Implement and Test Visual Consent Template and Process
Key facts
- Who runs it
- Washington University School of Medicine
- Where
- Chapel Hill, Salt Lake City, and St Louis, United StatesSee the 3 sites
- Trial code
- Status
- Terminated
- People taking part
- 266 people enrolled
- Started
- 10 Mar 2025
- Ended
- 24 Apr 2026
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Visual consent
- Standard consent
- Record updated
- 3 June 2026
- Why it stopped
- Insufficient funding
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 3 criteriaShow less
Other criteria
- Eligibility Criteria for Patients:
- Adult participants (18+) eligible for one of three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill. The eligibility criteria for the main trials are below:; UNC:; Basal-like PDAC Treated with Gemcitabine, Erlotinib, and Nab-paclitaxel (PANGEA) trial inclusion criteria:; Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information; Participant is willing and able to comply with study procedures based on the judgment of the investigator; Age ≥ 18 years at the time of consent; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1; Consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient; Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen; Washington University:; Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies (WeSHARE); Participants of the Knight Alzheimer Disease Research Center; Participants with available results from an Alzheimer Disease blood biomarker test; Participants who agreed to be contacted for additional research studies; University of Utah:; Huntsman Cancer Institute Total Cancer Care; Participants who have been diagnosed with any type of tumor or cancer; Participants with genetic predispositions or family history of cancer or tumors; Participant volunteers willing to share samples and data for research; Eligibility Criteria for Research Staff:
- Research staff/coordinators of one of the three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill
Where in United States
- University of North Carolina at Chapel Hill School of MedicineChapel Hill, United StatesNo longer taking part
- University of Utah Huntsman Cancer Institute (HCI)Salt Lake City, United StatesNo longer taking part
- Washington University School of MedicineSt Louis, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Research Staff: Standard ConsentExisting treatment, for comparison
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.
Treatment: Standard consent
- Research Staff: Visual ConsentTreatment being tested
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.
Treatment: Visual consent
- Participants: Visual ConsentTreatment being tested
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).
Treatment: Visual consent
- Participants: Standard ConsentExisting treatment, for comparison
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).
Treatment: Standard consent
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 3 June 2026