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

NCT06530953 | Not Yet Recruiting

• 1 other identifier: 30382
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Disease

Outcome Measures

Primary Outcomes (1)

• Follow up care

  Follow up care for referred healthcare need

  12 weeks post randomization

Secondary Outcomes (1)

• Trust in physicians

  12 weeks post randomization

Study Arms (2)

Patient Navigator/ Community Health Worker

ACTIVE COMPARATOR

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

Patient Navigator/Clinic Staff

ACTIVE COMPARATOR

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

Interventions

Patient Navigator Model BEHAVIORAL

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

Patient Navigator/ Community Health Worker; Patient Navigator/Clinic Staff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Riverside: lead

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann M Cheney, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann M Cheney, PhD

CONTACT

951-827-2917; ann.cheney@medsch.ucr.edu

Monica Wicker

CONTACT

IRB@ucr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: July 31, 2024
• Study Start: September 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: De-identified data will be available after the completion of main analysis and scientific dissemination.
• Access Criteria: Interested parties should contact the principal investigator at ann.cheney@medsch.ucr.edu