Rhode Island Asthma Integrated Response Program

NCT03583814 | Completed DMC

• 1 other identifier: U01HL138677
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in Asthma Symptom Free Days (Individual-Level)

  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)

  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)

  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)

  During Active Trial Period at Baseline and 12 month follow-up

• Changes in school absences (individual level)

  During Active Trial Period at Baseline and 12 month follow-up

Study Arms (3)

CASE Program only

ACTIVE COMPARATOR

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

CASE and HARP Programs

ACTIVE COMPARATOR

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; Behavioral: HARP Program

Standard Care

NO INTERVENTION

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.

Interventions

CASE Program 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 Program only; CASE and HARP Programs

HARP Program 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.

CASE and HARP Programs

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children with complex medical conditions (i.e., requiring on-site medical supervision of CHW)

Sponsors & Collaborators

• Rhode Island Hospital: lead
• State of Rhode Island Department of Health: collaborator
• Providence Public School District: collaborator
• Pawtucket School Department: collaborator
• Central Falls School District: collaborator
• Cranston Public Schools: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

• 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.

  PMID: 37088129 BACKGROUND

• McQuaid EL, Barker D, Chen ES, Coutinho MT, Cushman GK, Drew L, Elwy AR, Esteban CA, Jandasek BN, Kopel SJ, Pearlman D, Seifer R, Vivier P, Koinis-Mitchell D. Addressing Pediatric Asthma Disparities through RI-AIR's Community Approach: A Randomized Trial. Ann Am Thorac Soc. 2025 Nov;22(11):1709-1719. doi: 10.1513/AnnalsATS.202501-016OC.

  PMID: 40569168 DERIVED

Study Officials

• Elizabeth L McQuaid, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Daphne Koinis Mitchell, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: July 11, 2018
• Study Start: November 27, 2018
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available within one year of completion of the studies and dissemination of primary study results, and will be available for 10 years following the completion of the study.
• Access Criteria: Once they become available, researchers requesting the data would follow the published RI-AIR ACIP procedures. We will make the data available to potential users only under a NIH-approved data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant in any way; (2) a commitment to securing the data using appropriate information security that is compliant with the most recent federal guidelines that are outlined by our information security protocol; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)