Effectiveness of the Consent Process

NCT00630136 | Completed

• 1 other identifier: CMH080104
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parental Consent

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

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

Interventions

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.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gastroenterology primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (6)

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

  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.

  PMID: 9487325 BACKGROUND

• 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.

  PMID: 15610334 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.

  PMID: 16881949 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.

  PMID: 7360175 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.

  PMID: 8490411 RESULT

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nancy A Neilan, MT (ASCP)

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 6, 2008
• Study Start: February 1, 2008
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 24, 2010

Record last verified: 2008-10

Locations

US (1)