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

摘要

BackgroundInformed consent is an integral part of the preoperative counseling process. It is important that we know the best way to relay this information to patients undergoing surgery, specifically, hysterectomy. ObjectiveWe sought to determine whether supplementing normal physician counseling with a video presentation improves patient comprehension during the informed consent process for hysterectomy. Study DesignIn a randomized, mixed factorial controlled trial, standard physician counseling (control arm) was compared to physician counseling plus video presentation (video arm) during the prehysterectomy 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. ResultsFrom 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. ConclusionEnhancing prehysterectomy counseling with a video improves patient comprehension through day of surgery, increases thoroughness of counseling, and reduces physician time.