N/A
N=200
Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis (Antibiotics Alone vs. Appendectomy)
Appendicitis · Children
Bottom Line
View on ClinicalTrials.gov: NCT02110485 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Decision Self-Efficacy Scale — 100; 100 units on a scale — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Activation Tool (Other)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Peter Minneci
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decision Self-Efficacy Scale |
100; 100 | 0.03 sig |
| PRIMARY PedsQL 3.0 Healthcare Satisfaction Generic Module (Parent Report) |
98.3; 99.0 | .27 |
| PRIMARY Disability Days |
5; 6 | .67 |
| SECONDARY Patient Activation Measure (PAM) |
91; 100 | .17 |
| SECONDARY Number of Participants Readmitted |
15; 15 | .84 |
| SECONDARY PedsQL Pediatric Quality of Life Inventory and PedsQL Family Impact Module Scales |
88.0; 88.0 | .99 |
Summary
The purpose of this study is to determine if a patient activation tool (PAT) can improve decision making and patient centered outcomes in pediatric patients with appendicitis and their caregivers choosing between antibiotics alone and appendectomy.
Eligibility Criteria
Inclusion Criteria
- Age : 7-17 years
- Ultrasound (US) or Computed Tomography (CT) confirmed early appendicitis:
- US: hyperemia, <1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon
- CT: hyperemia, fat stranding, <1.1 cm in diameter, no abscess, no fecalith, no phlegmon
- White Blood Cell count < 18,000
- C-reactive Protein<4 (if obtained)
- Focal abdominal pain </= 48 hours prior to receiving antibiotics
Exclusion Criteria
- Positive urine pregnancy test
- Other significant co-morbidities:
- cardiovascular disease
- malignancy
- pulmonary disease
- severe developmental delay
Data sourced from ClinicalTrials.gov (NCT02110485). 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.