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FTOP - nationwide observational study


- candidate number22475
- NTR NumberNTR5309
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jul-2015
- Secondary IDsCHDR1416/P14.318 Centre for Human Drug Research/Ethics Committee Leiden University Medical Center
- Public TitleFTOP - nationwide observational study
- Scientific TitleA nationwide multicentre observational study to investigate the fitness to perform of around-the-clock medical specialists.
- ACRONYMFTOP (= Fit-to-Perform)
- hypothesisFatigue affects central nervous system function and, in the setting of the medical profession, could influence specialist performance, patient care and safety. ln contrast to other industries, for example the aviation industry, there are no "Fit to Perform" standards in medicine. With the wide implementation of quality of care monitoring systems, resident working hours limitations, expanding patient safety measures and increasing patient and governmental awareness about these aspects, it is imperative to develop an easy-to-use "Fit to Perform" test. A nationwide multicenter study will be conducted to provide representative data on fatigue of around-the-clock medical specialists. Fitness-to-perform of medical specialists will be measured in three different states of fatigue: pre-call, post-call and rested. When compared to the previously created relevant frames of reference (social, personal, and professional), one can assess whether the level of fatigue is acceptable or not. This test can be implemented in clinical practice to serve as an easy-to-use tool to assess fitness to perform of around the- clock medical specialists, and provide a basis for working-hour reforms. Ultimately, outcomes of this test can be coupled to patient outcomes to provide data on the relation between doctor's fatigue and patient safety.
- Healt Condition(s) or Problem(s) studiedMedical specialists
- Inclusion criteriaEligible subjects must meet all of the following inclusion criteria:

1. Subjects are around-the-clock medical specialists or medical registrars, employed at the participating hospitals within one of the following medical specialties:
a. Surgery;
b. Gynaecology;
c. Anaesthesiology;
d. lnternal Medicine;
e. Paediatrics.
2. lnformed consent has been provided.
- Exclusion criteriaEligible subjects must meet none of the following exclusion criteria:
1. A condition that in the opinion of the investigator would complicate or compromise the study, or the well-being of the subject (e.g. decreased vision or limited range of motion in the forearm or wrist)
2. Any known factor or condition that might interfere with study compliance, study conduct or interpretation of the results.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2015
- planned closingdate1-okt-2016
- Target number of participants1000
- InterventionsEffects of night-duty on performance
- Primary outcomePrimary Objective
1. Determine the physiological and subjective fitness of selected around the-clock medical specialists in three different states of fatigue.
- Secondary outcomeSecondary Objectives
1. Compare the level of post-call fatigue to the relevant frames of reference;
2. Compare "Fitness to Perform" between different areas of medical specialization in the Netherlands;
3. Compare "Fitness to Perform" between different medical centres;
4. lncrease knowledge about factors influencing "Fitness to Perform";
5. Compare subjective and objective levels of fitness and increase awareness regarding the possible dissociation between these levels.
- Timepoints1. Subjective outcome parameters:
a. Alertness
b. Mood
c. Personal stress level
d. Self-assessment of ability to perform (FTOP questionnaire)
2. Objective parameters:
a. Vigilance/Alertness (Adaptive tracking)
b. Visuo-motor coordination (Adaptive tracking)
c. General CNS-activity (Visual analogue scores reflecting drowsiness and fatigue)
- Trial web sitewww.ftop.eu
- status[default]
- CONTACT FOR PUBLIC QUERIES C.R.H. (Coen) Huizinga
- CONTACT for SCIENTIFIC QUERIESdr. K.E.A. van der Bogt
- Sponsor/Initiator Center for Human Drug Research (CHDR), Nederlandse Vereniging voor Heelkunde, Nederlandse Internisten Vereniging, Nederlandse Vereniging voor Obstetrie & Gynaecologie, Nederlandse Vereniging voor Kindergeneeskunde, Nederlandse Vereniging voor Anesthesiologie
- Funding
(Source(s) of Monetary or Material Support)
Stichting Kwaliteitsgelden Medisch Specialisten
- Publications
- Brief summaryThis is a nationwide observational multicenter study to investigate the physical and mental state of around-the-clock medical specialists using the FTOP-test. Subjects will function as their own control. The FTOP-test will be performed on the Mini-NeuroCart, a modified version of a test system for assessment of CNS function. Performance of subjects will be assessed at multiple points in time including: non-call, pre-call, and post-call assessment. Testing will occur on site, thereby minimizing the effect on normal daily clinical activities.
- Main changes (audit trail)
- RECORD17-jul-2015 - 20-aug-2015


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