Improving Informed Consent Process for Trauma Patients in the Emergency Department

Surgery Clinical Trial

Official title:

Improving Informed Consent Process for Trauma Patients in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338480
• Other study ID #: KMUH-IRB-980361
• Status: Completed
• Phase: N/A
• First received: April 18, 2011
• Last updated: April 5, 2017
• Start date: November 9, 2009
• Est. completion date: October 22, 2014

Study information

• Verified date: April 2017
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: October 22, 2014
• Est. primary completion date: October 22, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Surgery
• Trauma
• Wounds and Injuries

Intervention

Other:
• video
The videos will be developed and contain information on the procedure, risks, benefits, and alternatives of the surgery. The knowledge measure instrument will also be developed.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knowledge score	The primary outcome, patient understanding of the procedure, risks, benefits, and alternatives, will be determined by quantitative scores on the written examination	immediately after the intervention
Secondary	satisfaction	Secondary outcomes include patient satisfaction with the informed consent process, determined by a five-point ordinal satisfaction scale.	immediately after the intervention