Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Asthma CHAMPS full program, Asthma CHAMPS Wait List Control.
- Who it may be relevant to
- Registry conditions: Asthma in Children. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Asthma CHAMPS full program
Full program includes (1) education for staff, students, and caregivers (2) environmental education and intervention (3) asthma care coordination (4) resources - Behavioral Asthma CHAMPS Wait List Control
Stepped wedge design
Primary outcome measures
- Asthma-related absences [Time frame: 4 years]
- Emergency Department (ED) utilization for asthma by children [Time frame: 4 years]
- Hospitalization for asthma by children [Time frame: 4 years]
- Oral corticosteroid steroid prescription for asthma by children [Time frame: 4 years]
Secondary outcome measures (5)
- Intervention penetration as assessed by counts [Time frame: 4 years]
- Acceptability of Intervention (AIM) as assessed by a 4 item questionnaire [Time frame: 4 years]
- Intervention Appropriateness Measure (IAM) as assessed by a 4 item questionnaire [Time frame: 4 years]
- Feasibility of Intervention (FIM) as assessed by a 4 item questionnaire [Time frame: 4 years]
- Intervention Satisfaction as assessed by a composite measure [Time frame: 4 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Baltimore City Public Schools — Baltimore
Identifiers
NCT: NCT05814510 · IRB00301358 · HL157845