2019 Annual Report: A Pragmatic Approach to Benefit an Understudied Population

A new DCRI-led pragmatic clinical trial conducted in partnership with the Wake Forest School of Medicine will assess the effectiveness of statins in patients aged 75 or older.

Statins are known to lower cholesterol and reduce the risk of cardiovascular events for secondary prevention, or patients with known coronary artery disease (CAD), as well as primary prevention, or those without CAD who are at high risk of future cardiovascular events. However, few statin studies in primary prevention populations have included older adults.

PREVENTABLE is the largest pragmatic clinical trial with placebo-controlled drug assignment to date. It is also the first statin trial with a non-cardiovascular primary outcome. Instead, investigators will study whether statins could prolong survival free of new dementia or physical disability—a critical consideration for older adults looking to maintain independence. The study’s secondary outcome will include cardiovascular events as well as mild cognitive impairment.

PREVENTABLE will partner with PCORnet®, the National Patient-Centered Clinical Research Network, and the National VA Network to identify and recruit 20,000 participants aged 75 years or older and without CAD at 100 U.S. sites. Utilization of these two national resources is expected to enable investigators to enroll participants and collect health data faster and more efficiently than a traditional trial. Investigators will also use electronic health records (EHRs) to help ascertain patient outcomes.

The study will be funded over seven years from the National Institute on Aging in partnership with the National Heart, Lung, and Blood Institute and will be led by the DCRI’s Karen Alexander, MD (pictured above).

Karen Alexander, MD, principal investigator for PREVENTABLE, talks through pragmatic elements of the trial that will help investigators answer an important question more efficiently.

PREVENTABLE will use pragmatic elements throughout, including:

  • 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;
  • Pairing EHR data with other forms of follow-up, including calls and in-person visits for cognitive and functional assessments, to ensure complete collection of outcomes; and
  • Simplifying study drug delivery by shipping directly to patients.

This article originally appeared in the DCRI's 2018-2019 Annual Report. View more articles from this publication.