NCT05043038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

2.3 years

First QC Date

August 24, 2021

Last Update Submit

December 13, 2024

Conditions

Keywords

Medical EducationPhysician Well-BeingInternship and ResidencyWork Schedule ToleranceFatiguephysician BurnoutSleep Disruption

Outcome Measures

Primary Outcomes (5)

  • Change in Total Sleep Hours During Night Float

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

    3 weeks

  • Change in Rapid Eye Movement Sleep Hours During Night Float

    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

    3 weeks

  • Change in Daily Steps during Night Float Week

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

    3 weeks

  • Trends and Recovery Time in Total Sleep Hours, Rapid Eye Movement, and Daily Steps during a random night call schedule

    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

    4 weeks

  • Comparison in sleep and activity patters between a night float call schedule and a random night call schedule

    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.

    4 weeks

Secondary Outcomes (3)

  • Cohort 1: Change in PROMIS Positive Affect, Sleep Disturbance and Fatigue Scores During Night Float Week

    3 weeks

  • Cohort 2: Change in PROMIS Positive Affect, Sleep Disturbance, and Fatigue Scores throughout the Obstetric Anesthesia Rotation

    3 weeks

  • 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

Study Arms (2)

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). Participants will be asked to fill out PROMIS surveys weekly.

Obstetric Anesthesia Rotation

The residents will be followed and asked to wear the fitbit over a four week period during their rotation. Participants will complete three PROMIS surveys over the four week rotation, and as well as a follow-up PROMIS survey one week after the study period has completed

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Hospital

Palo Alto, California, 94305, United States

Location

Related Publications (7)

  • 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.

    PMID: 24053730BACKGROUND
  • 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.

    PMID: 6343602BACKGROUND
  • 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.

    PMID: 12405552BACKGROUND
  • 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.

    PMID: 27392266BACKGROUND
  • 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.

    PMID: 31149926BACKGROUND
  • 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.

    PMID: 32939368BACKGROUND
  • 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.

    PMID: 28326116BACKGROUND

MeSH Terms

Conditions

Sleep Disorders, Circadian RhythmFatigueParasomnias

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alexandra Ruan, MD

    Stanford University

    STUDY DIRECTOR
  • Pamela Flood, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

August 24, 2021

First Posted

September 13, 2021

Study Start

August 1, 2019

Primary Completion

November 30, 2021

Study Completion

August 30, 2024

Last Updated

December 18, 2024

Record last verified: 2024-12

Locations