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

Study Overview
=================
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).

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

Conditions
-----------------
Appendicitis, Children

Intervention / Treatment
-----------------
* Other: Patient Activation Tool


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Activation Tool<br>Patients and their caregivers will receive the patient activation tool in addition to standard consultation | Other: Patient Activation Tool<br>* 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.<br>|
| No Intervention: Standard Consultation<br>Patients and their caregivers will receive standard consultation alone | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision Self-Efficacy Scale | Decision Self-Efficacy will be measured using the Decision Self-Efficacy Scale which measures the participant's confidence in their ability to make decisions and consists of 11 questions regarding different aspects of decision making. This will be measured 1 hour after treatment decision has been made. The scale is a 5 point scale ranging from 0-not at all confident to 4-very confident. Higher scores are better. Scoring includes summing all items, dividing by 11; and multiplying by 25. A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy | 1 hour following decision | 
| PedsQL 3.0 Healthcare Satisfaction Generic Module (Parent Report) | Healthcare satisfaction will be measured at the time of discharge (average 1-2 days) using the PedsQL 3.0 Healthcare Satisfaction Generic Module- Parent Report. This survey measures the parent's satisfaction with the care their child received and measures six dimensions (information, inclusion of family, communication, technical skills, emotional needs, and overall satisfaction) using 24 items. Parents chose a score from 0-4; 0=never happy; 1=sometimes happy; 2=often happy; 3=almost always happy; 4=always happy, followed by the ability to respond not applicable Subscale scores are not reported If not applicable is chosen, the item is not scored nor included n the final sum. Scoring is based on a total sum for all items as well as a subscale sum for each of the 6 dimensions. Higher scores are better. Total scores range from 0-96 | 1 day from enrollment | 
| Disability Days | Disability days will be assessed at 1 year follow-up. Disability days is a composite of inpatient hospital days, emergency department visits, primary care physician visits and all days with limited activities referable to their appendicitis. | 1 year folow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Activation Measure (PAM) | Parent activation will be assessed with the Patient Activation Measure® (Parent-PAM®) using a version of healthy child parent PAM® adapted with permission. This 13 item scale and was derived from the short form version of the Patient Activation Measure®. The Parent-PAM® is used to assess the parent's activation in the management of their child's health. The 13 items have response options ranging from 1=strongly disagree to 4 strongly agree with an option to respond as not applicable. A total PAM score is calculated by summing all items and dividing by the number of items answered and multiplied by 13; total scores can range from 13-52. This score is transformed to a scale ranging from 0-100 with higher PAM scores indicating higher patient activation. | 1 hour | 
| Number of Participants Readmitted | Readmissions rates to any hospital within 1 year wil be assessed | 1 year | 
| PedsQL Pediatric Quality of Life Inventory and PedsQL Family Impact Module Scales | The PedsQL Pediatric Quality of Life Inventory is a 23 item survey with response options offered on a 5 point scale; 0= never been a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem. A total score is summed for each of the 4 dimensions as well as an overall score for the entire measure. The PedsQL Family Impact Module Scales include subscales: physical functioning; emotional functioning; social functioning; cognitive functioning; communication; worry; family functioning; daily activities; and family relationships. The options for this 5-point scale range from 0= never a problem to 4=always a problem). Items are reverse-scored and high scores indicate better family functioning. A total summed score is utilized. Each subscale can be summed individually and divided by the number of items in that. Total scores for this measure range from 0-92 | 30 day follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appendicitis, Pediatric, Children, Non-operative, Antibiotics alone