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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Disease
• Intervention / Treatment: Behavioral: Patient Navigator Model

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.

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

Contacts and Locations

• Study Contact: Name: Ann M Cheney, PhD; Phone Number: 951-827-2917; Email: ann.cheney@medsch.ucr.edu
• Study Contact Backup: Name: Monica Wicker; Email: IRB@ucr.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient Navigator/ Community Health Worker; The community health worker will contact the participant two days after their initial clinic visit. They will call the participant to offer support and counseling on accessing their follow-up visits with local healthcare system. Additionally, the PN will call 1 day prior to the scheduled appointment to offer support and information to the patient followed by a reminder text the morning of the appointment.	Behavioral: Patient Navigator Model; The patient navigator model is an evidence-based intervention to improve access to healthcare services.
Active Comparator: Patient Navigator/Clinic Staff; Clinic staff will contact the participant two days after their initial clinic visit. They will call the participant to offer support and counseling on accessing their follow-up visits with local healthcare system. Additionally, the clinic staff will call 1 day prior to the scheduled appointment to offer support and information to the patient followed by a reminder text the morning of the appointment.	Behavioral: Patient Navigator Model; The patient navigator model is an evidence-based intervention to improve access to healthcare services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow up care	Follow up care for referred healthcare need	12 weeks post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trust in physicians	Trust in physicians measured by 10-item physician trust Scale	12 weeks post randomization

Collaborators and Investigators

• Sponsor: University of California, Riverside
• Investigators: Principal Investigator: Ann M Cheney, PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 28, 2024
• First Submitted That Met QC Criteria: July 28, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 28, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 30382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared upon request to the study principal investigator.
• IPD Sharing Time Frame: De-identified data will be available after the completion of main analysis and scientific dissemination.
• IPD Sharing Access Criteria: Interested parties should contact the principal investigator at ann.cheney@medsch.ucr.edu
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

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