Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-26 @ 6:48 AM
Study NCT ID:
NCT04922632
Status:
TERMINATED
Last Update Posted:
2023-04-21
First Post:
2021-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Data-driven Approaches to Healthcare Provider Resilience & Burnout During COVID-19
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Data-driven Approaches to Healthcare Provider Resilience & Burnout During COVID-19
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding was exhausted
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: