Category Archives: Pragmatic 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.

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

ADAPTABLE Study Kick-Off Meeting: Determining the Path Forward for ADAPTABLE and Pragmatic Research

Patient engagement and patient-centricity are hot topics in clinical research and study teams are trying creative approaches to involve patients in the research process. These teams can look to the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial as an emerging model for patient engagement in randomized trials. Patient leaders, study investigators, and operations and research staff gathered together on October 28, 2016 in Washington D.C. to discuss ideas and strategies for making this novel, pragmatic study a success.
adapt-study

Continue reading ADAPTABLE Study Kick-Off Meeting: Determining the Path Forward for ADAPTABLE and Pragmatic Research

Researchers Discuss How ADAPTABLE Can Transform the World of Clinical Trials

Duke Clinical Research Institute researchers discussed how one of the largest pragmatic clinical trials in history has the potential to transform clinical research at this year’s annual meeting of the Drug Information Association (DIA) in Philadelphia. The DIA meets every year to bring together key thought leaders and innovators from across all disciplines involved in the discovery, development, and life cycle management of health care products.

Adrian F. Hernandez, MD, MHS, Director of Health Services and Outcomes Research, and Lesley Curtis, PhD, Director of the Center for Pragmatic Health Systems Research, spoke during separate sessions about their progress with the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) study.

Continue reading Researchers Discuss How ADAPTABLE Can Transform the World of Clinical Trials

ADAPTABLE: Answering an Important Clinical Question while Testing a New Approach to Conducting Pragmatic Clinical Trials

In April, Ty Rorick and Lisa G Berdan of the ADAPTABLE Coordinating Center at Duke Clinical Research Institute (DCRI) visited the Research Action for Health Network (REACHnet) team. “REACHnet has developed a very clever way of using tablets in some of their clinics to help reach potential participants previously identified using the computable phenotype. They have just enrolled their first ADAPTABLE patient and we’re very excited to see how tablet technology can help engage participants early in the screening process” said Lisa G Berdan, Director, DCRI Global Cardiovascular Outcomes Trials.

In this feature of Ask ADAPTABLE, Beth Nauman, Research Director at REACHnet, shares the network’s role in the National Patient-Centered Clinical Research Network (PCORnet) and ADAPTABLE.

Continue reading ADAPTABLE: Answering an Important Clinical Question while Testing a New Approach to Conducting Pragmatic Clinical Trials

PCORnet Announces Enrollment of First Participant in ADAPTABLE Aspirin Study

Patient-centered comparative effectiveness trial uses electronic health records to recruit participants.

PCORnet, the National Patient-Centered Clinical Research Network

www.pcornet.org

FOR IMMEDIATE RELEASE on Wednesday, April 27, 2016

Washington, D.C. – PCORnet, the National Patient-Centered Clinical Research Network today announced enrollment of the first patient in its ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) study, 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. Pragmatic trials are designed to reflect “real-world” medical care by recruiting broad populations of patients, embedding the trial into the usual healthcare setting, and leveraging data from health systems to produce results that can be readily used to improve patient care.

“PCORnet is shifting the research paradigm through studies like ADAPTABLE by introducing a new genre of patient-centered research where patients are engaged to improve the science of clinical trial design,” said Adrian F. Hernandez, MD, MHS, director of outcomes and health services research at the Duke Clinical Research Institute (DCRI) and PCORnet’s Coordinating Center Co-Principal Investigator. Continue reading PCORnet Announces Enrollment of First Participant in ADAPTABLE Aspirin Study

Novel New Study Could Finally Hold Answers to Questions about Aspirin Dosing

In CardioSource WorldNews, doctors Robert Harrington, Matthew Roe, and Adrian Hernandez discuss ADAPTABLE’s novel study design and the impact of the results for patients and their caregivers. 

“We are striving to answer an important clinical question that interests both patients and providers in a highly efficient way that takes advantage of data that is already being collected as part of routine care,” says Robert A. Harrington, MD, co-chair of ADAPTABLE. “It’s truly better integrating research into clinical practice and helping in the construct of the learning health care system.”

Another highlight of ADAPTABLE is that it includes patient involvement every step of the way.  According to Matthew Roe, MD, MHS, FACC, co-principal investigator for the trial, the trial includes targeted electronic outreach and electronic follow-up with patients in order to ultimately provide answers to questions like ‘How much aspirin should be taken each day to reduce risks of heart attack or stroke’ and/or ‘Do benefits and risks differ based on dose, health, age or other circumstance’?  Patient engagement is a key and defining aspect of this trial.

“We’re excited to be part of the first trial conducted through PCORnet which is a national research network that unites patients, clinicians, health systems and electronic health records to improve patient-centered outcomes,” said Adrian F. Hernandez, MD, MHS, FACC, director of outcomes and health services research at the Duke Clinical Research Institute and PCORnet’s Coordinating Center Principal Investigator. “Heart disease is the leading cause of death for men and women in the United States. The results of this study will help patients and those who care for them make better decisions about how aspirin therapy might be most helpful and ultimately could prevent as many as 88,000 death per year worldwide.”

Access the complete article (subscription required).

 

Adapting Good Clinical Practice Guidelines to Pragmatic Clinical Trials

An article published in Circulation by a group of authors from the Duke Clinical Institute, some of whom are investigators and leaders in ADAPTABLE describes tensions between pragmatic clinical trial design and Good Clinical Practice (GCP) guidelines, which were established in 1996 to help ensure the safety of participants in clinical trials and the validity of trial findings. Pragmatic clinical trials (PCTs) such as ADAPTABLE are designed to test interventions in real-world settings and populations rather than under highly controlled conditions, and thus rely on simplified procedures, such as those used for screening, informed consent, and participant follow-up. Continue reading Adapting Good Clinical Practice Guidelines to Pragmatic Clinical Trials