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Taking a Real-Time Approach to Identifying and Enrolling Patients in the ADAPTABLE Study

The Duke Heart Center, the second highest enrolling site in the ADAPTABLE study, recently celebrated a milestone with more than 1,000 patients enrolled. In this article, the team shares how they leverage their electronic health record (EHR) system to streamline the screening process for this pragmatic study designed to answer what is the best daily dose of aspirin for patients with heart disease.

The ADAPTABLE Duke Heart Center Team

They start by designing a report based on ADAPTABLE’s eligibility criteria. From this customized report, study coordinators receive a list of patients who have been automatically screened for the upcoming clinic day. Designed to minimize coordinator effort in identifying eligible patients, study coordinators use the list to confirm eligibility, remove any patients who have previously declined, and take note of the patient’s clinic appointment time so that a “Golden Ticket” can be delivered to clinicians to pass on to their eligible patients. A golden ticket is in invitation to eligible study participants to further explore and enroll in ADAPTABLE.

How is this daily list created? The customized report is run against EHR data available at ADAPTABLE Column in a EHR Multi-Provider Schedulethat moment (real time) to identify potential patients – as opposed to the previous process of querying the PCORnet Common Data Model (CDM), which is a much more static process of organizing EHR data. Once the EHR identifies the patients and associates them to the ADAPTABLE protocol, a rule is implemented and a new field named “ADAPTABLE” (see image to the right) is populated in the multi-provider schedule column that providers see. This column is effectively a flag so providers can readily recognize when a patient is eligible for ADAPTABLE. This is especially helpful since many providers use this screen as their clinic ‘home’ screen.

Leveraging the EHR in this way has provided research staff with a near real-time view of eligible patients in their clinic and has allowed for better communication with providers and support staff. Patients identified as potential participants by coordinators can be evaluated for appropriateness by providers before the clinic visit begins, and nurses can remind providers which patients to approach during the day. Using this process has been a successful strategy to identify a larger pool of potential participants as well as providing a more consistent approach to recruitment.

The ADAPTABLE Duke Heart Center team started implementing this process in October 2017. Since then the team has seen an increase in eligible patients on the daily clinic lists compared to the former CDM system. Between November 2017 and March 2018, 65% of patients enrolled were a result of this process. This number reflects both enrollments in clinic and patients self-enrolling from home.

Effectively using EHRs as a recruitment strategy requires transparency and communication with clinicians. Before implementing a new EHR study identification and recruitment process, the team recommends that clinicians are informed about the study and process. Although pragmatic studies are intended to reduce clinician and coordinator effort, the role of clinicians and research staff in ADAPTABLE remains critical. Patients want to hear about study opportunities from their doctors and doctors welcome the opportunity to discuss participation in research with their patients.

Finding ways to make research more practical is what ADAPTABLE and pragmatic clinical research is all about. Using EHRs in ADAPTABLE integrates conversations about participation into the clinical work flow, helping both clinicians and patients become more aware of the research question, and better understand if participation is the right choice.

ADAPTABLE Study Team Shares Patient Engagement Experiences in CardioSmart Pavilion at American College Cardiology Conference

Jacqueline Alikhaani, a rare disease heart patient and partner on the ADAPTABLE Study, is passionate about the value and impact of novel clinical research studies. Alikhaani is especially passionate about studies that leverage electronic health records and common data resources, and includes patient input at every critical step in the process. “One of the special things about the ADAPTABLE Study is that everything is laid out on the table for patients to see. We touch every part of the trial. I think we’re going to be a great model for other clinical trials,” said Alikhaani.

For the second consecutive year at the American College of Cardiology annual conference, patient partners, clinicians, and researchers discussed the patient-researcher partnership in the ADAPTABLE Study. ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and long-Term Effectiveness) is a pragmatic clinical trial that compares the effectiveness of two different daily doses of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease.

The panel presentation supported by CardioSmart included Alikhaani as well as another patient partner Bill Larsen; researchers Eileen Handberg and Daniel Munoz; and project leader Holly Robertson. Principal investigator Schulyer Jones moderated the session.

Eileen Handberg, Dan Munoz, Bill Larsen, Jacqueline Alikhaani, Holly Robertson, and Schuyler Jones

Larsen was introduced to ADAPTABLE through his work as a citizen scientist at the University of Florida. Larsen is most interested in reviewing study materials through the lens of a potential study participant. “I try to beat the drum of educating the general population about the importance of participating in clinical research,” said Larsen of his role in ADAPTABLE. Larsen is also looking forward to the day when results will be available and he and his fellow patient partners can help create result summaries using language easily understandable by patients.

Jones reinforced the immense contributions of the patient partners from the beginning of the trial and at every step along the way. He then turned the microphone to Munoz who said, “A lot of assumptions that we come in with as researchers and clinicians have been challenged, corrected, and improved upon by our Adaptors, the ADAPTABLE patient partner team.”

Handberg, who works closely with Larsen at the University of Florida site, explained that ADAPTABLE patient partners are embedded in the clinical research process and hold the research team accountable. “Bill [Larsen] and I are on a weekly call and without fail, Bill will inquire about enrollment and what can we do differently to improve our numbers.” Handberg also described how a successful recruitment postcard (see image at right) came about. “It was a patient-inspired and created piece that has resulted in a positive trend in enrollment.”

ADAPTABLE is funded by the Patient-Centered Outcomes Research Institute (PCORI) and is the first demonstration study of PCORnet, the National Patient-Centered Clinical Research Network. The study employs a wide range of digital and social media channels including a website, Twitter handle, and Facebook page to engage with study participants and the public at large. ADAPTABLE sends out a quarterly newsletter to study participants to introduce team members, provide study progress updates, and seek insights from participants on why they joined ADAPTABLE and the importance of patient-centered research.

“When I think of ADAPTABLE, I think of community,” said Robertson. “We are building a cardiovascular research community that not only includes the patient-partner voice but those of the study participants. Once the ADAPTABLE Study is complete, we’ll have a community of participants who we can engage with for future research projects to find out what’s important to them and what questions do they want answered by research. This community will be the legacy of ADAPTABLE.”

To learn more about the panel presentation, watch this video recap.

Celebrating Your Heart and February

The ADAPTABLE Team is excited for February, a month-long celebration of heart-health awareness. This a great time to think about what is known about heart disease, how heart-healthy choices can make a difference, and the potential impact of the results from the ADAPTABLE Study for patients and their doctors.

Heart Disease

Heart disease is the leading cause of death for American women and men, responsible for one in four deaths in the U.S. According to the Centers for Disease Control and Prevention, someone in the U.S. has a heart attack every 40 seconds, and every year 790,000 Americans have a heart attack. For 210,000 people this is their second heart attack. Unfortunately, once you have had a heart attack, your chance of having another one increases.

The good news is that there are actions you can take to protect your heart. Making heart-healthy food choices, taking prescribed medications, starting or following a regular exercise routine, having regular check-ups, and working with your physician to achieve your heart health goals are all important steps to help prevent another heart attack. Check out the resources listed at the end of this artcle to learn more.

Joining Forces in the ADAPTABLE Study

Daily aspirin is one of the medications doctors often prescribe to patients who have heart disease. Doctors know that the anti-blood-clotting action of aspirin can help prevent the occurrence of a second heart attack. However, the best dose (81 mg or 325 mg) of aspirin is uncertain and is not specified by clinical practice guidelines. To help answer this aspirin-dose question, patients, clinicians, and researchers have joined forces in ADAPTABLE.

ADAPTABLE will enroll and follow approximately 15,000 participants with heart disease who are randomly assigned to take either 81 mg or 325 mg aspirin daily. In addition to determining the best aspirin dose, the study will evaluate the overall benefits and side effects of the different aspirin doses by gender, age, ethnicity, race, and the presence of additional medical conditions, such as diabetes.

Impact of ADAPTABLE Study Results

The ADAPTABLE Team is committed to providing study participants, individuals living with heart disease, clinicians, and the public with study updates and results. These results will help patients with heart disease and their doctors answer questions about aspirin therapy such as:

  • How much aspirin should I take each day to reduce my risk for a heart attack or stroke?
  • Do the benefits of taking aspirin every day differ based on the dose?
  • Do the risks, such as bleeding, differ based on the dose?
  • Based on my health, age, and presence of other medical conditions, what is the best dose to protect my health?

We hope that your February is filled with heart-healthy choices and activities. Follow ADAPTABLE on Twitter @ADAPTABLEstudy and on Facebook where we will share heart-healthy recipes and tips for healthy living.

Heart-Healthy Resources

American College of Cardiology CardioSmart

American Heart Association (AHA)

AHA Go Red for Women

AHA Support Network

Centers for Disease Control and Prevention

The Heart Foundation

 

 

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.

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