Funds awarded by the Patient-Centered Outcomes Research Institute

The study, Reducing Caregiver Burden and Improving Outcomes for Children with Tracheostomies Living at Home, will advance our understanding of how to support caregivers of children with medical complexity at home and is well aligned with PCORI’s mission.

“We are thrilled to be able to pursue this innovative study that will examine a combination of high tech and high touch interventions—from acute care plans to meaningful connections with peer mentors. Our goal is to ensure that we are able to help caregivers and families focus on what matters most to them,” said Karen Sepucha, PhD, director of the Health Decision Sciences Center in the Division of General Internal Medicine at MGH.

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. In the hospital, qualified hospital staff monitor the children closely and address any problems, but at the moment of discharge, this responsibility shifts entirely to the caregiver, and represents a stressful change in their role.

Dr. Hartnick is working with Mass Eye and Ear and MGH Senior Nurse Coordinator and Co-Investigator Kevin Mary Callans, RN, to collaborate with parent caregivers on the design and implementation of several initiatives to support caregivers after discharge and ease caregiver burden.  The study will also involve family pediatricians, and provide tools to support their role as part of the extended care team.

The MGH team is working with six sites from across the country to evaluate the multi-faceted intervention in a pragmatic randomized controlled trial. Parent caregivers of children with tracheostomies were the driving force for the development of discharge planning interventions being tested in this project. The goal of the study is to determine whether the intervention reduces stress and burden on parents and improves health and safety for children with tracheostomies after they have been discharged to home.

The study team includes a large, committed group of advisors who will support the design and conduct of the study and have expertise in the lived experience of caregiving for children with tracheostomies, expertise in quality improvement methods, patient safety, diversity, equity and inclusion, care of medically complex children, care coordination, pediatric primary care and hospital leadership.  The findings will have wide reaching implications to shape clinical practice guidelines and to help hospitals incorporate these elements into existing discharge programs.

“The enthusiasm of the parent caregivers and the clinical team, including our colleagues at the participating sites, Cincinnati Children’s Hospital Medical Center, Rady Children’s Hospital- San Diego, Children’s Minnesota, Children’s National Hospital in Washington D.C., and Children’s Hospital of Philadelphia, really underscores how important this area is. Everyone recognizes the need to alleviate caregiver burden, and this study will help us find evidence-based solutions,” said Christopher Hartnick, MD, director of the Division of Pediatric Otolaryngology at Mass Eye and Ear, and director of the Pediatric Airway, Voice, and Swallowing Center at Mass Eye and Ear and Mass General for Children.

“This project was selected for PCORI funding not only for its scientific merit and commitment to engaging caregivers and other stakeholders, but also for its conduct in real-world settings. It has the potential to answer an important question about our coordination of care after discharge and fill a crucial evidence gap,” said PCORI Executive Director Joe Selby, MD, MPH. “We look forward to following the study’s progress and working with the team at Massachusetts General Hospital to share the results.”

The Reducing Caregiver Burden study was selected for PCORI funding through a highly competitive review process in which patients, clinicians and other stakeholders joined clinical scientists to evaluate the proposals. Applications were assessed for scientific merit, how well they will engage caregivers and other stakeholders and their methodological rigor among other criteria.

The Reducing Caregiver Burden study award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better informed healthcare decisions.

The Pediatric Aerodigestive Center at Mass Eye and Ear/ Mass General for Children includes a multi-disciplinary program that delivers a team-based approach and fosters parent engagement in caring for children with tracheostomies and breathing problems safely.

Click here to read more about the award.