Clinical trial NCT00630136: Effectiveness of the Consent Process
Official title: Effectiveness of the Consent Process Used for Outpatient Endoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parental Consent
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2008-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastroenterology primary care clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: determine if the parent/LAR has an understanding of why the endoscopy procedure has been recommended and what it involves
timeFrame: after obtaining consent for endoscopy but prior to endoscopy procedure
measure: determine if the parent/ LAR has an understanding of the probable benefits and risks associated with endoscopy
timeFrame: after obtaining consent for endoscopy but prior to endoscopy procedure
Secondary outcomes:
measure: determine if the parent/LAR knows who will be present during the procedure
timeFrame: after obtaining consent for endoscopy but prior to endoscopy procedure
measure: determine if the parent/LAR has an understanding of the importance of the consent process
timeFrame: after obtaining consent for endoscopy but prior to endoscopy procedure
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Nancy A Neilan, MT (ASCP)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rozovsky FA, Consent to Treatment: A practical Guide, 4th ed. Aspen Publishers 2007
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.