Improving Informed Consent Process for Trauma Patients in the Emergency Department

Not Applicable

Completed

• Conditions: Trauma; Surgery
• Interventions: Other: video

• Registration Number: NCT01338480
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing trauma patients in emergency department (ED) about risks, benefits, and alternatives to receiving surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-09
• Study First Submitted: 2011-04-18
• Study First Submitted QC: 2011-04-18
• Study First Posted: 2011-04-19
• Primary Completion: 2014-10-22
• Study Completion: 2014-10-22
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• 18 years of age or older
• scheduled to receive the surgery

Exclusion Criteria

• clinically unstable
• refuse to participate
• unable to understand the consent process for this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
video	video	Participants in the intervention group watched an educational video illustrating informed consent information

Primary Outcome Measures

Name	Time	Method
knowledge score	immediately after the intervention	The primary outcome, patient understanding of the procedure, risks, benefits, and alternatives, will be determined by quantitative scores on the written examination

Secondary Outcome Measures

Name	Time	Method
satisfaction	immediately after the intervention	Secondary outcomes include patient satisfaction with the informed consent process, determined by a five-point ordinal satisfaction scale.

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan