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Randomized controlled trial of a patient activation tool in pediatric appendicitis
Investigator (PI): Deans, Katherine
Performing Organization (PO): (Current): Nationwide Children's Hospital, Research Institute / (614) 722-2000
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2013
Final Year: 2018
Record Source/Award ID: PCORI/CE-12-11-4350
Funding: Total Award Amount: $1,680,020
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: 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: The objective is 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 health care 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; and will have similar disability days, length of stay, readmissions, and medical complications. More on this project: (1) 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. (2) 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.
MeSH Terms:
  • Adolescent
  • Appendicitis /*drug therapy
  • /*surgery
  • Caregivers
  • Child
  • Decision Making
  • Decision Support Systems, Clinical
  • Humans
  • Outcome Assessment (Health Care)
  • Parents
  • Patient Education as Topic /*methods
  • * Patient Participation
  • Patient Readmission
  • Patient Satisfaction
  • Patient-Centered Care
  • Pediatrics /*methods
  • Quality of Life
  • Randomized Controlled Trials as Topic
Country: United States
State: Ohio
Zip Code: 43205
UI: 20143280
CTgovId: NCT02110485
Project Status: Completed
Record History: ('2017: Project extended to 2017.',) ('2018: Project extended to 2018.',)