Rhode Island Asthma Integrated Response Program

Study Overview
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Brief Summary
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The study's purpose is to evaluate the RI-Asthma Integrated Response (RI-AIR) Asthma Care Implementation Program (ACIP). RI-AIR ACIP uses an electronic information system to screen children with asthma and identify what specific services each child needs based on the child's asthma symptom and health care status. Our main goal is to see if children experience better asthma outcomes as a result of participation in the program. We will provide our intervention to 434 urban, ethnically diverse children, between 2-12 years old with asthma, and their families and evaluate whether participating in the program improves children's asthma outcomes. The second goal is to evaluate how well the program is set up and how we can make improvements to better serve families of children with asthma. The third goal is to gather information and advice from community experts so that we can make the program sustainable. Families that take part in RI-AIR ACIP will participate in the program over the course of a year, including participating in the intervention, and brief follow up visits at 3, 6, 9 and 12 months after completing the intervention. All families will complete the CASE program, which takes place over the course of about 4 weeks and involves in-school or remote school-based asthma education for school aged children, after-school or remote education sessions for their parents, asthma care training for school staff, and an evaluation of asthma triggers in the school. Families of children who have more frequent asthma symptoms and emergency healthcare visits will also compete the HARP program, a home-based program consisting of 3 home sessions (over about 6 weeks) that include individualized asthma education and strategies and supplies for controlling environmental asthma triggers. Both CASE and HARP programs are carried out by certified asthma educators and community health workers. Each child's healthcare provider (HCP) and school nurse teacher (SNT) will receive a standardized, secure email indicating the child is participating in RI-AIR. This email will include a summary of the child's baseline assessment of asthma control and prior health care use, and a description of the program. At the conclusion of the child's participation, the HCP and SNT will receive a summary by secure email summarizing the child's asthma control at the end of the intervention, services delivered, and referrals made, and for HARP participants, triggers observed in the home and supplies and referrals provided.

Detailed Description
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The RI-AIR ACIP is community-based; it addresses community needs and gaps in care by: 1) enhancing asthma outcomes with services tailored to the child's level of asthma risk, 2) decreasing family burden by delivering services in homes and the local community, 3) enhancing communication between school, HCPs, and family, and 4) utilizing the RI-AIR Information Data System (IDS) to integrate data sources and generate a tailored referral. This study uses a randomized, stepped wedge trial (SWT) design to evaluate the effectiveness of the RI-AIR ACIP at both the individual and community levels. In an SWT, groups of individuals receive the intervention at different time points, the order in which they receive the treatment is randomized, and data are collected from groups over time. In this study, groups will be randomized at the community level. Selected high risk communities are geographic school catchment areas with the highest asthma utilization rates. High-risk areas will be randomly allocated to the Step, or year of active trial using a random numbers table. Thus, the year each catchment area receives intervention (i.e., participates in the active trial phase) will be randomized, and all families in this SWT will participate in both control (standard care) and intervention (active trial). This SWT design allows us to evaluate both individual-level outcomes as well as community-specific outcomes. During the active trial phase, families of children with asthma within the randomly selected communities will receive an asthma intervention. Families of children with asthma will be assigned to an intervention based on the child's level of asthma control. Individual-level data will be assessed over the course of the year of the active trial phase, while community-level data will be assessed annually over the study period.

Official Title
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Rhode Island Asthma Integrated Response Program

Conditions
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Asthma in Children

Intervention / Treatment
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* Behavioral: CASE Program
* Behavioral: HARP Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child age between 2 to 12 years Child lives in the identified catchment area Child meets screening criteria for current asthma Child's asthma status is not well-controlled or poorly controlled Caregiver must speak English or Spanish. Exclusion Criteria: Children with complex medical conditions (i.e., requiring on-site medical supervision of CHW)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The overall study utilizes a stepped wedge trial design with cluster randomization at the community level. All communities will have a baseline control period, active trial phase, and post-active trial phase follow-up period. During the active trial phase of this project, the strategy used to assign interventions to participants follows a Parallel Assignment study intervention model. During the active trial phase, individuals within that community will be assigned to an asthma intervention (1. CASE or 2. CASE and HARP) based on the child's level of asthma control. The SWT also allows us to compare community-level outcomes for participants who are not in the Active Trial (Intervention) period at that time and who are receiving standard care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CASE Program only<br>During the Active Trial Phase, families of children with asthma status defined as not well controlled will complete the CASE program. Outcomes for participants assigned to the CASE program will be compared in a pre-post within subject comparison. Regardless of intervention arm assignment, children are expected show improvement in asthma outcomes. The stepped wedge trial design of the overall study allows for comparison of outcomes of communities in the pre-active trial baseline control period, active trial phase, and post-active trial phase follow-up period. | Behavioral: CASE Program<br>* Controlling Asthma in Schools Effectively (CASE) provides school-based education and environmental assessments. This program takes place over the course of about 4 weeks and involves in-school or remote asthma education for school aged children, after-school or remote education sessions for their parents, asthma care training for school staff, and an evaluation of asthma triggers in the school.<br>|
| Active Comparator: CASE and HARP Programs<br>During the Active Trial Phase, families of children with asthma status that is defined as poorly controlled will complete the CASE and HARP programs. Outcomes for participants assigned to this arm (CASE and HARP) will be compared in a pre-post within subject comparison. Regardless of intervention arm assignment, children are expected show improvement in asthma outcomes. The stepped wedge trial design of the overall study allows for comparison of outcomes of communities in the pre-active trial baseline control period, active trial phase, and post-active trial phase follow-up period. | Behavioral: CASE Program<br>* Controlling Asthma in Schools Effectively (CASE) provides school-based education and environmental assessments. This program takes place over the course of about 4 weeks and involves in-school or remote asthma education for school aged children, after-school or remote education sessions for their parents, asthma care training for school staff, and an evaluation of asthma triggers in the school.<br>Behavioral: HARP Program<br>* Home Asthma Response Program (HARP) is a home-visiting program consisting of 3 home visits or remote sessions (over about 6 weeks). HARP provides individualized asthma education, home-based environmental assessment, and strategies and supplies for controlling environmental asthma triggers.<br>|
| No Intervention: Standard Care<br>Cluster-based randomization in the Stepped Wedge Trial allows for comparison of Community Based Outcomes for clusters (communities defined by school catchment areas) who are not yet in the active trial phase and are receiving Standard of Care at that time. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Asthma Control (Individual-Level) | Assessed by the Test for Respiratory and Asthma Control in Kids (TRACK) for 2-4 yr olds. | During Active Trial Period at Baseline, End of Treatment (EOT; which will occur between 1 to 2 months after baseline, depending on intervention assignment), 3 month follow-up after EOT, 6 month follow-up, 9 month follow-up, 12 month follow-up | 
| Change in Asthma Control (Individual Level) | Assessed by the Childhood Asthma Control Test (cACT) for 5-12 yr olds. | During Active Trial Period at Baseline, End of Treatment (EOT; which will occur between 1 to 2 months after baseline, depending on intervention assignment), 3 month follow-up after EOT, 6 month follow-up, 9 month follow-up, 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Asthma Symptom Free Days (Individual-Level) | Assessed by parent report using the standard questionnaire item, Symptom Free Days (SFDs) within previous 30-day period (Kirshnan et al., 2012). Parents are asked on how many days of the past 30 their child experienced asthma symptoms. This item is reverse-scored. Responses range from 0 to 30, with higher numbers indicating better functioning. | During Active Trial Period at Baseline, End of Treatment (EOT; which will occur between 1 to 2 months after baseline, depending on intervention assignment), 3 month follow-up after EOT, 6 month follow-up, 9 month follow-up, 12 month follow-up | 
| Change in caregivers' asthma self-efficacy, or their beliefs about how effectively they can manage their child's asthma (Individual-Level) | Caregiver report of Asthma Management Efficacy. The Parent Asthma Self Efficacy Scale (Bursch et al., 1999) measures parents' self-efficacy with regard to managing their children's asthma. This questionnaire yields a total self-efficacy score, as well as scores for 2 subscales: Attack Prevention and Attack Management. Scores are derived by computing means of the items comprising that scale. Scores range from 1 to 5 with higher scores indicating higher parental self efficacy. | During Active Trial Period at Baseline, End of Treatment (EOT; which will occur between 1 to 2 months after baseline, depending on intervention assignment), 12 month followup after EOT | 
| Change in Quality of Life related to Asthma as defined by the physical and emotional impact related to managing a child's asthma on the parent or caregiver (Individual-Level) | The Pediatric Asthma Caregiver's Quality of Life (QOL) Questionnaire (Juniper et al., 1996) assesses parent/caregiver's quality of life related to their children's asthma. This questionnaire yields a total score (overall QOL) as well as subscales related to parent's emotional functioning and activity functioning related to their child's asthma. The total score and subscales are each derived by computing a mean of the items comprising that scale. Scores range from 1 to 7 with higher scores indicating higher QOL. | During Active Trial Period at Baseline, End of Treatment (EOT; which will occur between 1 to 2 months after baseline, depending on intervention assignment), 3 month followup after EOT, 6 month followup, 9 month followup, 12 month followup | 
| Changes in health care utilization rates (Individual-level) | Assessed through electronic health record review of emergency department and inpatient visits | During Active Trial Period at Baseline and 12 month follow-up | 
| Changes in school absences (individual level) | Parent report of child's school absences | During Active Trial Period at Baseline and 12 month follow-up | 
| Changes in Asthma Health Care Utilization (Community-Level) | Community-based assessment of health care utilization using rates of emergency department visits and hospitalization for asthma from hospital data | 12 months pre- and post-intervention year | 
| Changes in number of School Absences (Community-Level) | Information from schools regarding children's school attendance across the academic year. | 12 months pre- and post-intervention year |