Gaining and maintaining asthma control in clinical trials: ACET program
Published online: December 5, 2018
Uncontrolled asthma is common, costly and disproportionately affects children from minority groups (predominately African American), low-income families, and single-parent households with financial hardship and familial strain. Successful asthma management is often complex, typically requiring repeated administration of multiple medications, and using complicated devices. National and international evidence-based guidelines have been developed to assist healthcare providers and patients gain control of asthma; however, they are often not implemented.
In a research report recently published in The Journal of Allergy and Clinical Immunology (JACI), Kercsmar and Sorkness, et al describe the development, implementation and performance of a computerized decision support tool to operationalize the National Asthma Education and Prevention Program (NAEPP) asthma guidelines throughout three multicenter clinical trials conducted by the National Institutes of Health (NIH) funded Inner City Asthma Consortium (ICAC). The trials used an innovative, computerized paradigm, the Asthma Control Evaluation and Treatment (ACET) Program to assess asthma control and adjust treatment at regular intervals throughout the trial. The ACET program included measures recommended in the NAEPP guidelines: day and night symptom frequency, short-acting beta agonist (albuterol) rescue use, lung function (FEV1), and systemic corticosteroid treatment of acute exacerbations.
Data were reported on participants in the control groups (non-intervention) in the 3 trials (n=1,443). Participants were ages 6-20 years, predominantly Black or Hispanic and highly allergic. At the screening visit (prior to study entry), less than 30% of participants were rated as well-controlled. Using the ACET algorithms to adjust treatment, the proportion of participants who then gained asthma control between the screening and randomization visits increased significantly in all trials; participants who gained control came from all 3 higher (worse) control levels in similar proportions. Between 51% and 70% were classified as well-controlled at the randomization visit, and the proportion of well-controlled participants remained constant or improved slightly from randomization until the last study visit. These data are displayed in an online, interactive figure (https://rhoinc.github.io/asthma-control-graphic/). Night symptoms were the most common determinant of control level; lung function (FEV1) was the driver of control level in approximately 30% of determinations.
We provide evidence that when asthma treatment guidelines are operationalized using a computerized decision support tool during multi-center clinical trial visits, good asthma control is gained and maintained in most inner-city children, adolescents, and young adults. ACET Program use in future ICAC protocols, as well as other clinical trials, could facilitate high-fidelity to treatment algorithms. ACET use in clinical settings also could encourage more extensive implementation of guidelines-based care among children with health disparities and traditionally more difficult to control asthma.
The Journal of Allergy and Clinical Immunology (JACI) is the official scientific journal of the AAAAI, and is the most-cited journal in the field of allergy and clinical immunology.
17-01655R3, A computerized decision support tool to implement asthma guidelines for children and adolescents