FatigueNCT01801345
The Effect of Fatigue on the Clinical Performance
A study testing Fatigued and Rested in people with Fatigue, run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Fatigued and Rested
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All attending anesthesiologists taking overnight call at Evanston Hospital will be eligible participants.
Who cannot join
- Resident physician or trainee, physician not taking overnight in house call.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fatigue on the Clinical Performance of Experienced Physicians: A Simulation Study
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.
- Conditions
- Fatigue
- Being tested
- Fatigued, Rested
- Keywords
- Human Performance, Clinical Performance
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FatiguedOther
RestedOther
| Study group | Role | What they receive |
|---|---|---|
| Rested | Other | Subjects will perform the scenario, once during a normal workday (rested) Receives: Other: Rested |
| Fatigued | Active comparator | Subjects will perform the scenario after working a 12-24 hour overnight shift (fatigued). Receives: Other: Fatigued |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance Score
Performance score on Stat c-section rating scale based on video rating by 2 raters
Measured: 24 months
Secondary outcomes (1)
Stanford Sleepiness Scale
SSS scores in rested and fatigue arms
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801345
- Sponsor's protocol ID
- EH12-048
- Status last verified
- Sep 2019
- First submitted
- 25 Feb 2013
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fatigue on the Clinical Performance of Experienced Physicians: A Simulation Study
- ClinicalTrials.gov ID
- NCT01801345
- Acronym / sponsor ID
- EH12-048
- Conditions
- Fatigue
- Keywords
- Human Performance, Clinical Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rested | Other | Other: RestedSubjects will perform the scenario, once during a normal workday (rested) |
| Fatigued | Active comparator | Other: FatiguedSubjects will perform the scenario after working a 12-24 hour overnight shift (fatigued). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All attending anesthesiologists taking overnight call at Evanston Hospital will be eligible participants.
Key exclusion criteria (1 listed)
- Resident physician or trainee, physician not taking overnight in house call.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatigued | Other | Fatigued |
| Rested | Other | Rested |
Primary outcome
Clinical performance Score
Time frame: 24 months
Performance score on Stat c-section rating scale based on video rating by 2 raters
1 secondary outcome
Stanford Sleepiness Scale
Time frame: 24months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigued and Rested in people with Fatigue, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance Score (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.