Community Partnership for Telehealth Solutions to Convey Information and Enhance Care

University of Arizona6,000 enrolled

Overview

Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention.

The PRIME study aims to improve colorectal cancer (CRC) screening and follow-up among predominantly Latinx populations by using video text messages, mailed FIT kits, and patient navigation. The study will address multi-level barriers to screening, including misinformation, lack of access, and social determinants of health. The hypothesis is that a multi-component intervention will increase CRC screening rates and follow-up care, reducing disparities in CRC outcomes.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

6,000

Conditions

Colorectal Cancer

Interventions

Video text messageBEHAVIORAL

Video text messages tailored to the Latinx population to educate and motivate patients to complete CRC screening.

In-clinic CRC screening promotionBEHAVIORAL

Stool-test orders, colonoscopy referrals.

Mailed FITBEHAVIORAL

Mailed FIT kits.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ages 45-64 * Eligible for colorectal cancer (CRC) screening * Current patients (seen in the clinic in the last 6 months) * Primary speaker of English or Spanish * Cell phone listed in Electronic Health Record (EHR) * No recent history of CRC screening * Resides in one of the neighborhoods included in the main trial Exclusion Criteria: * Colorectal disease (e.g., ulcerative colitis or colectomy) * Personal history of colorectal cancer * End-stage or life-threatening diseases * Known to be under hospice care * Living in a skilled nursing facility * Patients who decline research participation will be removed from the patient contact list

Locations (1)

AltaMed Health Services Corporation

Los Angeles, California, United States

RECRUITING

Outcomes

Primary Outcomes

CRC Screening Completion at the Individual Level

Measure the completion rate of colorectal cancer (CRC) screening at the individual level within 6 months of receiving the intervention. This will compare the proportion of participants in the post-intervention group versus the pre-intervention group.

Time frame: 6 months

Secondary Outcomes

FIT completion

Measure the completion rate of fecal immunochemical tests (FIT) within 6 months of receiving the intervention. This will compare the proportion of participants who complete FIT in the post-intervention group versus the pre-intervention group.

Time frame: 6 months

Rate of Follow-Up Colonoscopy Completion

Track the completion rate of follow-up colonoscopy within 12 months for participants with abnormal FIT results, comparing the post-intervention versus pre-intervention groups.

Time frame: 12 months

Time to follow-up colonoscopy

Measure the time from abnormal FIT result to the completion of follow-up colonoscopy, comparing the post-intervention versus the pre-intervention groups.

Time frame: Within 12 months post abnormal FIT result

Central Contacts

Gloria Coronado, PhD

CONTACT

5039147100 gdcoronado@arizona.edu

Katherine Mendoza, MPH

CONTACT

8477672847 katherinemendoza@arizona.edu

Data from ClinicalTrials.gov

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