Daily Checklists and Outcome in the Intensive Care Unit

NCT01396044 | Completed Results

• 1 other identifier: NUIRBSTU00013313
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 2

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.

Conditions

Critical Illness

Keywords

Quality improvement; Checklist; Critical care; Anti-bacterial agents; Mechanical ventilation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

  During hospitalization, an average of 2 weeks per patient (although individual patients may vary)

• Proportion of Successful Prompts

  During ICU admission, an average of 5 days (although individual patients may vary)

• Proportion of Patients-days on Which Empirical Antibiotics Were Used

  ICU admission

Study Arms (2)

Electronic checklist

EXPERIMENTAL

Electronic checklist

Other: Electronic checklist

Verbal prompting

EXPERIMENTAL

Verbal prompting with written checklist

Other: Verbal prompting

Interventions

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.

Electronic checklist

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.

Verbal prompting

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to a medical intensive care unit (MICU) team during the study timeframe

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Parker B. Francis Fellowship Program: collaborator

Study Sites (2)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 21616996 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Curtis Weiss
• Organization: Northwestern University

curtisweiss@northwestern.edu

(312) 695-6439

Study Officials

• Curtis H Weiss, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 18, 2011
• Study Start: July 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 4, 2012
• Results First Posted: December 4, 2012

Record last verified: 2012-11

Locations

US (2)