Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis (Antibiotics Alone vs. Appendectomy)



Status:Active, not recruiting
Conditions:Other Indications, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:7 - 17
Updated:10/14/2017
Start Date:March 2014
End Date:August 2017

Use our guide to learn which trials are right for you!

Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis to Determine Choice Between Antibiotics Alone vs. Appendectomy

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.

The objective of this study is to to determine if a patient activation tool (PAT) can improve
decision making and patient centered outcomes in pediatric patients with appendicitis and
their caregivers.

Hypothesis: A PAT that activates patient-caregiver dyads will improve decision making and
patient centered outcomes without compromising medical outcomes in children with
appendicitis. Specifically,the investigators expect the PAT to improve decision self-efficacy
and healthcare satisfaction without increasing disability days.

Methods/Outcomes: The investigators will perform a randomized controlled trial comparing a
PAT to standard surgical consultation in patient-caregiver dyads choosing between either
antibiotics alone or appendectomy for early appendicitis. The investigators will identify
differences in various components of decision making and patient centered outcomes including
caregiver decision self-efficacy, preparedness for decision making, decisional conflict,
decision regret, caregiver activation, caregiver and child satisfaction with care and health
related quality of life (HRQOL), and caregiver and child knowledge. The investigators will
also characterize the effects of a PAT on medical outcomes from appendicitis in patients
receiving the PAT compared to those receiving standard surgical consultation alone. The
investigators will determine differences in disability days, length of stay, readmission
rates, and medical complications related to treatment choice (e.g. infection, recurrence).

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
Exclusion Criteria:

- Positive urine pregnancy test

- Other significant co-morbidities:

- cardiovascular disease

- malignancy

- pulmonary disease

- severe developmental delay
We found this trial at
1
site
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Katherine J Deans, MD
Phone: 614-722-3066
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials