Improving Informed Consent Process for Trauma Patients in the Emergency Department
1 other identifier
interventional
172
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 9, 2009
CompletedFirst Submitted
Initial submission to the registry
April 18, 2011
CompletedFirst Posted
Study publicly available on registry
April 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2014
CompletedApril 7, 2017
April 1, 2017
5 years
April 18, 2011
April 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
satisfaction
immediately after the intervention
Study Arms (2)
video
EXPERIMENTALParticipants in the intervention group watched an educational video illustrating informed consent information
control
NO INTERVENTIONParticipants in the control group read an informed consent document.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years of age or older
- scheduled to receive the surgery
You may not qualify if:
- clinically unstable
- refuse to participate
- unable to understand the consent process for this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807, Taiwan
Related Publications (2)
Lin YK, Chen CW, Lee WC, Cheng YC, Lin TY, Lin CJ, Shi L, Tien YC, Kuo LC. Educational video-assisted versus conventional informed consent for trauma-related debridement surgery: a parallel group randomized controlled trial. BMC Med Ethics. 2018 Mar 9;19(1):23. doi: 10.1186/s12910-018-0264-7.
PMID: 29523129DERIVEDLin YK, Chen CW, Lee WC, Lin TY, Kuo LC, Lin CJ, Shi L, Tien YC, Cheng YC. Development and pilot testing of an informed consent video for patients with limb trauma prior to debridement surgery using a modified Delphi technique. BMC Med Ethics. 2017 Nov 29;18(1):67. doi: 10.1186/s12910-017-0228-3.
PMID: 29187226DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yen-Ko Lin, M.D.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
April 18, 2011
First Posted
April 19, 2011
Study Start
November 9, 2009
Primary Completion
October 22, 2014
Study Completion
October 22, 2014
Last Updated
April 7, 2017
Record last verified: 2017-04