Visual Consent for Clinical Trials

Recruiting at 2 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

Trial Summary

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 data supports the effectiveness of the Visual Consent Template treatment?

Research suggests that using an easy-to-read or visually enhanced consent form can improve patients' understanding and willingness to participate in clinical trials. This approach may lead to higher patient comprehension, lower anxiety, and greater satisfaction compared to standard consent forms. ^{1 2 3 4 5}

Is Visual Consent for Clinical Trials safe for humans?

The research articles do not provide specific safety data for Visual Consent for Clinical Trials or its related names. They focus on adverse event reporting and data management in clinical trials generally, but do not address the safety of this specific treatment. ^{6 7 8 9 10}

How does the Visual Consent Template treatment differ from other treatments?

The Visual Consent Template treatment is unique because it focuses on improving the informed consent process by using visual aids to make information clearer and more engaging for patients, unlike traditional consent forms that rely solely on text. ^{11 12 13 14 15}

What is the purpose of this trial?

The investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level. Each participating research team member will begin in the standard consent arm of the study. Subsequently, they will 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.

Eligibility Criteria

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

I have a family history or genetic risk for cancer.

Participants who agreed to be contacted for additional research studies

Participants of the Knight Alzheimer Disease Research Center

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

A randomized controlled study to assess patients' understanding of and consenting for clinical trials using two different consent form presentations. [2015]

2. France pubmed.ncbi.nlm.nih.gov

Informed consent to treatment in clinical trials. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Interactive method of informing patients of the risks of intravenous contrast media. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Heterogeneous but "standard" coding systems for adverse events: Issues in achieving interoperability between apples and oranges. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Serious Adverse Event Reporting Forms for Clinical Trials: A Comparative Korean Study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse event reporting in publications compared with sponsor database for cancer clinical trials. [2007]

11. United States pubmed.ncbi.nlm.nih.gov

A template for informed consent forms in medical examination and treatment: an intervention study. [2018]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Designing a Framework of Components to Support Patient Engagement in Research. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Study Comparing the National Cancer Institute's Original and Revised Consent Form Templates. [2019]

14. England pubmed.ncbi.nlm.nih.gov

A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Implementing a New Common Rule Requirement for Informed Consent: A Randomized Trial on Adult Asthma Patients. [2020]