What is the research about?
Approximately 4,000 US children require tracheostomy (trach) each year, where a small plastic tube is placed in the neck of children to allow them to breathe. Approximately one-half of these children are under the age of two and many are less than six months old. Parents or other caregivers are responsible for caring for these young children with a trach at home. This includes monitoring the child’s breathing and taking certain actions to restore breathing. Sometimes there are complications that are life-threatening. Parents are trained to identify and take appropriate actions before their child is sent home from the hospital. This training includes how to clean and change the trach, how to operate equipment and supplies that are delivered to the home, and when to seek help. This responsibility is enormously stressful, especially during the first several weeks at home.
Many hospitals, including the six leading hospitals participating in this study, have developed and rely on a “Trach Me Home” program to prepare parents, reduce their stress, and reduce trips to an emergency room.
The Trach Me Home program has been demonstrated to help relieve caregiver stress. This study is designed to measure the benefits of improving the coordination of care after discharge, further easing the burdens placed on parents and improving the health and safety for children with tracheostomies. We refer to these efforts as the “[email protected]” program.
Who can this research help?
The results of the study will have immediate implications for caregivers of children with tracheostomies as they transition from the intensive care units to hospital wards and after a few weeks, back home. It addresses three areas of improvement: (1) communication between hospital and family pediatricians at the time of discharge and after the child goes home, (2) ongoing efforts to relieve the burden and stress experienced by caregivers, and (3) collecting information that focuses directly on the experience of tracheostomy families.
The study will help families by learning how hospitals can support caregivers to safely care for their child with a trach as they resume life, work, and family activities. The study team will also examine how existing technology (e.g., Zoom calls, short videos that can be watched on their phones, and improvements in electronic medical records) can be used to improve communications between hospital care teams and the family pediatricians. Parents have enough on their plates without having to take on primary responsibility for the coordination between the hospital and pediatricians.
What is the research team doing?
The study team includes ear, nose, and throat specialists; nurses; parent partners; and research scientists at six hospitals. The study will enroll 300 adult caregivers of tracheostomy patients and will assign them by chance to either the combined Trach Me Home plus [email protected] or to just the Trach Me Home programs. The study team will survey caregivers four weeks after discharge to measure caregiver burden and again six months post-discharge to measure hospital readmissions and other outcomes. We will compare the results of caregivers in the combined arm to the Trach Me Home only arm. The research team will also survey family pediatricians to learn more about actions that help increase the coordination between hospitals and pediatricians. All research will be done in compliance with strict privacy standards that are in place at each of the participating hospitals.
Research methods at a glance.
- Design: Randomized controlled trial
- Population: Primary adult caregivers of children undergoing tracheostomies and their primary care pediatrician
- Intervention: The “[email protected]” program includes: (1) communication between hospital— (“inpatient”— and pediatrician— “outpatient”— care providers to provide coordinated care, (2) family education, and (3) calls from a peer mentor.
- Comparator: The Trach Me Home program that is delivered in the hospital and includes education and training for caregivers, as well as case management to ensure follow-up visits are scheduled and the home has all needed supplies and equipment
- Outcomes: Caregiver burden is primary outcome. Hospital and emergency room visits and pediatrician satisfaction with discharge communication are secondary outcomes.
- Timeframe: Primary outcome is four weeks post-discharge; other outcomes are six months post-discharge.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.