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OpenTrials
Completed

NCT Number: NCT00630136

Effectiveness of the Consent Process

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Effectiveness of the Consent Process Used for Outpatient Endoscopy

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 6, 2008
Registry last updated
Mar 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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