Active — Not RecruitingNot Applicable

Implement and Test Visual Consent Template and Process

United States266 participantsStarted 2025-03-10

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Change in feasibility (FIM) of implementation (Research Staff only)

Timeframe: From baseline to end of study (estimated to be 4 months)

Change in acceptability (AIM) of implementation measures (Research Staff only)

Timeframe: From baseline to end of study (estimated to be 4 months)

Change in appropriateness (IAM) of implementation measure (Research Staff only)

Timeframe: From baseline to end of study (estimated to be 4 months)

Change in organizational willingness and ability to implement strategies (Research staff only)

Timeframe: From baseline to end of study (estimated to be 4 months)

Trial details

NCT IDNCT06804837

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

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