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Safety, Fatigue, and Continuity in the Intensive Care Unit (ICU)

This study has been completed.
Information provided by (Responsible Party):
Christopher Parshuram, The Hospital for Sick Children Identifier:
First received: May 15, 2008
Last updated: May 28, 2015
Last verified: May 2015
The purpose of this study is to describe the features of continuity and quantify fatigue in three ICU resident work schedules, estimate the frequency of preventable adverse events, and inform the design and demonstrate the feasibility of a future multi-centre study.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety, Fatigue, and Continuity in the ICU: a Pragmatic Mixed-methods Study

Resource links provided by NLM:

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Fatigue [ Time Frame: 6 months ]
  • Continuity of patient care [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 6 months ]
  • Preventable adverse events [ Time Frame: 6 months ]
  • Feasibility [ Time Frame: 6 months ]

Enrollment: 19
Study Start Date: October 2008
Study Completion Date: December 2013
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

The overall goal of our research is to describe the optimal scheduling pattern for frontline physicians working in ICUs. Our hypothesis is that call schedule associated reductions in fatigue are counterbalanced by reductions in continuity, resulting in no change in the safety of patients.

This is a prospective before-after, two-centre study using a mixed-methods design. We will apply 3 work schedules, each for a period of 2 months over a 6 month period in the adult medical-surgical ICUs at two university affiliated hospitals in Toronto. In this mixed methods approach, quantitative and qualitative data will be collected concurrently, analysed separately, and their results compared, to produce an integrated interpretation of the impact of work schedule on the relationship between continuity and fatigue.

This will evaluate healthcare continuity and fatigue, describe adverse events in ICUs, identify the two best resident schedules for subsequent comparison, and demonstrate the feasibility of a future multi-centre study of physician scheduling.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Residents will be on their 2-month ICU rotations at one of two university affiliated hospitals in Toronto medical-surgical ICU. Residents in these ICU rotations are from internal medicine, surgery, emergency medicine and anesthesia training programs, and are supported by 2-3 critical care fellows, and 1 staff physician

Inclusion Criteria:

  • All residents at participating ICUs starting a rotation in Fall 2008
  • Staff members supervising and/or working with participating residents
  • Patients/family members under the care of the participating residents
  • Patients admitted to participating ICUs

Exclusion Criteria:

  • Lack of informed consent
  Contacts and Locations
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Please refer to this study by its identifier: NCT00679809

Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Chris Parshuram, MBChB, PhD The Hospital for Sick Children
Principal Investigator: Jan Friedrich, MD St. Michael's Hospital, Toronto
Principal Investigator: Thomas Stewart, MD Mount Sinai Hospital, New York
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christopher Parshuram, Staff Physician, The Hospital for Sick Children Identifier: NCT00679809     History of Changes
Other Study ID Numbers: 1000011945
Study First Received: May 15, 2008
Last Updated: May 28, 2015

Keywords provided by The Hospital for Sick Children:

Additional relevant MeSH terms:
Signs and Symptoms processed this record on April 28, 2017