Effectiveness of the Consent Process
The purpose of this study is to evaluate the effectiveness of the consent process currently used for outpatient endoscopy procedures at our hospital. Results from this study will be used to assist in making improvements in the way we communicate with parents, thereby enhancing the ability to provide informed consents.
|Study Design:||Observational Model: Ecologic or Community
Time Perspective: Prospective
|Official Title:||Effectiveness of the Consent Process Used for Outpatient Endoscopy|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|