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You are here

  • Randomized Controlled Trial of a Pati...

Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis

Project Summary  

Background: Patient activation tools (PAT) may improve patient-centered outcomes in emergency care. Emergency surgical procedures present stressful and difficult decisions. This is especially true in children, for whom caregivers must make difficult decisions quickly about the care of their child. Methods that can provide information about treatment choices and empower families to be involved in decision making may allow them to be more confident in their decision making (decision self-efficacy) and be happier with their care (satisfaction). We believe that the PAT described in this proposal can improve decision self-efficacy and satisfaction and may improve medical outcomes in children with appendicitis and their caregivers (patient-caregiver dyads).

Objective: To test if adding an interactive PAT to the routine surgical consultation process will improve outcomes related to decision making and satisfaction with care. Methods: Both the PAT and our proposed study were created in collaboration with a panel of stakeholders including patients, parents, doctors, nurses, and insurers. The computer-based interactive PAT informs patients and caregivers about appendicitis, helps them be more active in guiding their care, and helps them make a treatment decision that is best for them. Study subjects include caregivers and their children age 7–17 years diagnosed with early appendicitis. Each patient-caregiver dyad will be assigned to either standard surgical consultation or consultation plus the PAT. Each patient-caregiver dyad will then choose to treat the appendicitis with either surgery or antibiotics alone. The key outcomes we will measure include decision self-efficacy and satisfaction with care. We will measure other outcomes related to the decision-making process, including their understanding about the risks and benefits of each treatment option (knowledge), if they are comfortable with their decision (decisional conflict), or regret their decision (decision regret). We will also measure the number of days that the patient and caregiver spend away from normal activities (disability days: days in the hospital, days away from school or work, and days away from sports or other activities); quality of life; and medical complications such as infections, recurrence of appendicitis, and readmissions to the hospital. We will include 200 patients in this study (100 patients in each group).

Projected Patient Outcomes: The outcomes in this study represent important parts of the healthcare process that affect the lives of patients and their caregivers. Compared to patient-caregiver dyads receiving standard surgical consultation, we believe that those receiving the PAT will have:

  • Improved decision self-efficacy, knowledge, satisfaction with care, and quality of life and have decreased decisional conflict and decision regret.
  • Similar disability days, length of stay, readmissions, and medical complications.

More on this Project

Minneci PC, Mahida JB, Lodwick DL, Sulkowski JP, Nacion KM, Cooper JN, Ambeba EJ, Moss RL, Deans KJ. Effectiveness of Patient Choice in Nonoperative vs Surgical Management of Pediatric Uncomplicated Acute Appendicitis. JAMA Surg. 2015 Dec 16:1-8. doi: 10.1001/jamasurg.2015.4534. [Epub ahead of print] PubMed PMID: 26676711. (Abstract only available)

Minneci PC, Nacion KM, Lodwick DL, Cooper JN, Deans KJ. Improving Surgical Research by Involving Stakeholders. JAMA Surg. Published online February 10, 2016. doi:10.1001/jamasurg.2015.4898.

Thackeray J, Minneci PC, Cooper JN, Groner JI, Deans KJ. Predictors of Increasing Injury Severity Across Suspected Recurrent Episodes of Non-accidental Trauma: a Retrospective Cohort Study. BMC Pediatr. 2016 Jan 16;16(1):8. doi:10.1186/s12887-016-0540-y. PubMed PMID: 26772185; PubMed Central PMCID: PMC4715331.

Helping Families Make a Big Decision—Fast—about a Child's Appendicitis: A narrative on this project, which notes that while the traditional treatment to remove the appendix is surgery, antibiotics have emerged as an alternative—and researchers are testing an app that may help families quickly choose which option is best for their them.

Project Details

Principal Investigator
Katherine Deans, MD
Project Status
Awarded; In progress-Recruitment complete
Project Start Date
May 2013
Project End Date
December 2017
Organization
The Research Institute at Nationwide Children's Hospital
Year Awarded
2013
State
Ohio
Funding Announcement
Assessment of Prevention, Diagnosis, and Treatment Options
Primary Condition/Disease 
Digestive Systems Diseases
Project Budget
$1,680,020
Study Registration Information
HSRP20143280
NCT02110485
Page Last Updated: 
May 12, 2017

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