Back to resultsImproving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department
Primary Purpose
Cholecystitis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
video
Sponsored by
About this trial
This is an interventional health services research trial for Cholecystitis
Eligibility Criteria
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
Sites / Locations
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
video
Arm Description
Outcomes
Primary Outcome Measures
knowledge and satisfaction measure
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01476319
First Posted
August 1, 2011
Last Updated
April 5, 2017
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01476319
Brief Title
Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 9, 2009 (Actual)
Primary Completion Date
September 9, 2014 (Actual)
Study Completion Date
September 9, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Title
video
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
video
Intervention Description
The intervention group includes patients who obtain information about percutaneous cholecystostomy from a video will view at their bedside on a laptop.
Primary Outcome Measure Information:
Title
knowledge and satisfaction measure
Description
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.
Time Frame
immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department
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