November 18, 2020

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

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.”