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

NCT ID: NCT00679809

Last Updated: 2015-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Fatigue

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Christopher Parshuram

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chris Parshuram, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Jan Friedrich, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Thomas Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

St Michael's Hospital

Toronto, Ontario, Canada

Site Status

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Parshuram CS, Amaral AC, Ferguson ND, Baker GR, Etchells EE, Flintoft V, Granton J, Lingard L, Kirpalani H, Mehta S, Moldofsky H, Scales DC, Stewart TE, Willan AR, Friedrich JO; Canadian Critical Care Trials Group. Patient safety, resident well-being and continuity of care with different resident duty schedules in the intensive care unit: a randomized trial. CMAJ. 2015 Mar 17;187(5):321-9. doi: 10.1503/cmaj.140752. Epub 2015 Feb 9.

Reference Type DERIVED
PMID: 25667258 (View on PubMed)

Other Identifiers

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1000011945

Identifier Type: -

Identifier Source: org_study_id

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