How Involving Patients Makes Research Better

Including patient and caregivers as partners in research can have surprising results

August 16, 2016

Ebony Boulware, MD, MPH, has long been a proponent of working closely with patients and communities to improve their health.

But when she asked a team of patients and caregivers to review a research proposal she was writing, she was astounded by the feedback.

“Involving patients in the planning process completely changed the research project,” says Boulware, the principal investigator of PREPARE NOW, a study funded by the Patient Centered Outcomes Research Initiative (PCORI).

“It took the research in directions I hadn’t even considered from the outset of our grant planning.”

Ebony Boulware
"Involving patients in the
planning process completely
changed the research project.”
- Ebony Boulware, MD

Boulware is one of an increasing number of investigators at Duke (and elsewhere) who are embracing the new approach of involving patients in research in roles that extend beyond their participation as study subjects in clinical trials. Instead, these research teams are collaborating with patients to choose areas of research, design protocols that reduce barriers for participation, and produce information about the research that patients and caregivers can easily understand.

“In any other industry, there is user-centered design approach,” says Bray Patrick-Lake, the director of patient engagement for the Duke CTSA. “Why shouldn’t research and healthcare have the same?”


Changing What We Research

Boulware’s research study began as a plan to measure the effectiveness of using educational videos and booklets about chronic kidney disease (CKD) with patients before patients become acutely ill and needed dialysis.

Boulware and her co-investigator, Jamie Green, MD, of the Geisinger Health System in Pennsylvania, invited patients who had either experienced chronic kidney disease or were caregivers for patients with kidney disease to become co-investigators on the research proposal.

“When the patients and caregivers considered our initial ideas, they said ‘This isn’t enough,’” remembers Boulware. “They wanted to research so much more. They wanted comprehensive support to help them make decisions that would require changes throughout the health care system.”

So Boulware and the team rewrote the proposal.

Amy Swoboda
Amy Swoboda

Amy Swoboda, whose husband received a kidney transplant in 2012 after nearly a decade of living with CKD, remembers the satisfaction of influencing the research.

“Support from others with the disease has been huge for my husband and me,” she says. “So I was very vocal about involving the National Kidney Foundation’s peer to peer support network. Quite vocal. And we got it.”

Other changes initiated by the patient co-investigators included adding a kidney transitions specialist to the healthcare team for the pilot project, using predictive software to help physicians determine which patients are at higher risk for rapid decline, and measuring whether patient’s treatment preferences are entered into the medical record before patients develop kidney failure.

“It was a different idea—a better research proposal -- with the potential for much greater impact on patients’ health and well-being,” Boulware says.

The PREPARE NOW trial recruited its first patients into the program in Pennsylvania early in 2016.


Creating a Culture of Collaboration

Engaging patients at this level in research planning has growing support up and down the research food chain. Caregivers such as Swoboda see it as a way to influence research that may eventually improve the care they or their loved ones will receive. Funding organizations such as PCORI and the NIH see engaging patients as a crucial step to the future of science.

“[Patients’] input and perspectives as members of the research team help provide insights, focus, urgency and connectivity that can be instrumental in making the development, testing and deployment of new interventions more efficient and effective,” wrote Christopher Austin, MD, director of the National Center for Advancing Translational Science (NCATS) in his July 2016 newsletter.

Yet forging such patient/researcher collaborations isn’t easy. It requires rethinking about when and where and how to involve scientists and non-scientists in a scientific endeavor. It involves overcoming entrenched beliefs about the pros and cons of being involved in research. It requires developing trust and transparency.  

Duke’s new Community Connection and Collaboration Core (commonly referred to as C4) is ready to tackle these challenges.

Their informal motto -- “preparing community-ready researchers and research-ready communities”--reflects the idea that research must be an equitable partnership that respects, values, and incorporates the perspectives, values, and expertise of all stakeholders, including our communities and patients, in advancing science.

In May, the C4 staff hosted the first of a series of town hall sessions and meetings with community organizations, leaders, patients, and lay leaders. The goal is to learn how best to identify and engage in research and outcomes that matter most to patients, care partners, families and the broader community. Plans are also underway for a series of “research and community tours” this fall. Some tours will bring community members to tour Duke’s research labs and biobanks. Participants will also learn about the Institutional Review Board and other groups involved in research at Duke. Meanwhile, other tours will bring Duke research teams into the community to learn more about the history, vitality, strengths, and current health concerns of Durham.

Nadine Barrett
Nadine Barrett, PhD

“At the end of the day, as researchers we want our work to make a difference in impacting the health of our community,” says Nadine Barrett, PhD, the director of C4, which is part of Duke’s Center for Community and Population Health Improvement. “We can help that happen by making sure that the work we do in partnership with our community represents and reflects their perspectives and their views. Listening and authentically building and working together, is key to this process.”


Shaping Information

The ADAPTABLE trial is a PCORI-funded three-year trial comparing the effectiveness of two different daily doses of aspirin widely used to prevent heart attacks and strokes in individuals with heart disease. From its inception, ADAPTABLE has had a cadre of “Adaptors” who collaborate with researchers by testing the proposed patient experience and suggesting improvements.

Adrian Hernandez, MD

Adrian Hernandez, MD, principal investigator for the ADAPTABLE trial, says the Adaptors have influenced the study enormously.

“If the researchers had done this project in our traditional way, we would have had an 18-page printed consent form and a bland video to explain the research,” says Hernandez.

Instead, the Adaptors convinced the team to translate the consent process to a patient portal that tells the story about why you might want to get involved. The portal also allows prospective participants to complete the required informed consent online.

Hernandez says working with the Adaptors has been wonderfully equitable.  

“I thought that we’d have to spend lots more time explaining deep details of the research process,” he said. “But then I realized the ADAPTORS were there to teach the researchers what was important. We were learning, too.”


Partnering Around Publicity

Vincent Del Gaizo
Vincent Del Gaizo

Vincent Del Gaizo, the owner of a dry cleaning business in New Jersey, remembers vividly the moment the doctor told him his 15-month-old son – one of triplets – had juvenile idiopathic arthritis (JIA).

“You have a deer in the headlights reaction,” he says. “Your kid has been diagnosed with a disease you’ve never heard of and you don’t believe it happens to kids. It makes it hard for the doctor to talk about clinical trials at the same time.”

Fast forward 14 years, and Del Gaizo found a way to mitigate that frozen feeling.

It is Del Gaizo’s voice, among others, that parents now hear on a PREZI presentation when a physician is ready to ask parents if they want to enroll their child in the STOP JIA trial.

Del Gaizo is a co-investigator with Laura Schanberg, MD, a pediatric rheumatologist, in PARTNERS, a Patient Powered Research Network (PPRN) funded by PCORnet that focuses on arthritis. One of the many clinical trials this group is collaborating with is STOP-JIA, an observational trial that compares three standards of care for JIA.

“We figured a presentation from one parent to another would make it easier to spread the news,” Del Gaizo says. “We worked with the researchers to make sure the facts were all correct, but we created the whole PREZI to provide information based on what goes through a parent’s mind, not just to provide tons and tons of material.”

Lauren Revis

One of Schanberg’s patients, 18-year old Lauren Revis, is the youngest member of the STOP-JIA patient panel. Schanberg arranged a virtual introduction between Revis and Del Gaizo after reading Revis’ college entrance essay describing her refusal to let arthritis hold her back – even from setting a high school record for the 800-meter dash. Soon, Del Gaizo was on the phone inviting Revis to join the STOP-JIA patient panel meeting in Toronto, Canada. A few months later, Revis was designing the STOP-JIA newsletter.

“I was intimidated about being the youngest member on the panel, but I know I have benefitted from research done in the past, and I hope to be an inspiration for others who are newly diagnosed,” she says.

Laura Schanberg
Laura Schanberg, MD

Schanberg has come to appreciate how having the parents and caregivers such as Del Gaizo and Revis involved in planning, shaping, and explaining the science of clinical trials emphasizes the truth that everyone is working toward the same goal – improving health.

“To begin with, I wasn’t sure how [getting patients involved in research] would work, how I would feel about it, and whether it would just be an annoyance,” she says. “But working with the families helps me remember every day why I am doing this in the first place. It has been inspiring.”