West Philadelphia Controls Asthma

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

626 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-17

Study Completion Date

2022-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Childhood Asthma Community Health Workers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The Principal Investigator (PI) will be masked to the participant-level intervention group. Unmasking will occur if there is an adverse event that warrants investigation or if the Data Safety and Monitoring Board (DSMB) instructs the PI to become unmasked.

Study Groups

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P+S- (Partner School)

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.

Group Type ACTIVE_COMPARATOR

Yes We Can Children's Asthma Program

Intervention Type BEHAVIORAL

The Yes We Can Children's Asthma Program intervention is a medical-social model based on a chronic care approach, including risk stratification, clinical care management, social care coordination by a community health worker, and primary care physician asthma champions. This intervention includes asthma education, trigger reduction visits and care coordination. There will be five clinic visits and four home visits over 12 months implemented by the primary care CHW who is integrated into the primary care practice.

P-S+ (Partner School)

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.

Group Type ACTIVE_COMPARATOR

Open Airways for School Plus

Intervention Type BEHAVIORAL

Open Airways for Schools Plus was designed to improve the asthma self-management skills in children and enhance control of asthma in the school. The school intervention includes:

1. Open Airways for Schools curriculum for all students with asthma. Classes will be conducted by the school CHW once each semester.
2. Environmental classroom assessments conducted by school CHWs for students enrolled in the study. These teachers will receive classroom supplies to create a more asthma-friendly classroom environment.
3. Asthma education for school staff/personnel at the start of each school year.
4. School facility walk-through assessments to detect potential environmental asthma triggers will be conducted by the School District of Philadelphia.

P+S+ (Partner School)

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.

Group Type ACTIVE_COMPARATOR

Yes We Can Children's Asthma Program

Intervention Type BEHAVIORAL

The Yes We Can Children's Asthma Program intervention is a medical-social model based on a chronic care approach, including risk stratification, clinical care management, social care coordination by a community health worker, and primary care physician asthma champions. This intervention includes asthma education, trigger reduction visits and care coordination. There will be five clinic visits and four home visits over 12 months implemented by the primary care CHW who is integrated into the primary care practice.

School-Based Asthma Therapy

Intervention Type BEHAVIORAL

School-Based Asthma Therapy includes enhanced care coordination for prescribed daily controller medication. The school nurse will coordinate with teachers and the school CHW to schedule daily controller asthma medication administration. The school CHW will assist in obtaining a current asthma care plan and medication administration form from the primary care provider.

Open Airways for School Plus

Intervention Type BEHAVIORAL

Open Airways for Schools Plus was designed to improve the asthma self-management skills in children and enhance control of asthma in the school. The school intervention includes:

1. Open Airways for Schools curriculum for all students with asthma. Classes will be conducted by the school CHW once each semester.
2. Environmental classroom assessments conducted by school CHWs for students enrolled in the study. These teachers will receive classroom supplies to create a more asthma-friendly classroom environment.
3. Asthma education for school staff/personnel at the start of each school year.
4. School facility walk-through assessments to detect potential environmental asthma triggers will be conducted by the School District of Philadelphia.

P-S- (Partner School)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

P+ (Non-Partner School)

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.

Group Type ACTIVE_COMPARATOR

Yes We Can Children's Asthma Program

Intervention Type BEHAVIORAL

The Yes We Can Children's Asthma Program intervention is a medical-social model based on a chronic care approach, including risk stratification, clinical care management, social care coordination by a community health worker, and primary care physician asthma champions. This intervention includes asthma education, trigger reduction visits and care coordination. There will be five clinic visits and four home visits over 12 months implemented by the primary care CHW who is integrated into the primary care practice.

P- (Non-Partner School)

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Yes We Can Children's Asthma Program

The Yes We Can Children's Asthma Program intervention is a medical-social model based on a chronic care approach, including risk stratification, clinical care management, social care coordination by a community health worker, and primary care physician asthma champions. This intervention includes asthma education, trigger reduction visits and care coordination. There will be five clinic visits and four home visits over 12 months implemented by the primary care CHW who is integrated into the primary care practice.

Intervention Type BEHAVIORAL

School-Based Asthma Therapy

School-Based Asthma Therapy includes enhanced care coordination for prescribed daily controller medication. The school nurse will coordinate with teachers and the school CHW to schedule daily controller asthma medication administration. The school CHW will assist in obtaining a current asthma care plan and medication administration form from the primary care provider.

Intervention Type BEHAVIORAL

Open Airways for School Plus

Open Airways for Schools Plus was designed to improve the asthma self-management skills in children and enhance control of asthma in the school. The school intervention includes:

1. Open Airways for Schools curriculum for all students with asthma. Classes will be conducted by the school CHW once each semester.
2. Environmental classroom assessments conducted by school CHWs for students enrolled in the study. These teachers will receive classroom supplies to create a more asthma-friendly classroom environment.
3. Asthma education for school staff/personnel at the start of each school year.
4. School facility walk-through assessments to detect potential environmental asthma triggers will be conducted by the School District of Philadelphia.

Intervention Type BEHAVIORAL

Other Intervention Names

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Primary Care Intervention Primary Care and School Intervention (Partner School) School Intervention (Partner School)

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No