Results Summary
What was the research about?
Asthma is a common illness that makes it hard to breathe. When children’s asthma is not well controlled, they may need to miss school or limit their daily activities in other ways. Latino children are more likely to have asthma than are non-Latino White children.
Families who live in rural areas often don’t have access to care to help children control their asthma. In this study, the research team created and tested three programs for Latino children living in rural areas:
- A community program with a countywide media campaign about asthma. The program also tested air quality in schools and held a public meeting about clean air and health.
- A family program with community health workers who talked with families at their homes or by phone. They spoke English or Spanish. Families also received learning materials, a device to test children’s breathing, and asthma-safe cleaning supplies.
- A clinic program with asthma educators and case managers who helped patients manage asthma. Clinic staff also received training on asthma care and a new way to keep health records.
The research team compared children in four study groups:
- Community program only
- Community program plus family program
- Community program plus clinic program
- Community program plus family and clinic programs
What were the results?
Children in the community program only, the family program, or the family and clinic program didn’t differ in asthma symptoms, unplanned doctor visits, emergency room visits for asthma, or quality of life related to asthma.
Children in the clinic program—with or without the family program—had fewer unplanned doctor visits than those who weren’t in the clinic program.
Who was in the study?
The study included 400 Latino children ages 6–17 with asthma living in a rural area on the border of California and Mexico. The average age of children was 11, and 59 percent were boys. The average age of caregivers was 39, and 95 percent were women.
What did the research team do?
The research team assigned children by chance to receive the family program or not. Children received the clinic program if they were patients at one of three study clinics offering the program. Those receiving care at the other 12 clinics in the study didn’t receive the clinic program. All children had access to the community program.
Caregivers and children at least nine years old completed surveys at the start of the study and again one year later. The research team compared the programs after one year.
Children, caregivers, and community members gave input on the study.
What were the limits of the study?
The research team didn’t assign children by chance to the clinic program. As a result, the team can’t say for sure if the changes in unplanned doctor visits were because of the clinic program.
Future research could assign children by chance to receive the clinic program to learn whether results are because of the program.
How can people use the results?
Communities and clinics can refer to these methods and results when considering ways to improve asthma control for Latino children.
| How this project fits under PCORI’s Research Priorities PCORI identified asthma in African American and Hispanic/Latino populations as an important research topic. Patients, clinicians, and others wanted to learn how to encourage care that follows national asthma guidelines and improves patient-centered outcomes for African American and Hispanic/Latino populations. In 2013, PCORI launched an initiative on Treatment Options for African Americans and Hispanics/Latinos with Uncontrolled Asthma. The initiative funded this research project and others. |
Professional Abstract
Objective
To compare the effectiveness of asthma management programs for communities, clinics, and families on improving asthma control and quality of life (QoL) among Latino youth who live in rural areas and their caregivers
Study Design
| Design Element | Description |
|---|---|
| Design | 2x2 factorial design |
| Population | 400 Latino youth ages 6–17 with mild, moderate, or severe persistent asthma and their caregivers; all youth lived in rural areas |
| Interventions/ Comparators |
|
| Outcomes | Youth- and caregiver-reported asthma control (symptom frequency, unplanned asthma-related doctor visits, asthma-related emergency department visits); youth- and caregiver-reported asthma-related QoL |
| Timeframe | 1-year follow-up for primary outcomes |
This 2x2 factorial study nested within a community intervention compared approaches to improving asthma control and QoL among Latino youth who lived in rural areas and their caregivers. Researchers created three asthma management programs:
- The community program included a countywide media campaign to increase asthma awareness, a school air quality testing program, and access to a conference on environmental health.
- The family program included community health workers (CHWs) trained in asthma management. CHWs conducted four 60-minute home visits and four 10-minute phone calls and mailed four newsletters to each family over two months. They spoke in English or Spanish. CHWs also provided resources including a backpack of educational materials, a peak flow meter, and asthma-safe cleaning supplies.
- The clinic program included increased case management, asthma care training for staff, new electronic health record procedures, and four additional part-time asthma educators to support clinical care at 3 of the 15 study clinics.
All youth participating in the study lived in the county where researchers implemented the community program. Researchers randomized youth to either receive the family program or not. Youth received the clinic program if they were patients at one of the three study clinics implementing the program. Youth receiving care at the remaining 12 clinics in the study did not receive the clinic program. This approach resulted in four study groups:
- Community program only
- Community program plus family program
- Community program plus clinic program
- Community program plus family and clinic programs
The study included 400 Latino youth with mild to severe asthma in an inland rural county on the California-Mexico border. The average youth age was 11, and 59% were male. The average caregiver age was 39, and 95% were female.
Youth who were at least nine years old and caregivers completed surveys to assess study outcomes at baseline and again one year later.
Youth, caregivers, and community members provided input on the study.
Results
Youth receiving the community program only, the family program, or both the family and clinic programs did not differ significantly on any outcomes.
Youth who received the clinic program—with or without the family program—had fewer unplanned doctor visits than youth who did not receive the clinic program (p<0.05).
Limitations
Because researchers were unable to randomly assign youth to the clinic program, it is not possible to attribute changes in unplanned doctor visits to the clinic program with certainty.
Conclusions and Relevance
Youth who received the clinic program had fewer unplanned doctor visits. The clinic and family programs did not improve other asthma control or QoL outcomes.
Future Research Needs
Future research could randomly assign youth to the clinic program.
| How this project fits under PCORI’s Research Priorities PCORI identified asthma in African American and Hispanic/Latino populations as an important research topic. Patients, clinicians, and others wanted to learn how to encourage care that follows national asthma guidelines and improves patient-centered outcomes for African American and Hispanic/Latino populations. In 2013, PCORI launched an initiative on Treatment Options for African Americans and Hispanics/Latinos with Uncontrolled Asthma. The initiative funded this research project and others. |
Final Research Report
View this project's final research report.
Journal Citations
Related Journal Citations
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. Those comments and responses included the following:
- The reviewers asked the researchers to provide information on the minimally clinically important differences for outcome measures to help readers understand what amount of difference between groups would be considered clinically significant. The researchers responded that they were not aware of standards for minimally clinically important differences for their outcome measures but said they will explore this idea further and potentially include such analyses in the future.
- The reviewers noted the inconsistencies in the description of the study design, which initially did not seem to take into account the lack of random assignment to the clinic intervention. The researchers revised the methods, especially for the analytic and statistical methods section of the report. The researchers acknowledged that they had not yet examined outcome differences by clinic site. However, in four previous trials, outcomes from the different clinic sites had not varied significantly, so the researchers did not expect that differences among clinic sites led to different outcomes but said they will examine the issue further.
- The reviewers asked for a discussion of why the researchers decided to include youth with mild persistent asthma in the study after initially not intending to include such patients. The researchers replied that they originally planned to recruit only youth with moderate-to-severe persistent asthma but modified eligibility criteria one month into recruitment for several reasons. First, immediately classifying the severity of asthma in youth was difficult because of discrepancies in the data available. Second, the researchers recognized that patients with mild persistent asthma could also benefit from the planned family and clinic interventions. Third, including youth with mild persistent cases simplified the process for healthcare providers in working with youth with persistent asthma symptoms. Also, the researchers anticipated that recruiting adequate numbers of patient participants might prove challenging if they did not recruit youth with mild symptoms as well as more severe symptoms, so the researchers decided to modify their approach to recruitment early enough to avoid potential biases.