Rhode Island Asthma Integrated Response Program

Asthma in Children Clinical Trial

— RI-AIR  

Official title:

Rhode Island Asthma Integrated Response Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03583814
• Other study ID #: U01HL138677
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 27, 2018
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 432
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (6)

Lead Sponsor	Collaborator
Rhode Island Hospital	Central Falls School District, Cranston Public Schools, Pawtucket School Department, Providence Public School District, State of Rhode Island Department of Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Asthma Symptom Free Days (Individual-Level)	Assessed by parent report using the standard questionnaire item, Symptom Free Days (SFDs) within previous 30-day period (Kirshnan et al., 2012). Parents are asked on how many days of the past 30 their child experienced asthma symptoms. This item is reverse-scored. Responses range from 0 to 30, with higher numbers indicating better functioning.	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	Change in caregivers' asthma self-efficacy, or their beliefs about how effectively they can manage their child's asthma (Individual-Level)	Caregiver report of Asthma Management Efficacy. The Parent Asthma Self Efficacy Scale (Bursch et al., 1999) measures parents' self-efficacy with regard to managing their children's asthma. This questionnaire yields a total self-efficacy score, as well as scores for 2 subscales: Attack Prevention and Attack Management. Scores are derived by computing means of the items comprising that scale. Scores range from 1 to 5 with higher scores indicating higher parental self efficacy.	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
Secondary	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)	The Pediatric Asthma Caregiver's Quality of Life (QOL) Questionnaire (Juniper et al., 1996) assesses parent/caregiver's quality of life related to their children's asthma. This questionnaire yields a total score (overall QOL) as well as subscales related to parent's emotional functioning and activity functioning related to their child's asthma. The total score and subscales are each derived by computing a mean of the items comprising that scale. Scores range from 1 to 7 with higher scores indicating higher QOL.	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
Secondary	Changes in health care utilization rates (Individual-level)	Assessed through electronic health record review of emergency department and inpatient visits	During Active Trial Period at Baseline and 12 month follow-up
Secondary	Changes in school absences (individual level)	Parent report of child's school absences	During Active Trial Period at Baseline and 12 month follow-up
Secondary	Changes in Asthma Health Care Utilization (Community-Level)	Community-based assessment of health care utilization using rates of emergency department visits and hospitalization for asthma from hospital data	12 months pre- and post-intervention year
Secondary	Changes in number of School Absences (Community-Level)	Information from schools regarding children's school attendance across the academic year.	12 months pre- and post-intervention year