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

Presented at the American Congress of Obstetricians and Gynecologists Annual Clinical Meeting, Washington, DC, May 15, 2016, and American Congress of Obstetricians and Gynecologists Armed Forces District Meeting, Orlando, FL, Sept. 18, 2016.
https://doi.org/10.1016/j.ajog.2018.06.016Get rights and content

Background

Informed 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.

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 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.

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.

Introduction

Informed consent is a central aspect of the medical decision-making process, and represents an essential tenet of patient autonomy and respect for persons; this is especially critical before a patient undergoes a medical procedure.1 While informed consent has a medicolegal component, the primary aim is for the patient to understand the purpose, risks, benefits, and alternatives of the procedure when deciding on a treatment course.2 Unfortunately, due to the complexity of medicine and medical terminology and the overall health illiteracy of the general population, studies repeatedly show that patients poorly understand their medical treatments.3 Although patient autonomy requires diligent efforts to ensure patients comprehend their surgical procedures, this is made difficult by time constraints in the office, and the increasing pressure on physicians to provide better, more cost-effective health care while meeting high patient satisfaction standards.4 Novel techniques to deliver health care information that improve patient comprehension, satisfaction, and physician efficiency are paramount in this era of medicine governed by health care delivery reform.

AJOG at a Glance

  • To determine the effectiveness of audiovisual materials on providing informed consent for a large proportion of the gynecological patient population, namely those undergoing hysterectomy.

  • Patients who were presented with audiovisual aids for their preoperative counseling for their upcoming hysterectomy had better knowledge of their procedure and retention of that knowledge. Also, using these materials reduced the time the physician spent with the patient during their preoperative visit.

  • This is the first study performed evaluating audiovisual tools to provide informed consent for this type of procedure in the gynecological field. Therefore, it is directly applicable to our patient population as gynecologists.

In an effort to harness growing technology resources and improve counseling effectiveness, thoroughness, and efficiency, our study aims to determine whether including a video-based multimedia presentation improves patient comprehension during informed consent for hysterectomy. Secondary outcomes include patient satisfaction, thoroughness of counseling content, and physician time efficiency.

Hysterectomy provides a promising test arena for enhanced patient counseling and surgical consent for several reasons. Firstly, as one of the most common surgeries performed in the United States, with >400,000 cases per year,5 improvements in both comprehension and efficiency with this procedure alone have the potential for broad impact. Moreover, there are clear indications for hysterectomy, well-defined risks and benefits, and often, common alternatives to the procedure to discuss or consider. Discussion of the procedure should include expectations of preoperative, intraoperative (including a description of the procedure itself), and short- and long-term postoperative periods. These known factors lend themselves to inclusion in a standardized video presentation.

Section snippets

Materials and Methods

A prospective, randomized mixed factorial design was used to compare standard physician interaction (control arm) to standard physician interaction plus audiovisual presentation (experimental arm) during the preoperative visit for patients undergoing hysterectomy. The primary outcome was improvement in patient comprehension as measured by knowledge assessments at baseline, immediately postcounseling, day of surgery, and postsurgery. A sample size of 50 patients in each group was planned to

Results

In all, 120 patients were enrolled in the study, 109 of whom completed precounseling and postcounseling knowledge questionnaires (Figure 1). Precounseling average percent-correct scores were equivalent between the 2 cohorts (65.5% vs 62.1%, P = .17). Subjects in the video arm scored nearly 10% (9.9%; 95% confidence interval, 4.2–15.7%) higher on postcounseling questionnaires than the control arm (15.1% ± 2.04% improvement in the video arm vs 5.2% ± 2.1% in the control arm; P = .0009). Percent

Comment

Patient autonomy requires thorough counseling to allow proper informed consent before medical procedures. Our study demonstrates that by including a video presentation as adjunct to standard physician counseling, patients undergoing hysterectomy have improved comprehension about their procedure on the day of their preoperative counseling and the day of surgery compared to those who did not view the video. Additionally, providers frequently leave out key information that should be included in

Acknowledgment

We wish to acknowledge the residents and gynecology staff at San Antonio Military Medical Center (SAMMC). A special thank you to Ceci de la Garza and Lisa Hall, without whom this would not have been possible. Ceci de la Garza and Lisa Hall are both employed at SAMMC and have no funding sources to disclose. They were not compensated separately for their contribution to this research.

References (12)

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The authors report no conflict of interest. The views expressed herein are those of the authors and do not reflect the official policy or position of Brooke Army Medical Center, the US Army Medical Department, the US Army Office of the Surgeon General, the Department of the Air Force, the Department of the Army, the Department of Defense, or the US Government.

Cite this article as: Pallett AC, Nguyen BT, Klein NM, et al. A randomized controlled trial to determine whether a video presentation improves informed consent for hysterectomy. Am J Obstet Gynecol 2018;219:277.e1-7.

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