PCORnet® will play a major role in the largest pragmatic trial with placebo-controlled drug assignment to date and first statin trial with a non-cardiovascular primary outcome.
PCORnet®, the National Patient-Centered Clinical Research Network, will serve as a key resource for a new pragmatic trial studying effectiveness of statins in older adults without known cardiovascular disease. The National Institute of Aging and the National Heart, Lung, & Blood Institute will support the trial, recently announcing funding of $90 million to bring it to life.
The study, known as PREVENTABLE (Pragmatic Evaluation of Events and Benefits of Lipid-Lowering in Older Adults), will use PCORnet resources and the National Veterans Affairs (VA) Network to recruit 20,000 participants aged 75 or older at 100 U.S. sites. The study will identify outcomes via electronic health records.
PREVENTABLE represents the largest pragmatic trial to date with placebo-controlled drug assignment and the first statin trial conducted with a non-cardiovascular primary outcome. Investigators will instead study whether statins help older adults avoid new dementia or physical disability.
“Few statin studies in primary prevention populations have included individuals aged 75 or older, leaving many unanswered questions for older adults,” said Renee Leverty, program lead for Stakeholder Engagement at Duke Clinical Research Institute (DCRI), which will serve as the coordinating center for PREVENTABLE. “PCORnet and the VA Network are large, national resources with complementary strengths and established ties to the 75-plus community. We expect that this collaboration, combined with the powerful engagement tactics this study will deploy, will allow PREVENTABLE to bring important answers that will help this population make better-informed choices for their health.”
A PCORnet-inspired patient engagement strategy
The PREVENTABLE team will not only leverage PCORnet data resources, but also tap the successful patient engagement strategies deployed by previous PCORnet-enabled studies. For example, beginning in 2015, the ADAPTABLE study used the Network resources to embrace a new paradigm of patient and provider engagement in clinical research, successfully recruiting more than 15,000 participants. PREVENTABLE will use learnings from ADAPTABLE and will involve its DCRI principal investigators, Adrian Hernandez, MD, MHS, and Schuyler Jones, MD, throughout the study. Hernandez also serves as the principal investigator for the PCORnet Coordinating Center. Engagement strategies inspired by ADAPTABLE include:
- Embedding research in the health care system by enrolling patients in their usual care settings and in partnership with their primary care providers.
- Establishing a diverse Participant Advisory Group to give feedback on the protocol, e-consent, understanding the participant journey, recruitment and retention plans, participant experience, patient-reported outcomes, community engagement, and dissemination of results.
- Including Patient Engagement Representative Neely Williams on the PREVENTABLE Steering Committee and other engagement initiatives. Williams served as co-principal investigator on the PCORnet-enabled Bariatric Study and is a member of the PCORnet Steering Committee.
- Ensuring informational videos, recruitment materials, and the study’s e-consent platform have been tested by patients, community groups, and clinicians.
PREVENTABLE will also deploy funded community partner awards, an engagement tactic inspired by the National Institutes of Health’s All of Us Research Program’s Community & Provider Gateway Initiative. These awards will support engagement and retention of participants, who may otherwise be underrepresented. Financial support will be provided to organizations and groups with trusted relationships and demonstrated success in engaging these communities.
PREVENTABLE will be funded over 7 years. More information about PREVENTABLE is available via the National Institute on Aging, the DCRI, and PCORI.