Category Archives: News

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.

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.

An Aspirin a Day—But What’s the Best Dose?

In a new PCORI blog post recognizing American Heart Month, research partners Adrian Hernandez and Henry Cruz describe the progress and strengths of the ADAPTABLE Study. ADAPTABLE aims to improve the health of people with heart disease, but also to show what’s possible when you have an engaged community using a resource such as PCORnet for doing large pragmatic trials that answer important questions. Check out this blog to learn what’s happening with the patient-centric, aspirin dosing ADAPTABLE Study and what’s possible when researchers and patients collaborate.

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

Facebook Live Broadcast: What is the Optimal Dose of Aspirin for Patients with Heart Disease?

In conjunction with The American Heart Association  2016 Scientific Sessions and REACHnet CDRN Health in Our Hands Network,  ADAPTABLE will be live on Facebook on November 15 at 10:15 CST. Co-Principal Investigator, Dr. Matthew Roe, and patient participant, Ken Grigoire, will answer your questions about ADAPTABLE, a study that seeks to understand what is the optimal dose of aspirin for patients with heart disease.

facebook-live-broadcast

The ADAPTABLE study is being presented to fellow clinicians, researchers and scientists attending Scientific Sessions, Nov. 12th – Nov 16th in New Orleans. #AHA16 is the leading cardiovascular meeting in the country with more than 17,000 professionals attending annually. The scientific programming is designed to improve patient care by providing a forum for researchers and scientists to share significant advances in prevention, diagnosis and treatment of cardiovascular disease from different perspectives. www.scientificsessions.org.

Join us on November 15 at 10:15 CST for the LIVE Q&A by visiting: www.facebook.com/events/363697957306812/