Rhode Island Asthma Integrated Response Program (RI-AIR)

Lifespan

Status: Completed

Conditions: Asthma in Children

Treatments: Behavioral: CASE Program; Behavioral: HARP Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03583814

U01HL138677

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 432 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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432 participants in 3 patient groups

CASE Program only

Active Comparator group

Description:

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.

Treatment:

Behavioral: CASE Program

CASE and HARP Programs

Active Comparator group

Description:

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.

Treatment:

Behavioral: HARP Program

Behavioral: CASE Program

Standard Care

No Intervention group

Description:

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.