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Completed

NCT Number: NCT02110485

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

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.

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Activation Tool

Other

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.

Primary outcomes

  1. Decision Self-Efficacy Scale

    Time frame: 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

  2. PedsQL 3.0 Healthcare Satisfaction Generic Module (Parent Report)

    Time frame: 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

  3. Disability Days

    Time frame: 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 outcomes

  1. Patient Activation Measure (PAM)

    Time frame: 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.

  2. Number of Participants Readmitted

    Time frame: 1 year

    Readmissions rates to any hospital within 1 year wil be assessed

  3. PedsQL Pediatric Quality of Life Inventory and PedsQL Family Impact Module Scales

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Peter Minneci

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: Appy-PAT

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Apr 10, 2014
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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