A pragmatic study of the effectiveness of statins in adults aged 75 or older without known cardiovascular disease has successfully randomized the first 2,000 participants in partnership with PCORnet®, the National Patient-Centered Clinical Research Network. The study, known as Pragmatic Evaluation of Events and Benefits of Lipid-Lowering in Older Adults (PREVENTABLE), builds on past Network success in pragmatic approaches for clinical study design, including the highly lauded ADAPTABLE study of aspirin dosing in 15,000 patients with heart disease.

“Few studies are focused exclusively on participants aged 75 or older, in part because recruitment in this population is historically challenging,” said Schuyler Jones, who is helping lead the recruitment core for the study. “But insights into this population are also critically important—these are our friends, neighbors, parents and grandparents, and answers to research questions are central to their quality of life. Tailoring a trial to meet their needs is key, and as a large, nationally representative network with proven expertise in pragmatic trials, PCORnet is a huge asset in helping us achieve that goal.”

Bringing the ADAPTABLE approach to a harder-to-recruit patient population

The PREVENTABLE study is important because nearly half of Americans aged 75 or older take statins to reduce risk of cardiovascular events, but we don’t yet know if statins are helpful for older adults without heart disease. To find out, PREVENTABLE will enroll 20,000 participants, whom the team is engaging through a similar pragmatic design as the PCORnet-enabled ADAPTABLE study. Specific approaches carried forward from ADAPTABLE to make participation easier include:

• Embedding research in the health care system by enrolling patients in their usual care settings and in partnership with their primary care clinicians;
• Engaging potential participants during screening and recruitment by using informational videos, panel discussions with research participants, and an e-consent platform; and
• Pairing electronic health record data with other forms of follow-up, including calls and in-person visits for cognitive and functional assessments, to ensure complete collection of outcomes.

However, several aspects of PREVENTABLE make recruitment more challenging than ADAPTABLE. For instance, while ADAPTABLE looked at patients with known heart disease, PREVENTABLE participants do not have known heart disease and thus have fewer medical visits to facilitate recruitment. Because they are not ill, they may also be less motivated to join a study. Finally, PREVENTABLE’s recruitment effort is in the midst of the COVID-19 pandemic, which has disproportionately affected older adults and perhaps made them hesitant regarding trial participation.

“I have been proud of the study team’s efforts to pivot in response to these challenges and find novel ways to engage patients, whether that is in the clinic, in community centers, or on the pickleball court,” said Jones. “Slowly, but surely, we are bringing more participants into the fold, and we are tasked with enrolling our first 5,000 patients by August 2022. At the end of this study, we will have amassed a huge amount of knowledge around what it takes to recruit older participants for research, which will support future efforts to seek insights into this important, but vastly understudied population.”