Improving Informed Consent Process for Trauma Patients in the Emergency Department
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01338480
First received: April 18, 2011
Last updated: August 1, 2011
Last verified: April 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Trauma Surgery |
Other: video |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Improving Informed Consent Process for Trauma Patients in the Emergency Department |
Resource links provided by NLM:
Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Primary Outcome Measures:
- knowledge score [ Time Frame: immediately and 3 months after the intervention ] [ Designated as safety issue: No ]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 and completion time [ Time Frame: immediately after the intervention ] [ Designated as safety issue: No ]Secondary outcomes include patient satisfaction with the informed consent process, determined by a five-point ordinal satisfaction scale, and the time to complete the consent process for the surgery.
| Estimated Enrollment: | 240 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: video
The intervention group includes patients who obtain information about the surgery from a video will view at their bedside on a laptop.
|
Other: video
The videos will be developed and contain information on the procedure, risks, benefits, and alternatives of the surgery.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338480
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338480
Contacts
| Contact: Yen-Ko Lin, M.D. | +886-7-3121101 ext 7579 | yenko@ms16.hinet.net |
Locations
| Taiwan | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting |
| Kaohsiung, Taiwan, 807 | |
| Contact: Yen-Ko Lin, M.D. +886-7-3121101 ext 7579 yenko@ms16.hinet.net | |
| Principal Investigator: Yen-Ko Lin, M.D. | |
| Sub-Investigator: Chia-Ju Lin, R.N. | |
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
| Principal Investigator: | Yen-Ko Lin, M.D. | Kaohsiung Medical University Chung-Ho Memorial Hospital |
More Information
No publications provided
| Responsible Party: | Yen-Ko Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01338480 History of Changes |
| Other Study ID Numbers: | KMUH-IRB-980361 |
| Study First Received: | April 18, 2011 |
| Last Updated: | August 1, 2011 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
|
trauma surgery informed consent |
ClinicalTrials.gov processed this record on March 03, 2015