April 9, 2018 – An analysis of data from the PALM study suggests there may be a better way to reach underrepresented populations.
To help boost patient participation in clinical trials, researchers have developed a video-based consent tool to help reach populations that might not otherwise enroll.
When potential participants in the PALM (Patient and Provider Assessment of Lipid Management) study used video consent rather than traditional text, participating sites experienced shorter times from site approach to first patient enrollment and had a more diverse group of patients.
“Traditional text informed consent can be challenging for study subjects, including some older adults, minorities, and those with limited literacy,” said the DCRI’s Alexander Fanaroff, MD. “Video puts a lengthy document into the spoken language, and features real people enthusiastically speaking about the study to the viewer. We wanted to see what effect this tool could have on enrollment.”
The study was published recently in Circulation: Cardiovascular Quality and Outcomes.
In 2015, the PALM study enrolled 7,904 patients at cardiology, endocrinology, and primary care clinics across the U.S. to evaluate cholesterol management practices. Sixty-seven of the 153 participating clinics secured institutional review board (IRB) approval to use the tablet-based video — the remaining clinics did not receive IRB approval because of various regulatory barriers.
A single video was used for all of the sites and featured six vignettes totaling eight minutes in length. Modules described research studies in general, the rationale for the PALM study, detailed study procedures, and other core information found in the text version. A prototype was pilot tested at Duke University Medical Center in 2014, and the PALM video consent was built on feedback from that pilot.
Sites that approved video consent were likely to have a central IRB, according to Fanaroff, and tended to be rural and have a smaller number of providers. This meant that video consent could reach patients not always represented in clinical research, and that multiple patients could be enrolled at once.
Fanaroff’s team compared enrollment patterns and participant diversity between sites that did and did not use the video consent tool. They found that sites with video consent capability enrolled the same number of patients as those without – about three per week – but began enrollment 29 days sooner after site approach. More African-American, elderly patients, and those without college degrees were also enrolled at sites with video consent capability.
“There is considerable literature that videos can help patients with understanding and decision-making, but, to our knowledge, this is the first broad-scale use of video consent in a clinical trial,” said Fanaroff. “Video can help patients feel more comfortable with the process, and making it faster and simpler is certainly a win for clinical research.”
Fanaroff said that although more research is needed, the study showed that video informed consent is a promising tool for both the speed of enrollment and making the patient population more representative. “This way, we may be bringing new sites and patients into the fold,” he said.
Study co-authors include the DCRI’s Eric Peterson, MD, MPH; Tracy Wang, MD, MHS, MSc; Shuang Li, MS; Ann Marie Navar, MD, PhD; Vincent Miller; and Laura E. Webb, CCRP.