PaTH Network starts studying patients at four institutions with support from the Patient-Centered Outcomes Research Institute
Which health outcomes really matter to patients? That’s the question the PaTH Network is starting to investigate with the help of nearly $7 million in funding from the Patient-Centered Outcomes Research Institute (PCORI), a non-profit created through the Patient Protection and Affordable Care Act.
Four major university health systems—Penn State, University of Pittsburgh, Temple University and Johns Hopkins University—make up the PaTH Network. It’s one of 29 health data networks across the country and a coordinating center, collectively known as PCORnet, funded by PCORI.
PCORI’s mission is to help patients, their caregivers and healthcare providers make informed healthcare decisions based on outcomes that are relevant to those living with a particular condition. That means designing studies that track these patient-centered outcomes.
“It’s traditionally been the researchers who have determined what the outcomes should be in studies,” said Dr. Cynthia Chuang, professor of medicine and public health sciences and Penn State’s lead principal investigator on the project. “For a long time, that really seemed to make sense, until you think about: How do we know that these are the outcomes that really matter, and who should the outcomes matter to? When you think about it that way, it should be the patients who say, ‘Having my condition, these are the things that are most important to me.'”
While researchers typically focus on scientific measures like lab values, Chuang said, patients might be more focused on their quality of life, whether or not they can walk without using a walker or how they can take fewer medications.
The PaTH Network is using PCORI’s funding to study patient-centered outcomes for atrial fibrillation (AF or A fib, the most common type of irregular heartbeat) and idiopathic pulmonary fibrosis (IPF, a rare lung disease with an unknown cause). All of the clinical data research networks in PCORnet, including the PaTH Network, are also working together to better understand the development and treatment of obesity, as well as how some people maintain a healthy weight across their lifetime. By joining forces with other institutions, researchers will have far more patients involved in the study—potentially 3 million in the PaTH Network alone—making the study results much more powerful.
The benefits of larger studies are perhaps obvious for rare conditions, like IPF, for which a lone institution might only have a handful of participants. But large groups of participants also help advance research in more common conditions, like atrial fibrillation, that have many treatment options and no gold standard of care.
When Dave Ruppert found himself in the emergency department of St Joseph Medical Center in Reading in 2012 with symptoms that eventually led to a diagnosis of pancreatic cancer, he also found a new healthcare home. Impressed by the professionalism, personal attention and level of service he found at St. Joseph during that tough time, Ruppert later had all his medical services transferred to St. Joseph.
“It wasn’t just any one person, but everyone from the providers to the billing department,” he said. “They are willing to help you out, they understand you and you don’t get shuffled around. They take care of you as an individual, not as a number.”
When it was time for surgery, Ruppert benefitted from St. Joseph’s oncology partnership with Penn State Hershey that meant he was able to get the highest level of care through recommendations from local doctors.
That’s why Ruppert was pleased to learn that St. Joseph Regional Health Network has become part of Penn State Health, the university’s newly-formed health system that will also include Penn State Milton S. Hershey Medical Center.
“I always recommend St. Joseph to people, and I have high expectations for this,” he said. “I think it’s a really good move.”
Ruppert isn’t the only one who believes St. Joseph is a special place and that becoming part of the Penn State family will only improve it.
Marc Rovito, medical director of St. Joseph Cancer Center, has been a Penn State employee at St. Joseph for four years through a provider-service agreement with Penn State Hershey.
Three sets of shoulder presses, chat about the weather.
Three sets of chair stands, joke with the person on your right.
Three sets of arm pulls, encourage the person on your left.
This simple recipe – which combines strength training with socialization – has become a successful formula for older adults who participate in Band Together peer exercise groups throughout Central Pennsylvania.
Now, the program will expand to other parts of Pennsylvania thanks to $14 million in funding to Penn State College of Medicine from the Patient-Centered Outcomes Research Institute (PCORI). The money will be used to study the effectiveness of integrating strength training, balance exercises and walking for older adults who have had a fall-related fracture.
“I assumed it was because they never exercised,” he said.
After researching available programs, Sciamanna decided to start his own to help his patients develop the muscle and balance they needed to avoid falls. He knew it had to be something that wouldn’t require a gym membership, complicated equipment or heavy dumbbells. An exercise physiologist in cardiac rehab suggested using resistance bands.
What he came up with was a 45-minute routine that mixes five different strength-training exercises with one minute breaks in between for socialization and, recently has added some balance exercises.
In church halls and community rooms – basically anywhere the groups can meet for free – trained volunteers lead the sessions, setting up chairs in a circle and pulling out small duffel bags the colors of the rainbow – each matching the color of bands inside.
Yellow, at three-to-six pounds resistance, is the easiest band to use. Participants advance to other colors as their strength improves, eventually working with as much as 35 lbs. The most ambitious members use two bands at once, since the handles are thin enough, going up to 70 pounds. Exercises using the resistance bands are done seated, or standing and holding onto a chair.
Nancy Boerger of Hershey has been doing Band Together for a year and says she can now get up from a regular height toilet without problems.
“It’s much easier, and I’m sure it is from these exercises,” she said.
Anna and Jack Manning attend the classes together in common space where they live at Hershey Plaza. In the past year, both have been using their canes less.
“I have a walker, but I don’t need to use it anymore,” Anna said.
And then there’s Lois Leonard of Palmyra, who, at 86, is the oldest in her group. She started the program after her daughter in Texas saw an article about it in a Lebanon newspaper online and suggested she try it.
“I wasn’t looking for anything, but it is good exercise and good camaraderie,” she said.
The classes are free and open to anyone. “It seems to me that this is something all older adults should have access to as a service,” Sciamanna said.
That’s why, when the opportunity came to submit a proposal to PCORI, Sciamanna decided to see if he could get money to do a study to find out whether a program such as Band Together could prevent people from falling and breaking bones.
First, he had to get support from other organizations and institutions, and find some to partner with. “I had to see if it was a question worth asking and if others would be willing to partner with me,” he said.
What he came up with was a five-year study that will follow 2,100 older adults with a history of falls – half of whom will be randomly assigned to Band Together. For three years, those participants will attend walking groups and Band Together sessions with a coach, doing exercises for both strength and balance. Each year, all participants will take part in either a phone call or in-person meeting with study investigators.
Researchers will record information about fall-related injuries; muscle strength, bone strength, loneliness, depression and use of emergency medical care by study participants at 50 new sites in central Pennsylvania, Philadelphia and Pittsburgh.
Building on the patient involvement behind the Band Together initiative, three patients will be co-investigators on the current study and provide input. Other partners on the study include Health Dialog, The American College of Sports Medicine, American Orthopaedic Association, National Osteoporosis Foundation and Highmark Blue Shield.
Sciamanna’s hope is that the study will show that those who participate in Band Together have fewer falls. Then, he can apply to Medicare so it will pay for all Americans to participate in such programs.
“It’s a little pie in the sky, but they already pay for some things that are not that different than this,” he said. “It’s a very formal process, but by the time this is finished, we will be well positioned to make an application.”
By studying a larger sample of adults, insurance companies and Medicare will have the data to determine if such a service should be covered.
Rachel Moury, director of donor communications and stewardship for Penn State Hershey, said Honor Your Doctor funds that Sciamanna received made it possible for him to create the program and draw national attention to its potential.
“Some people think that a $50 gift doesn’t matter or can’t do much,” Moury said. “But it can combine with other $10 or $50 or $100 gifts to add up and raise attention for the work someone is doing.”
For Sciamanna, those donations led to the $14 million in funding that can potentially benefit many more people in the future.
- Jennifer Vogelsong
Identifying poisonous snakes and knotting climbing ropes to form a makeshift litter are not typically taught in medical school.
But emergency medicine doctors need to be creative, flexible and have a broad knowledge base.
That’s why Dr. Jeff Lubin, associate professor of emergency medicine and Life Lion division chief, took emergency medicine residents and medical students out of the emergency department and into the wild.
“It is very applicable,” Lubin said of the first wilderness medicine training offered by Penn State Hershey. “One of the things they need to understand is what happens outside the hospital, because they are going to be receiving those patients.”
Lubin worked with Life Lion flight paramedic and wilderness medicine enthusiast Saul Elertas to design the training at the Boy Scouts of America’s Camp Bashore near Jonestown in Dauphin County.
Dressed in fleece, sweatshirts and hiking boots against an unseasonably cool May morning, Elertas reminded the residents of basic rules about making assumptions, planning ahead and taking care of themselves outdoors.
None were complaining about the assignment.
“This was mandatory, but I would have volunteered anyway,” said Keane McCullum, a first-year medical student who is working as Lubin’s research assistant for the summer.
Dr. Neal Thomas has made research his life’s work.
The newly named associate dean for clinical research hopes to help Penn State Hershey’s clinical research mission grow. One reason he is vested in seeing the expansion of clinical research is because he was personally affected by it — twice.
“In 2002, my youngest son was born premature and was given a medicine called surfactant into his lungs to combat lung disease that can happen from prematurity,” Thomas, a professor of pediatrics and public health sciences, said.
Being a researcher involved with surfactant use in older children, and also studying the surfactant genes and their impact on young children with lung disease, he was aware of the early clinical trial literature treating premature lungs. The fact that his son benefited from that early work would strengthen Thomas’s research interest in surfactant for years to come.
“It probably saved his life, but it certainly affected his lungs so that he is completely healthy now,” Thomas said. ”That wouldn’t have happened if scientists and physicians hadn’t conducted the clinical research to get to that point.”
He personally benefited from clinical research last year after having a heart attack.
Dr. Rodrigue Mortel has received the Penn State Alumni Association’s Honorary Alumni Award. This award recognizes those who are not Penn State graduates but have made significant contributions to the university’s welfare through their commitment and service.
Dr. Mortel joins fewer than 100 people who have earned this distinction since its establishment in 1973.
“I know that only two to four people are selected each year, and that since the award has been set up, only three faculty from the College of Medicine have been recipients of this award,” Mortel said. “I am proud to find myself in a very small circle of distinguished people to be selected from the College of Medicine.”
Mortel served in a number of positions during his 30 years at Penn State Hershey. He was promoted to full professor in 1977, only five years after joining the faculty, and later became the chair of obstetrics and gynecology in 1983.“His leadership at Penn State has been so very instrumental in establishing this Medical Center as one of the premier institutions in the country,” said Dr. Chester Berlin, professor of pediatrics, in a nomination letter for Mortel. “Penn State was so very fortunate in having Dr. Mortel in leadership positions so early in the life of Penn State Hershey.”
Added Dr. A. Craig Hillemeier, dean, Penn State College of Medicine, CEO, Penn State Milton S. Hershey Medical Center and Health System and senior vice president for health affairs, Penn State, “Dr. Mortel’s prolific efforts over the years have supported the growth and reputation of Penn State College of Medicine and Penn State Milton S. Hershey Medical Center. By helping train aspiring physicians and conducting groundbreaking research in our labs, Dr. Mortel deserves to be recognized for his service to Penn State.”
In 1977 the U.S. Food and Drug Administration banned women “of child-bearing potential” from participating in clinical trials. This was in part due to thousands of children worldwide being born with missing and malformed limbs after their mothers had taken thalidomide — often prescribed in the 1950s for nausea and as a sleep aid.
A decade and a half later, in 1993, the FDA lifted this ban after Congress passed the National Institutes of Health Revitalization Act. However, as Alina Salganicoff noted in her keynote address at Penn State’s 2015 Women’s Health Research Day on April 28, women are still poorly represented in research and clinical trials.
Women’s Health Research Day was held at the Penn State College of Medicine campus for the second year in a row and researchers from both the Hershey and University Park campuses attended. Due to the number of applications this year, two more research presentation slots and 11 more poster presentations were added.
Poster presentations featured the work of faculty members, residents, graduate students and medical students. The researchers’ fields of expertise ranged from obstetrics and gynecology to kinesiology to public health sciences, and seemingly everywhere in between, covering a vast array of women’s health topics.