- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01338480
Improving Informed Consent Process for Trauma Patients in the Emergency Department
April 5, 2017 updated by: Yen-Ko Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
172
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: video
Participants in the intervention group watched an educational video illustrating informed consent information
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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.
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No Intervention: control
Participants in the control group read an informed consent document.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
knowledge score
Time Frame: immediately after the intervention
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The primary outcome, patient understanding of the procedure, risks, benefits, and alternatives, will be determined by quantitative scores on the written examination
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immediately after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
satisfaction
Time Frame: immediately after the intervention
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Secondary outcomes include patient satisfaction with the informed consent process, determined by a five-point ordinal satisfaction scale.
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immediately after the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yen-Ko Lin, M.D., Kaohsiung Medical University Chung-Ho Memorial Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 9, 2009
Primary Completion (Actual)
October 22, 2014
Study Completion (Actual)
October 22, 2014
Study Registration Dates
First Submitted
April 18, 2011
First Submitted That Met QC Criteria
April 18, 2011
First Posted (Estimate)
April 19, 2011
Study Record Updates
Last Update Posted (Actual)
April 7, 2017
Last Update Submitted That Met QC Criteria
April 5, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUH-IRB-980361
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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