Why eConsent Makes Such a Difference in Patient Adherence and Engagement
Informed consent is the gateway to participation in clinical trials. But consent isn't just a signature on a document. Consent is an ongoing conversation between the patient and the healthcare provider that starts with trial education and hopefully results in the participation agreement. It’s a critical step that can greatly influence patient enrollment, adherence and retention in the trial.
Traditionally, informed consent has been solicited using paper documents. In the past several years, however, digital consent tools such as electronic Consent (eConsent) and TeleConsent have become available and are poised to transform the clinical trial experience.
The benefits of eConsent
eConsent uses interactive multimedia content to educate patients about the goals and methods of the study, as well as to outline what the patient’s role will be. The content can be delivered remotely to a patient’s tablet or other device, or presented on-site using similar equipment. The information also can be presented in a televisit with a physician or other health care provider via TeleConsent. Digital consent tools by their very nature improve the experience of this first step of the clinical trial process for all stakeholders.
For patients, eConsent provides time and space to interact with the material at their own pace, perhaps sharing or discussing it with family members. Even if patients complete the consent process at a site, the information can be delivered to them in advance, allowing for time to digest the material, which is often complex, lengthy or both. A traditional paper-based informed consent document contains an average of 8,000 words, taking an average of 60 minutes for patients to read. IRB reviews of consent length have shown that some oncology study consent forms are over 12,000 words, exacerbating this issue further. By removing the pressure of having someone effectively looking over their shoulder, the experience can be much more comfortable and less intimidating.
Digital consent tools make it easier for sponsors and sites to meet enrollment targets, too. With remote screening, they are no longer limited to recruiting patients from a specific geographic area and instead can cast a wide net for eligible study participants from more diverse backgrounds. This in turn eases the time and staffing burden on sites and frees them up to develop stronger relationships with their patients.
Engagement is everything
Those relationships matter — a lot. Patients who feel valued are generally more committed to remaining enrolled and adherent or, in a word, engaged.
Strong patient engagement is important because it leads to fewer dropouts, reducing the costly delays that can occur while sponsors and sites scramble for replacements. Deeper engagement also tends to create better adherence with trial protocol activities such as taking medication, updating logs or diaries, and keeping site visit appointments. And better adherence leads to more robust data and more successful trial outcomes.
In a recent survey conducted by Advarra, patients were asked about their experiences during the informed consent process. Those who felt that all their questions were answered, as well as those who reported feeling intrinsically motivated to complete the study, were much more likely to remain enrolled. Specifically, 89 percent of participants who felt their questions were answered and 78 percent who said they felt motivated on their own stayed enrolled, while only 64 percent of those who felt their questions were not answered and 47 percent of those who were not internally motivated remained in the study.
Meanwhile, 35 percent of enrollees who dropped out early found the IC document difficult to comprehend, while only 16 percent who remained in the study felt the same way. With eConsent, patients can connect with health care providers at any point to discuss questions or concerns.
Other factors that affect patient engagement and commitment, according to the survey, include showing appreciation and recognition for the patients’ contributions; promptly responding to questions; and clearly discussing expectations during the informed consent conversation. When staff are too stressed with administrative requirements, they’re less able to provide this kind of collegial atmosphere. Using an electronic informed consent process — and possibly additional elements of remote clinical trials, such as ePRO or eCOA for outcomes reporting — can open up new opportunities for dialogue.
All learning styles welcome
Research has shown that eConsent can also be more effective than paper consent forms in enhancing comprehension. In a 2019 study from the Center for Information and Study on Clinical Research Participation (CISCRP), patients who completed their informed consent electronically overwhelmingly said it was easy to understand (61 percent said it was “very easy” and 33 percent said it was “somewhat easy”). In contrast, only 48 and 43 percent of those who received a paper document found it “very” or “somewhat” easy, respectively, to understand. Some studies have also shown that the interactive and customized components of eConsent forms — such as pop-up definitions, quizzes, audio and graphics — can make the content more compelling and easier to understand.
Not everyone learns best with written material. Providing a variety of communication channels means that those who learn by listening, watching or interacting with material can be equally successful.
Making the move to eConsent
Electronic consent is more engaging and improves comprehension. It can launch meaningful conversations between patients and health care providers, and lead to better patient adherence and retention.
It also enables sponsors and sites to enroll more people with greater diversity in less time, resulting in stronger data and lower costs. It can be used on site or remotely, whether in fully digital clinical trials or in hybrid trial designs.
In addition, eConsent is flexible and scalable to almost any study. Medable’s eConsent doesn’t even require an app download, so there’s no time lost with device provisioning. Its features can be adapted to almost any preferred workflow, and it meets regulatory requirements worldwide. Contact Medable today for a demo.