PREVENTABLE

PCORnet®-Supported PREVENTABLE Study Achieves 2K Participant Milestone Leveraging Pragmatic Lessons from the Network

Posted on by Jodi Snare

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.”

Clinical Trials In The Era Of COVID-19: How PREVENTABLE’s Pragmatic Design Is Helping It Power Through The Pandemic

Posted on by Jodi Snare

With shelter in place and travel bans disrupting traditional clinical research, many teams are adopting new strategies to keep patients safe and studies progressing throughout the COVID-19 pandemic. But PREVENTABLE, a study using the PCORnet® infrastructure to investigate whether taking a drug commonly used to lower cholesterol can help adults aged 75 and older prevent dementia, disability, and heart disease, needed no such overhaul. That’s because it was designed pragmatically from the start, a strategy that gave it the flexibility to weather the pandemic with minimal disruption.

“With PREVENTABLE, we are recruiting 20,000 patients aged 75 or older who we know have common barriers to participation in clinical trials like transportation obstacles, caregiver burden, and medical concerns,” said Schuyler Jones, who is helping lead the recruitment core for the study. “Designing the study in a way that makes research participation easier and more efficient for these participants was a top priority for us. When the pandemic hit and all of these barriers were exacerbated, we were ahead of the curve. There were very few areas to facilitate participation that we hadn’t already thought through on the front end.”

PREVENTABLE had to make only one amendment in response to COVID-19: adding a telehealth option to a previously required on-site visit. The rest of the study was already designed to make participation easy. For example, participants are identified and invited to be a part of the study via PCORnet and the VA Network, both of which have strong ties to the 75-plus community. Researchers then follow participants by phone visits, using electronic health records, the PCORnet Common Data Model, and Medicare data. The study drug is shipped directly to patients’ homes every three months, making participation especially appealing to older adults.

PCORnet as a resource for pragmatic success

PCORnet is central to the PREVENTABLE study’s pragmatic design. Thirty-two of the trial’s sites are affiliated with PCORnet Network Partners, and as the study moves ahead with site activation and enrollment, these relationships and PCORnet’s established infrastructure are key.

“We think of our PCORnet sites as the massive C-5 transport planes of PREVENTABLE,” said Karen Alexander, a principal investigator for PREVENTABLE, referring to the aircraft the U.S. military relies on for carrying large loads. “Once they leave the runway and take off, they will carry a tremendous proportion of our study’s participants and give us a lot of momentum toward successful completion of this research.”

Few studies are focused exclusively on participants aged 75 or older, making PREVENTABLE’s research important to this community. Statins, which are taken by nearly half of Americans who are over the age of 75, have been shown to reduce the risk of cardiovascular events for some patients, but we don’t yet know whether they are helpful for older adults without heart disease.

While PCORnet-affiliated sites and data resources are important aspects of PREVENTABLE, so too is the expertise embedded in the PCORnet community. The study is tapping lessons learned and strategies that proved successful in ADAPTABLE, a PCORnet-enabled pragmatic study of aspirin dosing in individuals with heart disease. These lessons have informed PREVENTABLE’s recent outreach efforts to boost enrollment, including mention in a newly published New York Times article, AARP publications, and local senior guides. In response to feedback that the 75-plus community wanted endorsement of the study by their trusted general practitioner, the PREVENTABLE team has worked to make contact with physicians in advance of visits from potential participants.

“Good pragmatic research is about showing effectiveness of an intervention in real-world clinical practice among broad patient groups, and that requires us to meet patients where they are and be flexible and anticipatory to their needs,” said Jones. “Many of the strategies we are deploying with PREVENTABLE can help fortify research protocols, not only to safeguard them in a pandemic, but through any disruption.”