Implement and Test Visual Consent Template and Process

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.

Study Overview

• Status: Terminated
• Conditions: Cancer; Alzheimer Disease
• Intervention / Treatment: Other: Standard consent; Other: Visual consent

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill School of Medicine
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah Huntsman Cancer Institute (HCI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Standard consent; Summary 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.	Other: Visual consent; Visual key information page
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).	Other: Visual consent; Visual key information page
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).	Other: Standard consent; Summary text only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in feasibility (FIM) of implementation (Research Staff only)	4 items on a Likert scale ranging from completely disagree to completely agree. Higher scores indicate greater feasibility. (1=completely disagree, 3= neither agree nor disagree, 5= completely agree)	From baseline to end of study (estimated to be 4 months)
Change in acceptability (AIM) of implementation measures (Research Staff only)	4 items on a Likert scale ranging from completely disagree to completely agree. Higher scores indicate greater acceptability. (1=completely disagree, 3= neither agree nor disagree, 5= completely agree)	From baseline to end of study (estimated to be 4 months)
Change in appropriateness (IAM) of implementation measure (Research Staff only)	4 items on a Likert scale ranging from completely disagree to completely agree. Higher scores indicate greater appropriateness. (1=completely disagree, 3= neither agree nor disagree, 5= completely agree)	From baseline to end of study (estimated to be 4 months)
Change in organizational willingness and ability to implement strategies (Research staff only)	Measure of organizational readiness for engagement (MORE) measure; 4-point scale (1=not willing, 4=; willing) report mean and SD; higher scores indicate higher level of readiness	From baseline to end of study (estimated to be 4 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of information provided in the consent (Participant only)	The investigators will ask up to7 true/false/unsure questions. Missing responses will be considered false/incorrect. An overall knowledge score will be calculated with the percentage of items correctly answered. Higher scores indicate greater participant understanding of the clinical trial.	At time of consent review (day 1)
Satisfaction of information provided in the consent (Participant only)	NIH Health Information National Trends Survey (HINTS); 5-items on a Likert scale (1=completely disagree, 3= neither agree nor disagree, 5= completely agree). Higher scores indicate higher satisfaction.	At time of consent review (day 1)
Decisional conflict (Participant only)	SURE measure; 4-item measure. Scores less than equal to 3 indicate the presence of decisional conflict	At time of consent review (day 1)
Number of enrollments to clinical trials (Participant only)	The investigators will document whether or not participants enroll in the trials.	At time of consent review (day 1)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)

Publications and helpful links

General Publications

• Cooksey KE, Goldstein EC, Lee CN, Mozersky J, Kaphingst KA, Liu J, Wu S, Volkmar M, Catalan-Gallegos V, Politi MC. Implementing and evaluating visual key information pages compared to text-based key information: protocol for a stepped-wedge cluster randomized trial. BMC Med Ethics. 2025 Nov 29;27(1):1. doi: 10.1186/s12910-025-01341-y.

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
• Huntsman Cancer Institute at University of Utah
• Lineberger Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Actual): April 24, 2026
• Study Completion (Actual): April 24, 2026

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Informed consent; Research ethics; Key information; Common Rule
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Neoplasms; Alzheimer Disease
• Other Study ID Numbers: 202501068; R01HS029310 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Prior to sharing, data will be redacted to strip all identifiers and strategies will be adopted to minimize risks of unauthorized disclosure of personal identifiers. Publicly available documentation will include the survey questions (including any relevant skip patterns), a codebook, univariate statistics for each variable, and study-level metadata. The codebook will include a brief description of each variable along with the question number and question text, variable name, variable label, value labels, and standard codes for missing values-including codes for non-applicable, "don't know," or prefer not to answer.

User information will be required to access data files. As part of the registration process, users must agree to the conditions of use governing access to the data, including restrictions around redistributing data, destruction of the data after analyses, immediate reporting of any disclosures, and proper acknowledgment of the data resource.

• IPD Sharing Time Frame: Final submission and release of the study data will occur 12 months following the end of data collection. Study data deposited will be available to the research community in perpetuity. Datasets underlying methodological publications will be shared at or prior to initial publication date.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound plan.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No