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.
Professional Abstract
Objective
To determine whether a tablet-based patient-activation app, along with standardized surgical consultation, can help children with appendicitis and their caregivers make informed, confident decisions about treatment compared with standardized surgical consultation alone
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 200 patient–caregiver dyads; patients were ages 7–17 years and were diagnosed with early appendicitis |
| Interventions/ Comparators |
|
| Outcomes | Decision self-efficacy, healthcare satisfaction, missed school days, disability days, ED visits, rehospitalizations |
| Timeframe | Up to 1-year follow-up for study outcomes |
This randomized controlled trial tested the effectiveness of a patient activation app designed to help caregivers and their children with early appendicitis make confident decisions about treatment. The team compared use of the app plus a standardized surgical consultation with the standardized surgical consultation alone.
The study included 200 pediatric patients diagnosed with early appendicitis, along with their caregivers. The patients received care from a hospital emergency department (ED) in Ohio. After diagnosis, the research team randomized the patient–caregiver dyads to one of two groups. In one group, patient–caregiver dyads received a standardized surgical consultation about treatment options from a physician on the research team. In the second group, patient–caregiver dyads received the standardized surgical consultation and used the app. The app presented the risks and benefits of each treatment option and included videos of patients and caregivers making decisions about treatment options, either inpatient antibiotic treatment or surgical removal of the appendix.
Of the patients, 87% were white, 7% were African American, 4% were more than one race, 3% were other or unknown, 1% were Asian, and 5% were Hispanic. The average patient age was 12, and 60% were male.
Immediately after deciding on a treatment, caregivers took a survey about their decision self-efficacy. After patient discharge, caregivers took a survey about healthcare satisfaction during hospitalization. Thirty days after deciding about treatment options, caregivers took the same surveys about decision self-efficacy and satisfaction during hospitalization. The research team looked at health records and interviewed children and their caregivers to determine the number of school days children missed, disability days caregivers took, and hospital readmissions in the year following treatment.
Six patient–caregiver dyads and five healthcare providers helped create the app and design the study.
Results
Scores for decision self-efficacy and preparation for decision making were significantly (p=0.03) higher for the consult-only group immediately after treatment decision compared with the group that used the app. However, both groups had high scores, and the differences were not clinically meaningful.
The group that used the app and the consult-only group did not differ in treatment chosen, healthcare satisfaction, number of school days missed or disability days taken, and return ED visits and hospitalizations.
Limitations
The same research physicians conducted the consultations in both groups. They may have included information from the app in all of their consultations. The standardized consultation may also have been more intensive than usual care for appendicitis in typical ED practice. These factors may have contributed to the finding of few differences in outcomes between groups.
Conclusions and Relevance
The research team found that adding use of the app to a standardized consultation did not lead to any differences in patient-reported or medical outcomes.
Future Research Needs
Future research can include multiple sites to reduce the possibility of both groups receiving the same intensity of consultation.
Final Research Report
View the final research report.
Journal Citations
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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.