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Boosting REsources And caregiver empowerment for Tracheostomy care at HomE (BREATHE) Study: study protocol for a
Karen Sepucha1,2, Kevin Callans3, Lauren Leavitt4
1Health Decision Sciences Center, Division of General Internal Medicine, Massachusetts General Hospital, 100 Cambridge St, 16th Floor, Boston, MA, 02114, USA. ksepucha@mgh.harvard.edu.
Insights
The BREATHE study aims to reduce caregiver burden for children with tracheostomies by providing enhanced support and resources. This research will improve pediatric tracheostomy care and caregiver well-being post-discharge.
Area of Science:
- Pediatric Healthcare
- Caregiver Support
- Respiratory Care
Background:
- Approximately 4000 US children annually require tracheostomy, shifting post-discharge care to family caregivers.
- Caregiving for children with tracheostomies, with or without ventilator support, significantly impacts caregiver well-being.
- Current discharge programs require enhancement to address caregiver burden and improve pediatric outcomes.
Purpose of the Study:
- To alleviate the burden and stress experienced by caregivers of children with tracheostomies at home.
- To enhance the safety and health outcomes for children following hospital discharge.
- To identify key facilitators and barriers in implementing comprehensive pediatric tracheostomy discharge programs.
Main Methods:
- A pragmatic, two-arm randomized trial (BREATHE Study) involving six US sites.
- Caregivers randomized to a comparator arm (current standard care) or an intervention arm (enhanced resources, social support, pediatrician communication).
- Data collection via caregiver surveys at baseline, 4 weeks, and 6 months; pediatrician surveys; and clinician interviews.
Main Results:
- The study will compare caregiver burden, readmission rates, and pediatrician satisfaction between the intervention and comparator groups.
- Analysis will focus on the effectiveness of the "Trach Plus" intervention in supporting families.
- Identification of implementation facilitators and barriers for pediatric discharge programs.
Conclusions:
- The BREATHE Study will provide crucial insights into optimizing hospital support for caregivers of children with tracheostomies.
- Findings will inform the development of improved discharge strategies to facilitate family reintegration into daily life.
- This research aims to enhance the overall care experience for children with tracheostomies and their families.
Background:
Annually, about 4000 US children undergo a tracheostomy procedure to provide a functional, safe airway. In the hospital, qualified staff monitor and address problems, but post-discharge this responsibility shifts entirely to caregivers. The stress and constant demands of caregiving for a child with a tracheostomy with or without ventilator negatively affect caregivers. The aims of the study are to relieve the burden and stress experienced by caregivers at home, improve safety and outcomes for children post-discharge, and identify facilitators and barriers to implementation of comprehensive pediatric discharge programs.
Methods:
The Boosting REsources and cAregiver empowerment for Tracheostomy care at HomE (BREATHE Study) is a pragmatic two-arm, randomized trial with six sites across the US. Caregivers of a child with a tracheostomy are randomized to comparator ("Trach Me Home") or intervention ("Trach Plus"). The Comparator arm is the current gold standard focusing on caregiver education, technical skill building, and case management. The Intervention arm contains all elements of the Comparator plus educational resources, social support and communication with the outpatient pediatrician. Caregivers will complete three surveys: baseline (pre-discharge), 4-week and 6-month post-discharge. Outpatient pediatricians will complete a survey to assess self-confidence in caring for a child with tracheostomy and satisfaction with discharge communication. Interviews with clinicians and staff will identify facilitators and barriers to implementation. The study will examine whether the Intervention arm leads to lower caregiver burden, lower readmission rates and higher pediatrician satisfaction than Comparator arm.
Discussion:
The BREATHE Study will advance our understanding of how hospitals can support caregivers with a child with a tracheostomy as they resume life, work, and family activities after discharge.
Trial Registration:
Registered on clinicaltrials.gov (NCT06283953). February 28, 2024.
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