Rhode Island Asthma Integrated Response Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-27

Study Completion Date

2024-08-31

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.

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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.

Conditions

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Asthma in Children

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CASE Program only

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.

Group Type ACTIVE_COMPARATOR

CASE Program

Intervention Type BEHAVIORAL

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.

CASE and HARP Programs

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.

Group Type ACTIVE_COMPARATOR

CASE Program

Intervention Type BEHAVIORAL

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.

HARP Program

Intervention Type BEHAVIORAL

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.

Standard Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CASE Program

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.

Intervention Type BEHAVIORAL

HARP Program

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.

Intervention Type BEHAVIORAL

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.