Remote Physiologic Monitoring of Resident Wellness and Burnout
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|ClinicalTrials.gov Identifier: NCT04304703|
Recruitment Status : Active, not recruiting
First Posted : March 11, 2020
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment|
|Resident Wellness Resident Burnout Sleep Stress Anxiety Depression||Device: WHOOP strap 3.0|
|Study Type :||Observational|
|Actual Enrollment :||38 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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).
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
|United States, Pennsylvania|
|Penn State Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Andrew Tinsley, MD||Milton S. Hershey Medical Center|