We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department

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.
ClinicalTrials.gov Identifier: NCT01476319
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : April 7, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Cholecystitis Other: video

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Actual Study Start Date : November 9, 2009
Primary Completion Date : September 9, 2014
Study Completion Date : September 9, 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: control
Experimental: video Other: video
The intervention group includes patients who obtain information about percutaneous cholecystostomy from a video will view at their bedside on a laptop.

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT01476319

Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
More Information

Responsible Party: Yen-Ko Lin, Attending Physician, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01476319     History of Changes
Other Study ID Numbers: KMUH-IRB-980360
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases