Back to resultsImproving Informed Consent Process for Trauma Patients in the Emergency Department
Primary Purpose
Trauma, Surgery
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
video
Sponsored by
About this trial
This is an interventional health services research trial for Trauma focused on measuring trauma, surgery, informed consent
Eligibility Criteria
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
Sites / Locations
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
video
control
Arm Description
Participants in the intervention group watched an educational video illustrating informed consent information
Participants in the control group read an informed consent document.
Outcomes
Primary Outcome Measures
knowledge score
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
satisfaction
Secondary outcomes include patient satisfaction with the informed consent process, determined by a five-point ordinal satisfaction scale.
Full Information
NCT ID
NCT01338480
First Posted
April 18, 2011
Last Updated
April 5, 2017
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01338480
Brief Title
Improving Informed Consent Process for Trauma Patients in the Emergency Department
Official Title
Improving Informed Consent Process for Trauma Patients in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 9, 2009 (Actual)
Primary Completion Date
October 22, 2014 (Actual)
Study Completion Date
October 22, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Surgery
Keywords
trauma, surgery, informed consent
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
video
Arm Type
Experimental
Arm Description
Participants in the intervention group watched an educational video illustrating informed consent information
Arm Title
control
Arm Type
No Intervention
Arm Description
Participants in the control group read an informed consent document.
Intervention Type
Other
Intervention Name(s)
video
Intervention Description
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.
Primary Outcome Measure Information:
Title
knowledge score
Description
The primary outcome, patient understanding of the procedure, risks, benefits, and alternatives, will be determined by quantitative scores on the written examination
Time Frame
immediately after the intervention
Secondary Outcome Measure Information:
Title
satisfaction
Description
Secondary outcomes include patient satisfaction with the informed consent process, determined by a five-point ordinal satisfaction scale.
Time Frame
immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yen-Ko Lin, M.D.
Organizational Affiliation
Kaohsiung Medical University Chung-Ho Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
29523129
Citation
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.
Results Reference
derived
PubMed Identifier
29187226
Citation
Lin 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.
Results Reference
derived
Learn more about this trial
Improving Informed Consent Process for Trauma Patients in the Emergency Department
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