Effectiveness of the Consent Process

Parental Consent Clinical Trial

Official title:

Effectiveness of the Consent Process Used for Outpatient Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630136
• Other study ID #: CMH080104
• Status: Completed
• Phase: N/A
• First received: February 27, 2008
• Last updated: March 23, 2010
• Start date: February 2008
• Est. completion date: March 2008

Study information

• Verified date: October 2008
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parental Consent

Intervention

Behavioral:
• interview
The parent/LAR who has consented to have their child undergo an outpatient endoscopy procedure will be interviewed prior to the procedure being performed.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. Review. — View 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. Review. — View Citation

Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ. 1993 Apr 3;306(6882):885-90. — View Citation

Rozovsky FA, Consent to Treatment: A practical Guide, 4th ed. Aspen Publishers 2007

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. Erratum in: J Gen Intern Med. 2006 Sep;21(9):1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	determine if the parent/LAR knows who will be present during the procedure		after obtaining consent for endoscopy but prior to endoscopy procedure	No
Secondary	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	Yes

External Links

•   Partnership for Clear Health Communication