NCT05281159

Brief Summary

In May of 2021, the United States Preventive Service Task Force (USPSTF) updated their colorectal cancer (CRC) screening guidelines by recommending screening at an earlier age for average-risk adults starting at the age of 45 years old (Grade B recommendation). This is in addition to their Grade A recommendations of continuing to screen average-risk adults ages 50-75 years old. As the investigators health system aims to screen the newly eligible population of average-risk patients between the ages of 45-49, the investigators proposed randomized controlled trial is aimed to determine the most effective patient outreach approach to increase patients' engagement with messages regarding CRC screening and screening uptake within this specific age-group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,509

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2022

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

February 27, 2022

Last Update Submit

November 9, 2023

Conditions

Keywords

Colorectal Cancer ScreeningBehavioral EconomicsColorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Opening link within SMS Text message

    Rate of clicking the link to MyChart within the SMS text message

    1 week after getting the initial text message

Secondary Outcomes (3)

  • Opening link within SMS Text Message

    1 month after getting initial text message

  • CRC45+ Choice MyChart Message opened

    1 month after getting the initial text message

  • Overall completion of any CRC screening test

    6 months after getting the initial text message

Study Arms (3)

Standard of Care

NO INTERVENTION

This group will receive a standard SMS text message indicating that they have a MyChart message from their provider about CRC screening and should follow a link to be screened.

"Risk Information"

EXPERIMENTAL

This group will receive an SMS text message highlighting their risk for CRC.

Behavioral: Risk Information

"Risk Information + Action"

EXPERIMENTAL

This group will receive an SMS message highlighting their risk for CRC and the importance of taking quick action.

Behavioral: Risk Information + Action

Interventions

This group will receive an SMS text message highlighting their risk for CRC on top of the content in the Control arm.

"Risk Information"

This group will receive an SMS text message highlighting their risk for CRC and the importance of taking quick action, on top of the content in the Control arm.

"Risk Information + Action"

Eligibility Criteria

Age45 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • UCLA Health patient
  • Age 45-49 (as of 2/1/2022)
  • Active primary care provider
  • Visit within the last 3 years

You may not qualify if:

  • Age \<45 or \>50 years old at time of randomization
  • Documented family history of CRC in EMR
  • History (personal or family) of prior adenomatous polyps in the EMR
  • History of high-risk cancer syndromes (e.g., Lynch, FAP)
  • Prior CRC screening with colonoscopy or FIT
  • Inactive MyChart status at enrollment
  • No documented SMS-capable phone number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA Health Department of Medicine, Quality Office

Westwood, Los Angeles, California, 90095, United States

Location

UCLA Vatche and Tamar Manoukian Division of Digestive Diseases

Westwood, Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel Assignment * Parallel-arm randomized controlled trial, * Three arms * Arm 0: Standard of care control (standard text messaging) * Arm 1: Experimental, "Risk Information" group * Arm 2: Experimental, "Risk Information + Action" group * Patient-level randomization stratified by arm assignment in CRC45+ Choice Evaluation. The investigators will also randomly assign patients into receiving the text message on one of ten workdays, stratifying by arm assignment in both the CRC45+ Choice Evaluation and CRC45+ Text Evaluation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, DOM Quality

Study Record Dates

First Submitted

February 27, 2022

First Posted

March 16, 2022

Study Start

February 21, 2022

Primary Completion

August 21, 2022

Study Completion

November 21, 2022

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations