiric Antibiotic Duration
timeFrame: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
measure: Proportion of Empiric Antibiotics
timeFrame: ICU admission
Secondary outcomes:
measure: Hospital Mortality
timeFrame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
measure: Length of Stay
timeFrame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
measure: Ventilator-free Days
timeFrame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
measure: Proportion of Successful Prompts
timeFrame: During ICU admission, an average of 5 days (although individual patients may vary)
measure: Proportion of Patients-days on Which Empirical Antibiotics Were Used
timeFrame: ICU admission
measure: Standardized Mortality Ratio
timeFrame: Hospital admission
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Curtis H Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.