Fatigue 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…
ID
Bron
Verkorte titel
Aandoening
A set of active round-the-clock medical specialists as well as active medical
registrars, both male and female, will be assessed for their performance on the
FTOP test.
Ondersteuning
Nederlandse Vereniging voor Heelkunde;
Nederlandse Internisten Vereniging;
Nederlandse Vereniging voor Obstetrie & Gynaecologie;
Nederlandse Vereniging voor Kindergeneeskunde;
Nederlandse Vereniging voor Anesthesiologie.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary Objective<br>
1. Determine the physiological and subjective fitness of selected around the-clock medical specialists in three different states of fatigue.
Achtergrond van het onderzoek
This 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.
Doel van het onderzoek
Fatigue 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.
Onderzoeksopzet
1. 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)
Onderzoeksproduct en/of interventie
Effects of night-duty on performance
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Eligible 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Eligible 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5169 |
| NTR-old | NTR5309 |
| Ander register | Centre for Human Drug Research/Ethics Committee Leiden University Medical Center : CHDR1416/P14.318 |