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

Fatigue Clinical Trial

Official title:

Safety, Fatigue, and Continuity in the ICU: a Pragmatic Mixed-methods Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679809
• Other study ID #: 1000011945
• Status: Completed
• Phase: N/A
• First received: May 15, 2008
• Last updated: May 28, 2015
• Start date: October 2008
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2013
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fatigue

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St Michael's Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue		6 months	No
Primary	Continuity of patient care		6 months	No
Secondary	Adverse events		6 months	No
Secondary	Preventable adverse events		6 months	No
Secondary	Feasibility		6 months	No