TracheostomyBREATHENCT06283953
Boosting Resources for Tracheostomy Care at Home
A study testing Trach Plus and Trach Me Home in people with Tracheostomy and Caregiver Burden, run by Massachusetts General Hospital at 6 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy, Caregiver Burden
- What is being tested?
- Trach Plus and Trach Me Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 6 sitesUnited States
- Study dates
- 16 May 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lead or primary adult caregiver (18 or older) of infants or children (0-17 years old) with tracheostomy who are planning for discharge to home, including children who are dependent on ventilator
Who cannot join
- 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 residing in the U.S. for at least 12 months after discharge
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University of San Diego Rady Children's Hospital
La Jolla, California, 92093
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
Children's National Medical Center, Children's Research Institute
Silver Spring, Maryland, 20910
About this study
Official title: Boosting Resources and Caregiver Empowerment for Trach Care at Home: A Pragmatic Randomized 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.
Read the detailed description
The study is focused on a rare and medically complex population of children with tracheostomies. The study is a Type I hybrid effectiveness-implementation study using a pragmatic randomized trial at six participating sites. 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 question[s] 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 randomly assigned to the Comparator arm (gold standard discharge program) or to the Intervention arm (gold standard program with other components). Caregiver participants will complete three surveys over the course of 6 months. The investigators will test two main hypotheses: the Intervention arm will have (1) significantly lower caregiver burden at 4 weeks post discharge (primary outcome) and (2) significantly lower readmissions or emergency room visits at 6 months post discharge than the Comparator arm.
The investigators will also survey pediatricians of participating patients at 6 months post discharge and examine whether intervention arm pediatricians have higher satisfaction with discharge communication than those in comparator arm.
- Conditions
- Tracheostomy, Caregiver Burden
- Being tested
- Trach Plus, Trach Me Home
- Keywords
- shared decision making, patient reported outcomes, tracheostomy, ventilator, caregiver, discharge program, pediatric
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trach PlusBehavioural
The Trach Plus program includes education, social support, and outreach to outpatient care team.
Trach Me HomeBehavioural
The Trach Me Home discharge program includes caregiver education, skills training and case management.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator Caregivers | Active comparator | TrachMeHome program delivered in the hospital including education, skills training and case management for caregivers Receives: Behavioral: Trach Me Home |
| Intervention Caregivers | Experimental | Trach Me Home and Trach Plus with additional education, outpatient care team communication and social support for caregivers. Receives: Behavioral: Trach Plus; Behavioral: Trach Me Home |
| Active Comparator Physicians | Active comparator | Primary care physicians' of the enrolled participant's child receiving discharge communication Receives: Behavioral: Trach Me Home |
| Intervention Physicians | Experimental | Primary care physicians' of the enrolled participant's child receiving outpatient care team communication prior to discharge Receives: Behavioral: Trach Plus; Behavioral: Trach Me Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden
Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden.
Measured: 4 weeks post-discharge
Secondary outcomes (6)
Medical Complications Associated with Tracheostomy
4-item modified Medical Complications Associated with Tracheostomy (MCAT) measure that includes 4 caregiver reported items to assess the total number of urgent medical visits, emergency room and readmissions for tracheostomy-related issues. Items are summed and scores start at 0 and there is no upper limit. Higher total numbers are worse.
Measured: 6 months post-discharge
6-month Readmission Rate
Percentage with one or more emergency room visits or hospital readmissions as documented in the electronic health record within 6 months of discharge.
Measured: 6 months post-discharge
Frequency of pediatrician communication
Percentage of pediatrician-specific communication with inpatient team prior to and/or shortly after discharge documented in electronic medical record or by pediatrician report.
Measured: 6 months post-discharge
Primary care pediatrician satisfaction
Clinician reported satisfaction with discharge communication scored from 0-100, higher scores indicate higher satisfaction with discharge communication.
Measured: 6 months post-discharge
Medical Complications Associated with Tracheostomy
4-item modified Medical Complications Associated with Tracheostomy (MCAT) measure that includes 4 caregiver reported items to assess the total number of urgent medical visits, emergency room and readmissions for tracheostomy-related issues. Items are summed and scores start at 0 and there is no upper limit. Higher total numbers are worse.
Measured: 4 weeks post-discharge
Caregiver Burden
Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden.
Measured: 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start16 May 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Children's Hospitals and Clinics of Minnesota, Children's National Research Institute, Rady Children's Hospital, San Diego, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Karen Sepucha, Massachusetts General Hospital
- Investigators
- Karen Sepucha, PhD, Principal investigator, Massachusetts General HospitalChristopher Hartnick, MD, Principal investigator, Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283953
- Sponsor's protocol ID
- 2023P001695
- Other IDs
- IHS-2022C1-26100
- Acronym
- BREATHE
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To promote research replicability, transparency and future use of the data, de-identified data sets will be created and will be available, by request, to outside researchers. The Data Package (comprised of the de-identified Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan, and analytic code from the project) will be deposited in the Patient-Centered Outcomes Research Institute's Data Repository at the ICPSR. Participant information sheets for the study will indicate that de-identified information will be deposited in an open access service to promote use of the data by other researchers. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set. No data will be provided from qualitative transcripts as this may lead to identifying information about participants. However, codes abstracted from qualitative transcripts may be made available.
Publications
Sepucha K, Callans K, Leavitt L, Chang Y, Vo H, Brigger M, Broughton S, Cahill J, Chinnadurai S, Germann J, Giordano T, Greenlick-Michals H, Javia L, Jayawardena ADL, Osthimer J, Patel RC, Redmann A, Roumiantsev S, Simmons L, Smith M, Tate M, Warren M, Whalen K, Yager P, Zalzal H, Hartnick C. Boosting REsources And caregiver empowerment for Tracheostomy care at HomE (BREATHE) Study: study protocol for a stratified randomization trial. Trials. 2024 Oct 28;25(1):722. doi: 10.1186/s13063-024-08522-x.
PubMed 39468582
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting Resources and Caregiver Empowerment for Trach Care at Home: A Pragmatic Randomized Trial
- ClinicalTrials.gov ID
- NCT06283953
- Acronym / sponsor ID
- BREATHE / 2023P001695
- Conditions
- Tracheostomy, Caregiver Burden
- Keywords
- shared decision making, patient reported outcomes, tracheostomy, ventilator, caregiver, discharge program, pediatric
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Children's Hospitals and Clinics of Minnesota, Children's National Research Institute, Rady Children's Hospital, San Diego, Patient-Centered Outcomes Research Institute
- Study start
- 16 May 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is focused on a rare and medically complex population of children with tracheostomies. The study is a Type I hybrid effectiveness-implementation study using a pragmatic randomized trial at six participating sites. 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 question[s] 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 randomly assigned to the Comparator arm (gold standard discharge program) or to the Intervention arm (gold standard program with other components). Caregiver participants will complete three surveys over the course of 6 months. The investigators will test two main hypotheses: the Intervention arm will have (1) significantly lower caregiver burden at 4 weeks post discharge (primary outcome) and (2) significantly lower readmissions or emergency room visits at 6 months post discharge than the Comparator arm.
The investigators will also survey pediatricians of participating patients at 6 months post discharge and examine whether intervention arm pediatricians have higher satisfaction with discharge communication than those in comparator arm.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Comparator Caregivers | Active comparator | Behavioral: Trach Me HomeTrachMeHome program delivered in the hospital including education, skills training and case management for caregivers |
| Intervention Caregivers | Experimental | Behavioral: Trach Plus, Behavioral: Trach Me HomeTrach Me Home and Trach Plus with additional education, outpatient care team communication and social support for caregivers. |
| Active Comparator Physicians | Active comparator | Behavioral: Trach Me HomePrimary care physicians' of the enrolled participant's child receiving discharge communication |
| Intervention Physicians | Experimental | Behavioral: Trach Plus, Behavioral: Trach Me HomePrimary care physicians' of the enrolled participant's child receiving outpatient care team communication prior to discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Lead or primary adult caregiver (18 or older) of infants or children (0-17 years old) with tracheostomy who are planning for discharge to home, including children who are dependent on ventilator
Key exclusion criteria (3 listed)
- 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 residing in the U.S. for at least 12 months after discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trach PlusThe Trach Plus program includes education, social support, and outreach to outpatient care team. | Behavioural | Intervention Caregivers, Intervention Physicians |
| Trach Me HomeThe Trach Me Home discharge program includes caregiver education, skills training and case management. | Behavioural | Active Comparator Caregivers, Active Comparator Physicians, Intervention Caregivers, Intervention Physicians |
Primary outcome
Caregiver Burden
Time frame: 4 weeks post-discharge
Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden.
6 secondary outcomes
Medical Complications Associated with Tracheostomy
Time frame: 6 months post-discharge
6-month Readmission Rate
Time frame: 6 months post-discharge
Frequency of pediatrician communication
Time frame: 6 months post-discharge
Primary care pediatrician satisfaction
Time frame: 6 months post-discharge
Medical Complications Associated with Tracheostomy
Time frame: 4 weeks post-discharge
Caregiver Burden
Time frame: 6 months post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Derived from this study: PubMed 39468582Sepucha K, Callans K, Leavitt L, Chang Y, Vo H, Brigger M, Broughton S, Cahill J, Chinnadurai S, Germann J, Giordano T, Greenlick-Michals H, Javia L, Jayawardena ADL, Osthimer J, Patel RC, Redmann A, Roumiantsev S, Simmons L, Smith M, Tate M, Warren M, Whalen K, Yager P, Zalzal H, Hartnick C. Boosting REsources And caregiver empowerment for Tracheostomy care at HomE (BREATHE) Study: study protocol for a stratified randomization trial. Trials. 2024 Oct 28;25(1):722. doi: 10.1186/s13063-024-08522-x.
- Individual participant dataSharing planned: Yes. To promote research replicability, transparency and future use of the data, de-identified data sets will be created and will be available, by request, to outside researchers. The Data Package (comprised of the de-identified Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan, and analytic code from the project) will be deposited in the Patient-Centered Outcomes Research Institute's Data Repository at the ICPSR. Participant information sheets for the study will indicate that de-identified information will be deposited in an open access service to promote use of the data by other researchers. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set. No data will be provided from qualitative transcripts as this may lead to identifying information about participants. However, codes abstracted from qualitative transcripts may be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Sepucha, PhD principal investigator
Massachusetts General Hospital
Christopher Hartnick, MD principal investigator
Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trach Plus and Trach Me Home in people with Tracheostomy and Caregiver Burden, run by Massachusetts General Hospital at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden (time frame: 4 weeks post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06283953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.