This article was originally featured in the BWH Bulletin.
When Paul Bauer, 74, became winded after climbing two or three flights of stairs, he didn’t initially give it much thought. No longer as active as he once was, he assumed lifestyle changes were to blame. Still, just to be safe, Bauer mentioned it to his primary care physician during a routine visit last year.
His offhand observation triggered a series of events that would result in Bauer learning he had cardiac amyloidosis, a disorder that causes an abnormal protein to build up in the heart tissue. These deposits can accumulate over time and result in serious complications, including heart failure. Treatment options are limited, and most focus on slowing the progression of the disease.
A patient in the Brigham’s Cardiac Amyloidosis Program, Bauer is the first North American patient to enroll in a clinical trial testing a novel therapy that BWH investigators hope will prove effective in dissolving this abnormal protein buildup. If successful, it could undo decades of damage to the heart in these patients. BWH is one of three sites worldwide participating in the study, led at the Brigham by Rodney Falk, MD, director of the Cardiac Amyloidosis Program, in partnership with BWH colleagues across several departments and disciplines, including Cardiovascular Medicine, Dermatology, Nursing, Pharmacy, and Radiology.
“It’s still in the early days, but we do know that this drug works well in animal models and in humans with amyloid in other organs, particularly the liver. If we find that this is effective in the heart, it would be a huge breakthrough for the tens of thousands of patients affected nationwide,” Falk says.
Bauer, who is in the early stages of the disease, is cautiously optimistic about what results he may see. A semiretired aeronautics engineer at Massachusetts Institute of Technology, the Lexington resident says his primary motivation for enrolling was to help advance science and medicine.
“I’ve been a researcher all my life, and I spend most of my time working with students in the laboratory. When Dr. Falk asked if I would consider being the first patient in this study, I was happy to contribute to medical research,” Bauer says.
Nursing Partnership Forms
But the science underlying the trial isn’t the only thing that makes it distinctive. It has also led to a special collaboration between BWH clinical and research nurses due to how the study is conducted.
Trial participants receive the therapy monthly over a six-month course. However, they must remain hospitalized for two weeks each month for treatment and observation in the Shapiro Cardiovascular Center. Bauer, who recently completed his second round of hospitalization for the study, says his wonderful experiences with BWH staff have mitigated any inconveniences the time commitment has caused.
“The staff here is outstanding—offering to do anything that would make my stay as pleasant as possible,” Bauer says. “What makes it not only tolerable but also enjoyable are all the people I’ve met.”
While it’s not unusual for clinical trial participants to be hospitalized during a study, they typically are admitted to Tower 9AB, the Center for Clinical Investigation (CCI) inpatient unit, under the care of research nurses who specialize in collecting data and samples in accordance with research protocols.
Because the therapy for this study carries a potential risk of cardiac arrhythmia, Falk and the outpatient CCI staff partnered with Shapiro nurses to enlist their specialized expertise and ensure the safest possible care for patients in the trial. The result: a close collaboration between two nursing teams that wouldn’t otherwise practice side by side.
“If a patient is participating in a study, there are many data collection points—investigational drug administration, blood and urine samples, EKGs—that must be timed very precisely to maintain the integrity of the protocol. It would be extremely difficult for a clinical nurse to collect all of that while performing the normal responsibilities of caring for not only this patient but their other patients as well,” explains Lauren Donahue, BSN, RN, an outpatient research nurse in the CCI working on the cardiac amyloidosis trial. “But because of the potential risks involved with this therapy, these patients needed to be in Shapiro. We thought, ‘Why don’t we bring our specialty to your specialty?'”
Participants are admitted to Shapiro 8 and receive day-to-day care from clinical nurses in the unit. When the research work is being conducted, the CCI team arrives on the floor to fulfill the study requirements.
“We didn’t want, in any way, to impinge on the duties of the clinical nurses. They were flexible and very enthusiastic partners,” Falk says. “There’s plenty of research going on in Shapiro, but those patients are there because they are very ill. This collaboration is unusual because our participants are in Shapiro as a precautionary measure, and the Shapiro nurses excel in managing potential cardiac issues.”
Karen Hanrahan, BSN, RN, a clinical nurse on Shapiro 8, says it has been gratifying to work with research nurses in this new, integrated way in support of the study.
“It’s a great collaboration,” she says. “It’s been so interesting to understand how the research nurses conduct clinical trials, and we’ve enjoyed being able to continue their work during off hours, when the research nurses are not available, by maintaining the precise timing of treatments and medications that the study requires.”
Jeanne Praetsch, MS, RN, CCRN, a professional development manager for Shapiro 8, says that early and ongoing communication between all the teams involved has been invaluable for clinical nurses.
“We met as a team to identify and address workflow and any possible barriers,” she says. “Education for the nursing staff and interprofessional collaboration resulted in a smooth process and satisfying experience for the patient and all members of the care team.”
ESPN’s Sean McDonough will host a two-day celebrity golf tournament to support cardiac amyloidosis research at BWH. McDonough’s father, legendary Boston Globe columnist Will McDonough, died suddenly from the disease in 2003. The event will be held Aug. 6-7 at The Ritz-Carlton Boston and Boston Golf Club. Learn more at SeanMcDonoughGolfClassic.org.