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

Duke University

Status: Terminated

Conditions: Burnout, Professional; Exhaustion, Caregiver; Covid19

Treatments: Behavioral: Transcendental Meditation (TM) and Experience Resolution Methodology (ERM); Behavioral: Transcendental Meditation (TM); Behavioral: Experience Resolution Methodology (ERM); Behavioral: Treatment As Usual (TAU)

Study type: Interventional

Funder types: Other

Identifiers

NCT04922632

Pro00106079

Details and patient eligibility

About

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 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.

Enrollment: 212 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 4 patient groups

Transcendental Medication (TM)

Experimental group

Description:

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.

Treatment:

Behavioral: Transcendental Meditation (TM)

Experience Resolution Methodology (ERM)

Experimental group

Description:

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.

Treatment:

Behavioral: Experience Resolution Methodology (ERM)

TM+ERM

Experimental group

Description:

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.

Treatment:

Behavioral: Transcendental Meditation (TM) and Experience Resolution Methodology (ERM)

Treatment As Usual (TAU)

Active Comparator group

Description:

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).

Treatment:

Behavioral: Treatment As Usual (TAU)