Effectiveness of the Consent Process

Effectiveness of the Consent Process Used for Outpatient Endoscopy

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.

Study Overview

• Status: Completed
• Conditions: Parental Consent
• Intervention / Treatment: Behavioral: interview

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Gastroenterology primary care clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City

Publications and helpful links

General Publications

• 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.
• Rozovsky FA, Consent to Treatment: A practical Guide, 4th ed. Aspen Publishers 2007
• 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.
• 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. Erratum In: J Gen Intern Med. 2006 Sep;21(9):1009.
• 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.
• 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.

Helpful Links

• Implementing a National Voluntary Consensus Standard for Informed Consent: A User's Guide for Healthcare Professionals

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: February 27, 2008
• First Submitted That Met QC Criteria: February 27, 2008
• First Posted (Estimate): March 6, 2008

Study Record Updates

• Last Update Posted (Estimate): March 24, 2010
• Last Update Submitted That Met QC Criteria: March 23, 2010
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Other Study ID Numbers: CMH080104