Category Archives: Pragmatic Research

ADAPTABLE Team Finishes Enrollment, Reflects on Lessons Learned

ADAPTABLE, the first large, pragmatic clinical trial to be coordinated at the Duke Clinical Research Institute, DCRI, recently celebrated a milestone as the trial reached its goal of enrolling 15,000 patients.

Many individuals living with heart disease are instructed to take aspirin to prevent heart attacks and strokes. However, aspirin can cause bleeding in some individuals, and there is no data available that can help physicians decide on the optimal dose to prescribe. ADAPTABLE will compare two different doses—a high dose of 325 mg and a low dose of 81 mg—to determine which is more safe and effective.













Using Real World Data from EHRs

ADAPTABLE, which is funded by the Patient-Centered Outcomes Research Institute (PCORI), is a pragmatic clinical trial, meaning that research is integrated in patient care and leverages technology to alleviate burden on patients and site staff. ADAPTABLE is a demonstration project of PCORnet, the National Patient-Centered Clinical Research network. Forty healthcare systems and three health plans are participating in ADAPTABLE.

ADAPTABLE draws data from electronic health records (EHRs), patient-reported outcomes, and insurance claims data to capture primary endpoints.

“ADAPTABLE is a ground-breaking clinical trial for several reasons, including primarily remote recruitment of patients outside of traditional research clinic settings, direct-to-patient follow-up, and surveillance of EHRs to identify patients for potential enrollment and to ascertain potential endpoints during follow-up,” said Matthew T. Roe, MD, MHS, co-principal investigator for ADAPTABLE. “Via a web-based platform, we conduct outreach to potentially eligible patients to ask them if they’re willing to provide informed consent via an electronic, web-based consent module, which then allows patients to self-randomize into the study. These approaches have never been used before for a large-scale clinical trial the size of ADAPTABLE.”

Viewing Patients as Partners

ADAPTABLE provides a new model of engaging with patients. Patient partners also known Adaptors represent the patient voice at every stage of the study by providing input on study recruitment, contributing to participant newsletters, participating in working groups, and presenting on ADAPTABLE at scientific meetings.

Incorporating a group like the Adaptors is reflective of DCRI’s mission to engage all stakeholders with the goal of improving the study participant experience in clinical research. Get to know and learn more about the Adaptors.

“Patients themselves may be the most important and yet underutilized voice in research,” said Adaptor Greg Merritt, of Ann Arbor, Michigan. “The ADAPTABLE Study is a wonderful example of how patients can assist researchers in prioritizing and studying what matters most to a patient who lives with an illness or disease every day. Their insight and perspective can help to uncover new ways to look at old problems.”

Learning Logistics through a Pragmatic Approach

The ADAPTABLE team—researchers, clinicians, and patients alike—has learned many lessons through the enrollment period of the first large pragmatic clinical trial conducted at the DCRI.

First and foremost, the researchers learned that collaboration between diverse organizations is critical in reaching a goal as large as 15,000 participants.

“Using novel tools and techniques, we are transforming how patients are identified and recruited for clinical trials,” Holly Robertson, PhD, project leader for ADAPTABLE, said. “We also developed strategies for clinician and patient engagement which are important in supporting recruitment and retention for virtual trials.”

The study team also shared that when recruiting patients, it is beneficial to contact potential participants through multiple modes of communication: online, by phone, through the mail, and in person.

“The ADAPTABLE study has encouraged increased collaboration and inspired us to work together to solve new interesting research challenges using a pragmatic approach,” said Schuyler Jones, MD, co-investigator for ADAPTABLE.

Click here for the complete article on DCRI.

Top Lessons Learned from ADAPTABLE Patient Partners

Leer este artículo en español.

ADAPTABLE patient partners, also known as Adaptors, provide input to the study team at every critical step in the research process. Adaptors are passionate about patient-centered research and draw on their personal work and life experiences to improve the study participant experience for current and future research participants. In this issue, we asked the Adaptors to share their top lessons learned from their experiences in ADAPTABLE.

  1. Mutual respect between patient leaders and researchers has helped build an engaged & caring community that improves the research experience for all involved.
  2. Our involvement as patient advisors in research is important because it can help our friends and family in the future.
  3. It is harder than we realized to recruit patients for studies like ADAPTABLE. That is why personal involvement from study participants is so important.
  4. We are encouraged by the participants who share their personal reasons for enrolling in ADAPTABLE and enjoy reading their stories.
  5. Patients have valuable insights about study procedures and how to address challenges. ADAPTABLE is truly an authentic patient-centered study!
  6. We learned researchers can be fun and are real people.
  7. Patient involvement in the beginning of a study can make a friendlier and better study.
  8. Patients shaping study communications has helped to engage our study community.
  9. Being involved in Adaptable has made us feel more empowered and proactive with our own healthcare. We hope this is also true for study participants.
  10. Patients and researchers need to be connected. Patient advisors can help researchers keep patients at the center of research by refining the research questions. The answers to these questions may help improve your quality of life.
  11. A good facilitator or liaison is crucial in helping guide and direct communications between the patient advisors and researchers. Study research budgets should account for the role of a facilitator.

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:

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.

ADAPTABLE Reaches Enrollment Milestone of 5,000 Participants

Enrollment for the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study has reached 5,000 participants. With its coordinating center based at the Duke Clinical Research Institute, the ADAPTABLE study is a large three-year pragmatic trial assessing two different doses of aspirin – 81mg and 325mg – to evaluate which dose is more effective for patients with cardiovascular disease.

“The ADAPTABLE team is excited to have reached the milestone of 5,000 patients enrolled,” said Matthew Roe, MD,  co-PI of the study. “The lessons learned from this groundbreaking trial will have a significant influence on future clinical trials that will be focused on less costly, more effective approaches for answering important clinical questions.”

Funded through a Patient-Centered Outcomes Research Institute (PCORI) award, the ADAPTABLE study is the first demonstration project to be conducted through PCORnet – the National Patient-Centered Clinical Research Network. ADAPTABLE represents the next generation of clinical trials, referred to as pragmatic trials, which leverages electronic health records to screen and enroll patients, significantly reducing the cost required to perform clinical trials.

Reaching the milestone of 5,000 enrolled participants between April 2016 and October 2017 with significantly fewer sites than traditional trials, the ADAPTABLE study has successfully demonstrated the power of the PCORnet system in enrolling patients quickly and at a lower cost to address important clinical questions.

“ADAPTABLE is pivotal for what’s possible for pragmatic clinical trials and real world evidence,” said Adrian Hernandez, MD, vice dean for clinical research, Duke University School of Medicine and co-PI of the study. 

DCRI’s Holly Robertson, Lisa Berdan, and Tyrus Rorick lead the ADAPTABLE study’s operational team.

“What makes ADAPTABLE special is that we are a patient-centered trial with patient partners who work closely with clinicians and researchers on all aspects of the trial,” said Robertson, PhD. “We are also building a patient community that fosters open communication between enrolled participants and the research team conducting the trial to break down the barriers between individuals who work in clinical trials and the people the studies are intended to help.”​

Congratulations to the ADAPTABLE team for reaching this important landmark!

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.

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 Study Reaches 1,000 Participant Milestone

On January 25, 2017 the ADAPTABLE Study randomized its 1000th  patient, an accomplishment resulting from patient partners, researchers, and clinicians coming together to “think big.” Reaching this milestone demonstrates the power of using novel ideas and creative collaborations to reach and engage participants.

The ADAPTABLE study will enroll and follow as many as 20,000 participants with heart disease as it seeks to understand what the optimal dose of aspirin is to prevent the occurrence of a future heart attack or stroke. While answering an important clinical question, the study team is simultaneously providing an innovative approach to conducting pragmatic clinical trials. Using electronic health records from participating health systems, eligible patients will use a web-based portal to self-consent, self-randomize and report data without the need for in clinic visits. In addition, electronic health information captured during routine care will be used to identify events that will provide researchers with additional health outcomes data to inform better decision-making.

ADAPTABLE is advancing patient-centered research with patients as architects of change. We invite you to meet the Adaptors, the study’s patient partners who are integral to the ADAPTABLE study team. Adaptors have participated in all aspects of the study including designing the patient portal, reviewing study materials, and actively participating in study meetings.  The Adaptors will also play a role in disseminating study updates and results to other patients and in the community.

Adaptors participating in study’s kick-off meeting.

ADAPTABLE continues to approach clinical trials differently and more efficiently and in doing so is changing the landscape of clinical research. Recently, the innovation of the ADAPTABLE study with its virtual enrollment and follow-up was recognized with a Best Practices Award by Clinical Informatics News. You can read more about this award here.

The ADAPTABLE study team will continue to pioneer and share large-scale pragmatic recruitment and patient engagement approaches. Follow the study and its journey to transform clinical research on Twitter and Facebook and mark your calendars for the next Facebook Live event on February 13, 2017 at 11:30 EST.

Duke Clinical Research Institute is the Coordinating Center for ADAPTABLE with Doctors Adrian Hernandez and Matthew Roe as the study’s Co-Principal Investigators. The Operations Team is led by Holly Robertson, Lisa Berdan, and Tyrus Rorick.

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.


2016 Year in Review: An Opportunity to Reflect on Highlights and Groundbreaking Accomplishments

As the year comes to a close, the ADAPTABLE Study team would like to wish everyone a
happy, healthy, and safe holiday and all the best in the New Year. This year has been a memorable year for ADAPTABLE and we would like to take a moment to reflect on accomplishments during 2016, several of which were groundbreaking and could not have been achieved without the hard work and dedication of our patient partners, clinicians, researchers, and study leaders.

ADAPTABLE Kick-Off Meeting

One of the highlights for many ADAPTABLE team members was the opportunity to meet in person and to interact with our patient partners at the ADAPTABLE Post Enrollment Kick-off Meeting. Watch this video for an inside glimpse of the meeting.

We hope that you join us in celebrating the many successes of 2016: Continue reading 2016 Year in Review: An Opportunity to Reflect on Highlights and Groundbreaking Accomplishments