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

Not Applicable

Completed

Conditions: Appendicitis
Children

Interventions: Other: Patient Activation Tool

Registration Number: NCT02110485

Lead Sponsor: Peter Minneci

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Activation Tool	Patient Activation Tool	Patients and their caregivers will receive the patient activation tool in addition to standard consultation

Primary Outcome Measures

Name	Time	Method
Decision Self-Efficacy Scale	1 hour following decision	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
PedsQL 3.0 Healthcare Satisfaction Generic Module (Parent Report)	1 day from enrollment	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
Disability Days	1 year folow-up	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.

Secondary Outcome Measures

Name	Time	Method
Patient Activation Measure (PAM)	1 hour	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.
Number of Participants Readmitted	1 year	Readmissions rates to any hospital within 1 year wil be assessed
PedsQL Pediatric Quality of Life Inventory and PedsQL Family Impact Module Scales	30 day follow-up	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