Effect of Night Float Call on Sleep and Activity Patterns Among Anesthesia Residents

Completed

• Conditions: Sleep Disorder, Shift Work; Sleep Disturbance; Fatigue

• Registration Number: NCT05043038
• Lead Sponsor: Stanford University

Brief Summary

With increasing awareness about physician fatigue and its effect on patient safety, residency programs are increasingly transitioning to a night float call system. In other industries, multiple night shifts in a row can cause a disruption in the circadian rhythm, sleep debt, shift work disorder, that is related to chronic medical conditions such as obesity and cardiovascular disease. We will evaluate the effect of different call structures on resident activity, sleep and self reported measures of wellness using a commercially available Fitbit device.

Detailed Description

Participants will be recruited via an email once they are scheduled for a week of night float in the Stanford Main Operating room or on their Obstetric Anesthesia rotation. Potential participants who are taking prescription medications that might affect their alertness during the study period will not be enrolled.

The investigators will quantify the changes in sleep pattern and activity during different call rotations. Self reported aspects of well being including fatigue, physical function, and positive affect will be assessed with NIH PROMIS surveys periodically during the study period. The investigators will use the Fitbit Alta HR data to quantify the change in total amount of sleep, sleep interruption and sleep phase and steps per day. Data will be analyzed only when it is coincident with heart rate data to correct for periods when the device is not used.

Activity will not alter from the participants normal except that they will wear the Fitbit and respond to the NIH PROMIS surveys over the study period.

Data from NIH PROMIS surveys, Fitbit and provided demographic information including age, sex and BMI, and number of previous night float periods previously completed. After association, data will be completely de-identified.

All data will be normalized to the participant's baseline value during the run-in week. The call week and post call week will be analyzed with a time series mixed effects model using R and/or NONMEM (a program for Nonlinear Mixed Effects Modeling). The effects of the above demographic variables will be assessed as potential covariates.

The investigators anticipate that this observational study will be the first of many studies looking at the effects of changing sleep patterns on activity and well-being

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-13
• Primary Completion: 2021-11-30
• Study Completion: 2024-08-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• All residents (PGY2-5) who have been scheduled for either general operating room night float call or obstetric anesthesia rotation

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Exclusion Criteria

• Participants who report taking prescription medications that may effect alertness during the study period will not be enrolled.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Total Sleep Hours During Night Float	3 weeks	The investigators will compare total sleep hours per 24 hour period during a baseline week, a night float week, and a recovery week
Change in Daily Steps during Night Float Week	3 weeks	The investigators will compare Steps per 24 hour period during a baseline week, a night float week, and a recovery week
Change in Rapid Eye Movement Sleep Hours During Night Float	3 weeks	The investigators will compare total Rapid Eye Movement sleep hours per 24 hour period during a baseline week, a night float week, and a recovery week
Comparison in sleep and activity patters between a night float call schedule and a random night call schedule	4 weeks	The investigators will compare trends in sleep hours, REM sleep, and steps between night float and random call schedule. Time to recovery to baseline sleep patterns will be assessed.
Trends and Recovery Time in Total Sleep Hours, Rapid Eye Movement, and Daily Steps during a random night call schedule	4 weeks	The investigators will compare change in fitbit sleep and steps data during random call night schedule and recovery after the call night during the obstetric anesthesia rotation

Secondary Outcome Measures

Name	Time	Method
Cohort 2: Change in PROMIS Positive Affect, Sleep Disturbance, and Fatigue Scores throughout the Obstetric Anesthesia Rotation	3 weeks	Participants will take a baseline survey prior to starting the rotation, at the halfway point, at the end of the four weeks, and one week after the conclusion of the study period.
Cohort 1: Change in PROMIS Positive Affect, Sleep Disturbance and Fatigue Scores During Night Float Week	3 weeks	Participants will take a survey prior to starting night float, at the end of night float week, and after one recovery week. The questions on the PROMIS survey are answered on a Likert scale and normalized to a scale 1-100 based on national average. The mean value for each survey is 50. A higher score would represent increased level of positive affect.
Change in PROMIS Positive Affect, Sleep Disturbance and Fatigue Scores over the study period in a night float versus a random call night system	4 weeks	The week to week changes in PROMIS scores between night float and a random call system will be assessed.

Trial Locations

Locations (1)

Stanford Hospital; 🇺🇸 Palo Alto, California, United States