Category Archives: Patient Engagement

When Patients Partner with Researchers

In ADAPTABLE, patients are more than study participants, they are partners with researchers and clinicians to improve cardiovascular health for all patients and those who care for them. Adaptors are patient representatives who have been involved in ADAPTABLE from the beginning. The Adaptors team works alongside the study team, participating in team meetings and providing review and input to the protocol, consent form, study portal, and study materials.

We talked with one of the Adaptors, Bill Larsen, who provided his perspective on the value patients bring to clinical research, the importance of patient-centered research, and the ADAPTABLE experience.

 

How can patients inform researchers in clinical trials?

I find it useful to think of medical research as a team effort. There are roles best suited for researchers and those best filled by patient representatives.

On the research side, there are leadership, operations (day-to-day research activities), and clinician roles. In addition, there is oversight by the Institutional Research Board (IRB) that reviews all proposed research to ensure that patient privacy and security concerns are addressed. An even wider net would include roles filled by the research funding sources and the health plan providers.

On the patient side, there are participants who are directly involved in the research study, the larger community who suffers from the condition being researched, and someone like me, the patient representative, or as we are known in ADAPTABLE, the Adaptor, who provide the patient perspective. There are seven individuals who comprise the Adaptors team. Although, we each bring varied experiences, we share a common thread of having heart disease or caring for a loved one who does.

As an Adaptor, I fit somewhere in the middle of the research team. It’s my responsibility to understand the various perspectives of the researcher, the study participant, the heart patient, and the views of my fellow Adaptors.

I view my role to be that of a communicator, asking questions that are sensitive to the roles of each player and of interest to those represented in the research study, and providing relevant information and feedback to the concerned parties. Active dialogue among all concerned is what enriches the conversation and leverages the contributions of each individual to best achieve the research goals of the team.

Here are a few of the questions that I have raised in ADAPTABLE, and continually review, as the project proceeds:

  • Is the proposed research really important to those most affected by the disease being studied?
  • Does the recruitment approach present any obstacles to the study participants?
  • Are the written recruitment materials clear and appealing?
  • Do follow-up calls to initial inquiries cover the points I believe are most important?
  • Are expectations for patient participation realistic?
  • Are safety and security issues satisfactorily addressed?
  • How will the participant be kept informed during the research process?
  • In reporting the final results, are there at least some that will be written in lay language?
  • Will results be distributed for maximum coverage to the affected population?

Patient representative can help ensure that the answers to these, and other, questions fully reflect the interests, concerns, and welfare of the entire patient population.

Why is patient-centered research important?

Until recent years, the focus of medical research has been heavily weighted toward basic science. This is understandable and undeniably important. It is essential for the development of new medications and procedures designed to benefit the patient.

But before the findings of basic science can be implemented, they must be tested in a real-world setting. The branch of medical research devoted to this stage is called “translational.” In order to translate the findings of basic scientific discoveries into actual solutions, they need to be tested in a controlled environment, typically in a clinical setting where the doctor and patient interact. How to achieve this is more complex than meets the eye. The concerns of both the doctor and patient must be addressed by the translational research team before success can be achieved.

Until recently, the voices of the researcher and the clinician were paramount, with only peripheral attention given to the concerns of the patient. One of the most significant provisions of the Affordable Care Act was the creation of the Patient-Centered Outcomes Research Institute. As its name suggests, this organization places primary emphasis on the PATIENT. It gives the patient an equal voice along with the researcher and clinician in the conduct of translational research. The ADAPTABLE study is a paradigm example of how this process has been put into practice.

From the very outset of the ADAPTABLE study, we Adaptors have provided the patient perspective in all aspects. We represent all areas of the country and bring great diversity of gender, race, ethnicity, and age. We work side by side with the research team and the other parties at every stage and throughout the endeavor. We raise key questions and will continue to do so throughout the duration of the project.

What activity do you appreciate most from your work on the ADAPTABLE Study?

It is the complete immersion in the whole research process, the opportunity to view it from the inside out and feel empowered to have an impact on a study with results that may potentially benefit so many people. From this, I have gained a greater appreciation of the complex environment of medical research, and the underappreciated importance of the expanded role the patient must play for the benefit of all.

Before my involvement in ADAPTABLE, I regret to say that I was a somewhat passive follower of medical research. Like many people, I am dealing with multiple health issues. I have surveyed the literature pertaining to these issues and have been frustrated by the difficulty of understanding and assessing these findings in their technical jargon, and even more frustrated at the slow pace of the findings. Why can’t they speak my language and why can’t they produce useful results faster?

Since ADAPTABLE, I have come to realize that THEY is US, and WE (patients) are being given the power and the voice to make a difference; we can accelerate the process by being more receptive to participating in research. We can no longer remain passive. We must get more involved. You might ask, “How?” There are many ways. You can participate in a research study or, similar to the role of the Adaptor, provide your perspective in a study. Other ways to get involved include participating in focus groups to help advise researchers on issues pertaining to your health condition during the formative stages of a project, or simply raising awareness within your communities of the importance of patient involvement in the research process.

I can personally attest to the benefits I have gained through participation in ADAPTABLE. Primarily, I can say unreservedly that the entire research team, from interactions with study leadership to the operations staff, we patient representatives participate on a peer-to-peer basis. They not only welcome our input, they seek it out. Secondly, I value greatly the interactions with my fellow Adaptors. We have only met twice in person, but we talk by teleconference biweekly. Although our common denominator is heart disease, we have personal implications that affect our lives in different ways. I am the richer for knowing the many ways in which each of us copes. The bond we have developed will last beyond ADAPTABLE.

What activities or hobbies do you enjoy?

I play duplicate bridge (competently but not expertly), participate in a twice-a-month Great Books Discussion group, listen to music (mostly classical, with a preference for live performances), love great movies, travel (summer music festivals are a special treat), do a little birding (with my wife, the real birder—600+ species on her life list), and follow my hometown Chicago sports teams (Go Cubs Go—please do not make me wait another 108 years for a World Series crown; I might not be around).

ADAPTABLE’s Patient-Researcher Partnership Serves as a Model of Engagement

The ADAPTABLE Study is featured as a model of patient engagement in Applied Clinical Trials.

As patients take more active roles in decision-making about health, healthcare, clinical trials, and regulatory activities, their influence has changed how sponsors and researchers view patient involvement in clinical research.Once regarded as “subjects” who had research performed on them, patients are now contributing across the spectrum of clinical development. Patients are asked to weigh in on the design and planning of research protocols, selection of outcomes and endpoints, development of recruitment and retention strategies, and dissemination of research results.

ADAPTABLE integrates patient partners (the Adaptors) into the study team to provide patient voices and perspectives in all aspects of the trial. By participating in ongoing study meetings, Adaptors hear firsthand about recruitment challenges and barriers to enrolling up to 15,000 patients in the ADAPTABLE study. Working with their local network researchers, Adaptors play a key role in tailoring the recruitment messages. Adaptors help develop and review recruitment materials, anticipating questions and identifying potential points of confusion. They offer input on study materials that facilitates understanding and enhances appeal to a broad audience, such as incorporating graphics and white space, reducing jargon and legalese, and using language that emphasizes the importance of clinical trials, the role of patients in the process, and the value of the patient voice in transforming healthcare. Adaptors have also contributed as authors in peer-reviewed literature.

Read the complete article to explore more models of patient engagement in research.

Heart Patients Help Doctors Determine Best Aspirin Dose

Doctors have known for decades that taking aspirin can reduce the risk for future heart attacks and strokes in people with cardiovascular disease. What is less clear is which dose is best. Participants in a new kind of clinical trial are helping them find out.

Which Aspirin Dose Is Best?

Some doctors prescribe a “baby aspirin” (81mg) once a day, while others recommend a full-strength (325mg) aspirin tablet. The difference is important because taking aspirin daily can potentially increase your risk of bleeding. Until now, there hasn’t been enough good-quality data to guide doctors’ decisions.

That’s where the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness) study comes in. Duke Clinical Research Institute is coordinating the study, one of the first to make patients key partners in an effort to gather vast amounts of data quickly and efficiently. People with heart disease and who are at high risk of having a heart attack or stroke are randomly assigned to take an 81mg or 325mg aspirin daily and are followed for up to 30 months. Eventually, as many as 15,000 people around the U.S. will participate.

Patients Appreciate Opportunity to Advance Medical Knowledge

Retiree John Turk started having shortness of breath and chest tightness while juggling the stresses of selling his Cleveland, OH, home and buying a new one in Raleigh to be near his daughter. He hadn’t had symptoms before.

“My general practitioner immediately referred me to Duke to get checked out,” Turk said. “Within a few weeks, I had bypass surgery.” Duke interventional cardiologist Schuyler Jones, MD, worked with Turk during his post-surgical recovery period and encouraged him to get involved in the ADAPTABLE study.

“If this helps, I’m glad to be part of it,” Turk said. “Makes me feel good to help with the research.”

For full story from Duke Health Blog: https://www.dukehealth.org/blog/heart-patients-help-doctors-determine-best-aspirin-dose-new-clinical-trial

2017: Year in Review

The ADAPTABLE Study team reflects on the many accomplishments and milestones throughout 2017 — a year of record enrollment, new network collaborations, and actively engaging with and sharing the voice of study participants. We wish you the best in 2018 and look forward to continuing to build a community where participants, researchers, and clinicians partner together to improve cardiovascular health.

ADAPTABLE Study Welcomes HealthCore and LHSNet Networks to the Team

The National Patient-Centered Clinical Research Network (PCORnet) demonstration study, ADAPTABLE, welcomes two new partners as participating networks: HealthCore-Anthem Research Network and Patient-Centered Network of Learning Health Systems (LHSNet).

HealthCore, a subsidiary of Anthem, is a health plan research network with 140 highly specialized, multi-disciplinary professionals dedicated to health services and outcomes research. Through Anthem, HealthCore has access to approximately 60 million individuals from across the United States. HealthCore began its initial outreach to 135,000 eligible patients covered by Anthem, and in less than a month more than 400 eligible patients have visited the ADAPTABLE patient portal and 104 of them have already enrolled. The addition of HealthCore as an enrolling site for ADAPTABLE creates a novel partnership where health plan claims data are contributing to the primary data collected in this clinical study.

LHSNet is a diverse network of health institutions across the mid-west and mountain states that collectively serve approximately 10 million patients including underserved and rural areas. Similar to HealthCore and other participating networks in ADAPTABLE, the six LHSNet sites will use a computable phenotype, an electronic formula within the health record system, to identify eligible patients at each of the participating locations.

Highlighting the collaborative nature of PCORnet, LHSNet leadership is actively incorporating best practices from currently enrolling sites to optimize clinician engagement, patient engagement, and recruitment strategies. “The collaborative environment between the site teams to work together and learn how to successfully manage a large pragmatic clinical study is something I have never witnessed on any other large clinical trial,” said Project Leader Holly Robertson, PhD. “It is definitely a unique experience and it is really exciting to be a part of such a novel study.”

The addition of these networks allows for the expansion of ADAPTABLE to new geographical areas and will help to support the goal of enrolling up to 15,000 patients to answer a simple but critical question that is important to individuals living with heart disease and their providers: What is the most effective dose (81mg or 325mg) of aspirin for patients with cardiovascular disease? “The ADAPTABLE demonstration study within PCORnet continues to break new ground with innovative ways to engage patients and clinicians in important, pragmatic clinical research, as demonstrated by the inclusion of HealthCore and LHSNet,” says ADAPTABLE Co-Principal Investigator Schuyler Jones, MD.

Sharing Art and Stories to Honor Clinical Trial Participants

Hero’s Journey Art Piece

ADAPTABLE patient partners participated in the Hero’s Journey art project. Sponsored by Eli Lilly, the national art project involves more than 1,000 participants and is intended to honor clinical trial participants and raise awareness of clinical trials.

In conjunction with Health eHeart Alliance, ADAPTABLE’s patient partners crafted the quote “Better health outcomes for all when patients partner with researchers” to represent their involvement in clinical research.

The brick is part of an eight-foot tall, egg-shaped, lighted sculpture that will be part of art exhibits across the country. The first sculpture, “Departure” is on display at an exhibit in LiveSTRONG Headquarters in Austin Texas. The second sculpture is part of an art exhibit in Indianapolis, Indiana. You can follow the art and join the conversation online using #herosjourneyart.

“ADAPTABLE is a best-in-class example of how to incorporate meaningful patient engagement in a clinical trial,” said Holly Robertson, PhD, ADAPTABLE Study project lead. “It’s exciting to be a part of a study that is transforming clinical research.”

Engagement, Research, and Evidence

Adrian Hernandez and Henry Cruz

ADAPTABLE is leading the way in patient-researcher partnerships.  A recent example of this collaboration is an insightful perspective piece for Circulation authored by Adrian Hernandez, ADAPTABLE Study Co-PI, and Henry Cruz, a patient Adaptor. Hernandez and Cruz discuss the need for and benefits of a national learning health system and how PCORnet, The National Patient-Centered Research Network is conducting research in “real-world settings” to achieve such a system.

The piece also mentions the ADAPTABLE study’s collaboration with Adaptors, a group of patient representatives who are shifting the role of patients in the research process from participant to partner, and how this collaboration creates an effective organizational vision that can be useful in addressing one of the nation’s most pressing public health problems: cardiovascular disease.

ADAPTABLE Study: Patient-Researcher Partnerships Produce Better Outcomes

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. Continue reading ADAPTABLE Study: Patient-Researcher Partnerships Produce Better Outcomes

NEJM Highlights How the ADAPTABLE Study is Changing Clinical Research

ADAPTABLE’s electronic consent processes and web-based design are featured in a multi-part review article by the New England Journal of Medicine on The Changing Face of Clinical Trials. New approaches to informed consent and innovative options for obtaining it have come about from technological advances and pragmatic research designs.

While answering the question of what is the best dose of aspirin for patients with heart disease, ADAPTABLE provides an innovative model to conduct pragmatic clinical trials. The ADAPTABLE study portal offers potential participants the opportunity to learn more about the study by watching a video and reading the consent form. If interested in participating, individuals self-consent, self-randomize, and return to the portal every three to six months to answer questionnaires and report data. In ADAPTABLE, participants do not need to have in-person study visits. Instead, electronic health records are used to identify participants and electronic health information is captured during routine care to identify events that provide researchers with additional health outcomes data to inform better decision-making.

In ADAPTABLE, patients are central to the study and have been involved in ADAPTABLE from the beginning, including consent development. Patients provided feedback and participated in interviews to help design the consent form that includes a comprehensive quiz. True for all studies, but especially for ADAPTABLE since the study is using web-based consent, the consent includes a six-item multiple choice quiz to assess a participant’s understanding of the study. You can read more about how the ADAPTABLE consent was designed by Duke Clinical Research Institute’s Program for Empirical Bioethics, headed by Co-Investigator, Laura M. Beskow, MPH, PhD.

ADAPTABLE Advances Groundbreaking Patient Engagement Model

February is ADAPTABLE’s time to shine.

The groundbreaking pragmatic clinical trial coordinated by the Duke Clinical Research Institute, ADAPTABLE is comparing the effectiveness of two different daily doses of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease. The study is funded through a PCORI grant and is the first demonstration project being conducted by PCORnet.

The study is embracing a new paradigm of patient engagement in clinical research. The ADAPTABLE patient partners, Adaptors, work alongside researchers in all aspects of the trial, including designing the protocol, consent form, study portal, and study materials, to ensure that the patient voice is incorporated into the study.

ADAPTABLE celebrated February’s Heart Month via its unique partnerships and patient engagement channels, most notably Facebook and its patient partners. The team held its second Facebook Live event and also participated in a national art project that celebrates clinical trial participants. Both were fantastic opportunities to engage with the community and spread awareness of the unique and innovative elements of ADAPTABLE.

Facebook Live Event

On February 13 the study team hosted its second Facebook Live event, broadcast live from Duke. DCRI’s Matthew Roe, MD, MHS, ADAPTABLE Co-Principal Investigator, moderated the event and was joined by DCRI’s Schuyler Jones and Daniel Munoz, MD, MPA from Vanderbilt University Medical Center. Clifton Walker, an ADAPTABLE participant who has heart disease and who is followed in the Duke Cardiology Clinic by Dr. Roe, shared his journey with heart disease and why he believes ADAPTABLE is important to finding the right dose of aspirin.

The event’s objective was to raise awareness of ADAPTABLE and how it is transforming clinical research with unique patient partnerships and innovative enrollment, recruitment, and retention strategies. Watch the video in case you missed the live event.

The team promoted the event to the ADAPTABLE community and beyond using a “social media kit” approach. The kit contained suggested tweets, Facebook posts, and images for organizations, networks, sites, and individuals to easily share on their channels. Immediately after the event, the video had 1.6K views. At the time of this article, the video has had more than 4.5K views with a reach of more than 20K people.

The first event, broadcast from AHA Scientific Sessions in November 2016, garnered 6.3K views with a reach of 30K people and featured Dr. Roe alongside an ADAPTOR, Ken Gregoire, from New Orleans.

These Facebook Live events, coupled with active Facebook and Twitter accounts for the ADAPTABLE trial, provide a robust and innovative way to connect with patients, clinicians, and the broader community and serve as a model for future patient-centered studies.

Hero’s Journey Art Piece

To showcase the tremendous patient engagement in ADAPTABLE, in January and February the study team coordinated participation in the Hero’s Journey art project. Sponsored by Eli Lilly, the national art project involves more than 1,000 participants and is intended to honor clinical trial participants and raise awareness of clinical trials.

ADAPTABLE’s patient partners, in conjunction with Health eHeart Alliance, crafted the quote “Better health outcomes for all when patients partner with researchers” to represent their involvement in clinical research.

The brick will become part of an eight-foot tall, egg-shaped, lighted sculpture (see photo below) that will tour the U.S. before Eli Lilly installs them permanently.

“ADAPTABLE is a best-in-class example of how the DCRI is at the leading edge of trials that incorporate meaningful patient engagement,” said Holly Robertson, PhD, ADAPTABLE project lead. “It’s exciting to be a part of a study that is transforming clinical research.”

Partnerships to Improve Clinical Research

In addition to using social media to reach patients, the study team is developing collaborations with the American Heart Association (AHA) and American College of Cardiology (ACC) to generate study awareness and education among patients with heart disease and the healthcare providers that treat them.

“ADAPTABLE has unique collaborations with patients, clinicians, health systems, and professional associations in a way that has never been done before on such a large scale in cardiovascular research,” said Co-Principal Investigator Matthew Roe, MD, MHS. “ADAPTABLE is truly a signature study in how collaborations can improve the conduct of clinical research.”

AHA will continue to feature ADAPTABLE through their social media channels and support future Facebook Live events. At the March ACC Scientific Sessions, the ADAPTABLE team will host a panel discussion in the Patient Engagement Pavilion. Two ADAPTORS, Henry Cruz and Tom McCormick, will be on the panel, joined by Drs. Robert Califf, Eileen Handberg, Sandeep Jain, and Fred Masoudi. Dr. Roe will moderate. The panelists will focus on informing conference attendees about the benefits of patient-centered research and how partnering with patients can lead to better research questions and protocols, and ultimately better outcomes for all.