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

Yen Ko Lin, Chao Wen Chen, Wei Che Lee, Yuan Chia Cheng, Tsung Ying Lin, Chia Ju Lin, Leiyu Shi, Yin Chun Tien, Liang Chi Kuo

Research output: Contribution to journalArticlepeer-review

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).

Original languageEnglish (US)
Article number23
JournalBMC Medical Ethics
Volume19
Issue number1
DOIs
StatePublished - Mar 9 2018

Keywords

  • Emergency department
  • Informed consent
  • Patient knowledge
  • Patient satisfaction
  • Trauma

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health(social science)
  • Health Policy

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