Enhanced Consent and Preparedness for Surgery: A Randomized Controlled Trial

Prior studies of patient decision aids in urogynecology have not shown benefit, but these tools may have been written at a reading level above that of the average patient.

The primary aim was to determine if consent using an audiovisual decision aid (AVDA) written below eighth-grade reading level in English or Spanish affects patient preparedness for surgery. Secondary aims included correlating health literacy with preparedness and assessing patient satisfaction with the decision for surgery.

We conducted a randomized controlled trial on patients undergoing surgery for pelvic organ prolapse or urinary incontinence. We compared standard informed consent (control) with watching the AVDA. The primary outcome was the overall response on the "Preoperative Preparedness For Surgery" questionnaire. Health literacy was assessed using the Short Test of Functional Health Literacy in Adults. Postoperatively, satisfaction with the decision for surgery was assessed.

One hundred fifty-one participants completed the study. In each group, 98.7% of participants strongly agreed or agreed that they felt prepared for surgery (AVDA 74/75, control 75/76, P = 0.364). Most participants had adequate health literacy (AVDA 82.1%, control 81.8%). Among those with low health literacy, there was no significant difference in preparedness for surgery between AVDA and control (P = 0.363). Most participants in both groups were satisfied with their decision for surgery (AVDA 98.6%, control 100%, P = 0.737).

Use of an audiovisual decision aid written below eighth-grade reading level did not significantly affect preparedness for surgery, even among participants with low health literacy. Preparedness for surgery was high in both groups.