Healthcare Worker Resilience as Measured by Physiologic Feedback

Sponsor
Stanford University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05033379
Collaborator
University of California, San Francisco (Other)
400
1
2
12.9
31

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Control
  • Behavioral: Resilience coaching
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Impact of Circadian Alignment, Autonomic Control, and Physiologic Feedback on Measures of Resilience: A Multicenter Randomized Controlled Trial
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Recovery [6 months]

    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

  1. Burnout [6 months]

    The Physician Fulfillment Index is a quantitative measure of physician burnout and will be administered at baseline and at the end of the study.

  2. Health Habits [6 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford Health Care Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University
  • University of California, San Francisco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cindy Kin, Assistant Professor of Surgery, Stanford University
ClinicalTrials.gov Identifier:
NCT05033379
Other Study ID Numbers:
  • 61917
First Posted:
Sep 2, 2021
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2022