Educational video-assisted versus conventional informed consent for trauma-related debridement surgery: a parallel group randomized controlled trial

Abstract

BackgroundWe investigated whether, in the emergency department (ED), educational video-assisted informed consent is superior to the conventional consent process, to inform trauma patients undergoing surgery about the procedure, benefits, risks, alternatives, and postoperative care.MethodsWe conducted a prospective randomized controlled trial, with superiority study design. All trauma patients scheduled to receive trauma-related debridement surgery in the ED of Kaohsiung Medical University Hospital were included. Patients were assigned to one of two education protocols. Participants in the intervention group watched an educational video illustrating informed consent information, whereas those in the control group read an informed consent document. The primary outcome was knowledge scores and the secondary outcome was assessment of patient satisfaction. A multivariable regression model, with predefined covariates, was used to analyze differences in knowledge scores and patient satisfaction levels between the groups.ResultsA total of 142 patients were enrolled, with 70 and 72 assigned to the intervention and control groups, respectively. Mean knowledge scores were higher in the intervention (72.57 ± 16.21 (SD)) than in the control (61.67 ± 18.39) group. By multivariate analysis, the intervention group had significantly greater differences in knowledge scores (coefficient: 7.646, 95% CI: 3.381–11.911). Age, injury severity score, and baseline knowledge score significantly affected the differences in knowledge scores. Significant improvements were observed in patients’ perception of statements addressing comprehension of the information provided, helpfulness of the supplied information for decision making, and satisfaction with the informed consent process. Multivariate analysis showed significant correlations between video education and patient satisfaction.ConclusionsBoth the educational approach and severity of injury may have an impact on patient understanding during the informed consent process in an emergency environment. Video-assisted informed consent may improve the understanding of surgery and satisfaction with the informed consent process for trauma patients in the ED. Institutions should develop structured methods and other strategies to better inform trauma patients, facilitate treatment decisions, and improve patient satisfaction.Trial registrationThe ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011 (retrospectively registered).Electronic supplementary materialThe online version of this article (10.1186/s12910-018-0264-7) contains supplementary material, which is available to authorized users.

A parental educational intervention to facilitate informed consent for pediatric procedural sedation in the emergency department: a parallel group randomized controlled trial

“…[44, [56][57][58] However, the effectiveness of preoperative education for pediatric patients and parents in the ED has not attracted much research interest. One study reported that standardized portable computer presentation was an effective way to improve education and facilitate the informed consent process in parents of children undergoing emergency surgery.…”

The Role of Advanced Technology Product Animations on Informing Patients with Gonarthrosis Preoperatively

“…Visual materials, especially animations, can be easily understood by patients with every educational level, including even non-literate patients, and provides a possibility to watch many times. In another study that investigated the understanding of informed consent form in surgical interventions by patients, approximately one-third of patients stated that they did not know its importance despite having signed the informed consent form (20,27). In another similar study that investigated the comprehension of the informed consent process by the patients who were scheduled for surgery, most of the patients stated that they knew the informed consent process partially, and the majority of them did not know what the informed consent form they signed was.…”

“…Each informational stage was limited to six items in order to evaluate the results of the informing objectively (17)(18)(19). After verbal and written informing, available knowledge levels of the patients were determined by asking open-ended questions (20)(21)(22)(23). The correct answers given to each open-ended question were scored with numbers 0-6 following the number of information given before.…”

Developing, Implementing, and Evaluating a Multimedia Patient Decision Aid Program to Reform the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Protocol for Quality Improvement (Preprint)

“…In addition to patient satisfaction, patients' attitudes toward using multimedia PtDA program to supplement the consent process survey was created based on the main benefits of using multimedia PtDAs identified in the literature [5,[9][10][13][14][15][16][17]. The survey consisted of 6 items of a 5-point Likert-type agreement scale where 5= strongly agree and 1= strongly disagree.…”

“…Multimedia is the "field concerned with the computer-controlled integration of text, graphics, drawings, still and moving images (video), animation, audio, and any other media where every type of information can be represented, stored, transmitted and processed digitally" [12]. The majority of the available studies used multimedia applications to support the informed consent process for surgeries and consistently found significant effects on reducing patient anxiety, improving patient understanding of the indications, risks, and benefits of the surgery, and increasing satisfaction with the informed consent process [5,[9][10][13][14][15][16][17].…”