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Use of a modified informed consent process among vulnerable patients: a descriptive study
Rebecca L Sudore1, C Seth Landefeld, Brie A Williams
1Division of Geriatrics, San Francisco Veterans Administration Medical Center, University of California, San Francisco, CA 94121, USA. rsucsf@yahoo.com
Journal of General Internal Medicine
|August 3, 2006
Summary
Patient literacy and race impact understanding of research consent forms. A modified consent process, using simplified language and repeated education, significantly improved comprehension for diverse older adults.
Area of Science:
- Clinical research methodology
- Health literacy research
- Patient education strategies
Background:
- Understanding patient characteristics associated with consent comprehension is limited.
- Modifications to the informed consent process may improve patient understanding.
Purpose of the Study:
- To describe a modified informed consent process.
- To determine if literacy and demographic factors are associated with understanding consent information.
Main Methods:
- A descriptive study of a modified consent process was conducted.
- The process included a sixth-grade reading level consent form, comprehension questions, and targeted education (teach-to-goal).
- Two hundred four ethnically diverse participants aged 50+ were enrolled.
Main Results:
- Mean participant age was 61 years, with 40% having limited literacy.
- Only 28% achieved full comprehension on the first attempt.
- Lower literacy and Black race were associated with needing more attempts (P=.04 and P=.03, respectively).
- After the second pass, 80% achieved comprehension.
- The teach-to-goal strategy resulted in 98% overall comprehension.
Conclusions:
- Lower literacy and minority status significantly impact understanding of research consent information.
- A modified consent process effectively achieved high comprehension rates, regardless of literacy or language barriers.
- Minimal additional education was needed with the modified approach.
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