Clinical trial NCT06100809: Does Fatigue Coaching Improve Functioning and Fatigue in Resident Night Shifts
Official title: Personalized Fatigue-Mitigation Lifestyle Coaching (PFMLC) to Improve Performance and Recovery Among Emergency Medicine Residents on Night Shifts
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fatigue
Shift Work Type Circadian Rhythm Sleep Disorder
Keywords: Fatigue
Shift Work
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Emergency Medicine (EM) requires 24/7 staff coverage resulting in healthcare workers' circadian rhythm disruptions that impair clinical and cognitive performance, physical recovery, and contribute to burnout. Multiple well-being surveys continue to highlight EM's challenges with sleep impairment due to the nature of the specialty. Despite evidence that lifestyle strategies effectively optimize performance and recovery, EM residents have variable lifestyle choices to prepare for overnight shifts. This prospective randomized controlled trial will examine whether a pre-shift personalized fatigue-mitigation lifestyle coaching (PFMLC) for EM residents on overnight shifts minimizes the effects of circadian rhythm disruptions on performance and recovery compared to those who receive one-time passive information on lifestyle practices. All participants will receive lifestyle strategy materials on fatigue mitigation to improve performance. Residents' self-reported and biometric data will inform PFMLC in the active arm. Performance and recovery from night shifts will be assessed by changes in sleep, heart rate variability, readiness/recovery, alertness, cognitive performance, and mental health using Fitbit and validated measures.

Detailed description: The investigators will use a block-randomized design utilizing each 28-day scheduling period as a block.

Baseline characteristics and confounding factors such as gender, habitual diet, sleep, and caffeine intake will be collected on the first night of the study. Outcome measures will be assessed at the beginning of the shift and between the hours of 2:00 AM to 5:00 AM when sleep propensity and decreased alertness peak.

Outcome measures include a) Stanford Sleepiness Scale (SSS): which takes about 15 seconds to complete. b) Work Exhaustion (4 questions overall): take 20 seconds to complete. c) electronic psychomotor vigilance test: take 3 minutes to complete. The psychomotor vigilance test is a gamified method to measure both vigilance and reaction time. Done on a phone, a colored block appears on the screen, and when a participant sees the block, the participant taps the screen. Reaction time is measured in milliseconds and the average reaction time over the 3 minutes is calculated by the program and reported to the participant as well as stored in the participant's profile.

Study participants will be required to participate in the study for a total of 18 days. Each study participant will contribute biometric data for 7 days before a string of at least 4 consecutive night shifts, then for another 7 days (for a total of 18 days). A self-care handout containing nutrition tips for fatigue mitigation in night shift workers will be given to all participants at the beginning of the study. A Fitbit device will be provided to all participants to measure biometrics data.

Control: The investigators will not provide personalized coaching and ask the control participants to follow and record their typical nightshift habits. The control participants will participate in the surveys and tests as above. Control participants will receive a daily text message to remind them to do the surveys and tests during their shifts. The investigators will instruct the control participants to make sure their phones are silenced during this time as part of better habits for sleep.

Eligibility criteria: Inclusion Criteria:

* emergency medicine resident
* scheduled to work at least 4 overnight consecutive shifts

Exclusion Criteria:

* not willing to wear Fitbit device during the study
* not willing to answer questionnaires
* not willing to receive text messages during the study
* not willing to meet with a lifestyle coach during the study
* not willing t0 download app to their personal smartphone or residency-supplied smartphone

Primary outcomes:
measure: Mean of the change in 3 overnight percentage changes (from pre-shift) in mean reaction time
timeFrame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
measure: Mean of the change in 3 overnight percentage changes (from pre-shift) in number of lapses in PVT
timeFrame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
measure: Mean of the change in 3 overnight percentage changes (from pre-shift) in aggregrate PVT score
timeFrame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
measure: Mean of the change in 3 overnight percentage changes (from pre-shift) in Stanford Sleepiness Scale
timeFrame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
measure: Mean of the change 3 overnight percentage changes (from pre-shift) in Noordsy-Dahle Subjective Experience Scale (NDSE) Modified version of Noordsy-Dahle Subjective Experience Scale (NDSE) for healthy adults includes 8 sub-domains:
timeFrame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
Secondary outcomes:
measure: Mean of total hours of sleep
timeFrame: 1 week of baseline, during the 1 week of night shifts, and for 1 week after the night shifts
measure: Mean of heart rate variability
timeFrame: 1 week of baseline, during the week of night shifts, and for 1 week after the night shifts
Other outcomes:
measure: Percentage change from baseline in NIH PROMIS Short Form Sleep-Related Impairment
timeFrame: 1 week of baseline, during the week of night shifts, and for 1 week after the night shifts
measure: Percentage change from baseline in Task Load Index
timeFrame: 1 week of baseline, during the week of night shifts, and for 1 week after the night shifts
Locations:
city: Worcester
country: United States
facility: UMassMemorial Health Care
state: Massachusetts
Study officials:
References: