search
Back to results

Lifestyle Coaching for Fatigue Mitigation in Emergency Medicine Residents

Primary Purpose

Lifestyle, Healthy, Sleepiness, Alertness

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized lifestyle coaching and educational handout
Handout
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lifestyle, Healthy focused on measuring physician well-being, occupational well-being, resident well-being, physician coaching, lifestyle coaching, night shifts

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle Coaching and Educational Handout

Educational Handout Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean of the 3 overnight percentage changes (from pre-shift) in Mean reaction time reciprocal of the a 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 percentage changes from pre to mid-shift between the control and intervention groups for the Mean reaction time reciprocal (lower is desirable) of the PVT test.
Mean of the 3 overnight percentage changes (from pre-shift) the 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 percentage changes from pre to mid-shift between the control and intervention groups for the number of lapses ( lower is desirable) of the PVT test.
Mean of the 3 overnight percentage changes (from pre-shift) in the 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 percentage changes from pre to mid-shift between the control and intervention groups for the number of false starts (lower is desirable) in the PVT test.
Mean of the 3 overnight percentage changes (from pre-shift) the Aggregate Score 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 percentage changes from pre to mid-shift between the control and intervention groups for the Aggregate Score (0 worst-100 best and derived from the number of lapses and false starts) of the PVT test.
Mean of the 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. Investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups
Mean of the 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: 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 percentage changes from pre to mid-shift between the control and intervention groups.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 5, 2023
Last Updated
August 22, 2023
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT06015646
Brief Title
Lifestyle Coaching for Fatigue Mitigation in Emergency Medicine Residents
Official Title
Lifestyle Education and Personalized Coaching for Fatigue Mitigation in Emergency Medicine Residents: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lifestyle, Healthy, Sleepiness, Alertness, Shift-Work Related Sleep Disturbance, Work Related Stress, Self Efficacy, Self-Compassion
Keywords
physician well-being, occupational well-being, resident well-being, physician coaching, lifestyle coaching, night shifts

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 at the beginning of the shift and in the middle of the shift at a time that is most convenient time for each participant, determined by them. 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.
Masking
InvestigatorOutcomes Assessor
Masking Description
One of the two principal investigators and researchers who analyze the data will be blinded to the group assignment.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Coaching and Educational Handout
Arm Type
Experimental
Arm Description
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.
Arm Title
Educational Handout Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized lifestyle coaching and educational handout
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Handout
Intervention Description
Participants will receive a one-page educational handout on strategies to minimize fatigue at the beginning of the study
Primary Outcome Measure Information:
Title
Mean of the 3 overnight percentage changes (from pre-shift) in Mean reaction time reciprocal of the a psychomotor vigilance test
Description
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 percentage changes from pre to mid-shift between the control and intervention groups for the Mean reaction time reciprocal (lower is desirable) of the PVT test.
Time Frame
Two time points (beginning and middle of night shifts) on each night for a total of 3 nights
Title
Mean of the 3 overnight percentage changes (from pre-shift) the number of lapses in psychomotor vigilance test
Description
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 percentage changes from pre to mid-shift between the control and intervention groups for the number of lapses ( lower is desirable) of the PVT test.
Time Frame
Two time points (beginning and middle of night shifts) on each night for a total of 3 nights
Title
Mean of the 3 overnight percentage changes (from pre-shift) in the number of false starts in the psychomotor vigilance test
Description
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 percentage changes from pre to mid-shift between the control and intervention groups for the number of false starts (lower is desirable) in the PVT test.
Time Frame
Two time points (beginning and middle of night shifts) on each night for a total of 3 nights
Title
Mean of the 3 overnight percentage changes (from pre-shift) the Aggregate Score of the psychomotor vigilance test
Description
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 percentage changes from pre to mid-shift between the control and intervention groups for the Aggregate Score (0 worst-100 best and derived from the number of lapses and false starts) of the PVT test.
Time Frame
Two time points (beginning and middle of night shifts) on each night for a total of 3 nights
Title
Mean of the 3 overnight percentage changes (from pre-shift) in Stanford Sleepiness Scale
Description
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 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
Title
Mean of the 3 overnight percentage changes (from pre-shift) in Noordsy-Dahle Subjective Experience Scale (NDSE)
Description
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 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 Outcome Measure Information:
Title
Mean of total sleep hours
Description
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.
Time Frame
3 weeks
Title
Mean of heartrate variability
Description
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.
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
Percentage change from baseline in NIH PROMIS Short Form Sleep-Related Impairment
Description
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.
Time Frame
3 weeks
Title
Percentage change from baseline in Task Load Index
Description
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.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryam S Makowski, PhD
Phone
6504975950
Email
nnaryann@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nikitha Menon, BA
Phone
6504978741
Email
nkmenon@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Al'ai Alvarez, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maryam S Makowski, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikitha K Menon, BA
First Name & Middle Initial & Last Name & Degree
Maryam S Makowski, PhD
First Name & Middle Initial & Last Name & Degree
Al'ai Alvarez, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lifestyle Coaching for Fatigue Mitigation in Emergency Medicine Residents

We'll reach out to this number within 24 hrs