You may already know that electronic informed consent (eConsent) can have a positive impact on participant retention, but that is only part of the challenge of meeting patient needs in a clinical trial. Four proven participant education techniques – interactive technology, plain language, images and comprehension tests – could be used in informed consent to overcome functional health literacy limitations, improve participant confidence, drive retention and reduce costs.  

My name is Nicole Latimer, and I am the CEO of Medrio. 

Before I joined the company, I spent several years at the helm of a patient education and lifestyle risk management company. In that role, I worked directly with leading clinical and patient educators in academic and community hospitals across the country – and I saw firsthand how applying the fundamentals of adult education theory and patient education strategies makes a real difference in participant consent and retention. Here are some of the best practices I’ve seen in participant education.

1) Choose interactive eConsent to engage participants.

When compared to traditional paper informed consent forms for health care procedures or clinical trials, interactive eConsent encourages full participant engagement in the material and enhances comprehension. Participants spend 72% more time on an interactive eConsent than a paper consent with identical information; they don’t just sign without reading.

As a result, participants who use eConsent generate higher comprehension scores, as well as, greater senses of satisfaction and enjoyment. Interactive eConsent also benefits more diverse populations. Minority and rural participants find eConsent easier to use, more interesting and easier to understand. 

2) Use plain language to address health literacy.

Most informed consent documents for clinical trials, written well above the U.S. average reading level of seventh-eighth grade (12 to 14 years old), are challenging for participants to understand – 36% of participants have low health literacy – but simple language can improve readability. Plain language is clear, concise, free of jargon and limits complex medical or statistical terminology. It allows readers to understand what is being communicated the first time they read or hear it.

Health information written in simplified language improves knowledge, recognition of terms and participant self-efficacy, even for participant populations with high health literacy. When applied to clinical trial consent forms, plain language also improves participant satisfaction and reduces participant anxiety.

3) Use images and videos to promote understanding.

Pictures and graphics with color can increase participants’ willingness to read by 80%. When compared to reading text, 80% of participants would rather watch a video. With the engaging nature of visuals, it is no surprise that participant education has used images for decades to promote interest in and recollection of health information. Beyond engagement, visuals improve participant comprehension and adherence. This improvement applies to participants of all educational levels, but for participants with low health literacy, images increase health knowledge and understanding significantly.

The benefits of including images and videos apply equally well to the informed consent process. In addition to enhanced understanding and adherence, including images and video in eConsent may help reduce anxiety for some participants, including those undergoing procedures.

4) Use quizzes to increase interest and comprehension.

Although the teach-back methodology is the gold standard for ensuring participant comprehension, it is resource intensive. Some participant education now uses the digital equivalent, test/feedback, which provides a more resource-efficient means to the same end. Quizzes embedded in eConsent can test participant comprehension and provide feedback on the trial elements that are confusing to participants. Supplemental information can be triggered and shared with the participant directly through eConsent.

In addition, an open-text field quiz question can ask participants to share their reasons for participating in a clinical trial. Knowing self-motivated participants are more likely to complete a trial, emphasizing motivation with participants, initially through eConsent and reinforced through interactions with site personnel, promotes retention.

Improving Patient Retention with eConsent

To improve participant retention, eConsent has many advantages compared to paper consent. The use of interactive, multimedia eConsent:

• Increases the likelihood that clinical trial participants will fully read, hear or see the information they need to know as they decide whether to participate
• Improves participants’ ability to understand study information
• Improves participants’ ability to remember and recall information
• Provides participants with clear expectations about what will happen during the clinical trial
• Enhances participant adherence to clinical instructions

All of these advantages increase the likelihood that participants will complete the clinical trial, which reduces the need to spend money on replacements or to extend trial timelines. In this sense, eConsent improves clinical trials.