The use of a low-literacy version of the Medicaid sterilization consent form to assess sterilization-related knowledge in Spanish-speaking women: results from a randomized controlled trial

Abstract

Objective: To learn whether a version of the Medicaid Sterilization Consent Form (SCF) adapted for populations of low-literacy can help Spanish-speaking women better understand the process and consequences of tubal sterilization.

Study design: We randomly assigned Spanish-speaking women, ages 21-45 years, to review either a "standard" or "low-literacy" version of the Medicaid SCF. We assessed sterilization-related knowledge using items from the Postpartum Tubal Sterilization Knowledge questionnaire, using as the primary outcome correct identification of least four or more knowledge items and as secondary outcome participants' preferred version of the SCF.

Results: Overall sterilization-related knowledge was low in both groups, with 33% of women (n=100) who reviewed the standard SCF form and 42% of those who reviewed the low-literacy form (n=100) correctly identifying four or more knowledge-related items (p=.19). Regarding specific items, women in the low-literacy SCF group were more likely than those in the standard SCF group to understand the permanence of sterilization (69% versus 49%, p<.01) and the time requirement between signing the consent document and undergoing sterilization (79% versus 59%, p<.01). The groups were similar in appreciating availability of equally effective nonpermanent contraceptive options (71% versus 64%, p=.29), time from signing to expiration (33% versus 38%, p=.46), or non-binding nature of sterilization consent (55% versus 62%, p=.32). Overall, 71% of participants from both groups preferred the low-literacy form.

Conclusion: In our patient population, characterized by low educational attainment and inadequate health literacy skills, a low-literacy SCF did not improve overall sterilization-related knowledge when compared to the standard SCF. The low-literacy version did improve understanding of the permanence of sterilization and time requirements to undergo the procedure.

Implications: Neither form conveyed an adequate level of knowledge to this vulnerable Spanish-speaking population. Therefore, a considerable need persists for detailed education regarding availability of equally effective reversible contraceptive options, procedure-related risks, and permanence of sterilization throughout the process of informed consent.

Keywords: Health literacy; Informed consent; Medicaid; Spanish-language consent forms; Spanish-speaking patients; Tubal sterilization.