Community Healthcare for Asthma Management and Prevention of Symptoms

Study Overview
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Brief Summary
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The purpose of this study is to systematically investigate across health center study sites participating in this study the process of adopting, integrating, implementing, and diffusing a minimum set of evidence-based interventions for the management of childhood asthma. Investigators hypothesized that an intervention that is evidence- and consensus-based (i.e., minimum elements to be integrated into existing practice, dosing of each element) would be implemented effectively, as measured by health center performance improvement on child health outcomes, health care utilization, and other measures (e.g., avoidable costs).

Detailed Description
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In this study, investigators combined childhood asthma counseling and environmental interventions proven effective in previous NIH-funded clinical trials, the National Cooperative Inner-City Asthma Study (NCICAS) and the Inner-City Asthma Study (ICAS), and a third study, Head-off Environmental Asthma in Louisiana (HEAL). These studies demonstrated that participant-tailored interventions reduce asthma morbidity. Through a process of consensus building, investigators adapted a hybrid of these interventions for use in primary care clinics located in medically underserved areas (FQHCs). Investigators recruited participants ages 5-12 years with poorly controlled, moderate-to-severe asthma to ensure comparability with previous studies. Unlike the earlier clinical trials, which limited eligibility to inner-city children in stable housing, CHAMPS enrolled participants regardless of housing situation (e.g., temporary/shared homes) and location (e.g., urban/rural). Investigators collaborated with 3 FQHCs in Arizona, Michigan, and Porto Rico to enroll children and implement the CHAMPS intervention but otherwise granted them discretion to make decisions about staffing, patient flow and other process determinations, while tracking what those entailed. Investigators also invited 3 additional FQHCs to recruit and enroll children in a comparison group that did not receive the intervention. The primary aim is to identify and understand barriers and solutions to the adaptation of an evidence-based asthma intervention at the system-level. The evaluation consists of determining how a system makes room for an intervention, identifying stakeholders to make it happen, documenting the process for replication, and monitoring processes and outcomes to ensure the integrity of the intervention remains intact. The process of implementation in the unique clinical settings presented by health centers will be described, including the facilitators and the barriers to the systematic adoption of an evidence-based childhood asthma intervention into routine practice. Of particular importance are those determinants related to in-home and community-based environmental risks, the limits of understanding on the part of parents and caretakers, and community-wide policies and practices that may create health risks. The secondary aim is to assess the effectiveness and cost-effectiveness of the evidence-based asthma intervention as implemented in health centers. The third and final aim is to develop a dissemination strategy and some tools for further take up of the intervention.

Official Title
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A Study of the Feasibility and Effectiveness of Implementing and Diffusing an Evidence-based Childhood Asthma Management Intervention in Community Health Centers

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: CHAMPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of asthma Currently receiving long-term asthma control therapy and either has symptoms consistent with persistent asthma or has evidence of uncontrolled disease or is not currently receiving long-term asthma control therapy and has symptoms consistent with persistent asthma and also has evidence of uncontrolled disease Caretaker speaks English or Spanish Exclusion Criteria: Younger or older children Mild, intermittent asthma

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CHAMPS Intervention<br>Tailored asthma education and counseling for children with moderate to severe asthma who have confirmed allergies to environmental triggers present in their homes provided through a combination of clinic and home visits | Behavioral: CHAMPS<br> <br> |
| No Intervention: Usual Care<br>Usual asthma care and management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma symptoms | Reduction in asthma symptom days in the past 4 weeks as measured by the Asthma Symptoms and Utilization (ASU) questionnaire | In the past 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilization of health care services | Reduction of utilization of Emergency Departments and hospitalizations in the past 12 months as measured by the Asthma Symptom and Utilization (ASU) questionnaire | In the past year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Evidence-based intervention, Implementation, Underserved communities