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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: School; Behavioral: Asthma education; Behavioral: Home environmental remediation; Behavioral: Informational mail

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; school + asthma education + home environment remediation	Behavioral: 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.; 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.; 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.
Experimental: Arm 2; asthma education + home environment remediation	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.; 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.
Active Comparator: Arm 3; enhanced standard of care	Behavioral: Informational mail; Family will be mailed publicly available asthma information every 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Health Care Utilization	Billing systems/insurance reports of frequency of child emergency department (ED) visits and hospitalizations due to asthma. A composite variable of frequency of emergency department visits and hospitalizations will be generated to arrive at one health care utilization outcome variable.	Child ED visits and hospitalizations in the last 9 months (from end of intervention/control phase to 9 month follow-up assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Controller Medication	Prescription for a controller medication (caregiver report)	Reported by caregiver at 9 month follow-up assessment
Child Asthma Action Plan	Caregivers reported whether their child had an updated asthma action plan for their child.	Reported by caregiver at 9 month follow-up assessment
Child Asthma Control	Child and caregiver complete the Childhood Asthma Control Test, which measures the frequency of daytime and nighttime asthma symptoms, activity limitations, and perception of disease control; higher scores = better asthma control. Total range of scores are from 0 to 27 and are a sum of scores.	Reported for child at 9 month follow-up assessment
Child Asthma Symptoms	Caregivers report number of days in the last 7 days that their child had asthma symptoms.	Reported by caregiver at 9 month follow-up assessment
Child Quality of Life	Children will complete a measure, the Pediatric Asthma Quality of Life Questionnaire, that assesses their level of quality of life related to child asthma; higher scores = better QOL. Total scores range from 1 to 7 and are an average of 23 items.	Reported by child at 9 month follow-up assessment
Caregiver Quality of Life	Parents complete a measure that assesses their level of quality of life (QOL) related to child asthma. The measure is the Pediatric Asthma Caregiver Quality of Life Questionnaire; higher scores = better QOL. A total score is determined from an average of items. Total scores range from 1 to 7.	Reported by caregivers at 9 month follow-up assessment

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Robin Everhart, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2018
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: HM20010240; U01HL138682 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Shared data will be free of identifiers that could link findings with research participants or lead to deductive disclosure of individual subjects.
• IPD Sharing Time Frame: After the grant period has ended, data have been de-identified, and major study hypotheses have been tested.
• IPD Sharing Access Criteria: Researchers should contact the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No