Visual Consent for Clinical Trials

Recruiting at 3 trial locations

Overseen By Krista Cooksey, B.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Cancer, Alzheimer's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

515 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance patient understanding of research studies by comparing standard text-based consent forms with new visual consent templates. It will involve research staff and participants across three different studies to test whether visual aids clarify information and ease decision-making. The trial seeks participants already involved in certain studies at Washington University, the University of Utah, or the University of North Carolina, who have specific conditions such as cancer or Alzheimer's risk. Research staff from these trials will also participate to evaluate the new process. As an unphased trial, this study offers a unique opportunity to contribute to improving patient comprehension in research.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this consent process is safe?

The informed consent process, including the visual consent template being tested, is generally safe for participants. These templates serve as tools to help people better understand research studies. They do not involve taking medication or undergoing medical procedures, so there is no risk of physical harm.

Research has shown that visual aids in consent forms can improve understanding. As a result, participants may feel more informed and confident about their decision to join a study. While no negative effects from these templates have been reported, the goal is to make the consent process clearer and more engaging.

Overall, this trial focuses on improving communication, not testing a medical treatment, so safety concerns are minimal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential advantages of using visual consent templates over the standard text-based consent forms in clinical trials. Traditional consent processes rely heavily on text, which can be challenging for individuals with varying levels of health literacy. The visual consent approach aims to make crucial information more accessible and engaging by incorporating visual aids, potentially improving understanding and satisfaction. By assessing the feasibility and acceptability of this method, researchers hope to enhance informed consent processes, leading to better participant engagement and possibly more informed decision-making.

What evidence suggests that this trial's consent methods could be effective?

Research has shown that visual aids in consent forms help people better understand study details. This improved understanding can ease their decision-making about joining a study. In this trial, participants in the Visual Consent arm will use these visual templates, which studies suggest reduce obstacles to research participation. By simplifying consent forms, these templates can also increase satisfaction with the information provided. Overall, visual aids aim to make the consent process clearer and more engaging for participants. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for research teams working with patients eligible for studies on Alzheimer's Disease or Cancer. Teams start using standard consent procedures and then switch to a visual consent method after being randomly chosen at different times.

Inclusion Criteria

Participants of the Knight Alzheimer Disease Research Center

Participants who agreed to be contacted for additional research studies

I have a family history or genetic risk for cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Standard Consent

Research staff begin in the standard consent arm, using text-only summaries for consent

4 months

Ongoing throughout the study

Visual Consent

Research staff are randomized to the visual key information page arm and undergo training to use visual consent with participants

4 months

Ongoing throughout the study

Follow-up

Participants and research staff complete surveys to assess feasibility, acceptability, and appropriateness of the visual consent process

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standard Consent
• Visual Consent Template

Trial Overview

The study compares the effectiveness of a new visual consent process against the traditional, text-based approach in conveying information to participants. It's set up so that over time, all researchers will get training and use the new method.

How Is the Trial Designed?

Group I: Research Staff: Visual Consent Experimental Treatment 1 Intervention

After beginning in the standard consent arm, the research staff will then be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study. Research staff will also complete a baseline survey to assess feasibility, acceptability, and appropriateness of using visual consent pages as well as their institution's willingness and ability to implement using visual key information pages into routine care. Research staff will also complete a post-study survey on attitudes toward consent, the intervention (feasibility, acceptability, appropriateness of the intervention), organizational readiness for participant engagement, and willingness to continue the invention.

Group II: Participants: Visual Consent Experimental Treatment 1 Intervention

Participants will view the visual consent summary and will complete surveys with measures of knowledge, satisfaction with the information, decisional conflict, and potential covariates (i.e., demographics and health literacy).

Group III: Research Staff: Standard Consent Active Control 1 Intervention

Each participating research team member will begin in the standard consent arm of the study. The standard consent consists of a summary using text only.

Group IV: Participants: Standard Consent Active Control 1 Intervention

Participants will view the standard consent consisting of summary text only and will complete surveys with measures of knowledge, satisfaction with the information, decisional conflict, and potential covariates (i.e., demographics and health literacy).

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

The study highlights the inefficiency of manual management of serious adverse events (AEs) and reactions (ARs) in clinical trials, emphasizing the need for improved reporting systems.

A new data model has been developed to facilitate automatic code generation for a software tool designed to assist in the management of AE/AR data, potentially enhancing the efficiency and effectiveness of regulatory compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials. Fonck, S., Deserno, T.[2018]

The highlights version of the informed consent document, which follows the revised US Federal Common Rule, significantly improved participants' retention of high-relevance enrollment information compared to the original full-length document (65% vs. 59% correct answers).

Other revised versions of the consent document did not show a significant improvement in knowledge retention compared to the full-length version, indicating that the structure and prioritization of information are crucial for effective communication in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a New Common Rule Requirement for Informed Consent: A Randomized Trial on Adult Asthma Patients. Yu, M., Fischhoff, B., Krishnamurti, T.[2020]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

The electronic informed consent (eIC) process was found to be user-friendly, with 83% of participants reporting it as easy to use, and it did not increase technology burden compared to traditional paper consent.

eIC significantly improved the completeness of consent documents, with no errors in 235 eIC consents compared to a 6.4% error rate in paper consents, while maintaining similar levels of comprehension and participant agency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods. Buckley, MT., O'Shea, MR., Kundu, S., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11927487/

Accelerating implementation of visual key information to ...

Visual KI templates can improve potential participant comprehension and in doing so, may reduce barriers to participation in research.

2.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/57/NCT06293157/ICF_001.pdf

Information for the participant and informed consent form ...

All medical experiments are submitted to the Bioethics Committee for scientific and ethical opinion. The design of this medical experiment was verified by the ...

3.

research.uky.edu

research.uky.edu/sites/default/files/2025-02/10160-form_c_med_and_hipaa.docx

Medical

We may ask you to sign a new consent form if the information is provided to you after you have joined the study. will you be given individual results from the ...

4.

fda.gov

fda.gov/media/88915/download

Informed Consent Guidance for IRBs, Clinical Investigators, ...

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not create any rights for any ...

5.

mrctcenter.org

mrctcenter.org/health-literacy/tools/overview/consent-guide/

Consent Guide - Health Literacy in Clinical Research

This section outlines the steps needed to create consent forms for research that not only comply with regulations but also present the content in ways that ...

6.

research.uci.edu

research.uci.edu/human-research-protections/subject-enrollment/informed-consent/drafting-the-informed-consent-form/

Drafting the Informed Consent Form - UCI Office of Research

The consent document is designed to provide information to potential subjects about a research study so they can make an informed decision about their ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06804837

Implement and Test Visual Consent Template and Process ...

The investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies.

8.

medresearch.umich.edu

medresearch.umich.edu/office-research/about-office-research/our-units/institutional-review-boards-irbmed/informed-consent-assent-templates

Informed Consent & Assent Templates

Explore downloadable templates, including standard consent and assent templates, as well as several specialty templates, for use in specific types of research ...

9.

research.umn.edu

research.umn.edu/sites/research.umn.edu/files/hrp-592-template-biomedical-consent-form.docx

592: Consent Form Template for Medical Research

If you agree, you will be asked to sign an additional consent form (i.e. Clinical Data Collection after Withdrawal Consent Addendum) and HIPAA authorization to ...