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Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476319
First Posted: November 22, 2011
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yen-Ko Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital
August 1, 2011
November 22, 2011
April 7, 2017
November 9, 2009
September 9, 2014   (Final data collection date for primary outcome measure)
knowledge and satisfaction measure [ Time Frame: immediately after intervention ]
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: None (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
  • 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.
 
Completed
22
September 9, 2014
September 9, 2014   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
April 2017

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