Does Fatigue Coaching Improve Functioning and Fatigue in Resident Night Shifts
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Massachusetts, Worcester
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
emergency medicine resident
scheduled to work at least 4 overnight consecutive shifts
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Personalized coaching
BehavioralPersonalized fatigue mitigation coaching.
Nutrition handout
BehavioralNutrition handout
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Mean of the change in 3 overnight percentage changes (from pre-shift) in mean reaction time
The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts. The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the PVT outcome of mean reaction time reciprocal (lower is desirable).
Time frame
Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]2
Mean of the change in 3 overnight percentage changes (from pre-shift) in number of lapses in PVT
The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts. The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the PVT outcome of number of lapses (lower is desirable).
Time frame
Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]3
Mean of the change in 3 overnight percentage changes (from pre-shift) in aggregrate PVT score
The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts. The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the PVT outcome of aggregate score (0 worst - 100 best).
Time frame
Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]4
Mean of the change in 3 overnight percentage changes (from pre-shift) in Stanford Sleepiness Scale
The Sleepiness Symptom Scale (SSS) is a validated subjective measure of sleepiness frequently used for research and clinical purposes. It evaluates sleepiness at specific moments in time using a single-item scale. Respondents select one of seven statements to indicate their level of perceived sleepiness. Score Range: The scale score ranges from 1 to 7, reflecting the varying degrees of sleepiness experienced by respondents. This test takes approximately 15 seconds to complete. Directionality: Higher scores on the SSS represent higher perceived sleepiness, while lower scores indicate increased alertness and desirable. The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups.
Time frame
Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]Secondary outcomes
1
Mean of total hours of sleep
Total sleep hours per 24-hour period during a baseline week, the period of night shifts, and a recovery week using FitBit Versa 4, between the two groups will be compared.
Time frame
1 week of baseline, during the 1 week of night shifts, and for 1 week after the night shifts2
Mean of heart rate variability
Heart rate variability per 24-hour period during a baseline week, the period of night shifts, and a recovery week using Fitbit Versa 4, between the two groups will be compared.
Time frame
1 week of baseline, during the week of night shifts, and for 1 week after the night shiftsOther outcomes
1
Percentage change from baseline in NIH PROMIS Short Form Sleep-Related Impairment
The NIH PROMIS Short Form Sleep-Related Impairment Scale is included as an exploratory outcome measure in this study. The Sleep-Related Impairment is designed to assess the impact of sleep-related impairment on various aspects of daily functioning and overall quality of life. Higher scores indicate greater sleep-related impairment. The NIH PROMIS takes about 1 minute to complete and will be measured at the beginning of the study and at the end of the study. The investigators will compare the percentage change from baseline between the two groups.
Time frame
1 week of baseline, during the week of night shifts, and for 1 week after the night shifts2
Percentage change from baseline in Task Load Index
The National Aeronautics and Space Administration\\ (NASA) Task Load Index (TLX) is included as an exploratory outcome measure in this study. The TLX is used to measure cognitive load. Lower scores are more desirable. The TLX takes about 1 minute to complete and will be measured at the beginning of the study and at the end of the study. The investigators will compare the percentage change from baseline between the two groups.
Time frame
1 week of baseline, during the week of night shifts, and for 1 week after the night shiftsSponsors and contacts
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Source ClinicalTrials.gov
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