Clinical trial NCT06530953: Comparing Two Linkage-to-Care Models for Latinx Immigrant Patients : A Pilot Comparative Clinical Effectiveness Trial
Official title: Comparing Two Linkage-to-Care Models for Latinx Immigrant Patients : A Pilot Comparative Clinical Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Disease
Lead sponsor: University of California, Riverside
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 question\[s\] it aims to answer \[is/are\]:

* 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 CHWs/promotoras 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.

Eligibility criteria: Inclusion Criteria:

* 1) live in the Coachella Valley, 2) 18 or older, 3) household income less than or equal to or below 200% of federal poverty guidelines, 4) do not currently have health insurance, and 5) have access to a telephone.

Exclusion Criteria:

* Do not speak English, Spanish or Purépecha (an indigenous dialect spoken among the Purépecha of Mexico).

Primary outcomes:
measure: Follow up care
timeFrame: 12 weeks post randomization
Secondary outcomes:
measure: Trust in physicians
timeFrame: 12 weeks post randomization
Other outcomes:
Locations:
Study officials:
affiliation: Principal Investigator
name: Ann M Cheney, PhD
role: PRINCIPAL_INVESTIGATOR
References: