Implement and Test Visual Consent Template and Process
Purpose
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.
Conditions
- Cancer
- Alzheimer Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- This is 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.
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Research Staff: Standard Consent |
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. |
|
Experimental Research Staff: Visual Consent |
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. |
|
Experimental Participants: Visual Consent |
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). |
|
Active Comparator Participants: Standard Consent |
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). |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT06804837
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine