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

Johns Hopkins University

Status: Enrolling

Conditions: Asthma in Children

Treatments: Behavioral: Asthma CHAMPS full program; Behavioral: Asthma CHAMPS Wait List Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05814510

HL157845 (Other Identifier)

IRB00301358

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,000 participants in 3 patient groups

School staff

Experimental group

Description:

School staff in a K-8 school participating in Asthma CHAMPS

Treatment:

Behavioral: Asthma CHAMPS Wait List Control

Behavioral: Asthma CHAMPS full program

Children with asthma

Experimental group

Description:

Aged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS

Treatment:

Behavioral: Asthma CHAMPS Wait List Control

Behavioral: Asthma CHAMPS full program

Caregivers of children with asthma

Experimental group

Description:

Caregiver of a child with asthma that is aged 5-13 enrolled in a Baltimore City Public School participating in Asthma CHAMPS

Treatment:

Behavioral: Asthma CHAMPS Wait List Control

Behavioral: Asthma CHAMPS full program