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

Completed

• Conditions: Fatigue

• Registration Number: NCT00679809
• Lead Sponsor: The Hospital for Sick Children

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 Timeline

• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-16
• Study First Posted: 2008-05-19
• Study Start: 2008-10
• Primary Completion: 2009-07
• Study Completion: 2013-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue	6 months
Continuity of patient care	6 months

Secondary Outcome Measures

Name	Time	Method
Adverse events	6 months
Feasibility	6 months
Preventable adverse events	6 months

Trial Locations

Locations (3)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

St Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada