Not every child who comes to the hospital is sick. Some of the families who visit The Children’s Hospital of Philadelphia on a regular basis are voluntary participants in research studies. Clinical research studies, including both clinical trials of new treatments and studies of healthy children’s development, are an essential component of pediatric research that can lead to novel discoveries and advancements for populations in need. Earlier this summer, we brought you the perspective of Chris Gantz, MBA, into some ways study coordinators can help families feel more engaged when participating in research. Now, we’re turning to some of our star coordinators themselves to learn more.
These studies wouldn’t be possible without the hard work and strategic planning that come from the study coordinators and their teams, but most people don’t know about how dedicated they are on a personal level to building a positive experience for families while collecting data to build new knowledge. Cornerstone sat down with Eileen Ford, a program manager, and Waynitra Hall, a program coordinator, who both work on clinical research studies in the Nutrition and Growth Lab at CHOP with principal investigator Babette Zemel, PhD. The pair of them gave us insight into what it’s like being in charge of research studies and why it’s important for people to participate in them. We also found out a variety of ways that participating in a clinical research study can be an inspiring and rewarding experience. Read on for the edited conversation.
What is your role in research at CHOP, and how long have you been here?
Ford: I have worked at CHOP for seven years. I have been managing two large studies. Both studies work with pregnant women and then follow their infants, so I know moms and babies really well. Hall: I've been working here for 12 years and have worked my way up from being a research assistant to where I am now. I have done three large studies here on children from birth to 21 years old. So I’ve worked with a wide range of different families and different aged children.
Tell me about the studies you’re currently working on.
Ford: The study I'm managing right now is called I-Gram, which stands for Infant Growth and Microbiome. The microbiome is the population of bacteria that lives in your body, and our study is looking at it in the gut of healthy individuals to try to see relationships with risk factors for childhood obesity. The way you study gut bacteria is through poop. You could say ‘stool’ or use some other term, but it’s important to make it as normal as possible with the moms since we're asking for their poop, so it’s better to just make fun of it.
We have a partner at Penn who recruits the mothers from their practice and then sends them to us, so the babies have to be born next door at HUP. We meet the babies at the hospital right after they’re born. We collect blood, urine, and poop from the babies and the moms a couple of times. Other than that, most of the process entails questionnaires and growth measurements. We measure the baby’s growth frequently throughout the study.
Hall: We're not collecting poop or any kind of samples. The study that I'm in charge of is looking at bone density and growth in healthy kids ages 12 months to 5 years old. We see our kids every six months and we do growth measurements as well. We do some scans of their bones to check their bone density. We have them play a little bit, run and walk and crawl and throw balls around and climb on the stairs, just observing basic motor skills, which we score as part of a gross motor assessment. Then we complete some questionnaires with their parents.
What kind of relationships and interactions do you have with the families of study participants?
Ford: We see them more than their friends and their families do because we see them every month for the first year and then every three months for the second year. So we get to know them really well.
Our philosophy is that they are our guests. They have no reason to be coming in to see us since we are looking at healthy individuals. So, when they come, we thank them profusely. When they want to reschedule, we reschedule profusely. We use study cell phones to text back and forth. They text us all of the time so there's a real sense of open communication and familiarity. You can go to a healthcare system and be late and be worried, but we're not those people. We're just laughing about poop.
Hall: Like Eileen said, our kids are also healthy so they don't have to be here. The parents come because they initially want to help out, but parents stay because they enjoy the community, they enjoy getting some assessments of their children to understand how they're growing, how they're eating, and how they're developing.
Our study also lasts for three years, so we see them quite frequently and have a bonded relationship with the parents by calling, texting, emailing, rescheduling and accommodating them on weekends, and all kinds of things.
Why do you think it’s important for people to participate in clinical research studies?
Hall: Families have an important role in creating new knowledge and information. I think the most important thing is that having participation of diverse members of the target population for a study helps us get an idea of what's going on and how we can help them. Participation makes the parents feel like they and their child are contributing to a group goal. Parents of kids with Down syndrome who enrolled in our study, which revised growth charts for kids with Down syndrome, were able to see that they now have a new chart that they can use to see how their child is growing compared to other kids with Down syndrome, instead of typically growing children.
Ford: Here at CHOP, we see so many children with so many diseases. Families should know that by participating in studies you can learn something specific about your child’s disease that may help your child or may help develop treatments for others. I think that keeping participants fully informed about the reasons for a particular study makes the case for them. For instance, in the I-Gram study, our population is all African-American women, and the reason for this is twofold: One, because African Americans by large are an understudied population, and the second reason is because in this particular study we're looking at risks for childhood obesity which is higher in African Americans. So we're looking at a problem particular to African-American children, with African-American children, and that is very well appreciated and understood by the mothers.
What are some of the things you have done to engage the participants in your studies?
Ford: In the I-Gram study, since we are collecting diapers from the babies, we give families a supplemental supply of diapers every month that they come as an incentive, in addition to the compensation families receive for their time and inconvenience in any study like this. A majority of our subjects are low-income families, or getting government assistance already, so it helps out quite a bit.
Another thing we do to keep them engaged, is take individual pictures of the mothers and their babies at every study visit, with their permission. At the end of the study, we give all of the mothers an album. It’s a big deal to them because it’s like watching their baby grow. On a sad note, we've had two infants in the study who have passed away. When we heard, we gave the mothers their albums, as well as a beautiful framed photo of the mother and her baby. It was really comforting to them, and a way of showing them that we care and that it is a real loss for us, too.
Hall: In other studies, we have done holiday cards, newsletters, birthday cards, any kind of card you can think of. We send cards every few months just to thank them for being in the study and remind them when we will be seeing them next. Kids enjoy getting mail and opening something up that's theirs, and they remember it, too.
As for the kids with Down syndrome, we had to work a little bit harder to get them engaged and understanding what was happening because they have a learning disability. We came up with the idea to have a child come in and dress up as a doctor. Then we took pictures of her completing the study procedures. We turned those pictures into a picture book for other patients so that they could see what was going to happen during the visit. They were more comfortable because they had someone who looks like them giving them a step-by-step guide of everything that’s going to happen to them.
What type of skills and preparation do you and your teams need to have to accomplish the work that you do?
Ford: We have great staff, and part of the key is to make sure that they are good listeners and very attentive to the participants and their families’ needs. It’s also important to have a good grasp and knowledge of health issues relevant to the type of participants and the study, like developmental milestones and infant nutrition in our case. For example, when a mom says she's feeding her baby 1 percent milk at six months, staff should know this is an issue that needs to be addressed and not just written down as data. They could say, "Have you talked to your doctor about that?" or, "Would you like us to provide you with some growth curves or growth charts to share with your doctor?" We’re not diagnosticians, so we just try to figure out what we can do to help.
It’s also important for us to be very basic with instructions. Our consent form is written as a Q&A to make it conversational, so that participants really understand the study and feel comfortable with their questions. When I train the recruiters at Penn, I ask them to practice by “recruiting” me first before they can recruit a patient, because they need to understand the consent forms and be able to answer questions. If your subjects know what the study is about, they know it’s well outlined, all their questions are asked, and you tell them what's next, then nothing is a surprise.
Hall: We get to know the families. We get to know which families are going to bring extra kids or siblings or cousins or grandmother, so we can plan ahead and look at the schedule and say, "This mom always has three kids with her, so let’s make sure we have a student here, extra food, and some coloring books and crayons just in case." If they need to change diapers, we have diapers and wipes. We have snacks and drinks if the kids get cranky. If the kid has had enough, we can take a break and get a movie, or just let the child and the parent take their own pace with it.
Everyone is different. It's the same visit and the same procedures, but you have to make it different for each family that comes in. If you tailor it to them, it makes it more fun.
What do you hope to achieve in your positions here at CHOP?
Hall: My goal is to be in charge of larger studies that involve more varied procedures and processes. I’m intrigued by the way CHOP is really trying to push research to the forefront and work on different recruitment methods. I am open to the idea of working on that avenue of getting families in the door, and using my experience with studies to keep them engaged and doing more.
Ford: I like being a manager because I enjoy making studies run. These are important research questions, and by doing this work I can go out in the world and feel like I'm contributing.
I also love working at CHOP because the employees here really do remember their child focus and their inner child. Having been at many other hospitals through a long career, I can tell you that this is just a wonderful place to work. So I hope that, as I grow up, I will stay at CHOP.
Families: If you are interested in having your child participate in a clinical research study, you can find open studies on CHOP’s clinical research finder. Studies are recruiting infants, children, and young adults with a variety of diseases and developmental conditions, as well as healthy and typically developing children.