Improving Consent Experiences in Clinical Trials
NCT07293520 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2025-12-26
Summary
This is a study to evaluate the impact of evidence-based visual key information (VKI) pages on participant's experiences with informed consent for research, enrollment in high-accruing studies that choose to use VKIs as part of their consent process, and research team perceptions of the implementation potential of VKIs in studies. Unlike in previous pilots conducted at Siteman Cancer Center, this study will assess changes in outcomes before and after a VKI is implemented in a study consent process.
Conditions
Interventions
- BEHAVIORAL
-
Standard Consent Form
The IRB-approved consent form will be used by research team staff during consenting process of participants for parent studies.
- BEHAVIORAL
-
Visual Key Information (VKI) page
A VKI page will be designed for each parent study based on study materials and current consent document. The VKI will be implemented in the consent material for the study.
Sponsors & Collaborators
-
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Mary C Politi, PhD · Washington University in St. Louis School of Public Health
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-25
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
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