At a recent educational session with GenomeWeb, titled Succeeding With eConsent and Patient Engagement, experts discussed best practices in eConsent and patient engagement drawn from some of the most ambitious research programs to date. Dr. Girish Nadkarni, Irene and Arthur M. Fishberg Professor of Medicine at the Icahn School of Medicine at Mount Sinai spoke about the Mount Sinai Million Health Discoveries Program. And Vibrent CEO, Praduman “PJ” Jain spoke about the collaboration with the National Institutes of Health’s All of Us Research Program.
Overall, research teams should address eConsent and patient engagement from the point of earning trust with participants, meeting them where they are over time, and making processes easy to encourage participation from patients and clinicians alike. Here are some of the highlights from the session.
In his introduction, PJ Jain stressed that patient engagement is not a ‘one and done’ endeavor. It occurs over time, at multiple touchpoints. “Fortunately,” he explained, “digital methods can greatly enhance the participant experience across the length of a study.” He stressed that research programs of all sizes can use what was developed for such large size cohorts at Mount Sinai and for the All of Us Research Program for smaller studies. Digital methods, although not one-size-fits all, are adaptable to different types of studies with varying needs.
Digital health research tools can, for instance, help in engaging and building trust with patients and their families through more personalized engagement. They can simplify data collection for participants, ultimately reducing and in some cases eliminating that burden. They improve data harmonization across genomics, phenotypic data, EMR, and beyond. And they support participants through return of results and information.
In line with personalized engagement, Dr. Nadkarni relayed that precision health research is leading a paradigm shift away from one treatment for all, towards more personalized medicine where patients derive greater benefit from more individualized therapies and clinical approaches. This is beyond mere group-based medicine, where patients are treated based on presence of certain biomarker parameters or genetic mutations.
“This aim for personalized medicine combines with genomics research as a way to achieve health equity,” Nadkarni said. Biobanks, for that matter, hold the keys to potentially solving the genetic, metabolic, and protein components for personalized medicine. The ability to optimally use a biobank is relatively difficult for a health system who is focused on standard of care, economics of care, and delivery high quality care all simultaneously to everyone equitably. Genomics is currently failing on diversity, with 78% of participants in large-scale genomics studies are of primarily European descent.
Enter Mount Sinai Million Health Discoveries Program, which leverages routine care with existing patients to obtain real-world data from adult and pediatric patients that are representative of the diverse ethnic and racial makeup of the New York metropolitan area. There tends to be a high degree of patient trust during a clinical encounter. Hence, the ability to utilize that trust to consent patients to capture genetic data capture in that setting allows for harnessing the highest amount of return, accelerating Mount Sinai’s goal of 1 million participants.
Mount Sinai Million Health Discoveries Program effectively leverages the clinical blood draws to consent patients to collect genomics data from their leftover/discard samples. They do this in marketing directly to consent patients and in utilizing Vibrent’s Research Cloud to eConsent, enroll, and survey patients.
In speaking about All of Us, PJ Jain relayed how multi-modal methods for consent have strengthened inclusivity for enrollment and participation from people who lack access to or comfort with technology. This included a computer-assisted telephone interview tool for teams to consent patients, in addition to paper and electronic consent. He mentioned that education can be scaled digitally to more easily consent patients, like with a video to easily explain a study’s aims and methods. Knowledge checks can be used to quiz potential enrollees for studies, and a contact button can help to bolster the more self-service element that eConsent provides. This ensures that participants can easily reach the study team in case they have specific questions or concerns.
In the Q&A session following the webinar, both Dr. Nadkarni and PJ Jain talked about integrating clinicians in the enrollment process, consulting IRB and patients for eConsent, as well as the utility of digital solutions in engaging patients. Dr. Nadkarni explained that including clinicians in research needs to be about making sure they understand the benefits of enrolling their patients. And as far as including them in an enrollment workflow, clinicians are busy and anything that disrupts them from offering quality care should be eliminated or reduced as much as possible.
To address concerns around eConsent, Dr. Nadkarni and his team worked closely with the Mount Sinai IRB and surveyed participants. Likewise, PJ Jain described how the All of Us team works closely with its IRB: “It wasn’t a ‘throw it over the fence’ and wait for a decision from the IRB. We work with them to help them understand the value and to show how many of the aspects that IRB cares about are addressed.”
In addition to All of Us, Dr. Nadkarni specified that Mount Sinai also uses computer-assisted telephone interviews as a way of gathering consent from thousands of participants. In either case, they employed additional staff to support their research teams in the interviewing process to address their high volume of participants.
Dr. Nadkarni commented that studies smaller than All of Us or the Mount Sinai Million Health Discoveries Program can be successful in recruiting diverse participants with scalable digital solutions. He mentioned that adhering to tenets described in the presentation are important in fostering diversity in the participant population. PJ Jain added that COVID made technology-based solutions the standard to reach patients, and that a clinic-based approach to trials and health research is no longer something that study teams can rely on. Teams must explore cost-effective methods to bring solutions to their research at-scale.
Best practices for informed consent and participation continue to evolve. Study teams need to evaluate their needs while also partnering with participants and other stakeholders like IRBs and clinicians to ensure that they are engaged at the right points over time, and in an efficient way that addresses their needs and concerns. Since solutions need to be practical for these different groups, newer approaches that have yielded successful programs require thoughtful decision making from researchers. While an oversimplification, the transaction between study teams and participants can be boiled down to trust in exchange for data.
Watch the webinar recording for important questions to ask your study team.
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