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Remote Physiologic Monitoring of Resident Wellness and Burnout

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04304703
Recruitment Status : Active, not recruiting
First Posted : March 11, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew Tinsley, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment
Resident Wellness Resident Burnout Sleep Stress Anxiety Depression Device: WHOOP strap 3.0

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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remote Physiologic Monitoring of Resident Wellness and Burnout
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


  5. 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.

  6. 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).

  7. 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.

  8. 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.

  9. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Internal Medicine Residents (categorical) at Penn State Hershey Medical Center (PGY-1 to PGY-3)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304703


Locations
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United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Andrew Tinsley, MD Milton S. Hershey Medical Center
Additional Information:
Publications:

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Responsible Party: Andrew Tinsley, Associate Professor, Gastroenterology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04304703    
Other Study ID Numbers: STUDY14522
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew Tinsley, Milton S. Hershey Medical Center:
Remote monitoring
Heart rate variability
Resident wellness
Resident burnout
WHOOP strap 3.0
Stress
Anxiety
Depression
Additional relevant MeSH terms:
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Depression
Burnout, Psychological
Behavioral Symptoms
Stress, Psychological