Back to resultsThe Effect of Fatigue on the Clinical Performance
Primary Purpose
Fatigue
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fatigued
Rested
Sponsored by
About this trial
This is an interventional other trial for Fatigue focused on measuring Human Performance, Clinical Performance
Eligibility 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.
Sites / Locations
- Evanston Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Rested
Fatigued
Arm Description
Subjects will perform the scenario, once during a normal workday (rested)
Subjects will perform the scenario after working a 12-24 hour overnight shift (fatigued).
Outcomes
Primary Outcome Measures
Clinical performance Score
Performance score on Stat c-section rating scale based on video rating by 2 raters
Secondary Outcome Measures
Stanford Sleepiness Scale
SSS scores in rested and fatigue arms
Full Information
NCT ID
NCT01801345
First Posted
February 25, 2013
Last Updated
September 9, 2019
Sponsor
NorthShore University HealthSystem
1. Study Identification
Unique Protocol Identification Number
NCT01801345
Brief Title
The Effect of Fatigue on the Clinical Performance
Official Title
The Effect of Fatigue on the Clinical Performance of Experienced Physicians: A Simulation Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NorthShore University HealthSystem
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Human Performance, Clinical Performance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rested
Arm Type
Other
Arm Description
Subjects will perform the scenario, once during a normal workday (rested)
Arm Title
Fatigued
Arm Type
Active Comparator
Arm Description
Subjects will perform the scenario after working a 12-24 hour overnight shift (fatigued).
Intervention Type
Other
Intervention Name(s)
Fatigued
Intervention Type
Other
Intervention Name(s)
Rested
Primary Outcome Measure Information:
Title
Clinical performance Score
Description
Performance score on Stat c-section rating scale based on video rating by 2 raters
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Stanford Sleepiness Scale
Description
SSS scores in rested and fatigue arms
Time Frame
24months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Fatigue on the Clinical Performance
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