Optimizing Sleep/Wake Related Cognitive Efficacy

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02412410
Collaborator
(none)
10
1
1
36
0.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Fatigue avoidance education
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Optimizing Sleep/Wake Related Cognitive Efficacy in Laborist Shifts: Toward Establishing Models of Safer Obstetrical Care
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Feb 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single

Single arm pilot study analyzing sleep data and calculated efficacy before and after fatigue avoidance education (comparator is same group after intervention)

Behavioral: Fatigue avoidance education
Grand Rounds presentation of consequences of fatigue and fatigue avoidance techniques

Outcome Measures

Primary Outcome Measures

  1. Optimizing efficacy through fatigue avoidance -Comparison of calculated efficacy scores before and after fatigue avoidance education [3 months]

    Comparison of calculated efficacy scores before and after fatigue avoidance education

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Physicians working in Laborist role, exclusion only by subject declining participation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Margaret Dow, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Margaret L. Dow, M.D., Assistant Professor Obstestrics-Gynecology, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02412410
Other Study ID Numbers:
  • 14-008496
First Posted:
Apr 9, 2015
Last Update Posted:
Feb 22, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Margaret L. Dow, M.D., Assistant Professor Obstestrics-Gynecology, Mayo Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 22, 2018