Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05281159 |
| Other study ID # |
CRC45+TEXT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 21, 2022 |
| Est. completion date |
November 21, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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:
1. 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)
2. 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.
