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OpenTrials
Completed

NCT Number: NCT00679809

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fatigue

    Time frame: 6 months

  2. Continuity of patient care

    Time frame: 6 months

Secondary outcomes

  1. Adverse events

    Time frame: 6 months

  2. Preventable adverse events

    Time frame: 6 months

  3. Feasibility

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2013
First posted
May 19, 2008
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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