Clinical trial NCT03583814: Rhode Island Asthma Integrated Response Program
Official title: Rhode Island Asthma Integrated Response Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: State of Rhode Island Department of Health
name: Providence Public School District
name: Pawtucket School Department
name: Central Falls School District
name: Cranston Public Schools
First posted: 2018-07-11
Enrollment: 432
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Asthma Control (Individual-Level)
timeFrame: 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
measure: Change in Asthma Control (Individual Level)
timeFrame: 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 outcomes:
measure: Change in Asthma Symptom Free Days (Individual-Level)
timeFrame: 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
measure: Change in caregivers' asthma self-efficacy, or their beliefs about how effectively they can manage their child's asthma (Individual-Level)
timeFrame: 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
measure: 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)
timeFrame: 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
measure: Changes in health care utilization rates (Individual-level)
timeFrame: During Active Trial Period at Baseline and 12 month follow-up
measure: Changes in school absences (individual level)
timeFrame: During Active Trial Period at Baseline and 12 month follow-up
measure: Changes in Asthma Health Care Utilization (Community-Level)
timeFrame: 12 months pre- and post-intervention year
measure: Changes in number of School Absences (Community-Level)
timeFrame: 12 months pre- and post-intervention year
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Elizabeth L McQuaid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Daphne Koinis Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cushman GK, Koinis-Mitchell D, Alsina M, Barker D, Drew L, DeCesare C, Yeo AJ, Durkin K, Elwy AR, Jandasek B, Pearlman DN, Vivier P, McQuaid EL. Design of a community-based, Hybrid Type II effectiveness-implementation asthma intervention study: The Rhode Island Asthma Integrated Response (RI-AIR) program. Contemp Clin Trials. 2023 Jun;129:107204. doi: 10.1016/j.cct.2023.107204. Epub 2023 Apr 23.