The BREATHE (Boosting REsources And caregiver empowerment for Tracheostomy care at HomE) study is a five-year, six-hospital trial that will advance understanding of how hospitals can better support caregivers of children with tracheostomies as they resume life, work, and family activities after discharge.
In the study, funded by the Patient-Centered Outcomes Research Institute (PCORI), hospital teams composed of ENT surgeons, pediatric intensive care unit staff, and nurses are joined by caregivers and pediatricians to deliver comprehensive, integrated, and coordinated care as patients transition from hospital to home.
As of May 2024, the BREATHE study (Trials.doi:10.1186/s13063-024-08522-x) had enrolled more than 40 participants from all six centers, noted co-investigator Kevin Mary Callans, BSN, RN, a pediatric case manager in the Pediatric Aerodigestive Center at Mass Eye and Ear Institute (MEEI) in Boston. Although the trial is recruiting patients through October 2026, “it already has yielded profound practice changes,” said Ms. Callans, who works with Christopher Hartnick, MD, MS, division director of pediatric otolaryngology at MEEI and the study’s co-principal investigator.
Teams from the six hospitals have been sharing best practices during the study design period and the first year of the trial. “When we meet, we all learn from each other,” Ms. Callans said. The study relies on Dr. Hartnick’s seminal work developing a validated measure of caregiver burden, the Pediatric Tracheostomy Health Status Instrument, she said.
The study evaluates interventions that enhance the ability of nurses, caregivers, and family pediatricians to care for these patients, with a focus on ventilators, suction machines, and other trach care equipment and supplies. Patients are randomly assigned to receive either a standard or enhanced set of interventions. Family stress and anxiety are among the outcome metrics being used. “By talking to someone with a lived experience caring for these complex patients, new families now have a way to have their often-overwhelming feelings validated,” Ms. Callans said. The goal is to convey that those feelings “are not a failing, but a natural, human response to an incredibly challenging situation—and that you can make it through this.”
A key to success in the BREATHE trials is its recruitment of a very diverse group of participants to address health literacy, language barriers, and other social determinants of health (SDOH), Ms. Callans said. “Studies have shown that it’s critically important for families to get training materials in the language that they speak,” she said. “So that’s why we were very focused on including [SDOH] in the BREATHE trial’s design, not to mention how we manage these patients in our daily practice.”
Co-investigator Matthew T. Brigger, MD, MPH, professor and division chief of pediatric otolaryngology and director of the Center for Pediatric Aerodigestive Disorders and Airway Surgery at Rady Children’s Hospital in San Diego agreed that there is an acute need to prove the efficacy of these interventions in a controlled clinical trial such as BREATHE.
As physicians, and particularly surgeons, Dr. Brigger said, “We tend to focus on getting through the difficulties of the initial procedure and acute care recovery. Then, sure, we all have a variety of parent training and teaching tools, but are they enough to give these families the support they need once they leave the hospital? Should they factor in social determinants of health? What’s really happening once these complex patients go home? Nobody has studied this in any systematic way.”
The stakes are high for getting this right. Dr. Brigger said, for example, that “there is a crisis in this country when it comes to getting skilled nursing care for these families.” They may qualify for several hours of home nursing care per day yet get none of those hours filled because of persistent shortages. So, it falls to the family to perform the tasks needed to care for these complex patients, whether it’s tracheostomy tube cleaning or replacement, tube suctioning, and in some cases even emergency resuscitation due to mucus plug formation and tube occlusion or accidental decannulation. “The list goes on and on,” he said.
That heavy load is one of the reasons why the BREATHE trial will be looking at whether its interventions lead to lower caregiver burden, Dr. Brigger said.
A Primary Goal—Looping in the Pediatrician
The BREATHE trial also will track hospital readmission rates and pediatrician satisfaction. The latter endpoint is key, Ms. Callans noted, because having the primary care physician on board with a child’s tracheostomy and ventilator care is critical to successful outcomes. The pediatricians understand this, Ms. Callans stressed. “We recently surveyed them, and many said they find out about a tracheostomy tube placement only after the patient shows up in their clinic.” That’s not ideal, “because they’ve known this family for years and have information they could give us that could help them.”
Ms. Callans and her specialist colleagues have responded “for some time now” by “involving the pediatricians on day one.” For example, to familiarize them with the underlying condition that led to a child’s tracheostomy tube placement, “we’ll send them our teaching videos through REDCap,” a secure web application for building and managing online surveys and databases. “This helps us stay in touch with the pediatrician and really make them part of the care team.” Additionally, every time a child with a tracheostomy comes into the emergency department, their pediatricians get a notification so they can stay connected to the patient and their caregivers.
Dr. Brigger agreed on the importance of engaging pediatricians and other primary caregivers who help manage these patients. As for whether those interventions in the BREATHE trial move the needle on outcomes, “we’ll see—it’s still early days.” But whatever the outcome, one thing is clear: “There’s just too much tracheostomy knowledge that doesn’t get imparted outside of large centers,” he said. “If you can’t teach that knowledge to these families early on so that they know what the horizon for ongoing management looks like, that’s a critical care gap. Hopefully, it’s one that the BREATHE study will help close.”
The Power of Videos
One strategy for closing that knowledge gap is through the use of QR code-enabled training videos, which are part of the enhanced intervention arm of the BREATHE trial. The videos are available in multiple languages to respond to the diversity of the study participants and the national population of trach patients (about 51% are from racial and/or ethnic minority populations). Additionally, the videos are about three minutes “because many of our families live in this TikTok world,” Ms. Callans said. “And we can quickly text or email a QR code to them for easy access, whether it’s on how to clean a tracheostomy tube or stoma care. We also have animated videos about the emotions triggered by having a child at home with a tracheostomy tube, because animations help patients take themselves out of the equation and be more open to its teachings.”
Being able to quickly access the videos via the QR codes “is hugely important,” Ms. Callans said. “It enables the families to ‘own’ their learning,” she explained. “I often feel like parents of medically complex children lose agency: You have this child that needs medications; then they need to be suctioned, or the trach tube or ventilator needs cleaning and maintenance.” As a result, “They never have a strong sense of control with all of that going on. But if we give them the ability to launch these quick three-minute videos, in a language they understand and in a format that really speaks to them, then they finally do have agency—you’re empowering parents to be active, educated, intentional members of the care team.”
Another intervention from the BREATHE trial that is already affecting care via shared learning is the use of peer mentors, Ms. Callans noted. The concept is fairly straightforward: having a family member who has cared for a tracheostomy and/or ventilator-dependent child share their lessons learned with new families who are first starting on this challenging journey. “We’ve had incredible success with this,” she said. “The feedback has been overwhelmingly positive.”
Still, “there’s no data to support any of these interventions,” Ms. Callans said. “That’s why this trial is so important.” The goal is not just to establish clinical efficacy. “It’s also to convince insurers that these are organic, low-cost measures that can be godsends to families.” As such, “they should be supported not just by clinicians but also by managed care.” That is the reason why the team has consultants on board from Blue Cross/Blue Shield. “We want them to pay for videos and other teaching materials for tracheostomy care in several languages,” she said. “But to do that, we need to show them this actually works; we can’t just expect them to take it on faith.” (The American Academy of Pediatrics is another trial advisor, Ms. Callans noted.)
Complex, High-Acuity Patients
Mark E. Gerber, MD, division chief of otolaryngology–head and neck surgery at Phoenix Children’s Hospital in Arizona, agreed that the lack of published data and standardized care pathways for home-based tracheostomy- and ventilator-dependent children can place these patients at risk. The degree of that risk, he noted, varies depending on patient acuity. “It’s one thing for a family to be taught and educated about basic tracheostomy tasks,” Dr. Gerber said. “It’s quite another thing to have an airway emergency in a child at home who is truly trach-dependent, where their airway above the tracheostomy is not patent and will not function.”
These complex, high-acuity patients are further imperiled by variations in the educational capacities of the families and the aforementioned ongoing home-care nursing shortages, he stressed. “And then you can throw in the reduced silicone availability creating tracheostomy tube shortages that started during and have persisted intermittently, since COVID-19. Hospitals and families have had difficulty getting the correct size trach tubes for patients, leading to the increased need for reuse of the trachs beyond the manufacturer’s guidelines, along with the need to now educate on how best to clean and inspect them to avoid potentially disastrous problems. That’s a lot for a family to handle.”
Fortunately, Dr. Gerber and his colleagues have devised several strategies for overcoming some of these barriers. One is a dashboard his team uses that lists all of their current pediatric tracheostomy and ventilator-dependent patients. The dashboard allows the team to see when the patient’s last pulmonology and otolaryngology visit occurred to ensure timely follow-up and specialty care. That tracking process begins, he noted, when these patients are admitted to the hospital. “Whether it’s for an airway problem or a non-airway problem if they have a trach, our trach team is notified of the admission,” he said. “By doing that, we’re keeping tabs on these kids so we’re not losing them in the system.”
First Things First: the Family Check-In
Amy Ashburn, DNP, FNP-BC, CORLN, who runs the tracheostomy services at Phoenix Children’s, underscored the importance of this proactive approach. “One of the most important things we do, starting from the very beginning, is to talk to the families about their living conditions before we even place the tracheostomy tube,” she said. “For example, are they living in a remote area, such as on a reservation, where they might not have access to electricity or water? This helps us address those challenges before the procedure and ensures we’re setting up the best possible outcome for both the patient and their family.” By getting everything in place ahead of time, Dr. Ashburn noted, “when the patient comes out of surgery, the parents can focus on their education and training, while we’ve already handled the logistical details. Plus, it allows us to really get to know the families, which is one of the most important keys to success.”
Ms. Ashburn and her team “also round on every hospitalized patient with a tracheostomy at least once a week,” she said. “We gather the pulmonologist team, the tracheostomy resource team, the ENTs, social workers, and caseworkers—we’re all together so that we know what the expectations are for these families and how best to meet them.”
Looping the tracheostomy patients’ primary care providers is another key task Ms. Ashburn’s team helps manage. Much of this has to be done remotely for patients who live far away, she noted. “They’ll send us pictures of the insertion site, for example, to let us see what they are seeing, and then, if needed, we can have one of our specialists take a look, troubleshoot, and initiate a plan of care.”
Some issues develop so fast that other measures need to be taken, which is yet another point of education Ms. Ashburn’s team provides. “We give all of the families telephone numbers for local emergency services such as the fire department and their local hospital, and we let them know the importance of acting fast when problems arise. We also encourage them to be proactive and let these facilities know a trach-dependent patient is living at the home.” Such advanced planning, she noted, “can really improve the quality and quickness of emergency support, as well as escalate priority for return of power at the time of any local outages.”
Another part of the support Ms. Ashburn’s team provides is an inpatient tracheostomy resource nurse. “The parents become very connected to her right from the start,” she said. “Families ask her questions all the time, and she responds with whatever teaching and training that’s needed. It’s so important for families to have someone who is accessible and who they feel safe with.”
The Aerodigestive Disorders Clinic Edge
Scott M. Rickert, MD, the associate director of children’s surgical services and director of the aerodigestive program (GUARD) at Hassenfeld Children’s Hospital at NYU Langone Health in New York, agreed that “it basically takes a village” to ensure optimal pediatric tracheostomy care. “The challenge with these complex patients is that they need a complex team,” Dr. Rickert said. That can include someone who helps manage the medical equipment to make sure patients and their family caregivers “will have the right trachs, the right suctions, the right ties, and also that the ventilator is the one they need,” he said.
It’s also important to meet families where their needs are, Dr. Rickert stressed. “A universal approach may not always be the best method,” he said. “We should engage with individual families, understand their resources, and discuss their needs at home in depth. Effective communication between the healthcare team, the family, and the patient is essential.”
In most cases, patients don’t have to return to the facility where the tracheostomy was performed; instead, “they’ll come to our aerodigestive clinic or our chronic tracheostomy clinic to make sure their ongoing care is where it needs to be,” Dr. Rickert said. Having one centralized location for these checkups is ideal, he noted, because if specialist care is needed, they are in that location or nearby and can provide the needed follow-up care.
For patients living in more rural or remote areas, even seemingly simple things such as traveling to a clinic for follow-up care can be fraught, Dr. Rickert noted. “Every time you transport a patient with a ventilator and a tracheostomy, there’s a safety issue,” including obstructions or even decannulation. Working with families, nurses, and other caregiver support staff is critical in these cases, he noted.
David Bronstein is a freelance medical writer based in New Jersey.
Real-World Challenges in the Trach-Dependent Child
Variations in how ventilator/tracheostomy-dependent children are managed put these patients at risk. But the problem isn’t always a lack of agreement in published consensus documents; it’s often the vagaries of real-world management, according to Julie Wei, MD, MMM, director, division of otolaryngology and the inaugural holder of the Dr. Alfred J. Magoline Endowed Chair in Otolaryngology at Akron Children’s in Ohio.
“Family caregivers are not reading consensus documents on this; they’re not traveling to national conferences on tracheotomy care,” Dr. Wei said. “So, it’s up to you as their pediatric ENT physician to coordinate that care, based on your clinical experience managing these vulnerable patients.”
One of the first steps, Dr. Wei said, is to know the real-world variables that can trip up that care. How often to change the tracheostomy is a good example. “If you understand how biofilms work, with billions of bacteria living on this indwelling foreign body that is interacting with the child’s mucus membrane, and there is a fever, a nasty color, and secretions, the child may have bacterial tracheitis, and a family caregiver should change the tracheostomy tube every day,” she said. “But has your team trained them to recognize those signs and symptoms and remove and change the tube effectively?”
Durable medical equipment (DME) companies can be another variable that can thwart even the most proactive care plans. “Don’t assume that just because you’ve written an order for a fresh trach tube to be sent to a patient’s house once a month, that actually is going to happen,” she said. In her years caring for these patients across multiple practice sites, Dr. Wei has gotten many calls from frustrated parents that the DME orders for tubes, cleaning materials, suction devices, and other essential equipment were thwarted by insurance delays or denials, logistical breakdowns, and other issues.
COVID-19 brought similar challenges into stark relief, recalled Dr. Wei, who at the time of the pandemic was the president of the American Society of Pediatric Otolaryngology (ASPO). When massive supply chain shortages started to disrupt ENT practice, she and colleagues at the American Academy of Otolaryngology-Head and Neck Surgery (AAOHNS) worked to solve or at least mitigate the logjam. The two societies formed a subcommittee of ENT physicians who examined factors that were contributing to supply breakdowns, as well as those that were exacerbating them.
In the case of tracheostomy care, one of the main factors was the economics of the DME industry. Medical supply companies, like most commercial entities, are focused on margins, Dr. Wei said. As a result, some manufacturer guidelines noted never to reuse tracheostomy tubes, and instead throw them away every two weeks or monthly. “Realistically, I never told parents to do that,” she said. “Why would you? Here is a child dependent on a reliable supply of tubes and related equipment, not just for quality of life but for survival, in some cases. We can’t just keep throwing stuff away.”
Armed with that realization, the ASPO–AAOHNS subcommittee worked with the U.S. Food and Drug Administration (FDA) to create an addendum that has both groups’ stamp of support, stating that it is okay to reuse tubes. “This was a big deal,” Dr. Wei said. “The fact that the FDA looked to pediatric ENT physicians for guidance on this says a lot about the ability and dedication of our subspecialty to care for these children.”
That dedication manifests in several other areas. For example, Dr. Wei’s team has developed a standardized checklist that they review to help decide when it is safe for a trach-dependent patient to be sent home or to a facility outside of Akron Children’s. The team also makes sure that two family members are trained in tracheostomy supportive care if the patients are going to live at home.
The other component Dr. Wei underscored is her team’s willingness to provide in-depth education, training, and other support to families, in sessions that often approach an hour. The reimbursement for those efforts is not commensurable with the time spent, she stressed. “I’d be better off focusing on procedures or other higher-paying activities, but that is not what motivates my ENT pediatric practice,” she said.
All aspects of that training, as well as the checklists Akron Children’s uses, are aimed at standardizing milestones the hospital can use to determine when it’s safe to send a trach-dependent patient home. “That is our responsibility as pediatric ENT leaders,” she said. “It’s got to be standardized across all key team members, because otherwise, you’d have patients staying in the hospital for varying amounts of time and for varying reasons. That’s not sustainable.”