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

BMC Medical Ethics. 2018;19(1):1-15 DOI 10.1186/s12910-018-0264-7

 

Journal Homepage

Journal Title: BMC Medical Ethics

ISSN: 1472-6939 (Online)

Publisher: BMC

LCC Subject Category: Medicine: Medicine (General): Medical philosophy. Medical ethics

Country of publisher: United Kingdom

Language of fulltext: English

Full-text formats available: PDF, HTML

 

AUTHORS


Yen-Ko Lin (Division of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University)

Chao-Wen Chen (Division of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University)

Wei-Che Lee (Division of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University)

Yuan-Chia Cheng (Division of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University)

Tsung-Ying Lin (Division of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University)

Chia-Ju Lin (College of Nursing, Kaohsiung Medical University)

Leiyu Shi (Department of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University)

Yin-Chun Tien (Department of Orthopedics, Kaohsiung Medical University Hospital, Kaohsiung Medical University)

Liang-Chi Kuo (Division of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University)

EDITORIAL INFORMATION

Open peer review

Editorial Board

Instructions for authors

Time From Submission to Publication: 25 weeks

 

Abstract | Full Text

Abstract Background We 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. Methods We 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. Results A 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. Conclusions Both 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 registration The ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011 (retrospectively registered).