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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher Parshuram, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00679809
First received: May 15, 2008
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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.


Condition
Fatigue

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 ] [ Designated as safety issue: No ]
  • Continuity of patient care [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Preventable adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Feasibility [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
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.

  Eligibility

Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679809

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
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, New York
  More Information

No publications provided

Responsible Party: Christopher Parshuram, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00679809     History of Changes
Other Study ID Numbers: 1000011945
Study First Received: May 15, 2008
Last Updated: December 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Resident
Safety
Fatigue
Continuity
ICU

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014