Effectiveness of the Champs Intervention on Asthma Symptoms As Implemented in Diverse Underserved Communities

Introduction: Evidence-based interventions (EBIs) for management of chronic diseases, such as asthma, are often translated into real-world practice with limited-to-no evaluation. This has made it difficult to assess if interventions from efficacious clinical trials retain efficacy when implemented in a real-world setting.  The CHAMPS study was designed to translate and evaluate EBIs from 2 successful NIH asthma clinical trials when adopted by FQHC primary care practices serving diverse and underserved populations.  The EBIs were:  1) the National Cooperative Inner City Asthma Study (NCICAS), and 2) the Inner City Asthma Study (ICAS), all of which were conducted in minority, low income, urban populations. A third study, the Head-off Environmental Asthma in Louisiana (HEAL), previously adapted components of these two evidence-based interventions into a novel, field-applicable, asthma counselor and environmental intervention to provide support for families with asthma in the aftermath of Hurricane Katrina.

Methods: Investigators from the Statistical and Clinical Coordinating Center for NCICAS/ICAS/HEAL (Rho) worked along with experts in health policy at George Washington University (GWU) and clinicians at 3 FQHCs to identify key components of the EBI to implement and evaluate for CHAMPS in a primary care setting.  In addition, traditional clinical trial protocols, including centralized training, quality control monitoring, manual of operations, case report forms, clinical data management, and participant recruitment and retention strategies were identified by Rho and considered by CHAMPS investigators, but not all were adapted.  Through careful collaboration with our research partners, we were able to translate many of the elements from our clinical trials into the CHAMPS program while still being flexible enough to adapt to the unique needs of the clinic healthcare setting.  We targeted 600 low-income and underserved pediatric patients with poorly-controlled, moderate-to-severe asthma (300 intervention; 300 comparison), from 6 FQHCs located in 3 states/jurisdictions.

Results: We compared morbidity between children receiving the CHAMPS intervention and comparison children and found that the intervention is effective in reducing symptoms.  Furthermore, when we compared results between each intervention/comparison FQHC pair in each jurisdiction, we found variation in the strength of the results, which can be explained, in part, by differences in adoption and implementation.  

Conclusions: Our experience shows that it is possible to successfully implement and evaluate clinical trial results in primary care settings that provide care to diverse and underserved populations. In addition, our study demonstrates that EBI for childhood asthma can remain effective in real world practices.