Safety, Fatigue, and Continuity in the Intensive Care Unit (ICU) - Full Text View

Sponsored by:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00679809

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

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	36
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 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

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

More Information

Responsible Party:	The Hospital for Sick Children ( Chris Parshuram/Principal Investigator )
Study ID Numbers:	1000011945
Study First Received:	May 15, 2008
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00679809
Health Authority:	Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:

Resident
Safety
Fatigue
Continuity
ICU

Study placed in the following topic categories:

Signs and Symptoms
Fatigue

ClinicalTrials.gov processed this record on January 15, 2009