Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05275530 |
| Other study ID # |
CRC45 |
| 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. UCLA Health previously implemented a fecal immunochemical test (FIT)
outreach program wherein FIT kits are mailed to average-risk patients overdue for CRC
screening twice annually to promote screening uptake. 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 maximize screening uptake within this 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.
Conventional screening options include both invasive (or direct-visualization) and
non-invasive (or stool-based) options. Invasive screening tests include flexible
sigmoidoscopy, CT colonography, and colonoscopy. Non-invasive screening tests include the
fecal immunochemical test (FIT), the high sensitivity guaiac fecal occult blood test, and
stool DNA testing. All of these screening tests are recommended by the USPSTF for CRC
screening.
Nationally (and at UCLA Health), the two most common CRC screening modalities are the
colonoscopy and the FIT. UCLA Health has previously implemented a FIT mailer outreach program
wherein FIT kits are mailed to average-risk patients overdue for CRC screening twice annually
to promote screening uptake. The program has been extremely effective in increasing CRC
screening adherence rates, with an increase in the health system's screening rate over the
past several years.
The investigators current study aims to determine the most effective patient outreach
approach to maximize CRC screening utilization in average-risk individuals ages 45-49 years.
In addition, the investigators aim to understand the impact of screening modality choice on
uptake of CRC screening, patients' preference for screening modality, and sociodemographic
differences in screening utilization among individuals ages 45-49 years.
There are approximately 18,000 patients eligible for inclusion. The investigators will
randomly assign approximately 17,000 average-risk patients aged 45-49 to one of four arms.
1,000 of the patients will be reserved for an internal pilot project. In all arms, all
patients will receive a text message encouraging them to access their patient communication
portal via Epic electronic health record (EHR) (referred to as "MyChart"). In all arms, once
a patient visits MyChart, a message on MyChart will state that they are due for CRC screening
and the importance of CRC screening. In the control (standard care) arm, patients will
treated as part of our "FIT-kit mailer program." These patients will receive a mailed FIT
kit, and the message on MyChart will encourage them to complete the FIT kit. In the "FIT Kit
Choice" arm, patients will be presented with the choice to complete screening with a FIT kit
or opt out of screening. In the "Colonoscopy Choice" arm, patients will be presented with the
choice to complete screening with a colonoscopy or opt out of screening. In the "Dual Choice"
arm, patients will be presented with the choice to complete screening with a FIT kit,
complete screening with a colonoscopy, or opt out of screening. After patients make the
choice in MyChart, the patient will be asked why they made that choice.
We will resend the message on MyChart (as a reminder) two weeks after they receive the
initial MyChart message. The reminder message content will be very similar to the content of
initial MyChart message, and differ by arm.
The investigators have competing predictions based on the literature about whether giving
people the option of choosing between two screening modalities (vs. neither) is better than
giving people the option of deciding whether to take one modality (vs. not). On the one hand,
offering people two modalities should increase flexibility and thus enhance participation; on
the other hand, choosing between two modalities could tax mental resources and create choice
avoidance, thus decreasing participation. Specifically:
In addition, the investigators have competing predictions based on the literature about
whether active choice is better than assigning people a screening modality. On one side,
active choice can make patients feel more empowered, thus enhancing participation in
screening. On the other side, active choice takes more of patients' cognitive and time
resources than following the assigned option, thus decreasing participation in screening.
Analysis Plan:
- Patient-level linear regression models with robust standard errors
- The primary model term will be indicator variables for arms that patients are assigned
to.
- Covariates will include age, sex, race/ethnicity, social vulnerability index (ZIP code
level), and baseline HM focus measure completion rate
- Treatment effects will be summarized using rate differences and 95% confidence intervals
- Exploratory analyses will investigate heterogeneous treatment effects by splitting the
sample into demographic subgroups and by testing for demographic x choice 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
- To analyze the effect of offering a choice between modalities (vs. single choice), we
will compare the single choice arms (arms 1 and 2) with the dual choice arm (arm 3).
- To analyze the effect of active choice, we will compare the control arm (arm 0) with (1)
active FIT choice arm (arm 1) and (2) the dual choice arm (arm 3).
- To assess both the effect of offering the dual choice (vs. single choice) and the effect
of active choice, we will analyze two samples: (1) patients who open their initial
MyChart message within 1 week of the date sent and (2) intention-to-treat regardless of
whether patients open the MyChart message. In addition, when assessing the effect of
offering the dual choice (vs. single choice), we will also examine patients who open
either the initial or the reminder MyChart message within 1 week.
