Evidence map›Paper›PMID 39468582›Full record

ArticleTrials2024

Boosting REsources And caregiver empowerment for Tracheostomy care at HomE (BREATHE) Study: study protocol for a stratified randomization trial.

Karen Sepucha, Kevin Callans, Lauren Leavitt, Yuchiao Chang, Ha Vo, Matthew Brigger, Stacey Broughton, Jennifer Cahill, Siva Chinnadurai, Janet Germann and 16 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06283953 (Boosting Resources and Caregiver Empowerment for Trach Care at Home), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06283953 naenrolling by invitationnot on this map

Boosting Resources and Caregiver Empowerment for Trach Care at Home: A Pragmatic Randomized Trial

TypeinterventionalSponsorMassachusetts General HospitalRan2024 to 2027Enrolled480ConditionsTracheostomy, Caregiver BurdenArmsTrach Plus, Trach Me Home
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Standardizing Tracheostomy Discharge Education Using an Interdisciplinary Hand-off Form: A Quality Improvement Study.ORL-head and neck nursing : official journal of the Society of Otorhinolaryngology and Head-Neck Nurses · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Karen SepuchaHealth Decision Sciences Center, Division of General Internal Medicine, Massachusetts General Hospital, 100 Cambridge St, 16th Floor, Boston, MA, 02114, USA. ksepucha@mgh.harvard.edu.ORCID http://orcid.org/0000-0002-3762-3880
Kevin CallansMassachusetts Eye and Ear Institute, Boston, MA, USA.
Lauren LeavittHealth Decision Sciences Center, Division of General Internal Medicine, Massachusetts General Hospital, 100 Cambridge St, 16th Floor, Boston, MA, 02114, USA.
Yuchiao ChangHealth Decision Sciences Center, Division of General Internal Medicine, Massachusetts General Hospital, 100 Cambridge St, 16th Floor, Boston, MA, 02114, USA.
Ha VoHealth Decision Sciences Center, Division of General Internal Medicine, Massachusetts General Hospital, 100 Cambridge St, 16th Floor, Boston, MA, 02114, USA.
Matthew BriggerRady Children's Hospital, San Diego, CA, USA.
Stacey BroughtonChildren's Minnesota, Minneapolis, MN, USA.
Jennifer CahillMassachusetts General Hospital, Boston, MA, USA.
Siva ChinnaduraiChildren's Minnesota, Minneapolis, MN, USA.
Janet GermannCincinnati Children's Hospital, Cincinnati, OH, USA.
Teresa GiordanoChildren's Hospital of Philadelphia, Philadelphia, PA, USA.
Hanna Greenlick-MichalsChildren's National Medical Center, Washington, DC, USA.
Luv JaviaChildren's Hospital of Philadelphia, Philadelphia, PA, USA.
Asitha D L JayawardenaChildren's Minnesota, Minneapolis, MN, USA.
Jeffery OsthimerRady Children's Hospital, San Diego, CA, USA.
Rosemary Chandy PatelChildren's Hospital of Philadelphia, Philadelphia, PA, USA.
Andrew RedmannChildren's Minnesota, Minneapolis, MN, USA.
Sergei RoumiantsevNeonatal Intensive Care Unit, Massachusetts General Hospital, Boston, MA, USA.
Leigh SimmonsHealth Decision Sciences Center, Division of General Internal Medicine, Massachusetts General Hospital, 100 Cambridge St, 16th Floor, Boston, MA, 02114, USA.
Matthew SmithDivision of Pediatric Otolaryngology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Michelle TateDivision of Pediatric Otolaryngology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Mollie WarrenBrigham & Women's Hospital, Boston, MA, USA.
Kimberly WhalenPediatric Intensive Care Unit, Massachusetts General Hospital, Boston, MA, USA.
Phoebe YagerPediatric Intensive Care Unit, Massachusetts General Hospital, Boston, MA, USA.
Habib ZalzalDivision of Pediatric Otolaryngology and Pediatrics, Children's National Medical Center, Washington, DC, USA.
Christopher HartnickMassachusetts Eye and Ear Institute, Boston, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnnually, 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.

methodsThe 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 registrationRegistered on clinicaltrials.gov (NCT06283953). February 28, 2024.

Indexed as

CaregiversTracheostomyCaregiver BurdenChildChild, PreschoolHealth Knowledge, Attitudes, PracticeHome Care ServicesHumansMulticenter Studies as TopicPatient DischargePower, PsychologicalPragmatic Clinical Trials as TopicSocial SupportStress, PsychologicalTime FactorsUnited StatesCaregiverDischarge planningPediatricsShared decision makingTracheostomyVentilator

Identifiers

PMID39468582
PMCPMC11514889

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.