Effectiveness of the Consent Process
|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: NCT00630136|
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : March 24, 2010
|Condition or disease||Intervention/treatment|
|Parental Consent||Behavioral: interview|
Obtaining informed consent before performing an invasive medical procedure or treatment is a crucial component of patient care. The manner in which the consent process is conducted impacts the doctor/patient relationship, patient safety and patient satisfaction. Many times, patients sign consent forms without reading or understanding them. Although the form has been signed, true informed consent has not been obtained. While there are many variables that impact the ability to truly consent, ineffective communication between the patient and health care providers hampers the process.
Evidence shows that improving the consent process by ensuring effective communication between the child's parent and health care team affords substantial benefit. A consent process well done strengthens the parent-provider relationship. It positively impacts risk management. It improves patient safety. It diffuses would-be litigants by helping parents have realistic expectations of care. The consent process should allow and encourage parents to exercise both their right and their responsibility to take an active role in their child's health care.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Effectiveness of the Consent Process Used for Outpatient Endoscopy|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Adult parent or legally authorized representative (LAR) of child who has consented to undergo an out-patient endoscopy at Children's Mercy Hospital as a diagnostic procedure
The parent/LAR who has consented to have their child undergo an outpatient endoscopy procedure will be interviewed prior to the procedure being performed.
- determine if the parent/LAR has an understanding of why the endoscopy procedure has been recommended and what it involves [ Time Frame: after obtaining consent for endoscopy but prior to endoscopy procedure ]
- determine if the parent/ LAR has an understanding of the probable benefits and risks associated with endoscopy [ Time Frame: after obtaining consent for endoscopy but prior to endoscopy procedure ]
- determine if the parent/LAR knows who will be present during the procedure [ Time Frame: after obtaining consent for endoscopy but prior to endoscopy procedure ]
- determine if the parent/LAR has an understanding of the importance of the consent process [ Time Frame: after obtaining consent for endoscopy but prior to endoscopy procedure ]
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): NCT00630136
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Nancy A Neilan, MT (ASCP)||Children's Mercy Hospital Kansas City|