Viewing Study NCT05394051



Ignite Creation Date: 2024-05-06 @ 5:42 PM
Last Modification Date: 2024-10-26 @ 2:33 PM
Study NCT ID: NCT05394051
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-11-09
First Post: 2022-05-19

Brief Title: Psychological Well-being and Burnout in Healthcare Workers During the COVID-19 Coronavirus Disease 2019 Pandemic
Sponsor: Northwestern University
Organization: Northwestern University

Study Overview

Official Title: Improving the Psychological Well-being and Burnout Due to the COVID-19 Pandemic in the Northwestern Medicine NM Healthcare Worker SARS-CoV-2 Cohort Severe Acute Respiratory Syndrome - Coronavirus 2
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Healthcare systems around the world have faced tremendous stress because of the COVID-19 pandemic Healthcare workers HCWs ie physicians nurses and support staff who serve as the foundation of the healthcare system report high levels of psychological stress and burnout which will likely worsen as the pandemic continues The consequences of stress and burnout can reduce quality of life for providers and lead to adverse health behaviors poor dietary choices reduced physical activity increased alcohol intake increases in weight etc among HCWs In addition burnout can have dire consequences on healthcare delivery effectiveness including poor quality of care and significant cost implications due to medical errors and HCW absenteeism and turnover In fact annual estimates of burn-out related turnover range from 7600 per physician to 16000 per nurse However programs focused on reducing burnout in HCWs have the potential to reduce costs to the healthcare system by 5000 per HCW per year Maintaining and recovering psychological and behavioral well-being is essential to ensuring we have a workforce that is resilient to acute and ongoing stressors such as the COVID-19 pandemic ensuring that they are capable of providing the highest level of quality and compassionate care to patients In this project we will strengthen the resiliency of the Northwestern Medicine NM healthcare system by implementing an online psychological well-being intervention PARK We will assess HCW willingness to engage in PARK which has been shown in other populations experiencing stress eg dementia caregivers general public coping with COVID-19 to be effective We will also assess if the PARK is effective in reducing stress and associated-burnout absenteeism and intentions to leave the workforce in a subset of 750 persons who have been participating in a study of HCWs at NM since Spring 2020 In the entire cohort we will measure the psychological well-being levels of burnout health behaviors absenteeism and plans to leave the workforce at three time periods the start middle and end of the study period and assess whether they differ by HCW characteristics including gender race and role in health care Results from this study will provide much-needed information 1 about the current state of psychological well-being and burnout among NM HCWs now over 1 ½ years into the pandemic 2 on the role of an online wellness intervention to improve well-being during a protracted pandemic and 3 about the contribution of PARK to reduce burnout HCW absenteeism and turnover and potential impacts on costs PARK has the potential to have a significant impact on not only NM HCWs but also to be generalizable to other healthcare organizations for addressing burnout and to contribute to lessons learned on how to support HCWs responding to future pandemics ensuring resiliency in the healthcare delivery system In addition we will work with our already engaged stakeholder committee to ensure results can provide actionable policy and fiscal insights Future opportunities will include collaboration with other healthcare systems to expand roll-out of the successful PARK intervention
Detailed Description: The COVID-19 pandemic has had a catastrophic impact on the world resulting in the death of millions of people It has placed an especially immense burden on healthcare workers HCWs who report damaged psychological well-being Recent evidence suggests the psychological impact is worsening as the pandemic persists The objective of this project is to assess and intervene to improve the psychological well-being among HCWs who have been active throughout the ongoing pandemic response We will evaluate the acceptability feasibility and early effectiveness of an online psychosocial wellness intervention designed to reduce burnout and promote psychological wellness among HCWs and describe workplace and personal characteristics associated with stress and burnout

Aim 1 Assess the psychological well-being depression anxiety positive affect meaning and purpose and burnout in an existing cohort of 3569 HCWs working at Northwestern Medicine NM during the COVID-19 pandemic using self-report questionnaires

Hypothesis 1 Higher burnout scores and evidence of poor psychological well-being high depression and anxiety and low positive affect and meaning and purpose will be observed in patient-facing HCWs than in administrators

Aim 2 Explore the associations of psychological well-being and burnout scores with health and cardio-metabolic behaviors ie sleep physical activity and health-related absenteeism

Hypothesis 2 Higher levels of emotional well-being will be associated with healthy behaviors

Aim 3 Evaluate the acceptability feasibility and effectiveness of the evidence-based Positive Affect Regulation sKills PARK intervention to improve psychological well-being and reduce burnout among HCWs in a randomized control trial RCT with a wait list control

Hypothesis 31 Participants will find PARK acceptable and feasible

Hypothesis 32 Compared to control participants those who have access to the PARK intervention will show improvements in psychological well-being and burnout

Long-term impact Our study will provide the foundation for a future randomized trial to determine the effect of PARK on psychological well-being burnout and downstream health behaviors and health outcomes among HCWs coping with significant stress The results of this study may be used to implement programs like PARK to strengthen the health care delivery system and provide needed support to HCWs as they continue to respond to this pandemic and prepare for future shocks to the healthcare system in Chicago and across the US

b Significance and contribution

Psychological stress and burnout are an ongoing significant threat to HCW well-being and to the health systems ability to continue to both respond to the pandemic and deliver quality people centered care Stress and burnout among HCWs have been linked to diminished quality of patient care including lower patient satisfaction with care and increased likelihood of medical errors and adverse health behaviors in HCWs Stress is the perception that the demands of a situation outweigh resources for coping with those demands When stress is ongoing as it has been during the pandemic it can lead to burnout The construct of burnout developed in studies of human-services workers is characterized by emotional exhaustion feeling emotionally drained by contact with patients depersonalization extreme detachment from patients and lack of personal accomplishment feelings of incompetence and lack of job success

This challenge of HCW stress and burnout preexisted the COVID-19 pandemic An Agency for Healthcare Research and Quality AHRQ study found that over half of primary care physicians felt stressed because of time pressures and other work conditions In a 2015 survey the AMA American Medical Association estimated rates of burnout at 40 among physicians in the US The presence of stress and burnout has been further intensified by COVID-19 The COVID-19 pandemic has had a significant impact on the health care workforce in the United States US where there have been 567599 cases and 1821 deaths from COVID-19 in HCWs as of October 1 2021 For frontline caregivers who have witnessed an even larger number of deaths in the US and around the world the psychological toll of the pandemic has been substantial During the first year of the pandemic 30-63 of HCWs reported stress depending on the setting with the highest rates among nurses In fact a Society of Critical Care Medicine survey found that self-reported stress scores nearly tripled during the COVID-19 pandemic and included high rates in the 3 main areas of burnout chronic exhaustion cynicism and perceived ineffectiveness Of course HCWs simultaneously faced other life stressors related to the pandemic such as family and other caregiver responsibilities eg illness and death in their own networks economic strains as well as fear of transmission to their family and friends due to workplace exposures This dual toll of workplace and household stressors has resulted in increased rates of burnout resulting in absenteeism and loss of people from the health care field when they are needed most

The challenges of stress and burnout need to be addressed for the COVID-19 pandemic and beyond to address the current crisis and ready the workforce for the next health system shock by broader system changes around work practices that go beyond this project but also by increasing individual resiliency through positive affect wellness interventions We propose to study the levels of stress and burnout and associations with health behaviors and health-related absenteeism in an existing longitudinal cohort of 3569 NM HCWs comprised of frontline providers and support and administrative staff We will also test the acceptability feasibility uptake and early effectiveness of an adapted on-line evidence-based intervention PARK to improve psychological wellbeing and levels of job burnout among this group PARK was adapted by Dr Moskowitz from a previously validated wellness intervention found to improve depression positive emotion and other aspects of psychological well-being across a range of populations but not HCWs Results from this study will 1 document psychological well-being health and cardio-metabolic behaviors and absenteeism in the entire cohort 2 assess the feasibility of an intervention previously shown to be efficacious in other populations and 3 explore the effectiveness of the intervention by comparing psychological well-being and burnout in those assigned to the intervention compared to those in a waitlist control condition We expect that PARK will improve overall stress burnout and well-being in NM HCWs

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