Remote Physiologic Monitoring of Resident Wellness and Burnout

November 3, 2021 updated by: Andrew Tinsley, Milton S. Hershey Medical Center
Resident wellness and physician burnout are under the spotlight more and more as data begins to show that there is a point of diminishing return on the number of hours in training. In 2003, resident work hours were restricted to less than 80 hours per week averaged over 4 weeks. This change was implemented in response to the robust body of evidence that increased work hours leads to decreased sleep, which in turn leads to medical errors and depression. These factors directly and indirectly lead to worse outcomes for patients. In residency, it is difficult objectively to assess when residents are beginning to experience burnout and depression. The investigators propose a study to determine whether tracking of certain heart rate parameters (resting heart rate and heart rate variability) as well as sleep can correlate to subjective assessment of resident wellness, burnout and depression. The investigators will also compare these measures to biomarkers of stress, such as salivary cortisol. The results of this study may lead to improved understanding of what truly causes burnout and may be an eventual target for intervention to help improve short- and long-term outcomes for resident physicians as well as their patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sleep deprivation contributes to workplace burnout, a psychological work-related syndrome characterized by depersonalization, emotional exhaustion and feelings of decreased personal accomplishment [Montgomery, 2019]. Medical residency training is associated with decreased sleep and exercise as well as an increase in burnout, which may also be associated with depression [Kamblach, 2019]. Resident wellness has become a focal point of many residency programs in order to prevent depression and long-term physician burnout. Many previous studies tracking sleep have used self-reporting, which institutes a certain level of bias, and some newer technologies such as FitBit tracking have become more prevalent [Case, 2015; de Zambotti, 2018]. Real-time physiologic metric tracking, such as resting heart rate (RHR) and heart rate variability (HRV), in addition to accurate sleep tracking, could provide a far more accurate and objective assessment of resident wellness [Sekiguchi, 2019]. These metrics have not been compared directly to subjective assessments of wellness, burnout and depression, thus their true value in this realm is unknown [Mendelsohn, 2019; Kamblach, 2018]. However, having an objective assessment of resident wellness, stratified by specific rotation, could help identify, develop, and institute interventions to prevent burnout and depression and improve resident well-being.

Previous studies have attempted to make an association between sleep hours, duty hours, exercise and wellness, burnout, depression; however, they have used primitive forms of physiologic tracking (i.e. counting steps as a surrogate for exercise and self-reporting of sleep), which is likely why the results have been relatively inconclusive [Mendelsohn, 2019; Kamblach, 2018; Poonja, 2018; Basner, 2017; Marek, 2019]. A systematic review and meta-analysis of studies attempting to identify factors associated with greater resident well-being showed that increased sleep and time away from work were the strongest influencers of improved resident wellness [Raj, 2016]. Objective, real-time assessment of sleep may identify a stronger association and the addition of RHR and HRV to this analysis could further validate subjective assessment of wellness.

HRV, or the fluctuation in the time intervals between adjacent heart beats, has never before been used to track resident well-being but it is an established metric for prediction and management of disease states such as heart failure [Jimenez-Morgan, 2017; Goessl, 2017, Shaffer, 2017; Bullinga; 2005; Tsuji, 1996]. HRV has been shown to predict mortality in Heart Failure with reduced Ejection Fraction (HFrEF) and new cardiac events (angina, myocardial infarction, coronary artery disease-related death, or HF) in the Framingham study, and it also correlates with improved hemodynamics in response to beta-blocker therapy for HF [Bullinga; 2005; Tsuji, 1996].

The investigators propose to use the WHOOP strap 3.0 for remote monitoring of residents to determine a relationship between its measured data (RHR, HRV, and sleep duration) and wellness using literature-validated surveys (Maslach Burnout Inventory, Mini-ReZ survey, Physician Well Being Index, Patient Health Questionnaire-9) [Montgomery, 2019; Linzer, 2016; Olson 2019; Kroenke, 2001; Levis, 2019]. There is no published literature or known ongoing studies investigating this relationship Recent studies have, however, validated the WHOOP device for sleep tracking and determined its efficacy to be nearly identical to that of the gold standard of polysomnography (PSG) [Berryhill, 2020]. This study also showed that the precision of HRV measurements using the wearable WHOOP device had less than 10% error when compared to continuous ECG monitoring, as part of PSG.

There is an established relationship between HRV and anticipated stress, quantified by salivary cortisol levels, yet there has not been studies linking salivary cortisol as a marker of stress, to subjective assessments in physicians nor against data from wearable devices. Biomarkers of stress (salivary cortisol and alpha-amylase) will compared at baseline and on different rotation considered to be associated with varying levels of stress (i.e. outpatient clinic and inpatient consult services versus the intensive care unit (ICU) setting) [Dickerson, 2004; Petrakova, 2015]. Saliva samples provided by subjects will allow the investigators to validate the WHOOP device as a novel tool to measure stress by allowing the team to assess the association between HRV and other device metrics and objective stress-based analytes found in saliva (e.g., cortisol and alpha amylase). These results will be correlated with each other and with work hours via duty logging to determine whether specific rotations in medical residency have better or worse objective and subjective metrics; these results will also be correlated to baseline (according to baseline characteristics survey).

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Internal Medicine Residents (categorical) at Penn State Hershey Medical Center (PGY-1 to PGY-3)

Description

Inclusion Criteria:

  • Internal Medicine Residents of Penn State Milton S. Hershey Medical Center (PGY-1 to PGY-3; categorical residents only).
  • Age greater than 18 years old.
  • Willing to wear WHOOP device for at least 80% of the time.
  • Willing to complete weekly surveys at least 80% of time.
  • Willing to provide and return saliva samples for analysis of stress biomarkers.
  • Own smart phone for pairing with WHOOP device.

Exclusion Criteria:

  • Preliminary or Transition-Year (TY) Internal Medicine Residents of Penn State Milton S. Hershey Medical Center

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Internal Medicine resident subjects
Subjects who are categorical Internal Medicine residents at Penn State Hershey Medical Center (PGY1-PGY3), and meet inclusion/exclusion criteria, will be enrolled in this study and wear the WHOOP strap 3.0 for real-time measurement of physiologic metrics.
Device: WHOOP strap 3.0
WHOOP strap 3.0, a photodiode-based device that tracks sleep, resting heart rate, and heart rate variability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate Variability (HRV)
Time Frame: 12 months, change measured every 2 weeks
Heart Rate Variability will be objectively measured nightly. Average HRV (over two weeks) will be assessed for change every two weeks over the duration of the study.
12 months, change measured every 2 weeks
Change in Maslach Burnout Inventory score (3 subscales: 0-54, 0-30, 0-48)
Time Frame: 12 months, change measured every 2 weeks

Maslach Burnout Inventory - Human Services Survey for Medical Personnel (MBI-HSS (MP)). The MBI-HSS (MP) is a variation of the MBI-HSS adapted for medical personnel. The most notable alteration is this form refers to "patients" instead of "recipients". The MBI-HSS (MP) scales are Emotional Exhaustion (9 questions), Depersonalization (5 questions), and Personal Accomplishment (8 questions).

Maslach Burnout Inventory score will be assessed every two weeks in survey format. Each question is scored 0-6, thus the subscale ranges are 0-54, 0-30, 0-48, respectively, with higher scores signifying higher levels of burnout for the emotional exhaustion and depersonalization subscales and lower scores signifying higher levels of burnout for the personal accomplishment subscale.
12 months, change measured every 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sleep (hours per night)
Time Frame: 12 months, change measured every 2 weeks
Sleep will be objectively measured nightly. Sleep (hours per night) will be assessed for change every two weeks over the duration of the study (average sleep per night over two weeks). Subscales for sleep will include duration of rapid eye movement (REM), slow wave sleep (SWS), and light sleep. Time in bed and naps will also be recorded.
12 months, change measured every 2 weeks
Change in Resting Heart Rate (RHR)
Time Frame: 12 months, change measured every 2 weeks
Resting Heart Rate will be objectively measured nightly. Average RHR (over two weeks) will be assessed for change every two weeks over the duration of the study.
12 months, change measured every 2 weeks
Change in Average Weekly Duty Hours
Time Frame: 12 months, change measured every 2 weeks
Weekly duty hours will be self-reported every two weeks, individually as week 1 hours and week 2 hours. Week 1 and week 2 hours will be averaged for each two-week block.
12 months, change measured every 2 weeks
Change in Mini ReZ score (15-76 scale)
Time Frame: 12 months, change measured every 2 weeks

The Mini-Z comprises 15 items which assess satisfaction, stress, burnout, work control, chaos, values alignment, teamwork, documentation, time pressure, excess electronic medical record (EMR) use at home, and EMR proficiency. It is scored on a scale of 15-76. A total score greater 60 represents a positive learning environment. Subscale 1 - Supportive Work Environment (questions 1-5): range 6-26 (greater than 20 is a highly supportive work environment). Subscale 2 - Work pace and EMR Stress (questions 6-10: range 5-25 (greater than 20 is an environment with good pace and manageable EMR stress). Subscale 3 - Resident Experience (questions 11-15): range 5-25 (greater than 20 is a positive and healthy resident experience).

Mini-ReZ will be assessed every two weeks in survey format.
12 months, change measured every 2 weeks
Change in Physician Well-Being Index (PWBI) (0-7 scale)
Time Frame: 12 months, change measured every 2 weeks
The Physician Well Being Index is a 7 question survey, scored 0-7, with lower scores indicative of better physician well being.
12 months, change measured every 2 weeks
Change in Patient Health Questionnaire-9 (PHQ-9) score (0-27 scale)
Time Frame: 12 months, change measured every 2 weeks
The PHQ-9 is a 9-question instrument given to subjects in a primary care setting to screen for the presence and severity of depression. PHQ-9 score will be assessed every two weeks in survey format. It is scored on a 0-27 scale, with higher scores signifying higher levels of depression. The PHQ-9 scores indicate mild (<4) to severe (20+) severe PD. The PHQ-9 also has a self-report item for suicidal ideation (SI).
12 months, change measured every 2 weeks
Change in Hospital Anxiety and Depression Subscale (HADS) score (0-42 scale, Anxiety: 0-21 subscale, Depression 0-21 subscale)
Time Frame: 12 months, change measured every week
The HADS consists of two scales; A (anxiety) - with 7 items [Cronbach's alpha = 0.78] and D (depression) - with 7 items [Cronbach's alpha = 0.71], each with scores ranging from 0-21; total scale scores range from 0-42, with higher scores indicating more distressing symptoms. The HADS has been validated with primary care patients.
12 months, change measured every week
Change in Perceived Stress Scale (PSS-4) score (0-16 scale)
Time Frame: 12 months, change measured every week
The PSS-4 consists of 4 items that assess perceived stress. The items are scored on a 4-point scale (Score range: 0-16; higher scores reflect greater perceived stress. The measure demonstrates strong internal consistency with a Cronbach's alpha of .88.
12 months, change measured every week
Change in Salivary Stress Biomarkers (cortisol, alpha-amylase)
Time Frame: 12 months; baseline during week 1 of study (2 consecutive collection days), clinic/consult rotations (4 consecutive weeks, every Friday), ICU (4 consecutive weeks, every Friday)
Saliva samples will be collected during baseline assessment (2 consecutive days) and during outpatient clinic/inpatient consult services (low stress) and ICU (high stress) rotations (weekly for 4 weeks, every Friday). Each collection day will have 3 collection times: wake-up (t=0), wake-up time + 30 min (t=30), night time (just prior to sleep) (NT).
12 months; baseline during week 1 of study (2 consecutive collection days), clinic/consult rotations (4 consecutive weeks, every Friday), ICU (4 consecutive weeks, every Friday)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 3, 2020

Primary Completion (ACTUAL)

June 30, 2021

Study Completion (ACTUAL)

June 30, 2021

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (ACTUAL)

March 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY14522

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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