Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yen-Ko Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01476319
First received: August 1, 2011
Last updated: November 17, 2011
Last verified: November 2011

August 1, 2011
November 17, 2011
March 2010
August 2012   (final data collection date for primary outcome measure)
knowledge and satisfaction measure [ Time Frame: immediately after intervention ] [ Designated as safety issue: No ]
One questionnaire will be used as an outcome measure tool. Participants will be asked to complete one questionnaire with knowledge test and satisfaction evaluation with the process of informed consent after the educational sessions.
Same as current
Complete list of historical versions of study NCT01476319 on ClinicalTrials.gov Archive Site
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Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department
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This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing patients in the emergency department (ED) about risks, benefits, and alternatives to receiving percutaneous cholecystostomy. Eligible patients will be approached when patients will be scheduled and waiting for receiving percutaneous cholecystostomy in the emergency department.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Cholecystitis
Other: video
The intervention group includes patients who obtain information about percutaneous cholecystostomy from a video will view at their bedside on a laptop.
  • No Intervention: control
    Intervention: Other: video
  • Experimental: video
    Intervention: Other: video
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
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August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients 18 years of age or older
  • scheduled to receive the percutaneous cholecystostomy

Exclusion Criteria:

  • clinically unstable
  • refuse to participate
  • are unable to understand the study process
Both
18 Years and older
No
Contact: Yen-Ko Lin, MD 886-7-3121101 ext 7579 yenko@ms16.hinet.net
Taiwan
 
NCT01476319
KMUH-IRB-980360
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Yen-Ko Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung Medical University Chung-Ho Memorial Hospital
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP