Amidst large vendor booths showcasing the latest advances in cardiovascular innovation at the 66th Annual American College of Cardiology Scientific Session and Expo, Henry Cruz and Tom McCormick, patient partners on the ADAPTABLE Study team, answered questions at the CardioSmart Patient Engagement Pavilion and later participated in a panel discussion on leveraging patient engagement to improve clinical research.
The ADAPTABLE Study (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) is a three-year pragmatic clinical trial that will compare the effectiveness of two different daily doses of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease. Cruz and McCormick serve as “Adaptors” on the ADAPTABLE Study – patient partners who work alongside researchers in all aspects of the trial, including designing the protocol, consent form, study portal, and study materials.
The ADAPTABLE Study Panel – “Leveraging Patient Engagement to Improve and Enhance Clinical Research” also included:
- Eileen M. Handberg, PhD, ARNP, Co-Director, OneFlorida CDRN;
- Sandeep Jain, MD, Associate Professor of Medicine, University of Pittsburgh and Investigator with the PaTH Clinical Data Research Network (CDRN);
- Fred Masoudi, MD, MSPH, FACC Professor of Medicine-Cardiology, University of Colorado and ADAPTABLE Study Steering Committee Member.
Matthew Roe, MD, MHS, Co-Principal Investigator of ADAPTABLE and Professor of Medicine-Cardiology, Duke University School of Medicine moderated the session.
Researchers at Montefiore Medical Center, a health system in the NYC-CDRN invited Cruz, a patient advocate for chronic disease awareness and education, to become involved in ADAPTABLE. When Cruz learned about ADAPTABLE, he knew ‘It was the right thing to do.’ Through PCORnet and electronic health records, ADAPTABLE is a model to generate evidence to answer critical medical questions.
McCormick who thinks of himself as a mathematician first and a heart patient second is a member of the ADAPTABLE Retention Working Group. McCormick has considered the question, “How do you make patients aware of ADAPTABLE? And, for those who enroll in the study, “How do you retain patients in this virtual study?” To assist with retention, the working group suggested a newsletter to engage participants. Both McCormick and his fellow Adaptor colleagues have contributed topic ideas and will have the opportunity to review and provide input to future issues.
Jain who has approached more than a thousand patients for ADAPTABLE at the University of Pittsburgh said the first step in their multi-touch recruitment effort was not patient engagement, but actually clinician awareness and education. Clinicians tend to have strong feelings about what dose (81 mg or 325 mg) of aspirin they prescribe their patients. After informing clinicians on the lack of evidence to suggest a preferred dose of aspirin, Jain stated that he received ‘buy-in’ from his colleagues regarding ADAPTABLE. Eileen Handberg, researcher at OneFlorida shared a similar experience and emphasized that patient and clinician engagement is an ongoing process. “We talked to our colleagues and showed them that the current American College of Cardiology (ACC)/ American Heart Association (AHA) Guideline Recommendations for cardiovascular conditions recommend a range with no data to support a preferred dose.” Results from ADAPTABLE have the potential to provide the missing data to inform current guidelines and change practice.
McCormick added that clinicians should be passionate about clinical research trials they are involved in but not assume their patients will readily sign up just because they are asked. The message to patients should be clear in stating why the physician thinks the study is important and that the patient may not receive any direct benefit from their participation.
Masoudi, who represents the American College of Cardiology (ACC) on the ADAPTABLE Steering Committee, said that ADAPTABLE aligns well with the College’s mission to transform cardiovascular care. ADAPTABLE is truly transformational with the question the study is asking, electronic outreach and network-based approach, and most importantly, how it is engaging patients. “I have been involved in a number of research studies, but this is the first study as a researcher that I have had the opportunity to work with patients who are contributing insights into the study design and operations. We are transforming patient care with patients.”
Handberg, who represents OneFlorida, described the network’s Citizen Scientist group, a diverse team of community members who provide critical insight and feedback on grants and research protocols. “The endpoints that researchers think are critical are often not important to patients,” said Handberg. “Researchers may focus on mortality; whereas, patients are concerned with having a stroke and living with a disability, and the impact that that has on their quality of life.”
In addition to answering a question of significant clinical importance with potential to change practice guidelines, the panelists all agreed that lessons learned from ADAPTABLE will transform the conduct of clinical trials. In response to a question from the audience about engaging ADPTABLE study participants, Roe said: “ADAPTABLE is a signature study of embedding research in clinical practice and improving the experience for both the patient and their physician.” That is the concept of a learning health system and we see ADAPTABLE as a model of how we can take care of patients and how we do research in the future.
In addition to learning the best way to approach and engage patients, ADAPTABLE is also learning about how to improve the dissemination of results. Handberg said that Adaptors will be going out to their communities to share results using approaches and language that resonates with their peers. Handberg anticipates that at the end of the study “will be a real celebration with patients and investigators that we answered a question that really matters to people.”
Check out photos from the ADAPTABLE Study Panel. Continue to follow the study on Twitter, Facebook, and look on the website for updates and lessons learned from this unique patient-centric, cardiovascular study.
The ADAPTABLE Study is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award. ADAPTABLE is the first demonstration project to be conducted through PCORnet, the National Patient-Centered Clinical Research Network. PCORnet is a PCORI-funded initiative designed to improve the nation’s capacity to conduct comparative clinical effectiveness research. More information about PCORnet can be found here.
The information presented on this website does not necessarily represent the views of PCORI, its Board of Governors or Methodology Committee. More information about PCORI can be found here.