AAD-PEPR Asthma clinical trials:
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The CHICAGO Plan
The CHICAGO Plan is a PCORI-funded, multi-center (6 centers in Chicago) 3-arm, pragmatic RCT. It will enroll English and Spanish speaking subjects (ages 5-11); primarily African American and Latino, from lower SES strata. Participants are recruited from asthma patients presenting at the ED with an asthma exacerbation. The study will compare three treatment arms: 1) a patient / family centered patient education tool, the CHICAGO Plan Action Plan after Emergency department discharge (CAPE) tool, 2) CAPE and 5 home visits with a multifaceted intervention by a community health worker (CAPE plus Home), and 3) usual care. The CAPE is a patient- and caregiver-centered approach to facilitating communication and education. Provided prior to ED discharge, it is intended to promote adherence to guideline-recommended care after ED discharge. Participants in the CAPE plus Home arm will receive the same CAPE intervention prior to ED discharge. In addition, a community health worker will conduct five home visits over 180 days to further promote asthma self-management skills and to reduce environmental triggers at home, utilizing Integrated Pest Management and other strategies as needed. Patients are randomized at the ED visit and followed up at 1, 3, and 6 months. Approximately half the participants will also be assessed 12 months after the intervention. The CHICAGO Plan estimates that 250 participants with 12 month follow-up will contribute data to this project. Given that participants are enrolled at a time of asthma exacerbation when they visit the ED, the CHICAGO Plan presents the best opportunity for demonstrating PROMIS measures’ sensitivity to change. In addition, this trial enables evaluation of PROMIS in both English and Spanish speaking populations.
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ASIST
ASIST is a PCORI- funded, pragmatic community study conducted in St. Louis, MO, in collaboration with pediatricians in community practice. ASIST is enrolling African American children (ages 6-17) with mild-moderate asthma. Participants are assessed at baseline, and followed up at 3, 6, 9, and 12 months post-intervention to evaluate the effectiveness of symptom-based steroid adjustment, compared to provider-based adjustment (standard of care). Projected recruitment for the proposed project is 170 participants. In contrast to the CHICAGO Plan, ASIST provides the opportunity to evaluate PROMIS measures in a group of patients with less severe symptomatology at baseline assessment. As such, less change (less improvement) is expected over time. ASIST also includes additional (i.e., non-PROMIS) PRO measures that we will include in our tests of concurrent and construct validity, including a comparison of relative responsiveness.
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School Inner-City Asthma Intervention Study (SICAS-2)
SICAS-2 is the interventional phase of the School Inner-City Asthma Study (SICAS 1), an NIH-funded, prospective study evaluating school and classroom specific environmental risk factors and asthma morbidity in the Northeast. SICAS-2 is a randomized intervention trial to evaluate the effectiveness of two environmental interventions, one classroom-based (High Frequency Particulate Air (HEPA) filter) and the other school wide (Integrated Pest Management), to reduce asthma allergens. There are four arms to the study: IPM School/Classroom Air Filter; IPM School/Classroom Sham (Placebo) Air Filter; Control School/Classroom Air Filter; Control School/Classroom Sham (Placebo) Air Filter. The study is recruiting elementary students (ages 4-15) with asthma from multiple classrooms in 40 Northeastern inner-city elementary schools. Children are extensively assessed prior to the intervention/school year and then followed up at 2, 4, 6, 8, and 10 months after school starts. The study collects detailed physiological, biological, patient-reported and environmental information, much of which is unique compared to the other 2 trials. This provides us with the unique opportunity to explore the association of PROMIS measures with biomarkers and physiological indicators of disease activity. As with the CHICAGO Plan, both English and Spanish-speaking participants will be enrolled.
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M-cPROs Asthma Project
Asthma affects approximately 9.5% (7.1 million) children in the United States, is one of the most common diagnoses of all pediatric emergency department (ED) visits, and is the top reason for hospitalization in school age children. Children who are black are more likely to have an emergency room visit (38.3%) than white children (15%). In addition, rehospitalizations within 30 days are 3% and within one year are 17.2%. Of the patients who are rehospitalized, 25% have more than one rehospitalization within a year.
The overall objective of the Midwest Child Patient Reported Outcomes (M-cPROs) Consortium is to advance the understanding and measurement of cPROs in children with chronic disease using the Patient Reported Outcomes Measurement Information System® (PROMIS®) to allow for widespread use in both clinical care and research to optimize the well-being and functioning of the child. To achieve this objective, the scientific research projects within the M-cPROs Consortium aim to: 1) improve outcomes that matter to children with chronic disease by: understanding the impact of disease factors, including acute disease exacerbations on patient pain behavior, pain quality, physical activity, physical stress experience, strength impact, and family relationships, assessing the relationship between the family relationships measure and other cPROs, and evaluating the impact of environmental stressors (e.g., socioeconomic deprivation) on patient pain behavior, pain quality, physical activity, physical stress experience, strength impact, and family relationships; 2) validate new PROMIS measures in multiple chronic disease populations to support a common metric for cPROs measurement in children with chronic disease; and 3) determine whether PROMIS measures are responsive to change in health and whether that change is clinically relevant in children with chronic disease.
The project consists of a prospective observational cohort study of asthma patients aged 5-17 years who will be followed for up to three years. We will also study asthma patients with disease exacerbations who present to the emergency department. The PROMIS measures that will be used include the Pediatric Profile 25, asthma impact, and the new PROMIS measures (pain behavior, pain quality, physical activity, physical stress experience, strength impact, and family relationships).
