Healthcare Worker Resilience as Measured by Physiologic Feedback

Impact of Circadian Alignment, Autonomic Control, and Physiologic Feedback on Measures of Resilience: A Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Burnout, Professional
• Intervention / Treatment: Behavioral: Control; Behavioral: Resilience coaching

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control Arm; Instruction about importance of sleep.	Behavioral: Control; Importance of sleep
Experimental: Coaching; Undergo resilience coaching	Behavioral: Resilience coaching; Arena Strive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery	Using WHOOP algorithm, recovery will be quantified using heart rate variability and sleep, and serve as a measure of stress and resilience	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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	6 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Stress; Occupational Diseases; Burnout, Psychological; Burnout, Professional
• Other Study ID Numbers: 61917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No