This trial is active, not recruiting.

Conditions appendicitis, children
Treatment patient activation tool
Sponsor Peter Minneci
Collaborator Patient-Centered Outcomes Research Institute
Start date March 2014
End date June 2017
Trial size 200 participants
Trial identifier NCT02110485, 4350, IRB13-00335


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose treatment
Patients and their caregivers will receive the patient activation tool in addition to standard consultation
patient activation tool
An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision.
(No Intervention)
Patients and their caregivers will receive standard consultation alone

Primary Outcomes

Decision Self-Efficacy
time frame: 1 hour
Healthcare satisfaction
time frame: 1 day
Disability Days
time frame: 1 year folow-up

Secondary Outcomes

Caregiver activation level
time frame: 1 hour
Readmission rate
time frame: 1 year
Health related quality of life (HRQOL)
time frame: 30 day follow-up

Eligibility Criteria

Male or female participants from 7 years up to 17 years old.

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

Additional Information

Official title Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis to Determine Choice Between Antibiotics Alone vs. Appendectomy
Principal investigator Katherine J Deans, MD
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Nationwide Children's Hospital.