Data-driven Approaches to Healthcare Provider Resilience & Burnout During COVID-19

Overview

The United States is battling dual pandemics: healthcare provider (HCP) exhaustion and COVID-19. The COVID-19 pandemic death toll has surpassed 595,000 and continues to climb as the worldwide outbreak continues. Moreover, we have yet to understand the health impacts of "long-COVID". As evidenced by the national burnout epidemic in HCPs, persistent workplace stress not only impacts personal provider wellbeing, but also influences effective practice and patient outcomes. To address this need, we propose a 4-year, multi-site, four-arm parallel-group randomized clinical trial (RCT) comparing 2 non-pharmacological interventions: Transcendental Meditation (TM) and Experience Resolution Methodology (ERM) to Treatment as Usual (TAU). Participation in this study lasts up to 24 months for enrolled participants and is considered minimal risks.

Full Title of Study: “Data-driven Approaches to Healthcare Provider Resilience & Burnout During COVID-19”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2022

Detailed Description

The United States is battling dual pandemics: healthcare provider (HCP) exhaustion and COVID-19. The COVID-19 pandemic death toll has surpassed 595,000 and continues to climb as the worldwide outbreak continues. Moreover, we have yet to understand the health impacts of "long-COVID". Taxed with an overloaded healthcare system, longer shifts, disrupted work-life balance, and the responsibility to uphold biosecurity with limited personal protective equipment (PPE), frontline HCPs are experiencing unprecedented levels of distress. A major and shared anxiety among HCPs is the fear of propagating the disease to their coworkers and their families. As evidenced by the national burnout epidemic in HCPs, persistent workplace stress not only impacts personal provider wellbeing, but also influences effective practice and patient outcomes. National institutes, such as the Joint Commission, are calling for the prioritization of healthcare workforce resilience in an effort to protect against rapid turnover, medical errors and suboptimal patient care. Resilience is defined as the "ability to respond to stress in a healthy, adaptive way, such that goals are met with minimal psychologic and physical cost". However, the major obstacle to systematically addressing HCPs burnout and building a resilience-based workforce is the sparsity of data on qualitative, physiologic, and biological predictors of resilience and evidence-based preventative, diagnostic, and treatment strategies. At this point, most health care institutions, if they are addressing burnout and resilience at all, offer a form of executive coaching. However, there is limited systematic evidence to support benefit. To address this need, we propose a 4-year, multi-site, four-arm parallel-group randomized clinical trial (RCT) that will be operationalized via three distinct aims: – Aim 1: To assess the efficacy of 1) Transcendental MeditationĀ® (TMĀ®) versus Treatment as Usual (TAU), 2) a form of coaching termed Experience Resolution Methodology (ERM) versus TAU, and 3) TM plus ERM versus TAU in increasing resilience and reducing burnout syndrome in HCPs. – Aim 2: To characterize the biometric, immunologic, and neuro-functional characteristics of HCPs' resilience and burnout. – Aim 3: To develop a medical predictive model and a composite resilience and burnout index. For this study, the term "health care provider" (HCP) will be all inclusive of any individual working in a health care setting with patient-facing responsibilities in addition to physician and physician trainees.

Interventions

  • Behavioral: Transcendental Meditation (TM)
    • TM is a mind-body program that allows the participant to experience progressively quieter, less excited states of mental activity, with growing experience of restful alertness in mind and body.
  • Behavioral: Experience Resolution Methodology (ERM)
    • ERM is a specific, protocolized coaching method that aims to maximize an individual’s performance, professional development and well-being by recognizing and resolving subjective stress associated with specific situations, circumstances, events or experiences.
  • Behavioral: Transcendental Meditation (TM) and Experience Resolution Methodology (ERM)
    • TM + ERM is an integrative method using both TM and ERM coaching with ERM with the aim of achieving an overall restful, alertness in mind and body and maximizing performance, professional development and well-being.
  • Behavioral: Treatment As Usual (TAU)
    • TAU is the existing Duke Health & Well-being services, such as the availability of acupuncture, integrative health coaching, integrative nutrition and weight management, personal exercise training, massage therapy, yoga therapy, mindfulness-based stress reduction (MBSR), experiencing mindfulness, group fitness classes, gentle yoga, or chair yoga, as well as additional resources such as Personal Assistance Services (PAS).

Arms, Groups and Cohorts

  • Experimental: Transcendental Medication (TM)
    • Transcendental Meditation (TM): a mind-body program that allows the participant to experience progressively quieter, less excited states of mental activity, with growing experience of restful alertness in mind and body.
  • Experimental: Experience Resolution Methodology (ERM)
    • Experience Resolution Methodology (ERM): is a specific, protocolized coaching method that aims to maximize an individual’s performance, professional development and well-being by recognizing and resolving subjective stress associated with specific situations, circumstances, events or experiences.
  • Experimental: TM+ERM
    • Transcendental Meditation (TM) and Experience Resolution Methodology (ERM): an integrative method using both TM and ERM coaching with ERM with the aim of achieving an overall restful, alertness in mind and body and maximizing performance, professional development and well-being.
  • Active Comparator: Treatment As Usual (TAU)
    • Treatment As Usual (TAU): is the existing Duke Health & Well-being services, such as the availability of acupuncture, integrative health coaching, integrative nutrition and weight management, personal exercise training, massage therapy, yoga therapy, mindfulness-based stress reduction (MBSR), experiencing mindfulness, group fitness classes, gentle yoga, or chair yoga, as well as additional resources such as Personal Assistance Services (PAS).

Clinical Trial Outcome Measures

Primary Measures

  • Change in resilience as measured by the Connor-Davidson Resilience Scale-25
    • Time Frame: Baseline to 3 months
    • The Connor-Davidson Resilience scale (CD-RISC) comprises of 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience

Secondary Measures

  • Change in burnout as measured by the Maslach Burnout Inventory (MBI).
    • Time Frame: Baseline to 3 months
    • The MBI consists of 3 scales to assess emotional exhaustion, depersonalization, and personal accomplishment with higher scores reflecting greater burnout. The MBI is composed of 22 items, each rated on a scale of 0 to 6. The higher scores reflect greater burnout.
  • Change in depression as measured by the Patient Health Questionnaire-9 (PHQ-9).
    • Time Frame: Baseline to 3 months
    • The PHQ-9 is a 9 question a 9 question survey that rates responses on a scale of 0 to 3, 0 being equivalent to “not at all” and 3 equivalent to “nearly every day”. The higher scores reflect greater depression in an individual.
  • Change in psychological distress as measured by the Subject Units of Distress Scales (SUDS).
    • Time Frame: Baseline to 3 months
    • The SUDS is a 0 to 10 scale that measures subjective intensity of disturbance or distress. The higher the score the great the individual’s psychological distress.
  • Change in quality of life as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF).
    • Time Frame: Baseline to 3 months
    • The Q-LES-Q-SF is an assessment that measures the degree of enjoyment and satisfaction experienced by individuals in various areas of daily functioning. It is a 16 item assessment on a scale of 1 to 5, 1 being equivalent to “very poor” and 5 being equivalent to “very good.” The higher scores reflect increased perceived quality of life.
  • Change in PTSD symptom severity as measured by the Post-Traumatic Stress Disorder (PTSD) checklist-5 (PCL-5).
    • Time Frame: Baseline to 3 months
    • The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with higher scores reflecting greater PTSD.
  • Change in sleep as measured by the Insomnia Severity Index (ISI).
    • Time Frame: Baseline to 3 months
    • The ISI is a patient-reported outcome that assesses the individual’s sleep patterns over the past 2 weeks. The ISI is a 7 item questionnaire on a scale of 0 to 4, 0 being “none” and 4 being “very severe”. The higher score indicates worse sleep quality.

Participating in This Clinical Trial

Inclusion Criteria

1. Full-time HCPs 2. A score of >= 5 on the Subjective Units of Distress Scale (SUDS) at baseline visit. 3. Willingness to address burnout symptoms by non-pharmacological means. 4. Willingness to wear the provided wearable device (e.g., Apple, Empatica, and/or eSense) at the designated study visits and/or determined coaching sessions, as well as wear an Apple device, if eligible to receive an Apple watch, from baseline for the duration of the study (up to 24 months). 5. Willingness to download the PatternHealth app on personal device. Exclusion Criteria:

1. Addition or change in dosage of psychotropic medications, beta-blockers, or anti-epileptic medications within the last 2 months 2. HCPs may re-present for screening again after 2 months has passed since their last change in the medication categories listed that previously excluded them for re-evaluation for study eligibility. 3. Current suicidal or homicidal ideation at the time of screening, as defined by the C-SSRS. 4. Prior instruction in the Transcendental Meditation (TM) technique by a certified instructor.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Duke University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Patty Lee, MD, Principal Investigator, Duke University
  • Overall Contact(s)
    • Patty Lee, MD, 919-684-0928, patty.lee@duke.edu

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