Implement and Test Visual Consent Template and Process

The Washington University

Status: Enrolling

Conditions: Alzheimer Disease; Cancer

Treatments: Other: Standard consent; Other: Visual consent

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06804837

R01HS029310 (U.S. AHRQ Grant/Contract)

202501068

Details and patient eligibility

About

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.

Enrollment: 515 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

515 participants in 4 patient groups

Research Staff: Standard Consent

Active Comparator group

Description:

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:

Other: Standard consent

Research Staff: Visual Consent

Experimental group

Description:

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:

Other: Visual consent

Participants: Visual Consent

Experimental group

Description:

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:

Other: Visual consent

Participants: Standard Consent

Active Comparator group

Description:

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:

Other: Standard consent