Effectiveness of the Consent Process

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00630136
First received: February 27, 2008
Last updated: March 23, 2010
Last verified: October 2008
  Purpose

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.


Condition Intervention
Parental Consent
Behavioral: interview

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Effectiveness of the Consent Process Used for Outpatient Endoscopy

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • determine if the parent/LAR has an understanding of why the endoscopy procedure has been recommended and what it involves [ Time Frame: after obtaining consent for endoscopy but prior to endoscopy procedure ] [ Designated as safety issue: Yes ]
  • determine if the parent/ LAR has an understanding of the probable benefits and risks associated with endoscopy [ Time Frame: after obtaining consent for endoscopy but prior to endoscopy procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • determine if the parent/LAR knows who will be present during the procedure [ Time Frame: after obtaining consent for endoscopy but prior to endoscopy procedure ] [ Designated as safety issue: No ]
  • determine if the parent/LAR has an understanding of the importance of the consent process [ Time Frame: after obtaining consent for endoscopy but prior to endoscopy procedure ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: February 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Gastroenterology primary care clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630136

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Nancy A Neilan, MT (ASCP) Children's Mercy Hospital Kansas City