RVA Breathes: A Richmond City Collaboration to Reduce Pediatric Asthma Disparities

NCT ID: NCT03297645

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2022-06-30

Brief Summary

The goal of this study is to evaluate a sustainable, community-engaged program to reduce asthma disparities among 5 to 11-year-old children in Richmond, Virginia. Richmond, an urban center, has been named the Asthma Capital, or "most challenging place to live in the U.S. with asthma," by the Asthma and Allergy Foundation three times in the last 5 years. To date, however, the city has no comprehensive, community-engaged asthma care program for those children at highest risk for poor asthma outcomes. To address this disparity, the study team engaged with community partners and completed a mixed-methods needs assessment to enhance understanding of the barriers and supports to asthma care for children and their families living in Richmond. Several key priority areas emerged: peer support, advocacy, treating the home as a system, increased school nurse education, and coordination with schools and providers. Working together, the community-engaged team translated needs assessment findings to RVA Breathes, a program coordinating asthma care across 4 sectors: family, home, community, and medical care.

Detailed Description

RVA Breathes includes family-based asthma self-management education (delivered by Community Health Workers [CHWs] with the Institute for Public Health Innovation), home environmental remediation (with Richmond City Health Department's Healthy Homes Initiative), and a school nurse component (with elementary schools in the Richmond City Public School System). These interventions capitalize among existing resources and relationships with stakeholders in Richmond, each of which is committed to RVA Breathes. Two hundred-fifty children with asthma and their caregivers participated in a randomized clinical trial of RVA Breathes. After completing a baseline assessment, families were randomized to one of three conditions: 1) asthma education + home remediation + school intervention, 2) asthma education + home remediation and 3) comparator condition (Enhanced Standard of Care, E-SOC). Families participated in the program for 9 months and completed follow-up assessments (post-treatment and 3-, 6-, and 9-month) to measure changes in healthcare utilization and the impact of the program on child asthma outcomes. Conditions were compared on the primary outcome of asthma-related healthcare utilization, including asthma specific ED visits and hospital admissions. Secondary outcomes included need for controller medication use, asthma control, asthma symptoms, asthma action plans, and quality of life. We will also evaluate the sustainability of RVA Breathes after 9 months (without active intervention), including a review of qualitative data from participants and stakeholders in the program. Findings from this trial will allow for dissemination and implementation of RVA Breathes as a sustainable program in the Richmond are.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Arm 1

school + asthma education + home environment remediation

Group Type: EXPERIMENTAL

School

Intervention Type: BEHAVIORAL

CHWs will ensure that families submit required health paperwork (e.g., asthma action plan, medication release form) and confirm with school nurses that children have the appropriate medications. School nurses will be given a standardized protocol to follow with clear guidelines for caring for students with asthma. The CHW assigned to the family will work with the school nurse to ensure that communication with the medical provider is occurring.

Asthma education

Intervention Type: BEHAVIORAL

CHWs will deliver evidence-based asthma education to parents and children. Content is drawn from existing asthma management programs, and adapted for families in Richmond. Between sessions, CHWs will call parents at least monthly to check in and assess family asthma management, including healthcare utilization since the last contact.

Home environmental remediation

Intervention Type: BEHAVIORAL

Healthy Homes will complete home-based environmental assessments using evidence-based protocols. Healthy Homes will provide real-time education and share information about their findings and recommendations for action. Families are provided with low-cost intervention materials (e.g., filters, pillow covers), as well as behavioral modifications to aid in the reduction of asthma triggers in the home.

Arm 2

asthma education + home environment remediation

Group Type: EXPERIMENTAL

Asthma education

Intervention Type: BEHAVIORAL

CHWs will deliver evidence-based asthma education to parents and children. Content is drawn from existing asthma management programs, and adapted for families in Richmond. Between sessions, CHWs will call parents at least monthly to check in and assess family asthma management, including healthcare utilization since the last contact.

Home environmental remediation

Intervention Type: BEHAVIORAL

Healthy Homes will complete home-based environmental assessments using evidence-based protocols. Healthy Homes will provide real-time education and share information about their findings and recommendations for action. Families are provided with low-cost intervention materials (e.g., filters, pillow covers), as well as behavioral modifications to aid in the reduction of asthma triggers in the home.

Arm 3

enhanced standard of care

Group Type: ACTIVE_COMPARATOR

Informational mail

Intervention Type: BEHAVIORAL

Family will be mailed publicly available asthma information every 3 months.

Interventions

School

CHWs will ensure that families submit required health paperwork (e.g., asthma action plan, medication release form) and confirm with school nurses that children have the appropriate medications. School nurses will be given a standardized protocol to follow with clear guidelines for caring for students with asthma. The CHW assigned to the family will work with the school nurse to ensure that communication with the medical provider is occurring.

Intervention Type: BEHAVIORAL

Asthma education

CHWs will deliver evidence-based asthma education to parents and children. Content is drawn from existing asthma management programs, and adapted for families in Richmond. Between sessions, CHWs will call parents at least monthly to check in and assess family asthma management, including healthcare utilization since the last contact.

Intervention Type: BEHAVIORAL

Home environmental remediation

Healthy Homes will complete home-based environmental assessments using evidence-based protocols. Healthy Homes will provide real-time education and share information about their findings and recommendations for action. Families are provided with low-cost intervention materials (e.g., filters, pillow covers), as well as behavioral modifications to aid in the reduction of asthma triggers in the home.

Intervention Type: BEHAVIORAL

Informational mail

Family will be mailed publicly available asthma information every 3 months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Enrolled in Richmond Public Schools
• Asthma-related emergency department visit/hospitalization within last year
• Physician-diagnosed asthma
• Richmond city resident

Caregiver inclusion: child's legal guardian living in same home for the last 6 months

Exclusion Criteria

• Severe medical or psychiatric condition (child or caregiver)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robin Everhart, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U01HL138682

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20010240

Identifier Type: -

Identifier Source: org_study_id