Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02412410 |
| Other study ID # |
14-008496 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
April 6, 2015 |
| Last updated |
February 21, 2018 |
| Start date |
February 2015 |
| Est. completion date |
February 2018 |
Study information
| Verified date |
February 2018 |
| Source |
Mayo Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a pilot study designed to elucidate sleep/wake patterns and associated cognitive
efficacy of laborists involved in shift work at Mayo Clinic Rochester.
Description:
Each of the ten physicians working laborist shifts will be asked to wear an actigraphy watch
(ReadiBand- Fatigue Science, Vancouver, BC) continually for three weeks in the winter
2014-2015 for initial data collection. A brief sleep education intervention based on
aerospace and military fatigue countermeasure training will be given at a one hour
departmental grand rounds presentation on April 20, 2015. This intervention will be based on
ACGME requirements for fatigue education for residents and will also address the latest data
on sleep and health, as well as fatigue countermeasures of nap recommendations, sleep
banking, and sleep hygiene. An additional two weeks of data will then be collected.
Data will be de-identified and entered into the Fatigue Science algorithm, which is validated
to detect sleep quantity and quality. This algorithm allows labelling of data to reflect
which type of shift, as well as its sequence in the schedule. For example, sleep/wake cycles
of the fourth night shift of a series can be identified as such, so that wakefulness during a
fourth night shift is not artificially compared to wakefulness during a first night of night
shifts. Average efficacy during each type of shift, as well as average efficacy during each
shift in a series of one type of shift can then be calculated. Efficacy is reported as a
percentage, based on a nomogram established through military wakefulness task exercises and
validated to correlate with blood alcohol level and with likelihood of human factor accident
risk through the Department of Defense, US Army, US Navy, US Marine Corps, and Federal
Railroad Association.
Calculated data on shift efficacy will significantly contribute to the growing literature on
the strengths of the laborist model, and will help with internal schedule structure to
continue to maximize efficacy. As laborist programs develop and expand, the investigators may
also be forerunners in describing optimal scheduling and staffing for programs of similar
size and scope. Ultimately, additional studies will use this innovative technology to
elucidate the assumed but not scientifically established relationship between sleep/wake
based cognitive efficacy and patient safety by superimposing the investigators' wakefulness
data on the investigators' tracked adverse events. This would be landmark in the
investigators' field and has the potential to effect groundbreaking safety measures in the
investigators' training and staffing.
