Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention

Community Health Equity Accelerator (CHEA): Community-Academic Asthma Partnership, Pediatric Asthma Intervention

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Behavioral: Promotora Home Visit

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Promotora; Two Hispanic Federation Promotoras (community health workers) will provide culturally competent, bilingual home visits for asthma-related education and evaluation and support for health-harming legal needs (e.g., mold, rodents), including an initial visit and a follow-up visit 6-8 weeks later.

Behavioral: Promotora Home Visit; 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 visits will begin with a survey which will evaluate concerns related to asthma for the child and the family, including their asthma control (via the ACT), their home environment (via screening for environmental exposures), and quality of life for the child. These surveys will be available in both online or physical forms for potential connectivity concerns, and Promotoras will have IPads for the online forms. The Promotoras, who have received specialized asthma training, will then address concerns raised by families, using the Clinical Pathway which will have resources for asthma-related concerns that are raised.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Referrals Resulting in Home Visit, to Assess Feasibility of Promotora Visits	Percent of referred participants (from all referrals placed) to the newly-established asthma home visiting Promotora Program that resulted in a home visit (in-person or virtual)	One Year
Percent of clinicians who use pathway, to assess feasibility of asthma pathway use	Percent of clinicians at participating practices who have accessed the asthma intervention pathway (using data from pathway utilization metrics)	One Year
Percent of patients for whom the pathway is used, to assess feasibility of asthma pathway use	Percent of patients for whom a clinician accessed the asthma pathway (using pathway utilization metrics) out of total potential children for whom it could be used (using deidentified electronic health (EHR) record data tool)	One Year
Count of use of individual asthma pathway component use	Count of use of individual asthma pathway components (using pathway utilization metrics)	One Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Asthma Control Test (ACT) for 4-11 years scores	The ACT (for 4-11 years) is a seven-item survey with likert scales for caregivers (3 questions, scores 0-5) and children (5 questions, scores 0-3) together. It is used to evaluate asthma control with total score range of 0 (poorly controlled) to 27 (well-controlled)	Baseline and 6-8 weeks later
Mean Pediatric Quality of Life (Peds-QL) scores	The Peds-QL is a 15 item survey with likert scales (0-4), with transformed scores out of 100, with a score range of 0 (poor quality of life) to 100 (high quality life).	Baseline and 6-8 weeks later
Mean number of hospital admissions for asthma	Total number of hospital admissions for asthma, evaluated via manual count via chart review.	Two years (year before and year after intervention)
Mean number of emergency department (ED) visits for asthma	Total number of ED visits for asthma, evaluated via manual count via chart review.	Two years (year before and year after intervention)
Mean number of urgent visits for asthma	Total number of urgent visits for asthma, evaluated via manual count via chart review.	Two years (year before and year after intervention)
Mean number of oral steroid prescriptions for asthma	Total number of oral steroid prescriptions for asthma, evaluated via manual count via chart review.	Two years (year before and year after intervention)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Hispanic Federation, Inc.
• Investigators: Principal Investigator: Julia Rosenberg, MD MHS, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Community Health Worker; Medical Legal Partnership; Health Harming Legal Needs
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 2000037314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No