Colo-rectal Cancer
Conditions
Keywords
Screening adherence
Brief summary
This is a 4 arm pragmatic trial to test a multicomponent intervention designed to improve adherence to colorectal cancer screening.
Interventions
BEHAVIORALBundled messaging intervention
A bundled intervention of text message, letter, and provider reminder. Text message content using behaviorally motivated messages will vary.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
The study will include adults who receive care at a local, multisite federally qualified health center, who have outstanding orders for colorectal cancer screening.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Established adult medicine patient at Cornell Scott Hill health (defined as having a CSHH primary care doctor or \>1 adult medicine visits in the last year). * Incomplete colorectal cancer screening test defined as an outstanding order for colonoscopy or stool-based CRC screening (e.g., fecal immunochemical test (FIT) or FIT-DNA testing), but no evidence of test completion at the time of randomization. Orders must have been placed between 90-365 days prior to randomization. OR * Abnormal stool-based test without follow-up, defined as an abnormal stool-based test result (e.g., positive FIT or FIT-DNA) with no completed diagnostic colonoscopy within 90 days of the result. Patients who meet this criterion will be included in a non randomized arm of the study.
Exclusion criteria
* Because this is a pragmatic study of a behavioral intervention to improve colorectal cancer screening adherence, any participants who otherwise meet the inclusion criteria will not be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with scheduled or completed colorectal cancer screening. | up to 3 months from randomization | Number of participants who completed or scheduled screening (colonoscopy or stool-based test) within 3 months of randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with abnormal stool-based test that complete a diagnostic colonoscopy. | up to 90 days from intervention | Number of participants with abnormal stool-based test who complete a diagnostic colonoscopy within 90 days of intervention. |
| Number of participants who complete screening. | up to 90 days from randomization | Number of participants who complete screening (stool-based testing or colonoscopy) within 90 days of randomization. |
| Number of participants who achieve the primary endpoint. | 6 months post randomization | Number of participants who achieve the primary endpoint (screening or scheduling of screening) at 6 months post randomization. |
| Number of participants who achieve the primary endpoint by message type. | up to 90 days from randomization | Number of participants who achieve the primary endpoint (screening scheduling or completion rate at 90 days) by message type (message A/B/C). |
| Number of participants who complete screening within 6 months of initial outreach. | up to 6 months from initial outreach | Number of participants who complete screening within 6 months of initial outreach by text message type (message A/B/C). |
| Number of participants who complete screening colonoscopy within 6 months of initial outreach. | up to 6 months from initial outreach | Number of participants who complete screening colonoscopy within 6 months of initial outreach by text message type (message A/B/C). |
| Number of participants who provide any response. | 7, 14, 21, and 90 days | Number of participants who provide any response to text messages by message type (message A/B/C). |
| Number of participants who achieve the primary outcome from among those who did and did not respond to any text message. | 6 months post randomization | Number of participants who achieve the primary outcome from among those who did and did not respond to any text message. |
| Number of providers who respond to reminders. | 6 months post randomization | Number of providers who respond to provider reminders through MyChart message, phone call, or in-clinic discussion. |
Countries
United States
Contacts
CONTACTIlana Richman, MD
PRINCIPAL_INVESTIGATORIlana Richman, MD
Yale University
Outcome results
None listed