West Philadelphia Controls Asthma (WPCA)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Community Health Workers; Childhood Asthma

Treatments: Behavioral: School-Based Asthma Therapy; Behavioral: Yes We Can Children's Asthma Program; Behavioral: Open Airways for School Plus

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03514485

17-013892

1U01HL138687-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 626 patients

Sex: All

Ages: 5 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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626 participants in 6 patient groups

P+S- (Partner School)

Active Comparator group

Description:

This arm includes children who attend one of the partnering schools and who are randomized to receive the primary care intervention Yes We Can Children's Asthma Program.

Treatment:

Behavioral: Yes We Can Children's Asthma Program

P-S+ (Partner School)

Active Comparator group

Description:

This arm includes children who attend one of the partnering schools and who are randomized to receive the school intervention Open Airways for Schools Plus.

Treatment:

Behavioral: Open Airways for School Plus

P+S+ (Partner School)

Active Comparator group

Description:

This arm includes children who attend one of the partnering schools and who are randomized to receive the enhanced school intervention Open Airways for Schools Plus, School-Based Asthma Therapy and the primary care intervention Yes We Can Children's Asthma Program.

Treatment:

Behavioral: Open Airways for School Plus

Behavioral: Yes We Can Children's Asthma Program

Behavioral: School-Based Asthma Therapy

P-S- (Partner School)

No Intervention group

Description:

This arm includes children who attend one of the partnering schools, and are randomized to the control group (no primary care or school intervention).

P+ (Non-Partner School)

Active Comparator group

Description:

This arm includes children who do not attend one of the partnering schools and who are randomized to receive the primary care intervention Yes We Can Children's Asthma Program.

Treatment:

Behavioral: Yes We Can Children's Asthma Program

P- (Non-Partner School)

No Intervention group

Description:

This arm includes children who do not attend one of the partnering schools and who are randomized to the control group (no primary care intervention and ineligible for the school intervention).