Lifestyle Coaching for Fatigue Mitigation in Emergency Medicine Residents

NCT06015646 | Withdrawn

• 2 other identifiers: IRB-67719254764
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleepiness; Alertness; Shift-Work Related Sleep Disturbance; Work Related Stress; Self Efficacy; Self-Compassion; Lifestyle, Healthy

Keywords

physician well-being; occupational well-being; resident well-being; physician coaching; lifestyle coaching; night shifts

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Mean of total sleep hours

  3 weeks

• Mean of heartrate variability

  3 weeks

Other Outcomes (2)

• Percentage change from baseline in NIH PROMIS Short Form Sleep-Related Impairment

  3 weeks

• Percentage change from baseline in Task Load Index

  3 weeks

Study Arms (2)

Lifestyle Coaching and Educational Handout

EXPERIMENTAL

Lifestyle coach-led 30-minute focused, personalized session in addition to educational handout containing lifestyle tips for fatigue mitigation in night shift workers, which will be given to all participants at the beginning of the study.

Behavioral: Personalized lifestyle coaching and educational handout; Behavioral: Handout

Educational Handout Control

ACTIVE COMPARATOR

An educational handout containing lifestyle tips for fatigue mitigation in night shift workers will be given to all participants at the beginning of the study. Personalized coaching will not be offered to participants in this arm.

Behavioral: Handout

Interventions

Personalized lifestyle coaching and educational handout BEHAVIORAL

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.

Lifestyle Coaching and Educational Handout

Handout BEHAVIORAL

Participants will receive a one-page educational handout on strategies to minimize fatigue at the beginning of the study

Educational Handout Control; Lifestyle Coaching and Educational Handout

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Medicine

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Sleepiness; Occupational Stress

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Al'ai Alvarez, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Maryam S Makowski, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One of the two principal investigators and researchers who analyze the data will be blinded to the group assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: The investigators will randomize the participants who have consented to participate in the study to intervention or control arms at the beginning of each of the 3-week study periods. Participants will wear a Fitbit watch for one week prior and one week after 3-4 night shifts. The baseline online survey will collect data on sex, training year, current satisfaction levels with lifestyle strategies, morning-evening chronotype, Sleep-related Impairment, and Task Load. During the nightshifts, the following outcome measures: psychomotor vigilance test, Stanford Sleepiness Scale, Task Load Index, and Noordsy-Dahle Subjective Experience Scale will be assessed during the window of circadian low (2 to 6 am) and at a time that is most convenient time for each participant. A final online survey will assess satisfaction levels with lifestyle strategies, Sleep-related Impairment, Task Load, and satisfaction and feedback about the program at the end of the study.

Study Record Dates

• First Submitted: August 5, 2023
• First Posted: August 29, 2023
• Study Start: March 31, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)