Enhanced Support for Tracheostomy Care at Home

(BREATHE Trial)

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best ways to support caregivers of children with tracheostomies after they return home from the hospital. It will examine how additional education and support, such as the Trach@Home or Trach Me Home programs, can assist caregivers in managing their child's care and reducing stress levels. Participants will be divided into two groups: one receiving standard care and the other receiving extra support. Researchers will compare outcomes such as caregiver stress and hospital readmissions. This study suits primary caregivers of children with tracheostomies who are preparing to bring their child home from the hospital. As an unphased trial, it offers caregivers the chance to contribute to research that could significantly enhance support systems for similar families.

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 prior data suggests that this protocol is safe for caregivers and children with tracheostomies?

Research has shown that children with tracheostomies cared for at home do not encounter more serious problems than those in specialized nursing facilities. This indicates that home care is as safe as professional settings. Another study highlighted that new methods in tracheostomy care have improved outcomes for these children. The absence of specific risks associated with the Trach Me Home and Trach@Home programs suggests they are generally well-tolerated. These findings provide reassurance about safety, though individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Support for Tracheostomy Care at Home trial because it explores innovative ways to improve home care for children with tracheostomies. Unlike traditional methods that primarily involve basic caregiver education before hospital discharge, this trial tests more comprehensive approaches like Trach@Home and Trach Me Home. These programs offer enhanced education, skills training, and ongoing communication with outpatient care teams, giving caregivers better tools and support. Additionally, they focus on improving communication between primary care physicians and hospital teams, which could streamline care transitions and improve outcomes for children.

What evidence suggests that this trial's treatments could be effective for supporting caregivers of children with tracheostomies at home?

Research has shown that the "Trach Me Home" program, an intervention in this trial, enhances caregivers' knowledge of tracheostomy care. One study found that caregivers participating in this program gained a better understanding and improved skills in managing tracheostomies. Additional research indicates that new tracheostomy care programs have led to better patient outcomes, such as fewer complications and hospital readmissions. In this trial, enhancements to the program, including extra education and communication support, are expected to further reduce caregiver stress and decrease hospital visits. Overall, these programs aim to empower caregivers and improve the quality of life for children with tracheostomies. ^{1 2 6 7 8}

Who Is on the Research Team?

Karen Sepucha, PhD

Principal Investigator

Massachusetts General Hospital

Christopher Hartnick, MD

Principal Investigator

Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11514889/

Boosting REsources And caregiver empowerment for ... Caregivers of a child with a tracheostomy are randomized to comparator (“Trach Me Home”) or intervention (“Trach Plus”). The Comparator arm ...

2. trachjournal.scholasticahq.com trachjournal.scholasticahq.com/article/140856

Tracheostomy Care in the Crosshairs: Supporting Science ... Individuals living with tracheostomies represent a medically complex population whose outcomes have measurably improved through innovations ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10635432/

Tracheostomy care quality improvement in low- and middle ... Tracheostomy care quality improvement in low- and middle-income countries: A scoping review. Msiba Selekwa.

4. hopkinsmedicine.org hopkinsmedicine.org/news/articles/2024/10/medical-professionals-and-patient-families-collaborate-to-improve-survival-rates-for-infants-with-tracheostomies

Medical Professionals and Patient Families Collaborate to ... Their protocol aimed at improving survival rates for infants with tracheostomies in need for respiratory support beyond hospitalization.

5. researchgate.net researchgate.net/figure/Effect-of-the-Trach-Me-Home-Protocol_tbl1_305711782

Effect of the "Trach Me Home" Protocol In this study, we compared caregiver knowledge and skill scores after a standardized theoretical and practical training program on tracheostomy care (IStanbul ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0954611121000986

Severe adverse events in children with tracheostomy and ... We observed no difference in the rate of severe adverse events between home care and specialized nursing care facility (0.21 [y-1]; median 0.0 (0.0–3.0) versus ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12375980/

The Impact of Tracheostomy Indication on Patient ... Following tracheostomy, 17.8% of all patients died during their hospitalization stay, with 3.8% of patients dying within 7 days of placement and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0007091220302695

Global Tracheostomy Collaborative: data-driven ... Ninety-two per cent of patients were admitted to a critical care unit, of which 92% were ventilated transiently. Eighty-seven percent of patients survived to ...