Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
1500

Summary

Conditions
Asthma in Children
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention 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)Primary Purpose: Treatment

Participation Requirements

Age
Between 2 years and 12 years
Gender
Both males and females

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 schoo...

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.

Tracking Information

NCT #
NCT03583814
Collaborators
  • State of Rhode Island Department of Health
  • Providence Public School District
  • Pawtucket School Department
  • Central Falls School District
  • Cranston Public Schools
Investigators
Principal Investigator: Elizabeth L McQuaid, PhD Rhode Island Hospital Principal Investigator: Daphne Koinis Mitchell, PhD Rhode Island Hospital