Use of a low-literacy informed consent form to improve women's understanding of tubal sterilization: a randomized controlled trial.

Abstract

To estimate whether the Medicaid-Title XIX Sterilization Consent Form (SCF) format--"standard" compared with "low-literacy"--is associated with women's understanding of tubal sterilization. This study was a randomized trial that took place in an obstetrics and gynecology residency clinic in the southeastern United States. Women, aged 21 to 45 years, were randomly allocated to receive a copy of either the standard or the low-literacy Medicaid-Title XIX SCF. A research assistant assessed women's sociodemographic characteristics, health-literacy skills, and understanding of sterilization using items from the Postpartum Tubal Sterilization Knowledge questionnaire. Women were also queried regarding their preferences for either version of the Medicaid-Title XIX SCF. We included 201 women in the study. Compared with women in the standard group (n=99), women in the low-literacy group (n=102) with no additional counseling better understood the length of time required between signing the form and undergoing sterilization (23.6% difference between groups, P<.01), the time interval until the form expired (33.7% difference between groups, P<.01), permanence of sterilization (15.7% difference between groups, P=.01), and that nonpermanent contraceptive options as effective as sterilization are available (8.2% difference between groups, P=.02). When given the choice to select either Medicaid-Title XIX SCF, 189 (94%) preferred the low-literacy version. Our results support replacing the standard Medicaid-Title XIX SCF with the low-literacy version to foster increased understanding of sterilization.