Lifestyle Coaching for Fatigue Mitigation in Emergency Medicine Residents

Self Efficacy Clinical Trial

Official title:

Lifestyle Education and Personalized Coaching for Fatigue Mitigation in Emergency Medicine Residents: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015646
• Other study ID #: IRB-67719
• Secondary ID: 254764
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: Maryam S Makowski, PhD
• Phone: 6504975950
• Email: nnaryann[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether personalized lifestyle coaching minimizes the negative impact of circadian disruption on performance and recovery in emergency medicine physician trainees during night shifts.

Description:

The goal of this study is to examine whether a brief personalized fatigue-mitigation lifestyle coaching (PFMLC) for emergency medicine residents on overnight shifts would minimize the negative effects of circadian rhythm disruptions on performance and recovery compared to those who receive one-time passive information on lifestyle practices.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Stanford Health Care (SHC) Emergency Medicine residents (PGY 1 to 4)
• Scheduled to work at least 3 consecutive overnight shifts at SHC Emergency Department.

Exclusion Criteria:

• Non-Stanford Health Care (SHC) Emergency Medicine residents
• Stanford Health Care (SHC) Emergency Medicine residents who are not rotating in Stanford Emergency Medicine Department

Related Conditions & MeSH terms

• Alertness
• Dyssomnias
• Emergencies
• Lifestyle, Healthy
• Occupational Stress
• Parasomnias
• Self Efficacy
• Self-Compassion
• Shift-Work Related Sleep Disturbance
• Sleepiness
• Work Related Stress

Intervention

Behavioral:
• Personalized lifestyle coaching and educational handout
Participants will receive a one-page educational handout on strategies to minimize fatigue at the beginning of the study. Participants will also receive a 30-minute focused, personalized lifestyle coaching within a week of the initial overnight shift. The lifestyle coach will be in close contact during the night shifts.
• Handout
Participants will receive a one-page educational handout on strategies to minimize fatigue at the beginning of the study

Locations

Country	Name	City	State
United States	Stanford Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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. It takes about 1 minute to complete and will be measured at the beginning of the study and at the end of the study. Investigators will compare the percentage change from baseline between the two groups. The minimum score is 8 and the maximum is 40 and linked to T-scores ranging from 30 to 80.1. With lower scores being more favorable.	3 weeks
Other	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 a measure of perceived workload and is used to measure cognitive load. Lower scores are more desirable. It takes about 1 minute to complete and will be measured at the beginning of the study and at the end of the study. Investigators will compare the percentage change from baseline between the two groups. The score ranges from 0 to 600 with lower scores being more favorable.	3 weeks
Primary	Mean of the 3 overnight reaction time reciprocal of the psychomotor vigilance test	The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the 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.; Investigators will compare the mean of the 3 overnight Mean reaction time reciprocal (lower is desirable) of the PVT tests between the control and intervention groups.	3 night shifts
Primary	Mean of the 3 overnight number of lapses in psychomotor vigilance test	The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the 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.; Investigators will compare the mean of the 3 overnight number of lapses ( lower is desirable) of the PVT test between the control and intervention groups.	3 night shifts
Primary	Mean of the 3 overnight number of false starts in the psychomotor vigilance test	The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the 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.; Investigators will compare the mean of the 3 overnight number of false starts (lower is desirable) in the PVT test between the control and intervention groups.	3 night shifts
Primary	Mean of the 3 overnight Aggregate Scores of the psychomotor vigilance test	The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the 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.; Investigators will compare the mean of the 3 overnight Aggregate Score (0 worst-100 best and derived from the number of lapses and false starts) of the PVT test between the control and intervention groups.	3 night shifts
Primary	Mean of the 3 overnight 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.; Investigators will compare the mean of the 3 overnight SSS scores between the control and intervention groups	3 night shifts
Primary	Mean of the 3 overnight Noordsy-Dahle Subjective Experience Scale (NDSE)	Modified version of Noordsy-Dahle Subjective Experience Scale (NDSE) for healthy adults includes 8 sub-domains: Global well-being, Delighted 1 to Terrible 7, Lower score better Anxiety: None 1 to Extreme 7, Lower score better Depression: None 1 to Extreme 7, Lower score better Energy: Tired 1 to Energized 7, Higher score better Motivation: None 1 to Strong 7, Higher score better Clarity of thought: Clouded 1 to Totally Clear 7, Higher score better Concentration: Poor 1 to Excellent 7, Higher score better Social interest: Alone 1 to With Others 7, Higher score better; This test takes approximately 90 seconds to complete. Investigators will compare the mean of the 3 overnight Noordsy-Dahle Subjective Experience Scale scores between the control and intervention groups.	3 night shifts
Secondary	Mean of total sleep hours	Investigators will compare total sleep hours per 24-hour period during a baseline week, a night float week, and a recovery week using FitBit Versa 4, between the two groups.	3 weeks
Secondary	Mean of heartrate variability	Investigators will compare the heart rate variability per 24-hour period during a baseline week, a night float week, and a recovery week using Fitbit Versa 4, between the two groups.	3 weeks