The Puerto Rico Asthma Integrated Response Program ("PR-AIR")

Lifespan

Status: Not yet enrolling

Conditions: Pediatric Asthma

Treatments: Behavioral: CASE-V remote version (Low Intensity Package); Behavioral: CASE-V and HARP-V remote version (Low Intensity package); Behavioral: CASE and HARP in person (High Intensity package); Behavioral: CASE in person version (High Intensity Package)

Study type: Interventional

Funder types: Other

Identifiers

NCT05999032

R01HL159701

Details and patient eligibility

About

The purpose of this study is to adapt and deliver an evidence-based multi-level intervention to reduce asthma disparities, and that promote and improve population health in the high-burden communities of San Juan, Puerto Rico.

The Puerto Rico-Asthma Integrated Response Program (PR-AIR) will be implemented and evaluated to address pediatric asthma disparities in San Juan, PR, an area of high asthma burden. This study unfolds in two phases: In Phase 1, the researchers will collaborate with community stakeholders to identify needs, barriers and facilitators of PR-AIR implementation. Phase 2 consists of an evaluation of low-intensity (virtual) and high-intensity (in-person) methods of PR-AIR implementation outcomes using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework and a mixed methods approach.

Full description

During the formative evaluation (Phase 1), the researchers will engage community stakeholders (primary caregivers of children with asthma, school personnel, asthma healthcare providers) to help identify, adapt and finalize strategies for PR-AIR implementation. The Consolidated Framework for Implementation Research (CFIR) will be used to identify barriers and facilitators of low-intensity and high-intensity implementation approaches, the Adaptome to guide intervention adaptation to the context of PR, and the CFIR-ERIC matching tool to identify strategies to support but low- and high-intensity implementation packages. Fifteen stakeholders will complete in-depth interviews early in Phase 1, and 16 will participate in two focus groups at the end of Phase 1 prior to the transition to Phase 2, in preparation for trial implementation. A collaborative of community stakeholders will be convened (the PR-AIR CC) to provide input throughout both phases of the trial.

In Phase 2 (Years 2-4) 480 urban children will be enrolled, ages 2-12 (expected retention for full protocol, n = 400) with asthma across 12 areas in San Juan with high asthma burden. Randomization is at the level of targeted geographic area, and data will be collected from groups in each of these areas over time. Individual-level (asthma control, QOL) and community-specific (ED use/hospitalizations, school absence) effectiveness outcomes will be evaluated. All families will participate in both a control (in our case, baseline period for the community indicators) and intervention (active trial). Each target area will begin with a low-intensity (virtual) implementation phase, and transition to a high-intensity implementation phase mid-year. Families enrolled in the first 5 months of the school year will receive the low-intensity intervention package, and those enrolled in the last 5 months of the school year will receive the high-intensity intervention package. Input will be collected throughout each year from community stakeholders about the trial, through in-depth interviews and surveys. Reach, Adoption, Implementation, and Maintenance will be measured using a mixed-methods approach at the end of each trial year (years 2 - 4). Repeated assessments will measure individual-level effectiveness outcomes (asthma control, QOL) at time points linked to the start of intervention participation; at enrollment, end of treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.

Enrollment: 480 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children between the ages of 2 and 12 years old
2. Children must reside in one of the identified catchment areas
3. Children must meet the screening criteria as having not well controlled or poorly controlled asthma

Exclusion criteria

1. Children with complex medical conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

Low-Intensity (Virtual) Intervention Implementation

Active Comparator group

Description:

During low intensity implementation, families of children with poorly controlled asthma will be referred to the remote version of HARP (HARP-V) and will receive CASE remotely (CASE-V). Children with not well controlled asthma will receive only CASE-V remotely.

Treatment:

Behavioral: CASE in person version (High Intensity Package)

Behavioral: CASE-V remote version (Low Intensity Package)

High Intensity (in-Person) Intervention Implementation

Active Comparator group

Description:

During high intensity implementation, all interventions are administered in person. Specifically, families of children with poorly controlled asthma will receive in-person versions of HARP and CASE. Children with not well controlled asthma will receive an in-person version of CASE only.

Treatment:

Behavioral: CASE-V and HARP-V remote version (Low Intensity package)

Behavioral: CASE and HARP in person (High Intensity package)