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

NCT ID: NCT06530953

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-12-31

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.

Conditions

Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Patient Navigator Model

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Patient Navigator Model

Intervention Type: BEHAVIORAL

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

Interventions

Patient Navigator Model

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

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Riverside

OTHER

Sponsor Role: lead

Responsible Party

Ann Cheney

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann M Cheney, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Central Contacts

Ann M Cheney, PhD

Role: CONTACT

Phone: 951-827-2917

Email: ann.cheney@medsch.ucr.edu

Monica Wicker

Role: CONTACT

Email: IRB@ucr.edu

Other Identifiers

30382

Identifier Type: -

Identifier Source: org_study_id