Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)
- Conditions
- Asthma in Children
- Interventions
- Behavioral: Asthma CHAMPS full programBehavioral: Asthma CHAMPS Wait List Control
- Registration Number
- NCT05814510
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
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:
1. Evaluate the effectiveness of a tailored implementation plan of Asthma CHAMPS in 32 Baltimore city elementary schools to reduce asthma disparities.
2. 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.
3. 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.
- Detailed Description
Implementation Aim: Evaluate the effectiveness of a tailored implementation plan of Asthma CHAMPS in 32 Baltimore city elementary schools to reduce asthma disparities.
Hypothesis: The investigators hypothesize that Baltimore City schools will have greater adoption and penetration of Asthma CHAMPS (e.g. more schools participating, and more staff and family asthma education sessions), greater feasibility/acceptability (e.g. more staff participating in asthma care activities, greater staff confidence in managing asthma) and greater satisfaction and appropriateness with a tailored implementation strategy compared to wait list-control group.
The long-term goal is to implement an evidence-based asthma intervention based on the Centers for Disease Control (CDC) recommended framework (EXHALE)14 within BCPS. To provide the foundation for success, the investigators will identify and engage local key stakeholders, conduct a community needs assessment to inform necessary refinement and adaptations of the interventions, and develop a tailored collaborative strategy to ensure successful implementation of an asthma intervention program. Results for this multi-phase project will identify best practices for implementation of a tailored multi-level asthma intervention program (Asthma CHAMPS: Community and Home Asthma Management Program in Schools), within Baltimore City Schools to reduce asthma disparities.
Effectiveness Aim: 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.
Hypothesis: Children with asthma who attend schools engaged in Asthma CHAMPS program will have improved asthma outcomes, including improved asthma control, reduced ED visits/hospitalizations and courses of oral corticosteroids and impact (reduced asthma-related school absences).
Qualitative Aim: 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Aged 18 or older
- Current caregiver of child with asthma or staff member at a Baltimore City K-8 Public School in Asthma CHAMPS
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Children with asthma Asthma CHAMPS full program Aged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS School staff Asthma CHAMPS full program School staff in a K-8 school participating in Asthma CHAMPS Caregivers of children with asthma Asthma CHAMPS full program Caregiver of a child with asthma that is aged 5-13 enrolled in a Baltimore City Public School participating in Asthma CHAMPS School staff Asthma CHAMPS Wait List Control School staff in a K-8 school participating in Asthma CHAMPS Children with asthma Asthma CHAMPS Wait List Control Aged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS Caregivers of children with asthma Asthma CHAMPS Wait List Control Caregiver of a child with asthma that is aged 5-13 enrolled in a Baltimore City Public School participating in Asthma CHAMPS
- Primary Outcome Measures
Name Time Method Asthma-related absences 4 years Administrative data from schools on attendance for child with asthma
Emergency Department (ED) utilization for asthma by children 4 years Counts of ED visits for asthma
Hospitalization for asthma by children 4 years Counts of hospital admissions for asthma
Oral corticosteroid steroid prescription for asthma by children 4 years Counts of prescribed oral corticosteroids for asthma
- Secondary Outcome Measures
Name Time Method Feasibility of Intervention (FIM) as assessed by a 4 item questionnaire 4 years 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.
Intervention penetration as assessed by counts 4 years Counts of asthma education sessions for family and staff
Intervention Satisfaction as assessed by a composite measure 4 years 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.
Acceptability of Intervention (AIM) as assessed by a 4 item questionnaire 4 years 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.
Intervention Appropriateness Measure (IAM) as assessed by a 4 item questionnaire 4 years 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.
Trial Locations
- Locations (1)
Baltimore City Public Schools
🇺🇸Baltimore, Maryland, United States