No registrations found.
ID
Source
Brief title
Health condition
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.
Sponsors and support
Nederlandse Vereniging voor Heelkunde;
Nederlandse Internisten Vereniging;
Nederlandse Vereniging voor Obstetrie & Gynaecologie;
Nederlandse Vereniging voor Kindergeneeskunde;
Nederlandse Vereniging voor Anesthesiologie.
Intervention
Outcome measures
Primary outcome
Primary Objective
1. Determine the physiological and subjective fitness of selected around the-clock medical specialists in three different states of fatigue.
Secondary outcome
Secondary 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.
Background summary
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.
Study objective
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.
Study design
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)
Intervention
Effects of night-duty on performance
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5169 |
| NTR-old | NTR5309 |
| Other | Centre for Human Drug Research/Ethics Committee Leiden University Medical Center : CHDR1416/P14.318 |