Improving Informed Consent in Pediatric Endoscopy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-03-31

Brief Summary

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Informed consent/assent in pediatric medicine is an accepted and important practice that has been rarely studied, tested for quality, or optimized for patient satisfaction. In the pursuit of enhancing and studying pediatric care, the investigators propose, as pediatric gastroenterologists, assessing the current state of parental and adolescent consent/assent in upper gastrointestinal endoscopy and offering a computer based education program to improve it. The investigators will look at outcomes that include anxiety, satisfaction, attainment of informed consent, and patient flow efficiency in a GI endoscopy suite.

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Detailed Description

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Two hundred first-time upper endoscopy patients from The Children's Hospital of Philadelphia will be prospectively selected for participation in the study. One hundred subjects will then be randomized to participate in either the standard consent arm or the electronic assisted informed consent (EAIC) arm. The electronic assisted informed consent web module is a professionally designed program by Emmi Solutions, LLC. Adolescents, if present and greater than 13 years of age, will undergo the program apart from their parent as a separate subgroup not included in the 100 randomized subjects. At time of endoscopy scheduling, the scheduler will ask the subjects if they would like to participate in the study. If interest is expressed the study coordinator or PI will contact the subject to explain the study and inform them of the study parameters. At time of phone contact, consent or assent via a verbal method will be performed. Once verbal consent is given by the subject or verbal assent by the adolescent subject they will follow the protocol. No incentives will be given to the subjects. Institutional Review Board (IRB) approval will be obtained.

Between 24 and 48 hours prior to endoscopy, the participant will have the option to access the web-based module outside the hospital or through a hospital-based kiosk. The web address used is http://www.pedsgiconsent.com. Just prior to starting the module, a five-minute electronic pre-intervention test will be given and its results recorded in an electronic database. This will gather demographic and pre-intervention state anxiety without personal identifying information. After the survey is complete, the educational module will be accessed. Upon completion, the subjects will print a confirmatory document of completion and a list of questions to hand to their physician at time of endoscopy. Hand written questions will also be permitted. Non-EAIC participants will perform a non-educational web program not related to gastroenterology and also have their endoscopy questions printed to give to their physician. The questions and confirmation sheet will also be presented to their physician at time of procedure. Participants will also have space to write further questions by hand on the form. The questions collected will be used to assess number and complexity of questions asked as influenced by the education program. The web module will record time duration taken for the program. After completing the program, the participants will report to the GI suite as previously scheduled. The procedure will occur without either the practitioner or nursing staff knowing in which arm of the study the participants are enrolled. After the questions are answered and formal GI endoscopy procedural consent is obtained, the question sheet will be deposited in a lock box in the endoscopy suite for review at a later time. Total time spent in the endoscopy suite will be recorded. Prior to the patient's endoscopy, but after formal consent is obtained, the participant will then take a ten minute electronic post-test to ascertain satisfaction (mGHAA-modified-Group Health Association of America Survey-9), change in state anxiety \[s-STAI-(Spielberger-State Trait Anxiety Inventory (state section)\], and change in understanding of consent parameters achieved. Satisfaction will be measured using the validated modified Group Health Association of America-9 Survey (mGHAA-9). It is a well-validated instrument used to measure patient satisfaction in adult endoscopy. Probing questions to evaluate the attainment of consent will be based on a modified survey taken from Woodrow's study titled, "How Thorough is the Process of Informed Consent Prior to Outpatient Gastroscopy?"(Consent-20)

Conditions

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Informed Consent Procedural State Anxiety Subject's Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Electronic Assisted Consent

Standard procedural consent performed by pediatric gastroenterologist plus assistance from computerized emmi module.

Group Type EXPERIMENTAL

Emmi Pediatric Upper Endoscopy Patient Education Module

Intervention Type OTHER

Emmi Pediatric Upper Endoscopy Patient Education Module as designed by EMMI SOLUTIONS, LLC

Control Consent

Standard procedural consent as performed by pediatric gastroenterologists

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Emmi Pediatric Upper Endoscopy Patient Education Module

Emmi Pediatric Upper Endoscopy Patient Education Module as designed by EMMI SOLUTIONS, LLC

Intervention Type OTHER

Other Intervention Names

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Pediatric Upper Endoscopy Patient Education Module Patient Education Module Upper Endoscopy Patient Education Module Endoscopy Patient Education Module

Eligibility Criteria

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Inclusion Criteria

* Parent of child undergoing 1st, elective, outpatient, sedated, upper endoscopy (EGD)
* Subject gives consent to participate
* Child of parent does not have a planned endoscopy intervention.