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The Effect of Fatigue on the Clinical Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01801345
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
NorthShore University HealthSystem

Study Description
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Brief Summary:
The primary aim of this randomized controlled trial is to examine the effect of fatigue on clinical performance in a simulated obstetric emergency. This scenario was chosen because it is a common clinical situation faced by anesthesia providers on call and therefore likely to occur when a provider is fatigued. Secondary outcomes will include the evaluation of other factors that worsen fatigue related decrement in performance including age, years of training/practice and clinical load prior to study participation.

Condition or disease Intervention/treatment Phase
Fatigue Other: Fatigued Other: Rested Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effect of Fatigue on the Clinical Performance of Experienced Physicians: A Simulation Study
Study Start Date : August 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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Arm Intervention/treatment
Rested
Subjects will perform the scenario, once during a normal workday (rested)
 Other: Rested
Active Comparator: Fatigued
Subjects will perform the scenario after working a 12-24 hour overnight shift (fatigued).
 Other: Fatigued


Outcome Measures
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Primary Outcome Measures :
  1. Clinical performance Score [ Time Frame: 24 months ]
    Performance score on Stat c-section rating scale based on video rating by 2 raters


Secondary Outcome Measures :
  1. Stanford Sleepiness Scale [ Time Frame: 24months ]
    SSS scores in rested and fatigue arms


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All attending anesthesiologists taking overnight call at Evanston Hospital will be eligible participants.

Exclusion Criteria:

  • Resident physician or trainee, physician not taking overnight in house call.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801345


Locations
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United States, Illinois
Evanston Hospital
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem
More Information
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Responsible Party: NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT01801345    
Other Study ID Numbers: EH12-048
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Keywords provided by NorthShore University HealthSystem:
Human Performance
Clinical Performance
Additional relevant MeSH terms:
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Fatigue