WELL Program for Caregiver Burnout

(WELL Trial)

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Colorado School of Public Health

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

360 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the WELL treatment for caregiver burnout?

Research shows that interventions like the Three Good Things, Gratitude Letter, and Looking Forward tools can improve well-being and reduce burnout in healthcare workers. Additionally, programs like Wellspring's Care for the Professional Caregiver Program and Mindfulness in Motion training have been effective in reducing emotional exhaustion and increasing resilience among healthcare professionals. ^{1 2 3 4 5}

Is the WELL Program for Caregiver Burnout safe for humans?

The research articles provided do not contain specific safety data for the WELL Program for Caregiver Burnout or similar interventions. ^{6 7 8 9 10}

How does the WELL treatment for caregiver burnout differ from other treatments?

The WELL treatment is unique because it focuses on enhancing wellness self-care through strategies like mindfulness and yoga, which are not typically emphasized in other caregiver programs. This approach helps caregivers cultivate their inner resources and connect with others for support, offering a novel way to address caregiver burnout. ^{11 12 13 14 15}

What is the purpose of this trial?

The WELL program is a multi-strategy early childhood education (ECE) center-based intervention focused on ensuring that formal ECE providers prioritize their own self-care and well-being and have access to resources and supports that improve their skills to have stable and responsive relationships with young children in their care. The overarching goals of this proposed project include: * To utilize Head Start-University partnerships to investigate constructs within the National Institute of Occupational Safety and Health (NIOSH) Worker Wellbeing framework (e.g., Workplace Physical Environment and Safety Climate, Workplace Policies and Culture) among Head Start staff (n=360 Head Start staff) that are most associated with overall well-being. * To adapt and refine the WELL program to target specific constructs that are most significantly related to overall well-being among the ECE workforce identified in Aim 1 and then to test the effectiveness of WELL (n=36 Head Start centers; n=360 Head Start staff). * To collect data to inform the implementation and dissemination of the WELL project research findings and products and initiate translation activities to achieve large-scale adoption.

Eligibility Criteria

This trial is for early childcare education providers who work at Head Start-funded centers in Colorado, caring for children aged 0-5. Participants must be at least 18 years old.

Inclusion Criteria

I work at a Head Start-funded center in Colorado, caring for children 0-5 years old.

Exclusion Criteria

N/A

Timeline

Control

ECE centers receive standard health promotion/professional development opportunities and usual care is documented

Varies by cohort

WELL Intervention

Implementation of the three-strategy WELL intervention begins, focusing on organization-level, interpersonal-level, and individual-level supports

1 year

Plan for Sustainability

Year allocated to plan for sustaining project infrastructures and activities with follow-up technical assistance

1 year

Sustaining WELL

First phase of withdrawal of research intervention support while maintaining support for research data collection

1 year

Observing Sustainability at a Distance

Withdrawal of all funding supports while observing the implementation and sustainability of WELL intervention

1 year

Follow-up

Participants are monitored for the effectiveness of the WELL intervention on well-being and other outcomes

5 years

Treatment Details

Interventions

• WELL

Trial Overview The WELL program aims to help ECE providers focus on self-care and well-being, ensuring they can form stable relationships with the children they care for. The study will adapt and test the WELL program's effectiveness across various Head Start centers.

Participant Groups

Group I: WELL intervention Experimental Treatment 1 Intervention

'WELL intervention' is when implementation of the one-year, three-strategy WELL intervention begins (see description).

Group II: Control Active Control 1 Intervention

In the stepped wedge design, ECE centers start the trial at the same point in time and act as controls with no intervention until they are randomized to crossover from control to intervention conditions.

Who Is Running the Clinical Trial?

Colorado School of Public Health

Lead Sponsor

Trials

13

Recruited

32,300+

Findings from Research

Three web-based interventions—Three Good Things, Gratitude Letter, and Looking Forward Tool—were tested in three studies involving a total of 521 healthcare workers, showing significant improvements in emotional exhaustion, depression, happiness, work-life balance, and emotional recovery after the interventions.

Despite some exceptions in long-term effects, these brief and engaging tools demonstrate promise in alleviating burnout among healthcare workers, highlighting the potential for simple self-care strategies to enhance well-being in this high-stress profession.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three Good Tools: Positively reflecting backwards and forwards is associated with robust improvements in well-being across three distinct interventions. Adair, KC., Kennedy, LA., Sexton, JB.[2021]

The Ohio State University Wexner Medical Center implemented a comprehensive, multiyear program starting in 2010 to reduce provider burnout and improve resilience, which included cultural change, mindfulness training, and wellness programs, resulting in improved patient satisfaction and reduced safety events.

Mindfulness training, particularly through the Mindfulness in Motion program and 'flipped classroom' approaches, significantly enhanced provider well-being, reduced emotional exhaustion, and increased resilience among staff, faculty, and residents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Reduce Burnout and Improve Resilience: Impact on a Health System's Outcomes. Moffatt-Bruce, SD., Nguyen, MC., Steinberg, B., et al.[2020]

An 8-month intervention in the Medical Oncology Department significantly reduced Emotional Exhaustion (EE) scores among health professionals, particularly in Day Hospital operators, indicating the effectiveness of structured support and reflection in combating burnout.

The study highlights that oncology healthcare workers are at high risk for burnout, emphasizing the need for targeted interventions and personal health strategies to be integrated into routine care to prevent and manage this syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Burnout and Oncology: an irreparable paradigm or a manageable condition? Prevention strategies to reduce Burnout in Oncology Health Care Professionals. Bui, S., Pelosi, A., Mazzaschi, G., et al.[2021]

The 'Buddy Study' program, which includes a seminar and peer support for healthcare professionals after adverse events, received positive feedback from participants, with 91.6% satisfied with the seminar content and 69.1% feeling it helped them manage their emotional responses.

The program fostered a compassionate culture and attentiveness to colleagues' wellbeing, although it highlighted the need for ongoing support and visibility to maintain its effectiveness, suggesting that while valuable, peer support should complement other forms of support rather than replace them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of'the Buddy Study', a peer support program for second victims in healthcare: a survey in two Danish hospital departments. Schrøder, K., Bovil, T., Jørgensen, JS., et al.[2022]

A second victim support intervention was implemented in a 500-bed University Hospital in Granada, Spain, providing structured emotional support to healthcare workers involved in serious adverse events (SAEs) over two years, with 135 workers receiving second-level support.

The intervention led to increased notification rates of SAEs and high acceptance among professionals, enhancing the visibility of support actions and contributing to a stronger culture of patient safety within the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second Victim Support at the Core of Severe Adverse Event Investigation. Cobos-Vargas, A., Pérez-Pérez, P., Núñez-Núñez, M., et al.[2023]

Physicians involved in adverse events often experience emotional distress, which significantly increases their risk of burnout, with an adjusted odds ratio of 1.90 for those affected.

Peer support is a crucial factor in reducing burnout among physicians after adverse events, as those who received such support had a lower risk of burnout (adjusted odds ratio of 0.65), highlighting the importance of fostering supportive environments in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multispecialty Physician Online Survey Reveals That Burnout Related to Adverse Event Involvement May Be Mitigated by Peer Support. Gupta, K., Rivadeneira, NA., Lisker, S., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Three Good Tools: Positively reflecting backwards and forwards is associated with robust improvements in well-being across three distinct interventions. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Alleviating emotional exhaustion in oncology nurses: an evaluation of Wellspring's "Care for the Professional Caregiver Program". [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Interventions to Reduce Burnout and Improve Resilience: Impact on a Health System's Outcomes. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Building a Program on Well-Being: Key Design Considerations to Meet the Unique Needs of Each Organization. [2019]

5. Italy pubmed.ncbi.nlm.nih.gov

Burnout and Oncology: an irreparable paradigm or a manageable condition? Prevention strategies to reduce Burnout in Oncology Health Care Professionals. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of'the Buddy Study', a peer support program for second victims in healthcare: a survey in two Danish hospital departments. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Safety Culture and Workforce Well-Being Associations with Positive Leadership WalkRounds. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Second Victim Support at the Core of Severe Adverse Event Investigation. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Multispecialty Physician Online Survey Reveals That Burnout Related to Adverse Event Involvement May Be Mitigated by Peer Support. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Engaging All Employees in Efforts to Achieve High Reliability. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Caregivers of People With Disabilities: A Program to Enhance Wellness Self-Care. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

The Role of Unpaid Volunteers in a Group Caregiving Approach: Validation of the Share the Care™ Program. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

A stress-busting program for family caregivers. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Training family caregivers of older adults: a program model for community nurses. [2004]

15. Ireland pubmed.ncbi.nlm.nih.gov

Burnout prevention: a review of intervention programs. [2022]