Enhanced Consent and Preparedness for Surgery: A Randomized Controlled Trial

Objectives: In the post-COVID and telemedicine era, there is increasing demand for tools to augment virtual surgical counselling. Decision aids are educational tools to assist patients facing medical decisions. Prior studies of handouts and videos have not shown benefit in helping patients feel prepared for urogynecologic surgery, but these materials may have been written at a reading level above that of the average patient. The primary aim is to determine if surgical consent using an audiovisual decision aid (AVDA) written below an 8th grade reading level in English or Spanish affects patient preparedness for surgery. Secondary aims include correlating health literacy with preparedness and assessing for the impact of AVDA on patient satisfaction and regret after surgery.

Methods: We conducted a randomized controlled trial on patients undergoing surgery for pelvic organ prolapse (POP), stress urinary incontinence (SUI), or urge urinary incontinence (UUI). We compared standard verbal informed consent (control) with watching the AVDA (AVDA group). 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 (STOFHLA). Postoperatively, satisfaction and regret with decision for surgery was assessed using validated questionnaires.

Results: A total of 155 participants completed the study. The most common surgical indication was POP (101 participants) followed by SUI (66). 17% of participants spoke Spanish as their primary language, and 47% had a college degree. Of 78 participants in the AVDA group, 74 (95%) strongly agreed or agreed that they felt prepared for surgery compared with 75 of 77 participants (97%) in the control group (p=0.364). Most participants in both groups had adequate health literacy (AVDA 82.1%, control 81.8%, Table 1). Participants with lower health literacy on the STOHFLA who were randomized to AVDA were not more likely to feel prepared for surgery compared with controls with lower health literacy (p=0.363). Most participants were satisfied with their decision for surgery (AVDA 98.6%, control 100%). The AVDA group was not more likely than control participants to report satisfaction with their decision for surgery (p=0.737).

Conclusions: Preparedness for surgery and satisfaction are high and regret is low in both groups. Use of an audiovisual decision aid written below 8th grade reading level in English or Spanish did not significantly affect these outcomes, even among patients with low health literacy. Verbal informed consent is effective, but there may be additional benefits to AVDA such as for visual learners or those with low English proficiency and these should be investigated further.