Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507943
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Community Health Equity Accelerator CHEA Pediatric Asthma Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Community Health Equity Accelerator CHEA Community-Academic Asthma Partnership Pediatric Asthma Intervention
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 familys 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
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 familys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None