Informed Consent Clinical Trial
Official title:
Improving Informed Consent and Assent in Pediatric Endoscopy
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.
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)
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01546194 -
A Survey of Patient's Attitudes Towards Consent For Clinical Research In Anesthesiology
|
||
Completed |
NCT05505058 -
One-time Informed Consent for Research in Prison
|
N/A | |
Recruiting |
NCT06140043 -
Augmented Reality for Orthognatic Surgery Patient Education
|
Phase 2/Phase 3 | |
Completed |
NCT01933139 -
Informed Consent for Hysterectomy: Effectiveness of Audio-visual Presentations on Patient Comprehension
|
N/A | |
Completed |
NCT00032565 -
EQUIC-SM: Enhancing Quality of Informed Consent
|
N/A | |
Completed |
NCT01778582 -
Perspective-taking, and Examining the Clinical Trial Informed Consent Process
|
||
Not yet recruiting |
NCT06104137 -
MOOC Applications Related to Shared Decision Making in Bariatric Surgery
|
N/A | |
Not yet recruiting |
NCT04614688 -
Assessing the Impact of a Patient Education Platform to Augment the Informed Consent Process for Obstetrics and Gynecology Procedures
|
N/A | |
Withdrawn |
NCT02799407 -
Electronic Consent of Numerous Subjects Employing Novel Techniques Trial
|
N/A | |
Completed |
NCT03960723 -
Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures
|
||
Completed |
NCT03555760 -
Patients' Readings of Pre-operative Informed Consent Forms
|
||
Completed |
NCT03405766 -
Barriers in the Process of Achieving Informed Consent From Critically Ill Patients
|
||
Recruiting |
NCT06192511 -
Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening
|
N/A | |
Completed |
NCT02541799 -
Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium
|
Phase 2 | |
Completed |
NCT01635842 -
Informed Consent and Clinical Trials
|
N/A | |
Withdrawn |
NCT02332837 -
Interactive Tool for Informed Consent
|
N/A | |
Completed |
NCT02885532 -
Capacity to Consent in Acutely Intoxicated Emergency Department Patients
|
N/A | |
Completed |
NCT03503487 -
Surgical Planning and Informed Consent
|
N/A | |
Completed |
NCT04627597 -
Patients' Comprehension and Internalization of Operative Consent Form
|
||
Completed |
NCT04493866 -
Quality Improvement Study on Operative Consent Forms
|