4 Proven Participant Education Techniques to Improve Electronic Collection of Informed Consent

Better eConsent through education best practices

Author: Nicole Latimer, Chief Executive Officer

Need Better Clinical Trial Retention? Start with eConsent, but that is only part of the challenge of meeting participant needs in a clinical trial. There are still opportunities to evolve informed consent. Luckily, improving the informed consent process through eConsent, especially for the 36% ^[1] of participants with low health literacy, doesn’t need to be complicated. Cues can be taken from participant education, which now uses more interactive multimedia to improve understanding, set expectations and drive adherence.

Before I joined Medrio, 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, rather than passive paper consent, 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% ^[2] 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 ^[3]. Minority and rural participants find eConsent easier to use, more interesting and easier to understand. 

2) Use plain language to address health literacy challenges.

Most informed consent documents for clinical trials, written well above the U.S. average reading level of 7th to 8th grade (12 to 14 years old) ^[4], are challenging for participants to understand, but simple language can improve readability ^[5]. 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^[6]. When applied to clinical trial consent forms, plain language also improves participant satisfaction and reduces participant anxiety ^[7].

3) Use images and videos to promote understanding and adherence.

Pictures and graphics with color can increase participants’ willingness to read by 80% ^[8]. When compared to reading text, 80% of participants would rather watch a video ^[9]. With the engaging nature of visuals, it is no surprise that participant education has used images ^[10] for decades to promote interest in and recollection of health information. Beyond engagement, visuals improve participant comprehension ^[11] and adherence ^[12]. This improvement applies to participants of all educational levels, but for participants with low health literacy, images increase health knowledge ^[13] and understanding significantly.

The benefits of including images and videos apply equally well to the informed consent process ^[14]. In addition to enhanced understanding and adherence, including images and video in eConsent may help reduce anxiety ^[15] for some participants, including those undergoing procedures.

4) Increase interest and test comprehension with quizzes.

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 ^[16], 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 ^[17] 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.

References

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2. Rowbotham, M. C., Astin, J., Greene, K., & Cummings, S. R. (2016). Interactive informed consent: Randomized comparison with paper consents. PLOS ONE. Retrieved September 13, 2022.
3. Simon, C. M., Schartz, H. A., Rosenthal, G. E., Eisenstein, E. L., & Klein, D. W. (2018, May 23). Perspectives on electronic informed consent from patients underrepresented in research in the United States: A FOCUS Group Study. Journal of empirical research on human research ethics : JERHRE. Retrieved September 13, 2022.
4. Marchand, L. (2017, March 22). What is readability and why should content editors care about it? Center for Plain Language. Retrieved September 13, 2022. 
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8. Xerox (Ed.). (2017). 20 ways to share color knowledge fact sheet. Xerox. Retrieved September 13, 2022, from https://www.office.xerox.com/latest/COLFS-02UA.PDF 
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11. Guo D., Zhang S., Wright K.L., McTigue E.M. (2020, January 24). Do you get the picture? A meta-analysis of the effect of graphics on reading comprehension. AERA Open. 2020;6(1) 233285842090169. Retrieved September 13, 2022.
12. Houts, P. S., Doak, C. C., Doak, L. G., & Loscalzo, M. J. (2006). The role of pictures in improving health communication: a review of research on attention, comprehension, recall, and adherence. Patient education and counseling, 61(2), 173–190. Retrieved September 13, 2022.
13. Schubbe, D., Scalia, P., Yen, R. W., Saunders, C. H., Cohen, S., Elwyn, G., van den Muijsenbergh, M., & Durand, M. A. (2020). Using pictures to convey health information: A systematic review and meta-analysis of the effects on patient and consumer health behaviors and outcomes. Patient education and counseling, 103(10), 1935–1960. Retrieved September 13, 2022.
14. Glaser, J., Nouri, S., Fernandez, A., Sudore, R. L., Schillinger, D., Klein-Fedyshin, M., & Schenker, Y. (2020). Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review. Medical decision making : an international journal of the Society for Medical Decision Making, 40(2), 119–143. Retrieved September 13, 2022.
15. Zhang, M. H., Haq, Z. U., Braithwaite, E. M., Simon, N. C., & Riaz, K. M. (2019). A randomized, controlled trial of video supplementation on the cataract surgery informed consent process. Graefe’s archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 257(8), 1719–1728. Retrieved September 13, 2022.
16. Glaser, J., Nouri, S., Fernandez, A., Sudore, R. L., Schillinger, D., Klein-Fedyshin, M., & Schenker, Y. (2020). Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review. Medical decision making : an international journal of the Society for Medical Decision Making, 40(2), 119–143. Retrieved September 13, 2022.
17. Gabales, S. (2022, June 22). Retention in clinical trials: Keeping patients on protocols. Advarra. Retrieved September 13, 2022.