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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00679809
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
Christopher Parshuram, The Hospital for Sick Children

Tracking Information
First Submitted Date May 15, 2008
First Posted Date May 19, 2008
Last Update Posted Date June 1, 2015
Study Start Date October 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2008)
  • Fatigue [ Time Frame: 6 months ]
  • Continuity of patient care [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 16, 2008)
  • Adverse events [ Time Frame: 6 months ]
  • Preventable adverse events [ Time Frame: 6 months ]
  • Feasibility [ Time Frame: 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety, Fatigue, and Continuity in the Intensive Care Unit (ICU)
Official Title Safety, Fatigue, and Continuity in the ICU: a Pragmatic Mixed-methods Study
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Fatigue
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Parshuram CS, Amaral AC, Ferguson ND, Baker GR, Etchells EE, Flintoft V, Granton J, Lingard L, Kirpalani H, Mehta S, Moldofsky H, Scales DC, Stewart TE, Willan AR, Friedrich JO; Canadian Critical Care Trials Group. Patient safety, resident well-being and continuity of care with different resident duty schedules in the intensive care unit: a randomized trial. CMAJ. 2015 Mar 17;187(5):321-9. doi: 10.1503/cmaj.140752. Epub 2015 Feb 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 28, 2015)
19
Original Estimated Enrollment
 (submitted: May 16, 2008)
36
Actual Study Completion Date December 2013
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00679809
Other Study ID Numbers 1000011945
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christopher Parshuram, The Hospital for Sick Children
Study Sponsor The Hospital for Sick Children
Collaborators Not Provided
Investigators
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
PRS Account The Hospital for Sick Children
Verification Date May 2015