Increasing Engagement With Messages Regarding CRC Screening Among Adults Aged 45-49 (CRC45+TEXT)
Primary Purpose
Colorectal Cancer, Colorectal Neoplasms
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Risk Information
Risk Information + Action
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring Colorectal Cancer Screening, Behavioral Economics, Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- UCLA Health patient
- Age 45-49 (as of 2/1/2022)
- Active primary care provider
- Visit within the last 3 years
Exclusion Criteria:
- 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
Sites / Locations
- UCLA Health Department of Medicine, Quality Office
- UCLA Vatche and Tamar Manoukian Division of Digestive Diseases
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Standard of Care
"Risk Information"
"Risk Information + Action"
Arm Description
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.
This group will receive an SMS text message highlighting their risk for CRC.
This group will receive an SMS message highlighting their risk for CRC and the importance of taking quick action.
Outcomes
Primary Outcome Measures
Opening link within SMS Text message
Rate of clicking the link to MyChart within the SMS text message
Secondary Outcome Measures
Opening link within SMS Text Message
Rate of clicking the link to MyChart within the SMS text message during 1 month
CRC45+ Choice MyChart Message opened
Rate of opening MyChart message
Overall completion of any CRC screening test
Rate of completion of any CRC screening (FIT Kit or Colonoscopy) within the observation window.
Full Information
NCT ID
NCT05281159
First Posted
February 27, 2022
Last Updated
May 23, 2022
Sponsor
University of California, Los Angeles
Collaborators
UCLA Vatche and Tamar Manoukian Division of Digestive Diseases, UCLA Anderson School of Management, Carnegie Mellon University, UCLA Department of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05281159
Brief Title
Increasing Engagement With Messages Regarding CRC Screening Among Adults Aged 45-49
Acronym
CRC45+TEXT
Official Title
Quality Improvement Study Aimed at Increasing Engagement With Messages Regarding CRC Screening Among Adults Aged 45-49 (CRC45+ TEXT).
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
August 21, 2022 (Anticipated)
Study Completion Date
November 21, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
UCLA Vatche and Tamar Manoukian Division of Digestive Diseases, UCLA Anderson School of Management, Carnegie Mellon University, UCLA Department of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Colorectal cancer (CRC) is the second leading cause of cancer-related death for both men and women in the United States. One in 17 Americans will suffer from CRC during their lifetime and early detection of cancers and polyps by screening is shown to reduce CRC mortality. In 2021, the USPSTF updated its CRC screening guidelines to start screening average-risk individuals at the age of 45 years due in part to a rising incidence of CRC and premalignant polyps in younger patients.
This current study will be a nested study within a larger investigation to determine the most effective patient outreach approach to increase patients' engagement with messages regarding CRC screening and CRC screening utilization in average-risk individuals ages 45-49 years. Here the investigators are testing which type of SMS messaging is most effective in prompting people to review MyChart message regarding CRC screening and thus increasing CRC screening uptake among individuals 45-49 years old.
There will be three different text messages that have been formulated utilizing behavioral science principles, and then randomize them equally among the eligible population. There will be stratified patient randomization based on arm assignment in our 'CRC45+ Choice' evaluation to prevent cross-study contamination. The arms for this investigation will be 1) Control, 2) Risk Information and 3) Risk Information + Action. In the control (standard care) arm, patients will receive the standard SMS text message. In the Risk Information arm, patients will receive a message indicating their risk for colorectal cancer, on top of the content in the Control arm. Finally, in the Risk Information + Action arm patients will receive risk information and importance of taking quick action, on top of the content in the Control arm. The investigators will also randomly assign patients into receiving our text message on one of ten workdays, stratifying by arm assignment in both the CRC45+ Choice Evaluation and CRC45+ Text Evaluation.
We will send text reminders to patients two weeks after they receive the initial text message. Reminder content will be very similar to the content of initial text message, and differ by arm.
For this investigation the investigators hypothesize:
Hyp 1: Patients assigned to the Risk Information + Action Arm (Arm 2) will have a higher click rate than patients assigned to the Control Arm (Arm 0)
Hyp 2: Patients assigned to the Risk Information + Action Arm (Arm 2) will have a higher click rate than patients assigned to the Risk Information Arm (Arm 1)
Analysis: The investigators will utilize patient-level ordinary least squares (OLS) estimation, with statistical inferences based on model-robust standard errors. The primary model term will be indicator variables for arm assignment.
The analysis will adjust for sex, race/ethnicity, social vulnerability index (at the ZIP code level), and MyChart logins decile.
Treatment effects will be summarized using rate differences and 95% CI's. Exploratory analyses will investigate heterogenous treatment effects by demographic subgroups by splitting the sample into each demographic subgroup as well as by testing demographics and text message arm interactions. Sensitivity analyses will be performed without covariates, and using logistic regression models in place of linear regression models. Missing covariate values will be handled by including 'unknown' indicators, along with mean imputation for quantitative covariates.
The investigators will additionally explore how click rates within the SMS message vary with the day of the week.
Primary analyses will use intention-to-treat protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Neoplasms
Keywords
Colorectal Cancer Screening, Behavioral Economics, Colorectal Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
"Risk Information"
Arm Type
Experimental
Arm Description
This group will receive an SMS text message highlighting their risk for CRC.
Arm Title
"Risk Information + Action"
Arm Type
Experimental
Arm Description
This group will receive an SMS message highlighting their risk for CRC and the importance of taking quick action.
Intervention Type
Behavioral
Intervention Name(s)
Risk Information
Intervention Description
This group will receive an SMS text message highlighting their risk for CRC on top of the content in the Control arm.
Intervention Type
Behavioral
Intervention Name(s)
Risk Information + Action
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opening link within SMS Text message
Description
Rate of clicking the link to MyChart within the SMS text message
Time Frame
1 week after getting the initial text message
Secondary Outcome Measure Information:
Title
Opening link within SMS Text Message
Description
Rate of clicking the link to MyChart within the SMS text message during 1 month
Time Frame
1 month after getting initial text message
Title
CRC45+ Choice MyChart Message opened
Description
Rate of opening MyChart message
Time Frame
1 month after getting the initial text message
Title
Overall completion of any CRC screening test
Description
Rate of completion of any CRC screening (FIT Kit or Colonoscopy) within the observation window.
Time Frame
6 months after getting the initial text message
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
UCLA Health patient
Age 45-49 (as of 2/1/2022)
Active primary care provider
Visit within the last 3 years
Exclusion Criteria:
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
Facility Information:
Facility Name
UCLA Health Department of Medicine, Quality Office
City
Westwood
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Vatche and Tamar Manoukian Division of Digestive Diseases
City
Westwood
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
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Increasing Engagement With Messages Regarding CRC Screening Among Adults Aged 45-49
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