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| Name | Class |
|---|---|
| UCLA Vatche and Tamar Manoukian Division of Digestive Diseases | UNKNOWN |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | No Intervention-"Standard Care" UCLA Health has a mailed FIT outreach program. This group will receive standard FIT mailer protocol. They will receive a tailored MyChart message indicating the importance of CRC screening and not be presented with a choice for screening modalities. | |
| FIT Choice | Experimental | This group will receive a tailored message via MyChart with information about CRC screening and using the FIT kit for noninvasive screening. They will then have to actively choose if they want CRC screening with a FIT kit vs no screening. If they opt for screening, the investigators will mail them a FIT kit. |
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| Colonoscopy Choice | Experimental | This group will receive a tailored message via MyChart with information about CRC screening and colonoscopy for CRC screening. They will then have to actively choose if they want CRC screening with a colonoscopy vs no screening. If they opt for screening, the investigators will direct them to our patient navigators to get scheduled for a colonoscopy. |
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| Dual Choice | Experimental | This group will receive a tailored message via MyChart with information about CRC screening and using either the FIT kit or colonoscopy for CRC screening. They will then have to actively choose if they want CRC screening with a FIT kit, a colonoscopy, or no screening. If they opt for screening, the investigators will either mail them a FIT kit or direct them to our patient navigators to schedule a colonoscopy, depending on their choice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active FIT Choice | Behavioral | The investigators will send randomized participants a message via MyChart indicating the benefits of CRC screening, along with tailored information about FIT as a screening strategy. At the end of the message, participants will complete a survey asking them to indicate if they would like to be screened for CRC with a FIT, or if they prefer no screening whatsoever. The investigators will then ask follow-up questions to better understand the reason patients made their respective choices. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall completion of any Colorectal Cancer Screening test | Rate of completion of any CRC screening (FIT Kit or Colonoscopy) throughout the observation window. | 6 months after getting the text message |
| Measure | Description | Time Frame |
|---|---|---|
| Selection of modality in MyChart Survey | Frequency of CRC screening choice indicated in the MyChart survey per arm | within 4 weeks from receiving the initial MyChart message |
| CRC screening order placed by any modality |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Health Department of Medicine, Quality Office | Los Angeles | California | 90095 | United States | ||
| UCLA Vatche and Tamar Manoukian Division of Digestive Diseases |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40758331 | Derived | Galoosian A, Dai H, Croymans D, Saccardo S, Fox CR, Goshgarian G, De Silva S, Han MA, Vangala S, May FP. Population Health Colorectal Cancer Screening Strategies in Adults Aged 45 to 49 Years: A Randomized Clinical Trial. JAMA. 2025 Sep 2;334(9):778-787. doi: 10.1001/jama.2025.12049. |
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We do not plan to make any individual participant data available.
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Parallel-arm randomized controlled trial
Patient-level randomization
Four arms
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| Active Colonoscopy Choice | Behavioral | The investigators will send randomized participants a message via MyChart indicating the benefits of CRC screening, along with tailored information about colonoscopy as a screening strategy. At the end of the message, participants will complete a survey asking them to indicate if they would like to be screened for CRC with a colonoscopy, or if they prefer no screening whatsoever. The investigators will then ask follow-up questions to better understand the reason patients made their respective choices. |
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| Active Dual Choice | Behavioral | The investigators will send randomized participants a message via MyChart indicating the benefits of CRC screening, along with tailored information about FIT Kit and Colonoscopy screening. At the end of the message, participants will complete a survey asking them to indicate if they would like to be screened for CRC with either a FIT or Colonoscopy, or if they prefer no screening whatsoever. The investigators will then ask follow-up questions to better understand the reason patients made their respective choices. |
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The frequency of ordering FIT Kit or Colonoscopy in the "FIT Kit Choice", "Colonoscopy Choice" and "Dual Choice" arms
| within 6 weeks from receiving the initial MyChart message |
| Colorectal cancer screening uptake by modality | Rate of completion of CRC screening by specific modality (FIT Kit or Colonoscopy) throughout the observation window. | 6 months after getting the initial MyChart message |
| Westwood, Los Angeles |
| California |
| 90095 |
| United States |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |