Category Archives: Clinician Engagement

Importance of Diversity in Clinical Research

The main phases of a clinical research study include: 1) identification and recruitment of study participants, 2) data collection and monitoring, 3) analysis of study results, and 4) distribution of study findings. ADAPTABLE team members are currently focused on the first two phases. In this article, we explore why it is important that people of different ages, races, ethnic groups, and genders are included in clinical trials.

How Does Who you are Impact Your Risk for Disease?

Sex, age, race, and ethnicity all play an important role in how different diseases, medicines, and treatments affect people. For example, the American Heart Association (AHA) states that the prevalence of high blood pressure in African-Americans is the highest in the world. African-Americans are disproportionately affected by obesity and more likely to have diabetes than non-Hispanic whites. The Centers for Disease Control and Prevention (CDC) estimates that for American Indians/Alaska Natives and Asian Americans/Pacific Islanders, heart disease is second only to cancer. Heart disease affects women as much as men, but symptoms and the warning signs for women aren’t the same as in men.

Despite what is known about how certain groups of people may respond differently to disease; traditionally, the majority of cardiovascular clinical research study participants are white men. Increasing diversity in clinical research studies is a priority for the Food and Drug Administration and the ADAPTABLE team in making sure results provide evidence that is relevant and helpful to a wide range of people. Diversity in clinical research studies helps ensure that the results will have an impact on the people the study is intended to help.

How Can Researchers Work to Improve Diversity in Clinical Research?

So how do researchers work to ensure representation from a range of participants in clinical research studies? The short answer is education, trust, partnership, and access.

Providing Education: Too often people who choose not to participate in trials say that they lack information. Providing educational resources about clinical research—what it is, why it is important, and how to participate—is a good first step to filling this information gap and increasing participation of underrepresented groups. To be effective these resources must be written in plain language, culturally appropriate, and available in local languages.

Establishing and Building Trust in Communities: Lack of trust in clinical research by minority groups continues as a reason individuals decline participation in trials. PCORnet, the National Patient-Centered Clinical Research Network, is leading a shift in its approach to clinical research from the traditional sense of work that is done to the community to work that is done with the community. PCORnet has hosted events focused on fostering trust in clinical research and provides patients, caregivers, and others opportunities to partner with researchers to improve the clinical research process.

Involving patients as partners: By sharing their experiences on what it’s like to live with a disease, thoughts on treatments, and what research topics are most important, patients can make a significant impact on all aspects of clinical research, from the design of the study to the dissemination or sharing of the results.  In ADAPTABLE, a diverse group of patient partners called the Adaptors are integral team members who are passionate about representing and reflecting the best interests, concerns, and welfare of potential, current, and future clinical research participants.

ADAPTABLE team members frequently participate in community health fair events to provide information about clinical research, the ADAPTABLE study, and heart-health awareness. These events provide opportunities to engage with people, to make personal connections, and build trust with community members.

Jacqueline at a local health event talking about ADAPTABLE and heart health.

As a woman of color and a heart disease patient, Adaptor Jacqueline Alikhaani, is passionate about using her personal health experiences to not only heighten awareness of patient-centered research, but to enhance diversity in clinical trials. “One of the biggest advantages we have with ADAPTABLE is the diversity of the Adaptors team. We have women, men, and people from different races, ethnic, and socioeconomic backgrounds. We are bringing a wealth of experiences to help shape the design and direction of the study,” says Jacqueline. You can learn more about Jacqueline and how she serves as an architect of change in spreading the word about the role of patients in research and increasing minority participation in clinical research.

 Providing access to research: When designing a clinical trial, researchers plan to have study sites spread across the country and located in racially diverse communities to increase participation from everyone. ADAPTABLE enrolls participants from large health systems that are part of PCORnet’s Clinical Data Research Networks.

Want to learn more?

 If you are looking for general information about clinical research or resources about diversity in clinical research, check out the following resources:

Center for Information & Study on Clinical Research Participation

Minorities in Clinical Trials Fact Sheet

Engagement in Research

 

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.

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/

 

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

The Role and Importance of the Clinician in ADAPTABLE

In this feature of Ask ADAPTABLE, Dr. Schuyler Jones, an investigator with the Duke Clinical Research Institute Coordinating Center, discusses the role and importance of the clinician in the ADAPTABLE study.

Q: What is the role of the clinician in ADAPTABLE?

SJ: The role of the clinician in ADAPTABLE is that of support. Patients, especially older patients, like to hear about and discuss participation in clinical trials with their clinicians. We hope that clinicians will be able to answer questions, confirm eligibility, and validate that participating in ADAPTABLE may be of benefit to their patients. We expect that clinicians will be aware of ADAPTABLE and discuss the benefits and attributes of the study:

  • Low-risk study for the participant
  • Answers an important clinical question
  • Defines an effective model for the conduct of clinical research

Watch this video to learn more about the role of clinicians in ADAPTABLE and how clinicians can be ADAPTABLE champions.

Q: What types of challenges do clinicians face in clinical research and how can studies like ADAPTABLE help? Continue reading The Role and Importance of the Clinician in ADAPTABLE

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

ADAPTABLE Presented to the American College of Cardiology Board of Governors

ADAPTABLE physician leaders Robert Harrington and Matthew Roe along with operations team leaders Lisa Berdan and Tyrus Rorick presented ADAPTABLE to the American College of Cardiology (ACC) Board of Governors (BOG) on April 1, 2016 during the annual ACC scientific sessions. The ACC BOG is the grassroots liaison organization that represents the local state ACC chapters within the ACC headquarters. Their presentation generated a thoughtful discussion about the goals and objectives of ADAPTABLE.  The BOG members expressed uniform support in communicating the importance of ADAPTABLE to local chapter leaders and local ACC state members and constituents to raise awareness of the trial among cardiologists across the United States. The ADAPTABLE team committed to providing the BOG with study updates, to connect local chapter leaders with the leaders of ADAPTABLE at the participating CDRNs and health care systems, and to work together with the BOG to facilitate the widespread dissemination of information about ADAPTABLE to the cardiology community.  

 

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