Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922632
Status:
TERMINATED
Last Update Posted:
2023-04-21
First Post:
2021-06-08
Brief Title:
Data-driven Approaches to Healthcare Provider Resilience Burnout During COVID-19
Sponsor:
Duke University
Organization:
Duke University
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 595000 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 595000 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:
None
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?:
None