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NCT Number: NCT06530953

Comparing Two Linkage-to-Care Models for Latinx Immigrant Patients : A Pilot Comparative Clinical Effectiveness Trial

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Patient Navigator Model

Behavioral

The patient navigator model is an evidence-based intervention to improve access to healthcare services.

Primary outcomes

  1. Follow up care

    Time frame: 12 weeks post randomization

    Follow up care for referred healthcare need

Secondary outcomes

  1. Trust in physicians

    Time frame: 12 weeks post randomization

    Trust in physicians measured by 10-item physician trust Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Ann M Cheney, PhD

CONTACT

[email protected]

951-827-2917

Monica Wicker

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, Riverside

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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