Clinical trial NCT05043038: Effect of Night Float Call on Sleep and Activity Patterns Among Anesthesia Residents
Official title: Effect of Night Float Call on Sleep and Activity Patterns Among Anesthesia Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorder, Shift Work
Fatigue
Sleep Disturbance
Keywords: Medical Education
Physician Well-Being
Internship and Residency
Work Schedule Tolerance
Fatigue
physician Burnout
Sleep Disruption
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit participants who are PGY2-5 and part of the Stanford Hospital Department of Graduate Medical Education, which means they will generally be between 26-36 years of age. We will aim to recruit an equal number of males and females which is reasonable give the demographic distribution of Anesthesia residents. Finally, we aim to have a people with a variety of races and ethnicity involved but this will not be specifically targeted or evaluated due to the limited pool of eligible subjects.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Total Sleep Hours During Night Float
timeFrame: 3 weeks
measure: Change in Rapid Eye Movement Sleep Hours During Night Float
timeFrame: 3 weeks
measure: Change in Daily Steps during Night Float Week
timeFrame: 3 weeks
measure: Trends and Recovery Time in Total Sleep Hours, Rapid Eye Movement, and Daily Steps during a random night call schedule
timeFrame: 4 weeks
measure: Comparison in sleep and activity patters between a night float call schedule and a random night call schedule
timeFrame: 4 weeks
Secondary outcomes:
measure: Cohort 1: Change in PROMIS Positive Affect, Sleep Disturbance and Fatigue Scores During Night Float Week
timeFrame: 3 weeks
measure: Cohort 2: Change in PROMIS Positive Affect, Sleep Disturbance, and Fatigue Scores throughout the Obstetric Anesthesia Rotation
timeFrame: 3 weeks
measure: Change in PROMIS Positive Affect, Sleep Disturbance and Fatigue Scores over the study period in a night float versus a random call night system
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital
state: California
Study officials:
affiliation: Stanford University
name: Alexandra Ruan, MD
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Pamela Flood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belayachi J, Benjelloun O, Madani N, Abidi K, Dendane T, Zeggwagh AA, Abouqal R. Self-perceived sleepiness in emergency training physicians: prevalence and relationship with quality of life. J Occup Med Toxicol. 2013 Sep 21;8(1):24. doi: 10.1186/1745-6673-8-24.
citation: Asken MJ, Raham DC. Resident performance and sleep deprivation: a review. J Med Educ. 1983 May;58(5):382-8. doi: 10.1097/00001888-198305000-00003.
citation: Cavallo A, Jaskiewicz J, Ris MD. Impact of night-float rotation on sleep, mood, and alertness: the resident's perception. Chronobiol Int. 2002 Sep;19(5):893-902. doi: 10.1081/cbi-120014106.
citation: Davis MC, Kuhn EN, Agee BS, Oster RA, Markert JM. Implications of transitioning to a resident night float system in neurosurgery: mortality, length of stay, and resident experience. J Neurosurg. 2017 Apr;126(4):1269-1277. doi: 10.3171/2016.5.JNS152585. Epub 2016 Jul 8.
citation: Dunn LK, Kleiman AM, Forkin KT, Bechtel AJ, Collins SR, Potter JF, Kaperak CJ, Tsang S, Huffmyer JL, Nemergut EC. Anesthesiology Resident Night Float Duty Alters Sleep Patterns: An Observational Study. Anesthesiology. 2019 Aug;131(2):401-409. doi: 10.1097/ALN.0000000000002806.
citation: Nizamuddin SL, Nizamuddin J, Latif U, Tung A, Klafta JM, Lee SM, Ku CM, Stahl DL, Lee J, Shahul SS. Be Active and Be Well? A Cross-sectional Survey of US Anesthesia Residents. J Educ Perioper Med. 2020 Apr 1;22(2):E640. doi: 10.46374/volxxii-issue2-nizamuddin. eCollection 2020 Apr-Jun.
citation: Lee HA, Lee HJ, Moon JH, Lee T, Kim MG, In H, Cho CH, Kim L. Comparison of Wearable Activity Tracker with Actigraphy for Sleep Evaluation and Circadian Rest-Activity Rhythm Measurement in Healthy Young Adults. Psychiatry Investig. 2017 Mar;14(2):179-185. doi: 10.4306/pi.2017.14.2.179. Epub 2017 Mar 6.