Clinical trial NCT02110485: Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis (Antibiotics Alone vs. Appendectomy)
Official title: Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis to Determine Choice Between Antibiotics Alone vs. Appendectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Children
Keywords: Appendicitis
Pediatric
Children
Non-operative
Antibiotics alone
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-04-10
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

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

Primary outcomes:
measure: Decision Self-Efficacy Scale
timeFrame: 1 hour following decision
measure: PedsQL 3.0 Healthcare Satisfaction Generic Module (Parent Report)
timeFrame: 1 day from enrollment
measure: Disability Days
timeFrame: 1 year folow-up
Secondary outcomes:
measure: Patient Activation Measure (PAM)
timeFrame: 1 hour
measure: Number of Participants Readmitted
timeFrame: 1 year
measure: PedsQL Pediatric Quality of Life Inventory and PedsQL Family Impact Module Scales
timeFrame: 30 day follow-up
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Katherine J Deans, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Minneci PC, Nacion KM, Lodwick DL, Cooper JN, Deans KJ. Improving Surgical Research by Involving Stakeholders. JAMA Surg. 2016 Jun 1;151(6):579-80. doi: 10.1001/jamasurg.2015.4898. No abstract available.
citation: Minneci PC, Cooper JN, Leonhart K, Nacion K, Sulkowski J, Porter K, Wei L, Deans KJ. Effects of a Patient Activation Tool on Decision Making Between Surgery and Nonoperative Management for Pediatric Appendicitis: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jun 5;2(6):e195009. doi: 10.1001/jamanetworkopen.2019.5009.