Remote Physiologic Monitoring of Resident Wellness and Burnout

NCT04304703 | Completed

• 1 other identifier: STUDY14522
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Resident Wellness; Resident Burnout; Sleep; Stress; Anxiety; Depression

Keywords

Remote monitoring; Heart rate variability; Resident wellness; Resident burnout; WHOOP strap 3.0; Stress; Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• Change in Heart Rate Variability (HRV)

  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)

  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 Outcomes (9)

• Change in Sleep (hours per night)

  12 months, change measured every 2 weeks

• Change in Resting Heart Rate (RHR)

  12 months, change measured every 2 weeks

• Change in Average Weekly Duty Hours

  12 months, change measured every 2 weeks

• Change in Mini ReZ score (15-76 scale)

  12 months, change measured every 2 weeks

• Change in Physician Well-Being Index (PWBI) (0-7 scale)

  12 months, change measured every 2 weeks

Study Arms (1)

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

Interventions

WHOOP strap 3.0 DEVICE

WHOOP strap 3.0, a photodiode-based device that tracks sleep, resting heart rate, and heart rate variability.

Internal Medicine resident subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (27)

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• West CP, Shanafelt TD, Cook DA. Lack of association between resident doctors' well-being and medical knowledge. Med Educ. 2010 Dec;44(12):1224-31. doi: 10.1111/j.1365-2923.2010.03803.x.

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• Bullinga JR, Alharethi R, Schram MS, Bristow MR, Gilbert EM. Changes in heart rate variability are correlated to hemodynamic improvement with chronic CARVEDILOL therapy in heart failure. J Card Fail. 2005 Dec;11(9):693-9. doi: 10.1016/j.cardfail.2005.06.435.

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  PMID: 34236995 DERIVED

Related Links

• WHOOP measures 3 physiological markers: Heart Rate Variability (HRV), Resting Heart Rate (RHR), and sleep. HRV measures the variation in time between each heart beat. RHR is measured during sleep each night for consistent, controlled readings.

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Andrew Tinsley, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Gastroenterology

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 11, 2020
• Study Start: July 3, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 5, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)