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

Peter Minneci

Status: Completed

Conditions: Appendicitis; Children

Treatments: Other: Patient Activation Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT02110485

IRB13-00335

4350

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Patient Activation Tool

Experimental group

Description:

Patients and their caregivers will receive the patient activation tool in addition to standard consultation

Treatment:

Other: Patient Activation Tool

Standard Consultation

No Intervention group

Description:

Patients and their caregivers will receive standard consultation alone