Effectiveness of the Consent Process

Completed

• Conditions: Parental Consent

• Registration Number: NCT00630136
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-02-27
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Posted: 2008-03-06
• Status Verified: 2008-10
• Last Update Submitted: 2010-03-23
• Last Update Posted: 2010-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult parent or legally authorized representative (LAR) of child who has consented to undergo an out-patient endoscopy at CMHC as a diagnostic procedure
• Ability to converse in English
• Provided implied consent prior to data collection and verbal consent after data collection to participate in this research study

Exclusion Criteria

• Any parent/ LAR under the age of 18 years
• Time constraint or verbally stating they do not wish to provide study data prior to child undergoing endoscopy
• Stating they do not wish to have these data used as study data after completion of the interview

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
determine if the parent/LAR has an understanding of why the endoscopy procedure has been recommended and what it involves	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	after obtaining consent for endoscopy but prior to endoscopy procedure

Secondary Outcome Measures

Name	Time	Method
determine if the parent/LAR has an understanding of the importance of the consent process	after obtaining consent for endoscopy but prior to endoscopy procedure
determine if the parent/LAR knows who will be present during the procedure	after obtaining consent for endoscopy but prior to endoscopy procedure

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States