Texas Children’s Hospital (TCH) is an internationally recognized, full-service pediatric hospital located in the Texas Medical Center in Houston. Since opening its doors in 1954, TCH has cared for more than 1 million children from every corner of the world. The largest pediatric hospital in the country, TCH is affiliated with the Baylor College of Medicine and is its primary training site. George B. Mallory, M.D., associate professor of pediatrics at Baylor College of Medicine, and director of the lung transplant program at TCH, sought a new solution to reliably and efficiently monitor patients’ post-transplant lung function after the children return home. Dr. Mallory turned to Terry Hull, C.R.T., R.C.P., director of operations of Terry Respiratory for assistance.
Terry Respiratory specializes in high-end, home-based respiratory services for infants and children. Terry Respiratory provides clinical care and personalized service to enable children with complex respiratory care needs to enjoy the highest quality of life possible at home.
Hull developed a solution for Dr. Mallory with the SpiroCard® spirometer from QRS Diagnostic Plymouth, Minn. QRS is a provider of innovative design and development of software-based medical devices contained entirely in computer cards. Terry Respiratory’s solution provides a cost-effective alternative for precise monitoring of patients’ post-transplant lung function directly from their homes.
The Challenge: Remote Monitoring of Pulmonary Function
Approximately 60 children in the United States receive lung transplants annually, primarily because of cystic fibrosis or pulmonary hypertension. The United Network for Organ Sharing officially approved the lung transplant program at Texas Children’s in June 2002. Dr. Mallory anticipates that TCH will transplant 10 pediatric patients in 2003, 15 in 2004 and 20 annually thereafter, making it one of the premier programs in the world.
Post-transplant survival is a daunting challenge for this relatively new, high-tech procedure. Lungs are more likely to become infected and undergo immunologic rejection than any other solid organs. Therefore, precise monitoring of patients’ post-transplant lung function is essential. “Decreased pulmonary function is an early, and critical, indicator of possible graft malfunction,” Mallory said. “Careful, detailed, ongoing surveillance of lung health is one of the keys to good outcomes.
We need to intervene early in the course of any respiratory infections or any potential episode of rejection.”
Before coming to Houston in September 2001 to establish TCH’s lung transplant program, Dr. Mallory started the transplant program at St. Louis Children’s and directed medical services there for nine years. He was responsible for the care of 130 lung transplant patients in St. Louis. His patients and their parents went home with a conventional spirometer for at-home testing of the volume and velocity of airflow from the children’s transplanted lungs.
“We did not have a direct, automated way to get the actual numbers and monitor flow-volume curves remotely. We asked families to send us written logs of the test results,” Mallory said. “One of our disappointments in St. Louis was poor adherence to our requests for daily spirometry after we had sent our patients home.” Determined to find a better way in Houston, Dr. Mallory asked David Blanco, R.P.F.T., in the Pulmonary Diagnostic Laboratory at TCH and Hull at Terry Respiratory to identify alternatives for evaluation.
The Search for a Spirometer
“From the start, we all agreed on the essential attributes of an ideal solution,” Hull said. “We had to have an absolutely accurate spirometer that would be convenient and easy for kids and their families to use at home. And, it had to support real-time, remote access to the test results so TCH could monitor patients’ lung function at any time, and no matter how far from Houston they live. The ability to conduct remote monitoring is especially important, since TCH lung transplant patients come from all over Texas and surrounding states as well.
To find alternatives for Dr. Mallory, Hull sought advice from Respironics, Murrysville, Pa. Respironics is widely recognized as a provider in the respiratory medical device industry. “For me, Respironics has always been a source of innovation and quality in respiratory medical devices,” Hull said. “So, it was instinctive for me to contact my Respironics representative,” said Ben Kitchen, R.R.T.
Respironics serves as a primary distributor of QRS Diagnostic spirometry devices to the home health care market in the United States. Kitchen provided three different QRS spirometers for review.
Initially, discussions at TCH centered primarily on Sensaire?, a handheld spirometer with a built-in touch screen and real-time graphics. After several more meetings, Respironics’ Kitchen recommended consideration of SpiroCard because of its digital storage of test results. SpiroCard utilizes QRS’ patented PC Card technology to deliver complete diagnostics in portable, upgradeable and affordable computer cards. QRS PC Card devices slide into the PC Card drives of PDAs, notebook computers and handheld PCs, enabling them to work as full-function medical devices for diagnostic testing. The SpiroCard spirometry device features clear, concise and accurate testing and conveniently saves and stores hundreds of test results.
Blanco, the pulmonary diagnostic lab technician at TCH, reviewed the technical specifications and literature on SpiroCard. “We learned, for instance, that independent testing has verified that the QRS device exceeds the American Thoracic Society’s accuracy standards,” Hull said.
“Most importantly, David tested SpiroCard side-by-side with his spirometer in our pulmonary lab at Texas Children’s,” Mallory said. “SpiroCard was dead-on accurate.”
Assembling the Complete Solution
In July 2002, having chosen SpiroCard as the preferred device for spirometry, Terry Respiratory and TCH then explored how they could deploy the device in a way that would enable remote access to test results. “I knew that we could use SpiroCard with the Office Medic? data management software from QRS to collect and then store and manage the test results on a PC,” Hull said. “The proverbial light bulb clicked on when I realized that we could put SpiroCard and Office Medic on a notebook PC with pcAnywhere?.” With pcAnywhere from Symantec, Cupertino, Ca., Dr. Mallory’s team at TCH could access the children’s spirometry results via a modem connection at any time. And, geographic distance from Houston would not be a problem or barrier.
“We had our solution for at-home spirometry with digital data storage, remote monitoring and automated communication,” Mallory said. “Then, we needed to get insurers’ agreement to pay for it.” That task fell to Hull at Terry Respiratory.
Hull had to secure coverage and arrange reimbursement with payers. He formulated a complete, packaged solution, including:
A year’s supply of QRS’ pre-calibrated, disposable mouthpieces for SpiroCard;
Lifetime, 24-7 support of the PC Card device, all the software components and the computer;
All processing of payer approvals. Payers reimburse Terry Respiratory from $6,500 to $8,500 for this complete solution.
“Having spent some $200,000 to $300,000 to take care of kids prior to a transplant and for the transplant itself, the additional cost for home-based spirometry and remote monitoring is a modest, incremental investment for the payers,” Hull said.
“Plus, it eliminates the need for many follow-up office visits and repeat visits to the hospital pulmonary diagnostic lab.”
Post-transplant, TCH patients receive SpiroCard and their notebook PC at TCH. This gives Dr. Mallory’s team, including David Blanco and Pegg Dobmeier, B.S.N., R.N., lung transplant coordinator, the opportunity to introduce and explain the solution to children and their parents. The children try SpiroCard themselves at TCH pulmonary lab to ensure that they can use the device correctly.
“I’ve had the wonderful opportunity to see how the kids’ faces light up the first time they use SpiroCard. These kids have struggled just to breathe and have dreamed of living a normal life, and they have spent so much time in doctors’ offices and hospitals,” Hull said. “After having had their lung function tested so many, many times in various clinics and hospitals, they immediately realize that SpiroCard gives them personal control and freedom. Dr. Mallory’s team can monitor their lung function without the children having to leave home yet again and go to the hospital. They value the freedom of just being out and away from the hospital.”
For the first three months post-transplant, patients generally test their lung function twice a day. After that, spirometry is usually done once a day. The professionals at the TCH pulmonary department connect to the children’s computers to verify that they have performed their spirometry tests and then assess the results. Thus, TCH accesses the results right from its center, and the solution has worked well for the five school-age children transplanted so far in Houston. The solution is easy to use, and compliance has been excellent.
“The solution that Terry developed with us effectively solves the problems I had encountered in St. Louis,” Mallory said. “It enables us to ensure appropriate follow-up care for the children.”
“QRS designed SpiroCard to make spirometry more affordable and accessible in primary care settings, while providing the accuracy that hospitals and specialists expect and require,” said Spencer Lien, chief executive officer, QRS Diagnostic. “With our support, and assistance from Respironics, Terry Respiratory developed an application of our software-based medical device technology-at-home testing and remote monitoring of patients for whom pulmonary function testing is critical, children with lung transplants. We see Terry Respiratory’s solution for Texas Children’s as a great model for the innovative use of our PC Card medical devices to advance home health care.”