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

Sponsor:

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

History of Changes

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:

MedlinePlus related topics: Injuries Wounds

U.S. FDA Resources

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

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

Additional relevant MeSH terms:

Emergencies
Wounds and Injuries
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

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