Open AccessUse of a Modified Informed Consent Process among Vulnerable Patients: A Descriptive Study
Author(s) -
Sudore Rebecca L.,
Landefeld C. Seth,
Williams Brie A.,
Barnes Deborah E.,
Lindquist Karla,
Schillinger Dean
Publication year - 2006
Publication title -
journal of general internal medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.746
H-Index - 180
eISSN - 1525-1497
pISSN - 0884-8734
DOI - 10.1111/j.1525-1497.2006.00535.x
Subject(s) - medicine , informed consent , process (computing) , medline , family medicine , alternative medicine , law , pathology , computer science , political science , operating system
BACKGROUND: Little is known about patient characteristics associated with comprehension of consent information, and whether modifications to the consent process can promote understanding. OBJECTIVE: To describe a modified research consent process, and determine whether literacy and demographic characteristics are associated with understanding consent information. DESIGN: Descriptive study of a modified consent process: consent form (written at a sixth‐grade level) read to participants, combined with 7 comprehension questions and targeted education, repeated until comprehension achieved (teach‐to‐goal). PARTICIPANTS: Two hundred and four ethnically diverse subjects, aged ≥50, consenting for a trial to improve the forms used for advance directives. MEASUREMENTS: Number of passes through the consent process required to achieve complete comprehension. Literacy assessed in English and Spanish with the Short Form Test of Functional Health Literacy in Adults (scores 0 to 36). RESULTS: Participants had a mean age of 61 years and 40% had limited literacy (s‐TOHFLA<23). Only 28% of subjects answered all comprehension questions correctly on the first pass. After adjustment, lower literacy ( P =.04) and being black ( P =.03) were associated with requiring more passes through the consent process. Not speaking English as a primary language was associated with requiring more passes through the consent process in bivariate analyses ( P <.01), but not in multivariable analyses ( P >.05). After the second pass, most subjects (80%) answered all questions correctly. With a teach‐to‐goal strategy, 98% of participants who engaged in the consent process achieved complete comprehension. CONCLUSIONS: Lower literacy and minority status are important determinants of understanding consent information. Using a modified consent process, little additional education was required to achieve complete comprehension, regardless of literacy or language barriers.