Clinical trial NCT06239844: Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English
Official title: Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Languages Other Than English (Nav-TEAM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 570
Sex: ALL
Minimum age (years): 4
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed study builds on a successful local model of asthma navigation and care coordination to support meeting social determinants of health (SDOH) needs using a lay health worker model that has improved asthma outcomes among urban racial/ethnic minority school children. This model is currently being disseminated via community-engaged processes to select school districts across Colorado. Community advisory board members from that initiative identified increasing language inclusivity as a priority in program dissemination.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Nav-Team study reviews how well the asthma navigators/coordinator program can improve the lives of asthmatic children, and their caregivers, by providing additional assistance and education. Aim 1 of the study will partner with immigrant serving community organizations to hold meetings that will help tailor the programs. Aim 2 of the study looks at data to help see if the program is working to help children and their caregivers. Aim 2a looks at difference in emergency department use between families that did not use the Nav-Team program and those that did. Aim 2b reviews how well the Nav-Team program did with reaching and connecting with the asthma child and caregiver community. Aim 2b, also reviews the costs of the program, how well the program did will sticking to the program goals, and how well the staff was able to keep up with providing education and help.

Detailed description: Children in families with healthcare communication in a language other than English are at increased risk of poor asthma care and worse asthma outcomes compared to those without a language barrier. As the most common chronic childhood disease, asthma causes substantial family- and patient-level burden as well as economic impact. Caregivers of children with asthma whose healthcare communication is in languages other than English (LOE) are more likely to report poor asthma care experiences, less use of recommended asthma management practices, and higher hospitalization rates compared to children with caregivers with English healthcare communication. A focus on improving asthma care specifically for families who communicate in LOE is needed to address such disparities.

Asthma navigators play a key role in asthma education and care coordination, resulting in improved asthma outcomes, particularly for low-income and racial/ethnic minority children but studies have not focused on children in LOE families. The proposed study builds on a successful local model of asthma navigation and care coordination to support meeting social determinants of health (SDOH) needs using a lay health worker model that has improved asthma outcomes among urban racial/ethnic minority school children. This model is currently being disseminated via community-engaged processes to select school districts across Colorado. Community advisory board members from that initiative identified increasing language inclusivity as a priority in program dissemination. However, school feasibility concerns and limited opportunities for cultural and language tailoring prevent focusing on this priority. Addressing these barriers, the Navigating Toward Equitable Asthma Management Program (Nav-TEAM) is an adaptation of evidence-based asthma navigation specifically for children in families who communicate in LOE.

Nav-TEAM will include core components of evidence-based asthma navigation/care coordination through a different implementation approach and via specific tailoring for LOE families. Children with asthma and their families will be connected to Nav-TEAM via their healthcare provider rather than the school. Nav-TEAM encounters will take place via telehealth because frequent asthma care in clinic can be difficult for families, and home visits present coordination challenges and increased costs. While emerging research points to inequitable reach of telehealth for LOE patients/families, the telehealth program at the proposed study health system, is committed to equity via integrated interpretation and continuous improvement to increase use with LOE families informed by research partnerships to assess telehealth equity.

Use of lay health workers to provide asthma education and care coordination is a well-established effective intervention. Nav-TEAM will build on the successes of school and home-visiting programs affiliated with the study health system, Children's Hospital Colorado (CHCO) with a novel focus on reaching LOE families. As with existing CHCO asthma navigation programs, Nav-TEAM will align with EXHALE, the Centers for Disease Control and Prevention National Asthma Control Program compilation of asthma management strategies that have been proven to reduce asthma-related ED visits, hospitalization, and healthcare costs. EXHALE strategies include EDUCATION on asthma -self-management, X-TINGUISHING smoking and exposure to secondhand smoke, Home Visits, ACHIEVEMENT of guidelines-based medical management, LINKAGES and coordination of care across settings, ENVIRONMENTAL policies \& best practices to reduce asthma triggers.

When will Nav-TEAM Encounters occur and what will take place during encounters? Families will participate in the Nav-TEAM intervention for 9 months which is similar to the length of school- and home-based programs. There will be scheduled Nav-TEAM encounters with additional encounters to follow-up any asthma-related clinic, ED or hospital visits. We expect most patients will complete ≈6 encounters based on current utilization patterns. Encounters will follow an intervention guide used in existing programs with some adapted elements based on Aim 1 feedback and tailoring. There will be the availability to schedule Nav-TEAM encounters during evening hours and to accommodate families' work schedules.

The overall scientific goals of this community-engaged study are to: evaluate the effectiveness of Nav-TEAM on pediatric asthma outcomes for 320 children whose families communicate in LOE, evaluate implementation outcomes, and assess cost and contextual factors to support sustained implementation, scale up and scale out. The study will be implemented in a large primary care clinic serving primarily Medicaid-insured children and in subspecialty pediatric pulmonary clinics using the Practical Robust Implementation and Sustainability Model (PRISM) - inclusive of RE-AIM (Reach, Effectiveness, Adoption, Implementation Maintenance outcomes with an equity lens- as the guiding Dissemination \& Implementation Science framework.

Eligibility criteria: eria for Nav-TEAM Intervention Dyads include:

* Child aged 4-12 years.
* Child with persistent asthma (defined by currently prescribed controller medication).
* Parent/legal guardian who is at least 18 years old.

Exclusion criteria for Nav-TEAM Intervention Dyads include:

* Child aged under 4 and over 12 years of age.
* Child with no persistent asthma (defined by currently prescribed controller medication).
* Parent/legal guardian who is under 18 years old.
* Any parent/legal guardian whose preferred spoken language is English.
* Child requires additional continuous respiratory support (e.g,. tracheostomy with home ventilation, continuous daytime oxygen).
* Child is enrolled in another study health system associated asthma navigation program (e.g. school or home-visiting programs).
* Spoken non-English preferred healthcare language of parent/legal guardian.
* Child does NOT require additional continuous respiratory support (e.g., nighttime use of Continuous positive airway pressure machine for obstructive sleep apnea would be eligible).
* Child does NOT have a complex medical/genetic condition that affects swallowing or lung function (e.g. g-tube with aspiration, cystic fibrosis)
* Child is NOT enrolled in another study health system associated asthma navigation program (e.g. school or home-visiting programs).

Primary outcomes:
measure: Asthma-related emergency department (ED) utlization
timeFrame: 12 months
Secondary outcomes:
measure: Parent-reported asthma-related ED utilization
timeFrame: 12 months
measure: Asthma hospitalization
timeFrame: 12 months
measure: Parent-reported asthma-related hospitalization
timeFrame: 12 months
measure: Asthma Exacerbations
timeFrame: 12 months
measure: Asthma Control
timeFrame: 12 months
measure: Missed School Days
timeFrame: 12 months
measure: Missed Work Days
timeFrame: 12 months
measure: General child health
timeFrame: 12 months
measure: Child asthma-related quality of life
timeFrame: 12 months
measure: Parent asthma-related quality of life
timeFrame: 12 months
measure: Parent asthma self-efficacy
timeFrame: 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References: