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Clinical Trials/NCT02412410
NCT02412410CompletedNot Applicable

Optimizing Sleep/Wake Related Cognitive Efficacy in Laborist Shifts: Toward Establishing Models of Safer Obstetrical Care

Mayo Clinic1 site in 1 country10 target enrollmentStarted: February 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Optimizing efficacy through fatigue avoidance -Comparison of calculated efficacy scores before and after fatigue avoidance education

Study Overview

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.

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
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
30 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Single

Experimental

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

Intervention: Fatigue avoidance education (Behavioral)

Outcomes

Primary Outcomes

Optimizing efficacy through fatigue avoidance -Comparison of calculated efficacy scores before and after fatigue avoidance education

Time Frame: 3 months

Comparison of calculated efficacy scores before and after fatigue avoidance education

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Margaret L. Dow, M.D.

Assistant Professor Obstestrics-Gynecology

Mayo Clinic

Study Sites (1)

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