Clinical trial NCT03514485: West Philadelphia Controls Asthma
Official title: West Philadelphia Asthma Care Implementation Plan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Asthma
Community Health Workers
Keywords: asthma disparities
community health worker
childhood asthma
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Education-Plus, Inc.
name: The School District of Philadelphia
name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-05-02
Enrollment: 626
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A factorial design has enhanced statistical power and can handle cluster randomization of schools. Statistical methods will be used to estimate variation in the effect across schools over time. Linear mixed effects models with random intercepts and slopes for school, and fixed effects for the school-level intervention, time, and time-by-intervention interaction will be applied. Second, marginal models using generalized estimating equations will produce robust estimates that adjust for clustering at the school level. Third, assumption-free, randomization-test-based methods do not rely on assumptions of parametric models. Investigators will use conventional levels of statistical significance (p=0.05) for all pre-specified comparisons for our objectives. Variability of the intervention effect across schools will reflect consistency of intervention effects and thus generalizability in new settings. Both mixed effects models and permutation-test methods will estimate variance components.
Primary purpose: TREATMENT

Brief summary: This project uses community health workers (CHW) or lay health educators to implement asthma interventions that have been proven to work in the primary care setting and in schools. The objective is to integrate the home, school, healthcare system, and community for 600 school-aged asthmatic children in West Philadelphia through use of CHWs.

The children enrolled in the study will be randomized to one of four groups including: primary care CHW, school CHW, primary care and school CHW or the control group (no CHW).

Detailed description: The Community Asthma Prevention Program (CAPP) at the Children's Hospital of Philadelphia has a two-decade history of utilizing CHWs to improve asthma outcomes of children in Philadelphia. Building on this foundation, a network of stakeholders was established including, The West Philadelphia Asthma Care Collaborative (WEPACC), with representation from public housing, healthcare, community, and schools. As a result of assessment of local needs, resource mapping, and months of planning, Investigators designed an asthma care implementation program with the broad objective of integrating home, school, healthcare system, and community for school-aged asthmatic children in West Philadelphia. Investigators seek to accomplish this goal using CHWs to deliver sustainable patient-centered evidence-based interventions. The evidence-based interventions include (1) a primary care-based Yes We Can intervention with home visitation and (2) a comprehensive and rigorously evaluated school-based intervention, Open Airways for schools and School Based Asthma Therapy. CHWs will function as the hub of each interventions, serving either as primary care CHWs or school CHWs to provide a network of education, care coordination support, and to facilitate communication for families of children with asthma between the four sectors. This project seeks to integrate interventions in a comprehensive and sustainable manner to reduce asthma disparities in poor, minority children.

Using a factorial design, Investigators will recruit and randomize 640 asthmatic children (ages 5-13 years) from up to five inner-city primary care clinics who attend one of 36 West Philadelphia schools to one of four study conditions: both interventions (both primary care and school CHWs intervention), primary care CHW or school-CHW alone, or control and follow for one year. As a part of this project the Investigators seek to accomplish the following objectives:

Objective 1. Compare effectiveness of the primary care and school interventions to improve asthma control and reduce symptom days using main and simple effects from the factorial design.

Objective 2. Explore moderators and mechanisms of effectiveness and sustainability of the interventions.

Objective 3. Use mixed methods to explore implementation determinants and outcomes of school intervention that promote effectiveness, fidelity and sustainability

Objective 4. Examine the costs, savings, and cost effectiveness associated with the intervention and implementation strategies to promote sustainability.

Eligibility criteria: Inclusion Criteria:

1. Children 5-13 years of age and their parents/guardians
2. Children with a diagnosis of asthma
3. Children with uncontrolled asthma (as evidenced within the previous 12 months by an asthma exacerbation requiring oral steroids -OR- an Emergency Department (ED) visit for asthma -OR- an inpatient admission for asthma)
4. West Philadelphia residence in zip code 19104, 19131, 19139, 19142, 19143, 19151 or 19153
5. Children in grades K-8
6. Pediatric primary care received at Children's Hospital of Philadelphia Care Network (CN) Karabots, Cobbs Creek, or South Philadelphia locations or pediatric care received at the Pediatric and Adolescent Medicine Centers of Philadelphia (PAMCOP) serving West Philadelphia residents
7. Parental/guardian permission (informed consent) and, if appropriate, child assent
8. English Language Speaking

Exclusion Criteria:

1. Subjects with other chronic respiratory illnesses such as cystic fibrosis
2. Cyanotic congenital heart disease
3. Mental retardation and/or cerebral palsy (MRCP)
4. Severe Neurological Disorder
5. Cyanotic congenital heart disease
6. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Primary outcomes:
measure: Change in Asthma Control
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in Daytime Asthma Symptoms
timeFrame: Baseline and 12 months
measure: Change in Nighttime Symptoms
timeFrame: Baseline and 12 months
measure: Change in School Absences
timeFrame: Baseline and 12 months
measure: Change in Emergency Department (ED) Visits
timeFrame: Baseline and 12 months
measure: Change in Hospitalizations
timeFrame: Baseline and 12 months
measure: Change in Asthma Emotional Functioning Domain
timeFrame: Baseline and 12 months
measure: Change in Activity Limitations Domain
timeFrame: Baseline and 12 months
measure: Baseline School Organizational Climate Index
timeFrame: At start of school intervention
measure: Baseline School Leadership
timeFrame: At start of school intervention
measure: Baseline School Staff Attitudes
timeFrame: At start of school intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Tyra Bryant-Stephens, MD
role: PRINCIPAL_INVESTIGATOR
References: