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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interview | Behavioral | The parent/LAR who has consented to have their child undergo an outpatient endoscopy procedure will be interviewed prior to the procedure being performed. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Gastroenterology primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Nancy A Neilan, MT (ASCP) | Children's Mercy Hospital Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Rozovsky FA, Consent to Treatment: A practical Guide, 4th ed. Aspen Publishers 2007 | ||
| 9487325 | Background | Communicating with patients who have limited literacy skills. Report of the National Work Group on Literacy and Health. J Fam Pract. 1998 Feb;46(2):168-76. | |
| 15610334 |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Result |
| Dewalt DA, Berkman ND, Sheridan S, Lohr KN, Pignone MP. Literacy and health outcomes: a systematic review of the literature. J Gen Intern Med. 2004 Dec;19(12):1228-39. doi: 10.1111/j.1525-1497.2004.40153.x. |
| 16881949 | Result | Sudore RL, Landefeld CS, Williams BA, Barnes DE, Lindquist K, Schillinger D. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med. 2006 Aug;21(8):867-73. doi: 10.1111/j.1525-1497.2006.00535.x. |
| 7360175 | Result | Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent -- why are its goals imperfectly realized? N Engl J Med. 1980 Apr 17;302(16):896-900. doi: 10.1056/NEJM198004173021605. |
| 8490411 | Result | Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ. 1993 Apr 3;306(6882):885-90. doi: 10.1136/bmj.306.6882.885. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |