Improving Informed Consent Process for Trauma Patients in the Emergency Department
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|ClinicalTrials.gov Identifier: NCT01338480|
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : April 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Trauma Surgery||Other: video||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Improving Informed Consent Process for Trauma Patients in the Emergency Department|
|Actual Study Start Date :||November 9, 2009|
|Actual Primary Completion Date :||October 22, 2014|
|Actual Study Completion Date :||October 22, 2014|
Participants in the intervention group watched an educational video illustrating informed consent information
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.
No Intervention: control
Participants in the control group read an informed consent document.
- knowledge score [ Time Frame: 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
- satisfaction [ Time Frame: immediately after the intervention ]Secondary outcomes include patient satisfaction with the informed consent process, determined by a five-point ordinal satisfaction scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338480
|Kaohsiung Medical University Chung-Ho Memorial Hospital|
|Kaohsiung, Taiwan, 807|
|Principal Investigator:||Yen-Ko Lin, M.D.||Kaohsiung Medical University Chung-Ho Memorial Hospital|