Effectiveness of the Consent Process

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of the Consent Process Used for Outpatient Endoscopy

Conditions
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Parental Consent

Intervention / Treatment
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* Behavioral: interview


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>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 | Behavioral: interview<br>* The parent/LAR who has consented to have their child undergo an outpatient endoscopy procedure will be interviewed prior to the procedure being performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine if the parent/LAR knows who will be present during the procedure |  | 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 |  | after obtaining consent for endoscopy but prior to endoscopy procedure |