N/A
N=142
Improving Informed Consent in Pediatric Endoscopy
Informed Consent · Procedural State Anxiety · Subject's Satisfaction
Bottom Line
View on ClinicalTrials.gov: NCT00899392 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Attainment of Informed Consent as Measured by Consent Instrument (Consent-20) — 37.36; 33.2 Units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Emmi Pediatric Upper Endoscopy Patient Education Module (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Attainment of Informed Consent as Measured by Consent Instrument (Consent-20) |
37.36; 33.2 | <0.0001 sig |
| SECONDARY Subject (Parental) Satisfaction as Measured by Modified Group Health Association of America-9 Survey (mGHAA-9) |
41.79; 41.46 | >0.05 |
| SECONDARY Subject (Parental) State Anxiety as Measured by the Spielberger-State Trait Anxiety Inventory (s-STAI) (State Section) |
42.17; 37.17; 38.77; 33.76 | >0.05 |
| SECONDARY Questions Asked by Subjects (Parents) |
2.03; 3.06 | 0.0053 sig |
| SECONDARY GI Suite Flow Efficiency Measured in 15 Minute Increments |
— | — |
Summary
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.
Eligibility Criteria
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.
Exclusion Criteria
- Does not speak or understand English
- Does not give consent to participate
- Does not complete consent instrument at a minimum during study
Data sourced from ClinicalTrials.gov (NCT00899392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.