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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT05043038
Collaborator
(none)
27
1
28
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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. 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 the week before, during, and after the night float call week. Self reported aspects of well being including fatigue, physical function, and positive affect will be assessed with NIH PROMIS surveys at the end of each week 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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    27 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Night Float Call on Sleep and Activity Patterns Among Anesthesia Residents
    Actual Study Start Date :
    Aug 1, 2019
    Actual Primary Completion Date :
    Nov 30, 2021
    Actual Study Completion Date :
    Nov 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    General Anesthesia Night Float

    The residents will be followed over a three week period - one week prior to night float (baseline), the week of night float, and one week after night float (recovery).

    Outcome Measures

    Primary Outcome Measures

    1. Change in Total Sleep Hours During Night Float [3 weeks]

      We will compare total sleep hours per 24 hour period during a baseline week, a night float week, and a recovery week

    2. Change in Rapid Eye Movement Sleep Hours During Night Float [3 weeks]

      We will compare total Rapid Eye Movement sleep hours per 24 hour period during a baseline week, a night float week, and a recovery week

    3. Change in Daily Steps during Night Float Week [3 weeks]

      We will compare Steps per 24 hour period during a baseline week, a night float week, and a recovery week

    Secondary Outcome Measures

    1. Change in PROMIS Positive Affect 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.

    2. Change in PROMIS Sleep Disturbance 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 levels of sleep disturbance

    3. Change in PROMIS 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 levels of fatigue.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All residents (PGY2-5) who have been scheduled for either general operating room night float call
    Exclusion Criteria:
    • Participants who report taking prescription medications that may effect alertness during the study period will not be enrolled.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford Hospital Palo Alto California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Study Director: Alexandra Ruan, MD, Stanford University
    • Principal Investigator: Pamela Flood, MD, Stanford University

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Alexandra Ruan, Clinical Assistant Professor, Stanford University
    ClinicalTrials.gov Identifier:
    NCT05043038
    Other Study ID Numbers:
    • 51495
    First Posted:
    Sep 13, 2021
    Last Update Posted:
    Dec 13, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alexandra Ruan, Clinical Assistant Professor, Stanford University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 13, 2021