Enhanced Support for Tracheostomy Care at Home

(BREATHE Trial)

Recruiting at 5 trial locations

Overseen By Karen Sepucha, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Transfer to facility, Language barrier, Residency

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

480 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Trach@Home, Trach Me Home?

Research shows that self-management and home care for tracheostomy patients can improve satisfaction and potentially reduce complications like infections. Programs that provide structured support and assess patient competence, like the Nottingham System, help identify and address potential problems early, suggesting that similar approaches in Trach@Home, Trach Me Home could be effective. ^{1 2 3 4 5}

Is home tracheostomy care safe for children?

Research shows that with proper training and equipment, home tracheostomy care for children is generally safe. Complications are rare, and families appreciate having their children at home. ^{6 7 8 9 10}

How is the Trach@Home, Trach Me Home treatment different from other tracheostomy care options?

The Trach@Home, Trach Me Home treatment is unique because it focuses on enhancing support for tracheostomy care at home, emphasizing the training and education of caregivers to manage emergencies effectively, which can improve long-term outcomes and reduce hospitalizations. ^{3 7 11 12 13}

What is the purpose of this trial?

The goal of this trial is to advance the understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main questions it aims to answer are: * What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home? * How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge? Caregiver participants will be randomly assigned to receive Trach Me Home (gold standard discharge program) or Trach Me Home with additional components. Caregiver participants will complete three surveys over the course of 6 months. Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge (primary outcome) and fewer hospital readmissions at 6 months than those in Trach Me Home arm.

Research Team

Christopher Hartnick, MD

Principal Investigator

Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital

Karen Sepucha, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adult caregivers (18+) of children (0-17 years) with tracheostomies, preparing to take their child home from the hospital. Caregivers must be able to read/write in English, Spanish, Mandarin, or Arabic and plan to stay in the U.S. for at least 12 months post-discharge.

Inclusion Criteria

I am the main caregiver for a child with a tracheostomy planning to go home.

Exclusion Criteria

Patients transferred to other hospital or facility (and/or not discharged to home during study period)

Primary caregiver unable to read or write in English, Spanish, Mandarin, or Arabic

Not planning to reside in the U.S. for at least 12 months after discharge

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers receive the Trach Me Home program or Trach Me Home with additional components, including education, skills training, and case management

6 months

3 surveys over 6 months

Follow-up

Participants are monitored for caregiver burden and hospital readmissions post-discharge

6 months

Treatment Details

Interventions

• Trach@Home
• Trach Me Home

Trial Overview The study compares two support programs: 'Trach Me Home' and an enhanced version with additional components. It aims to determine which program better reduces caregiver burden after discharge and lowers hospital readmissions within six months.

Participant Groups

Group I: Intervention Physicians Experimental Treatment 2 Interventions

Primary care physicians' of the enrolled participant's child receiving outpatient care team communication prior to discharge

Group II: Intervention Caregivers Experimental Treatment 2 Interventions

Trach Me Home and Trach Plus with additional education, outpatient care team communication and social support for caregivers.

Group III: Active Comparator Physicians Active Control 1 Intervention

Primary care physicians' of the enrolled participant's child receiving discharge communication

Group IV: Active Comparator Caregivers Active Control 1 Intervention

TrachMeHome program delivered in the hospital including education, skills training and case management for caregivers

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Children's Hospitals and Clinics of Minnesota

Collaborator

Trials

67

Recruited

5,022,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Children's National Research Institute

Collaborator

Trials

227

Recruited

258,000+

Rady Children's Hospital, San Diego

Collaborator

Trials

42

Recruited

14,300+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Self-management of patients with tracheostomy in the home setting: a scoping review. [2023]

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

Risk of death at home or on hospital readmission after discharge with pediatric tracheostomy. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Tracheostomy self care: the Nottingham System. [2019]

4. Italy pubmed.ncbi.nlm.nih.gov

[Home care to tracheotomized patients: evaluation of the customer satisfaction in the city of Milano]. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Factors that influence user satisfaction: tracheotomised home mechanical ventilation users' experiences. [2013]

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

The Trach Safe Initiative: A Quality Improvement Initiative to Reduce Mortality among Pediatric Tracheostomy Patients. [2020]

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

The safety of home tracheostomy care for children. [2019]

8. India pubmed.ncbi.nlm.nih.gov

A Single Center Experience of Pediatric Tracheostomy. [2019]

9. Japan pubmed.ncbi.nlm.nih.gov

[Tracheostomy for home-care patients with severe motor and intellectual disabilities]. [2020]

10. Chile pubmed.ncbi.nlm.nih.gov

[Clinical experience in home care of children with tracheostomy]. [2006]

11. France pubmed.ncbi.nlm.nih.gov

[Problems raised by the technique and supervision of home ventilation of chronic respiratory insufficient patients (author's transl)]. [2006]

12. Ireland pubmed.ncbi.nlm.nih.gov

Simulation-based education to improve emergency management skills in caregivers of tracheostomy patients. [2019]

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

Emergency airway and ventilator procedures for community based home care staff validation of an educational program. [2019]