Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity

NCT ID: NCT06542835

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

6000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2027-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Video text message, mailed FIT, and social needs navigation

Tailored video text message, mailed FIT, and navigation to address patients' social needs.

Group Type EXPERIMENTAL

Video text message

Intervention Type BEHAVIORAL

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

Mailed FIT

Intervention Type BEHAVIORAL

Mailed FIT kits.

Social needs navigation

Intervention Type BEHAVIORAL

Patient navigation to address social needs.

Usual care

Colorectal cancer (CRC) screening offers during in-person clinic visits.

Group Type ACTIVE_COMPARATOR

In-clinic CRC screening promotion

Intervention Type BEHAVIORAL

Stool-test orders, colonoscopy referrals.

Reminders

Intervention Type BEHAVIORAL

Centralized text and/or telephone reminders for ordered tests.

Interventions

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Video text message

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

Intervention Type BEHAVIORAL

In-clinic CRC screening promotion

Stool-test orders, colonoscopy referrals.

Intervention Type BEHAVIORAL

Mailed FIT

Mailed FIT kits.

Intervention Type BEHAVIORAL

Social needs navigation

Patient navigation to address social needs.

Intervention Type BEHAVIORAL

Reminders

Centralized text and/or telephone reminders for ordered tests.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Diego State University

OTHER

Sponsor Role collaborator

AltaMed Health Services Corporation

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Gloria Coronado

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Escaron, PhD

Role: PRINCIPAL_INVESTIGATOR

AltaMed Health Services Corporation

Locations

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AltaMed Health Services Corporation

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gloria Coronado, PhD

Role: CONTACT

5039147100

Katherine Mendoza, MPH

Role: CONTACT

8477672847

Facility Contacts

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Anne Escaron, PhD

Role: primary

323-695-3601

References

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Rivelli JS, Schneider JL, Vaughn KA, Locher BW, Shaw MC, Martinez LS, Ruiz E, Thompson JH, Escaron AL, Coronado GD. Improving animated instructional videos for colorectal cancer screening: An application of learner verification and revision. Transl Behav Med. 2025 Jan 16;15(1):ibaf020. doi: 10.1093/tbm/ibaf020.

Reference Type DERIVED
PMID: 40526315 (View on PubMed)

Other Identifiers

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STUDY00004612

Identifier Type: -

Identifier Source: org_study_id

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