Colorectal Cancer Screening Outreach

N/ANot Yet RecruitingNCT07345676

Yale University2,000 enrolled

Overview

This is a 4 arm pragmatic trial to test a multicomponent intervention designed to improve adherence to colorectal cancer screening.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

2,000

Conditions

Colo-rectal Cancer

Interventions

Bundled messaging interventionBEHAVIORAL

A bundled intervention of text message, letter, and provider reminder. Text message content using behaviorally motivated messages will vary.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Established adult medicine patient at Cornell Scott Hill health (defined as having a CSHH primary care doctor or \>1 adult medicine visits in the last year). * Incomplete colorectal cancer screening test defined as an outstanding order for colonoscopy or stool-based CRC screening (e.g., fecal immunochemical test (FIT) or FIT-DNA testing), but no evidence of test completion at the time of randomization. Orders must have been placed between 90-180 days prior to randomization. OR * Abnormal stool-based test without follow-up, defined as an abnormal stool-based test result (e.g., positive FIT or FIT-DNA) with no completed diagnostic colonoscopy within 90 days of the result. Patients who meet this criterion will be included in a non randomized arm of the study. Exclusion Criteria: * Because this is a pragmatic study of a behavioral intervention to improve colorectal cancer screening adherence, any participants who otherwise meet the inclusion criteria will not be excluded.

Locations (1)

Cornell Scott Hill Health

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Number of participants with scheduled or completed colorectal cancer screening.

Number of participants who completed or scheduled screening (colonoscopy or stool-based test) within 3 months of randomization.

Time frame: up to 3 months from randomization

Secondary Outcomes

Number of participants with abnormal stool-based test that complete a diagnostic colonoscopy.

Number of participants with abnormal stool-based test who complete a diagnostic colonoscopy within 90 days of intervention.

Time frame: up to 90 days from intervention

Number of participants who complete screening.

Number of participants who complete screening (stool-based testing or colonoscopy) within 90 days of randomization.

Time frame: up to 90 days from randomization

Number of participants who achieve the primary endpoint.

Number of participants who achieve the primary endpoint (screening or scheduling of screening) at 6 months post randomization.

Time frame: 6 months post randomization

Number of participants who achieve the primary endpoint by message type.

Number of participants who achieve the primary endpoint (screening scheduling or completion rate at 90 days) by message type (message A/B/C).

Time frame: up to 90 days from randomization

Number of participants who complete screening within 6 months of initial outreach.

Number of participants who complete screening within 6 months of initial outreach by text message type (message A/B/C).

Time frame: up to 6 months from initial outreach

Central Contacts

Ilana Richman, MD

CONTACT

203 737 1024 ilana.richman@yale.edu

Data from ClinicalTrials.gov

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