Healthcare Worker Resilience as Measured by Physiologic Feedback
Primary Purpose
Burnout, Professional
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Resilience coaching
Sponsored by
About this trial
This is an interventional prevention trial for Burnout, Professional
Eligibility Criteria
Inclusion Criteria:
- Study participants will include full time clinically active healthcare workers
Exclusion Criteria:
- Exclusion criteria will be anyone who is not a full-time clinical healthcare worker
Sites / Locations
- Stanford Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control Arm
Coaching
Arm Description
Instruction about importance of sleep.
Undergo resilience coaching
Outcomes
Primary Outcome Measures
Recovery
Using WHOOP algorithm, recovery will be quantified using heart rate variability and sleep, and serve as a measure of stress and resilience
Secondary Outcome Measures
Burnout
The Physician Fulfillment Index is a quantitative measure of physician burnout and will be administered at baseline and at the end of the study.
Health Habits
Changes in sleep metrics (duration of sleep, quality of sleep, and pre-sleep habits including light exposure and eating habits before sleep) and diet habits (evaluated by dietary pattern, ie, traditional Westernized, healthy Mediterranean, unhealthy - animal protein and alcohol, at beginning and end of the study) will be assessed
Full Information
NCT ID
NCT05033379
First Posted
August 17, 2021
Last Updated
April 7, 2022
Sponsor
Stanford University
Collaborators
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT05033379
Brief Title
Healthcare Worker Resilience as Measured by Physiologic Feedback
Official Title
Impact of Circadian Alignment, Autonomic Control, and Physiologic Feedback on Measures of Resilience: A Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
University of California, San Francisco
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
Reliably achieving peak performance requires balancing the strain of the prior day with sufficient recovery to be ready for the next day. Surgery has a long standing tradition long hours of hard work often at the expense of adequate sleep. Decreased sleep and recovery has physiologic consequences which can be measured using biometric data. The goal of this study is to quantify surgeon performance and biometric data to understand how modifiable behaviors including mindfulness training and diet can maximize recovery and performance. The goal of this study is to quantify the impact if modifiable daily behaviors including sleep, nutrition, in order to understand the factors that contribute to high level performance, burnout, and physician wellbeing in surgical trainees and attendings.
Detailed Description
Informed consent will be obtained prior to participation in the research study. A member of the research team will provide the participant with the consent form and allow them adequate time to read and ask questions prior to giving consent. If consent is not obtained, the participant will not be allowed to participate in the research study.
Participants will be asked to wear a biometric sensor for six months. The biometric sensor (The WHOOP strap) collects heart rate, heart rate variability, activity, and sleep metrics. Half of the participants will complete coaching to improve resilience with Arena Strive and half will be a control group instructed that sleep is important. In the latter 3 months of the study, the control group will have the opportunity to wear a continuous glucose monitor. At the completion of the study period all participants will have access to Arena strive coaching.
Other data gathered will be in the form of surveys and comments from subjects on wellness, burnout, modifiable activities including sleep, nutrition, glucose levels using continuous glucose monitoring, exercise and mindfulness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
Experimental
Arm Description
Instruction about importance of sleep.
Arm Title
Coaching
Arm Type
Experimental
Arm Description
Undergo resilience coaching
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Importance of sleep
Intervention Type
Behavioral
Intervention Name(s)
Resilience coaching
Intervention Description
Arena Strive
Primary Outcome Measure Information:
Title
Recovery
Description
Using WHOOP algorithm, recovery will be quantified using heart rate variability and sleep, and serve as a measure of stress and resilience
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Burnout
Description
The Physician Fulfillment Index is a quantitative measure of physician burnout and will be administered at baseline and at the end of the study.
Time Frame
6 months
Title
Health Habits
Description
Changes in sleep metrics (duration of sleep, quality of sleep, and pre-sleep habits including light exposure and eating habits before sleep) and diet habits (evaluated by dietary pattern, ie, traditional Westernized, healthy Mediterranean, unhealthy - animal protein and alcohol, at beginning and end of the study) will be assessed
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Study participants will include full time clinically active healthcare workers
Exclusion Criteria:
Exclusion criteria will be anyone who is not a full-time clinical healthcare worker
Facility Information:
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Healthcare Worker Resilience as Measured by Physiologic Feedback
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