Implement and Test Visual Consent Template and Process
2 other identifiers
interventional
266
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Mar 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2025
CompletedFirst Posted
Study publicly available on registry
February 3, 2025
CompletedStudy Start
First participant enrolled
March 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
April 27, 2026
April 1, 2026
1.2 years
January 27, 2025
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
Knowledge of information provided in the consent (Participant only)
At time of consent review (day 1)
Satisfaction of information provided in the consent (Participant only)
At time of consent review (day 1)
Decisional conflict (Participant only)
At time of consent review (day 1)
Number of enrollments to clinical trials (Participant only)
At time of consent review (day 1)
Study Arms (4)
Research Staff: Standard Consent
ACTIVE COMPARATOREach participating research team member will begin in the standard consent arm of the study. The standard consent consists of a summary using text only.
Research Staff: Visual Consent
EXPERIMENTALAfter 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.
Participants: Visual Consent
EXPERIMENTALParticipants 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).
Participants: Standard Consent
ACTIVE COMPARATORParticipants 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).
Interventions
Visual key information page
Summary text only
Eligibility Criteria
You may qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27599, United States
University of Utah Huntsman Cancer Institute (HCI)
Salt Lake City, Utah, 84112, United States
Related Publications (1)
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.
PMID: 41318540DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2025
First Posted
February 3, 2025
Study Start
March 10, 2025
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- Access Criteria
- Researchers who provide a methodologically sound plan.
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.