Katie Thomas, MD, assistant medical director for
Intermountain Medical Center, uses e-consent.
Thanks to caregivers teaming up in new and critical ways, patients can now sign up to participate in almost 40 Intermountain research studies anywhere, anytime via electronic consent (e-consent). The new process was essential to allowing research studies to go forward during the pandemic.
Prior to joining a research study, patients must provide consent. In the past, the consent process had to be completed in person. But innovative caregivers have now developed an electronic consent process that meets legal and privacy requirements and is convenient and easy for patients. The new e-consent process is expected to save Intermountain more than $13.3 million over five years, while offering improved safety, access, and a better patient experience.
“Our research IT, Care Transformation Information Systems (CTIS), and precision genomics teams came together to make e-consent a reality,” says Lincoln Nadauld, MD, PhD, chief of precision health and academics. “We started with face-to-face consenting and that has been successful. But in a digital world and with a pandemic pushing people to stay home—we knew we needed electronic consenting capabilities.”
Pulling together such a big project that would reach hundreds of thousands of Intermountain research participants was no easy feat.
“It required a lot of hard work at the very front line,” Dr. Nadauld says. “We needed our HerediGene team to work closely with our CTIS team. We needed to work closely with our communications teams. It was a team of teams to come together and make this a reality.”
Pallavi Ranade
Pallavi Ranade, CTIS director of research informatics and precision health, says the teams involved were able to avoid high costs and accommodate large, systemwide studies with limited resources.
“The electronic consent allowed us to keep patients and caregivers safe during the pandemic,” Pallavi says, “It also allowed for rapid deployment of urgent COVID-19 clinical trials, thus making potentially life-saving treatments accessible to our patients. Our challenge was to develop an electronic consenting system that was easy to use, intuitive, robust, and flexible. And I’m happy to say we’ve achieved that through creativity, persistence, and teamwork.”
Some clinical trials enabled by e-consenting assessed the safety and efficacy of novel treatments to fight COVID-19. The e-consent system improved patient experience of the consent process by including video, audio, graphics, and an interactive experience for the CorCal Study and HerediGene: Population Study. Plus, patients can learn about and consent to research studies in four languages.
Ben Chisum
“The REDCap web application provided a strong and flexible framework to develop e-consent in an efficient and standard method,” says Ben Chisum, application system technology analyst. “When the pandemic hit, we were able to rapidly develop and deploy multiple simultaneous consents for our clinical trials. The collaboration with our research groups in terms of requirements, along with the increased demand, rapidly enhanced our expertise and efficiency. These advances translated to speedier development, smoother deployment, and ultimately increased cost savings. We couldn’t have accomplished it without tremendous collaboration and contributions from our research teams, regulatory bodies, and leadership.”
Caregivers who helped in the e-consent collaboration include:
- Research IT: Ben Chisum and Anuja Gutal
- CTIS: Pallavi Ranade, small apps team (for ongoing support), and server and storage team
- Clinical Research Teams: cardiovascular, precision genomics, and pulmonary/critical care
- Enterprise analytics
- Office of Research
- Financial analysis: Kurt Witzel
“The best of what Intermountain has to offer is reflected in this success,” Dr. Nadauld says.