Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)

Study Overview
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Brief Summary
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The long-term goal is to implement an evidence-based asthma intervention based on the Center for Disease Control's recommended framework (EXHALE) within Baltimore City Public Schools (BCPS). As part of a stepped wedge pragmatic trial the investigators will: Evaluate the effectiveness of a tailored implementation plan of Asthma CHAMPS in 32 Baltimore city elementary schools to reduce asthma disparities. Conduct a pragmatic trail using a stepped wedge design to evaluate implementation of a school and home asthma intervention program to reduce asthma-related absences, healthcare utilization and exacerbations and improve asthma control, among children enrolled in 32 Baltimore City elementary schools. Use qualitative methods (observation and semi structured interviews) to obtain stakeholder feedback (parents, community health workers, school personnel and administrators) on impact of Asthma CHAMPS, identify potential refinements in intervention and implementation strategies, and evaluate impact of local adaptation and fidelity on implementation success and sustainability.

Official Title
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Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)

Conditions
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Asthma in Children

Intervention / Treatment
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* Behavioral: Asthma CHAMPS full program
* Behavioral: Asthma CHAMPS Wait List Control


Participation Criteria
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Eligibility Criteria
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Adult Inclusion Criteria: Aged 18 or older Current caregiver of child with asthma or staff member at a Baltimore City K-8 Public School in Asthma CHAMPS Exclusion Criteria: Unwilling to consent Children with asthma Inclusion Criteria: Asthma diagnosis Currently enrolled in Baltimore City K-8 Public School participating in Asthma CHAMPS Exclusion Criteria: Unwilling to provide assent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: School staff<br>School staff in a K-8 school participating in Asthma CHAMPS | Behavioral: Asthma CHAMPS full program<br>* Full program includes (1) education for staff, students, and caregivers (2) environmental education and intervention (3) asthma care coordination (4) resources<br>Behavioral: Asthma CHAMPS Wait List Control<br>* Stepped wedge design<br>|
| Experimental: Children with asthma<br>Aged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS | Behavioral: Asthma CHAMPS full program<br>* Full program includes (1) education for staff, students, and caregivers (2) environmental education and intervention (3) asthma care coordination (4) resources<br>Behavioral: Asthma CHAMPS Wait List Control<br>* Stepped wedge design<br>|
| Experimental: Caregivers of children with asthma<br>Caregiver of a child with asthma that is aged 5-13 enrolled in a Baltimore City Public School participating in Asthma CHAMPS | Behavioral: Asthma CHAMPS full program<br>* Full program includes (1) education for staff, students, and caregivers (2) environmental education and intervention (3) asthma care coordination (4) resources<br>Behavioral: Asthma CHAMPS Wait List Control<br>* Stepped wedge design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma-related absences | Administrative data from schools on attendance for child with asthma | 4 years | 
| Emergency Department (ED) utilization for asthma by children | Counts of ED visits for asthma | 4 years | 
| Hospitalization for asthma by children | Counts of hospital admissions for asthma | 4 years | 
| Oral corticosteroid steroid prescription for asthma by children | Counts of prescribed oral corticosteroids for asthma | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention penetration as assessed by counts | Counts of asthma education sessions for family and staff | 4 years | 
| Acceptability of Intervention (AIM) as assessed by a 4 item questionnaire | 4 item measure of implementation outcome often considered leading indicator of implementation success. Administered on a 5 point Likert scale with higher scores indicating greater agreement with specific items. | 4 years | 
| Intervention Appropriateness Measure (IAM) as assessed by a 4 item questionnaire | 4 item measure of implementation outcome often considered leading indicator of implementation success. Administered on a 5 point Likert scale with higher scores indicating greater agreement with specific items. | 4 years | 
| Feasibility of Intervention (FIM) as assessed by a 4 item questionnaire | 4 item measure of implementation outcome often considered leading indicator of implementation success. Administered on a 5 point Likert scale with higher scores indicating greater agreement with specific items. | 4 years | 
| Intervention Satisfaction as assessed by a composite measure | Composite measure administered to staff and caregivers with items assessing asthma management motivation and confidence. Answer options are on a scale of 1-10 with higher scores generally indicating greater agreement. | 4 years |