Clinical trial NCT06507943: Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Official title: Community Health Equity Accelerator (CHEA): Community-Academic Asthma Partnership, Pediatric Asthma Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Keywords: Medical Legal Partnership
Community Health Worker
Health Harming Legal Needs
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Hispanic Federation, Inc.
First posted: 2024-07-18
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this pilot is to initiate an academic-community partnership and launch a multi-level intervention that includes an asthma exposure pathway (an online decision support and resource) and a health Promotora program that will provide culturally responsive asthma support alongside legal and medical services to improve access to asthma care and ultimately improve asthma-related outcomes in the New Haven region.

Detailed description: In this will be a prospective, non-randomized, observational, multi-level pilot intervention, general pediatricians and specialists in New Haven, Connecticut will utilize a newly developed clinical pathway that will be publicly available at the Yale Pediatrics Clinical Pathways website and accessible within the electronic health record (EHR) via integrated software to submit referrals for participants in a Promotora (Community Health Worker) asthma home-visiting intervention.

The Hispanic Federation Promotoras, who are partners in this study who have received Human Subjects research training, will enroll participants in the study. For each participating family, Promotora home visits will be scheduled 6-8 weeks apart, with in-person or virtual visits conducted per the family's preference. The Promotoras, who have received specialized asthma training, will address concerns raised by families, using the clinical pathway as a resource (the pathway will have resources for asthma-related concerns that are raised). A clinician from the study team will be on call at all times for the Promotoras in case urgent questions arise, and weekly case-conferences will be arranged to discuss any additional needs for support.

In this study, the primary outcomes will include measures of feasibility of both Promotora home visits and pathway utilization. The investigators will evaluate secondary outcomes using an interrupted time series analysis to evaluate asthma-related outcomes. In addition to survey data, asthma exacerbation metrics will be collected from the electronic health record.

Eligibility criteria: Inclusion Criteria:

Children with a diagnosis of asthma with at least one of the following:

* Oral steroid prescription in past 12m
* ED visit for asthma in past 12m
* Hospital admission for asthma in past 12m
* Asthma control test (ACT) score at visit ≤19
* Concern for asthmogenic exposure in the home (such as mold, pests, smoking, or pollution)
* At least one missed follow-up appointment for asthma
* At least one asthma exacerbation in the prior year
* Interested in asthma education (such as education in how to prevent asthma or how to administer medications)
* Concern for medication non-adherence

Exclusion Criteria:

* Living outside of New Haven Zip Code

Primary outcomes:
measure: Percentage of Referrals Resulting in Home Visit, to Assess Feasibility of Promotora Visits
timeFrame: One Year
measure: Percent of clinicians who use pathway, to assess feasibility of asthma pathway use
timeFrame: One Year
measure: Percent of patients for whom the pathway is used, to assess feasibility of asthma pathway use
timeFrame: One Year
measure: Count of use of individual asthma pathway component use
timeFrame: One Year
Secondary outcomes:
measure: Mean Asthma Control Test (ACT) for 4-11 years scores
timeFrame: Baseline and 6-8 weeks later
measure: Mean Pediatric Quality of Life (Peds-QL) scores
timeFrame: Baseline and 6-8 weeks later
measure: Mean number of hospital admissions for asthma
timeFrame: Two years (year before and year after intervention)
measure: Mean number of emergency department (ED) visits for asthma
timeFrame: Two years (year before and year after intervention)
measure: Mean number of urgent visits for asthma
timeFrame: Two years (year before and year after intervention)
measure: Mean number of oral steroid prescriptions for asthma
timeFrame: Two years (year before and year after intervention)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale
state: Connecticut
Study officials:
affiliation: Yale University
name: Julia Rosenberg, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: