Visual Consent for Clinical Trials

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

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 am 18 years old or older.

I am fully active or can carry out light work.

Participant Groups

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.

4Treatment groups

Experimental Treatment

Active Control

Group I: Research Staff: Visual ConsentExperimental Treatment1 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 ConsentExperimental Treatment1 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 ConsentActive Control1 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 ConsentActive Control1 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).