Results Summary

What was the research about?

Appendicitis occurs when the appendix, a part of the intestine, becomes infected. Appendicitis can cause stomach pain and vomiting. If the infection isn’t treated, it can lead to serious complications. Caregivers—parents or guardians—usually find out children have appendicitis when they bring them to the emergency room, or ER, for these symptoms.

Surgery and antibiotics are two options to treat appendicitis that is in early stages. These options have different benefits and harms. Surgery is effective, but children may miss one or two weeks of school. Antibiotics often work and avoid the discomforts of surgery. But some patients still need surgery later. Choosing a treatment can be stressful because caregivers need to decide soon after the doctor gives the diagnosis.

In this study, the research team created an app on a tablet computer to help caregivers make informed, confident decisions. The app explained treatment benefits and harms. The app also showed videos of caregivers making treatment decisions.

What were the results?

Caregivers and children who used the app didn’t differ from caregivers and children who didn’t use the app in

  • How often caregivers chose each treatment
  • Caregiver confidence in the treatment decision
  • Caregiver satisfaction with the child’s medical care
  • Number of days caregivers took off work and children missed school
  • Number of return visits to the hospital

Who was in the study?

The study included 200 pairs of children and caregivers. The children were 7 to 17 years old and were diagnosed with early appendicitis. The children received care at an ER in Ohio. Of these children, 87 percent were white, 7 percent were African American, 4 percent were multi-race, and 4 percent were another race or their race was unknown. Also, 5 percent were Hispanic. The average age was 12 years, and 60 percent were boys.

What did the research team do?

After diagnosis, the research team assigned the pairs by chance to one of two groups. In one group, a doctor talked with the pairs about treatment options. In the other group, the pairs used the app to help them choose a treatment. Then they had the same type of conversation with a doctor as pairs in the first group did.

Right after making their treatment decision, caregivers took a survey about their confidence in that decision. After children left the hospital, their caregivers took a survey about satisfaction with care. Thirty days after making the treatment decision, the caregivers took these surveys again. A year later, the caregivers reported how many work and school days they or their children missed because of treatments. The team also tracked how often children went back to the hospital in that year.

Patients, caregivers, and healthcare providers helped design the app and plan the study.

What were the limits of the study?

It’s possible that the doctors talked about information from the app with patients who had only a conversation about treatment. Also, the conversation may have given more information than ERs usually give to caregivers. After the conversation, caregivers may have had all the information they needed to feel confident in their decisions. These factors may have led to the lack of differences in results between groups.

In the future, researchers can test the app with patients in more sites with patients in each group receiving care from different doctors.

How can people use the results?

Both apps and consultations may be effective ways to help caregivers make decisions with doctors in the ER about how to treat appendicitis.

Final Research Report

View this project's final research report.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:

  • Reviewers asked the researchers to elaborate on the methodological limitations of the study, since they found no difference in outcomes between the intervention and control groups. The researchers expanded their discussion of limitations, including a note that t the lack of baseline measurement of outcomes limited their comparisons for determining how much outcomes improved after the intervention. In addition, the post-intervention outcome measures were high in both groups, indicating a ceiling effect and not much room for improvement. Finally, in response to stakeholder input, the researchers compared the intervention group to best available standard care rather than usual care, reducing the differences in care delivery between groups.
  • Reviewers asked why the researchers completed the study if an interim analysis could have shown that the patient activation tool seemed to have no measurable efficacy. The researchers said they decided to complete the project after an analysis halfway through the study in order to make sure that the patient activation tool had no negative effects. They also completed the project because they thought the patient activation tool might lead to fewer disability days, one of the outcomes being measured. The researchers noted that a PCORI team reviewed the interim results and agreed with the researchers that it would be useful to complete the trial.
  • Reviewers asked the researchers to elaborate their rationale for the study and why they thought that a computational tool would lead to better results than talking with an experienced clinician alone. The researchers explained that the patient activation tool included additional features compared to the standardized consultation. The additional features included video explanations for the risks and benefits of different treatment options and interactive exercises to help patients prioritize the risks and benefits of each treatment. Ultimately, both groups took about 20 minutes for each intervention, a clinician consultation versus a consultation plus use of the patient activation tool.

Conflict of Interest Disclosures

Project Information

Katherine Deans, MD
The Research Institute at Nationwide Children's Hospital
$1,621,341
10.25302/02.2020.CE.12114350
Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis

Key Dates

May 2013
December 2018
2013
2018

Study Registration Information

Tags

Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: April 11, 2024