Clinical trial NCT05814510: Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)
Official title: Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Baltimore City Public Schools
name: Baltimore City Health Department
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-04-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Asthma-related absences
timeFrame: 4 years
measure: Emergency Department (ED) utilization for asthma by children
timeFrame: 4 years
measure: Hospitalization for asthma by children
timeFrame: 4 years
measure: Oral corticosteroid steroid prescription for asthma by children
timeFrame: 4 years
Secondary outcomes:
measure: Intervention penetration as assessed by counts
timeFrame: 4 years
measure: Acceptability of Intervention (AIM) as assessed by a 4 item questionnaire
timeFrame: 4 years
measure: Intervention Appropriateness Measure (IAM) as assessed by a 4 item questionnaire
timeFrame: 4 years
measure: Feasibility of Intervention (FIM) as assessed by a 4 item questionnaire
timeFrame: 4 years
measure: Intervention Satisfaction as assessed by a composite measure
timeFrame: 4 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore City Public Schools
state: Maryland
Study officials:
affiliation: JHU
name: Michelle N Ealin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: JHU
name: Meredith McCormack, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: