A randomized controlled trial to determine whether a video presentation improves informed consent for hysterectomy

BACKGROUND: Informed consent is an integral part of the pre-operative counseling process. It is important that we know the best way to relay this information to patients undergoing surgery, specifically, hysterectomy. OBJECTIVE: We sought to determine whether supplementing normal physician counseling with a video presentation improves patient comprehension during the informed consent process for hysterectomy. STUDY DESIGN: In a randomized, mixed factorial controlled trial, standard physician counseling (control arm) was compared to physician counseling plus video presentation (video arm) during the pre-hysterectomy informed consent process. Primary outcome was improvement in patient comprehension measured by assessments at baseline, postcounseling, day of surgery, and postsurgery. Patient satisfaction was measured by a validated questionnaire. Audiotaped patient-physician interactions were analyzed to determine time spent counseling, number of patient questions, and whether standard counseling included 11 predetermined critical components included in the video. A sample size of 60 per group (N = 120) was planned to compare both groups. RESULTS: From May 2014 through June 2015, 120 patients were enrolled and 116 randomized: 59 to the video arm and 57 to the control arm. All characteristics were similar between groups. Video arm subjects demonstrated greater improvement in comprehension scores in both postcounseling (9.9% improvement; 95% confidence interval, 4.2-15.7%; P=.0009) and day-of-surgery questionnaires (7.2% improvement; 95% confidence interval, 0.96-13.4%; P=.02). Scores 4-6 weeks after surgery returned to baseline for both groups. Control subjects were less likely to be counseled about risk of thrombosis (P <.0001), colostomy (P <.0001), further medical/surgical therapy (P=.002), hormone replacement therapy (P <.0001), or postoperative expectations (P <.0001). Physicians spent more time counseling patients who did not watch the video (8 vs 12 minutes, P=.003) but number of questions asked by patients in each group was similar. CONCLUSION: Enhancing prehysterectomy counseling with a video improves patient comprehension through day of surgery, increases thoroughness of counseling, and reduces physician time.