Clinical trial NCT04053556: Cognitive Performance After a Night Shift in Internal Medicine Residents
Official title: Evaluation on the Effect on Cognition and Emotional Exhaustion With a Change of Long Night Shift System Versus Reduced Night Shift in Residents of Internal Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Deprivation
Burnout, Professional
Cognition Disorders
Keywords: sleep deprivation
internal medicine residency
on call
cognitive impairment
burn out
safety
depression
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Internal Medicine residents in formation who were on the second or third year of the Internal Medicine residency of the Italian Hospital of Buenos Aires who work 24 hours shifts and whose work day continues to a maximum of 36 total hours and who consented to the study.

Brief summary: A quasi-experimental design where internal medicine residents in a high complexity hospital were assessed after a 24-hour shift for cognitive impairment by a trained neurologist.

Detailed description: The investigators conducted a cross sectional study during the 2014-2016 period in a high complexity school hospital in Buenos Aires. Second and third year Internal Medicine residents who consented to participate were included.

A neurologist conducted a cognitive evaluation to the residents who had done 24 hours shifts (with sleep deprivation) within 6 hours of its end.

Auditory memory deficit was evaluated (PASAT - Paced Auditory Serial Addition Test), verbal fluency (FAS), direct and indirect Digit-Span, Rey auditory verbal learning test (RAVLT) and Continuous Performance Test 2 (CPT2).

Results were presented as means of standardized scores (z score) with their interquartile range (IQR).

Eligibility criteria: Inclusion Criteria:

* Internal Medicine residents on the second or third year of formation.

Exclusion Criteria:

* Denial to participate in the study or to the informed consent.

Primary outcomes:
measure: Neurological evaluation using Paced Auditory Serial Addition Test (PASAT)
timeFrame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
measure: Burn Out
timeFrame: through study completion, an average of one year
measure: Conners Continuous Performance Test 2 (CPT)
timeFrame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
measure: Rey auditory verbal learning test (RAVLT)
timeFrame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
measure: F-A-S test
timeFrame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
measure: Direct and indirect digit span
timeFrame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Secondary outcomes:
measure: Depression
timeFrame: through study completion, an average of one year
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires, Peron 4190
state: Capital Federal
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Diego H Giunta, MD
role: STUDY_CHAIR
References: