Clinical trial NCT04922632: Data-driven Approaches to Healthcare Provider Resilience & Burnout During COVID-19
Official title: Data-driven Approaches to Healthcare Provider Resilience & Burnout During COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burnout, Professional
Exhaustion, Caregiver
Covid19
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 4-year, multi-site, four-arm parallel-group randomized clinical trial (RCT).
Primary purpose: TREATMENT

Brief summary: 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.

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 Meditation® (TM®) 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in resilience as measured by the Connor-Davidson Resilience Scale-25
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Change in burnout as measured by the Maslach Burnout Inventory (MBI).
timeFrame: Baseline to 3 months
measure: Change in depression as measured by the Patient Health Questionnaire-9 (PHQ-9).
timeFrame: Baseline to 3 months
measure: Change in psychological distress as measured by the Subject Units of Distress Scales (SUDS).
timeFrame: Baseline to 3 months
measure: Change in quality of life as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF).
timeFrame: Baseline to 3 months
measure: Change in PTSD symptom severity as measured by the Post-Traumatic Stress Disorder (PTSD) checklist-5 (PCL-5).
timeFrame: Baseline to 3 months
measure: Change in sleep as measured by the Insomnia Severity Index (ISI).
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Sangeeta Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References: