Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530953
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Comparing Two Linkage-to-Care Models for Latinx Immigrant Patients A Pilot Comparative Clinical Effectiveness Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparing Two Linkage-to-Care Models for Latinx Immigrant Patients A Pilot Comparative Clinical Effectiveness Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 goal of this randomized clinical comparative effectiveness trail is to compare the effects of patient navigator models on follow-up care in Latinx and Indigenous Mexican immigrant patient populations The main questions it aims to answer isare
Participants randomized to PN-CHW compared to the PN-CS model will be more likely to follow through with follow-up care referrals
Trust will be a driving factor as to why PN-CHW will be a more effective intervention for the patient population
Researchers will compare patients in a patient navigator community health worker PN-CHW intervention to those in a patient navigator clinical staff PN-CS intervention to see which model of linkage to care is more effective for follow-up care in the patient population
Participants will be asked to
Complete a baseline survey about healthcare access
Receive calls and text messages from either a CHW or clinical staff
Complete a follow up survey
Participants randomized to PN-CHW compared to the PN-CS model will be more likely to follow through with follow-up care referrals
Trust will be a driving factor as to why PN-CHW will be a more effective intervention for the patient population
Researchers will compare patients in a patient navigator community health worker PN-CHW intervention to those in a patient navigator clinical staff PN-CS intervention to see which model of linkage to care is more effective for follow-up care in the patient population
Participants will be asked to
Complete a baseline survey about healthcare access
Receive calls and text messages from either a CHW or clinical staff
Complete a follow up survey
Detailed Description:
The research project will be conducted at a free clinic that serves a primarily Spanish-speaking Latinx patient population in the Inland Southern California region Patients in this study will be randomized to one of two intervention arms Arm 1 PN model delivered by CHWspromotoras and Arm 2 PN model delivered by clinic staff CHWs who live in the region and work at the free clinic will deliver the PN model for Arm 1 participants CHWs have a detailed knowledge of local health resources as well as lived experience of the barriers patients in their community face when accessing healthcare services Medical students who are volunteer clinic staff will deliver the PN model for Arm 2 participants Medical students are the doctors in training who provide primary care services to patients at the CVFC under the supervision of well-established physicians Baseline data and follow-up data at 12 weeks will be collected along with qualitative interviews with patients in both arms of the study
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