Colorectal Cancer Clinical Trial
Official title:
Effect of Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits on Colorectal Cancer Screening
Verified date | November 2021 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a pragmatic, randomized, controlled trial of a geographically randomized intervention in which all eligible patients will receive a mailed fecal immunochemical test (FIT) kit (the GeoMail study). In this study, all ZIP Codes in Dallas County will be randomized to either treatment or usual care. Patients in treated neighborhoods will receive kits at the same time; patients in usual care neighborhoods will receive FIT kits randomly throughout the year. All eligible patients will receive a FIT kit each year. The trial will be conducted in a racially and socioeconomically diverse cohort of patients served by an integrated safety net delivery system. This study represents a pragmatic adaptation to the "FIT first" population health screening strategy in which all eligible patients are mailed FIT kits. All patients will also have access to whatever colorectal cancer (CRC) screening is recommended through usual visit-based care.
Status | Completed |
Enrollment | 8653 |
Est. completion date | August 30, 2021 |
Est. primary completion date | August 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 64 Years |
Eligibility | Inclusion Criteria: - Males and females - Age 50-64 years - Seen at least one time at a Parkland primary care clinic within one year prior to randomization - Participants in Parkland's medical assistance program for the uninsured (Parkland Financial Assistance), Medicaid, or private/other insurance - All races and ethnicities Exclusion Criteria: - Up-to-date with CRC screening, defined by: 1. Colonoscopy in the last 10 years 2. Sigmoidoscopy in the last 5 years 3. FIT in the last 11 months - Prior history of CRC, total colectomy, inflammatory bowel disease, or colon polyps - Address or phone number not on file - Incarcerated |
Country | Name | City | State |
---|---|---|---|
United States | Parkland Health & Hospital System | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | Cancer Prevention Research Institute of Texas, Parkland Health and Hospital System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient-level Colorectal Cancer (CRC) Screening | Defined as screening completed within 6 months of when the FIT kit is mailed for each patient by any recommended screening modality (FIT, colonoscopy, sigmoidoscopy; i.e., the proportion of treated vs. usual care patients who have completed screening). Screening will be measured using electronic medical record procedure, result, and billing data (Parkland-specific, CPT, ICD9/10 codes) and will be considered complete when satisfactory (e.g., adequate sample collection) FIT or colonoscopy test results are received. | Assessed after 12 months of mailings are complete (i.e., 18 months after start of GeoMail). | |
Secondary | Neighborhood-level Screening | Defined for each neighborhood (defined as patient block group of residence) as the number of all screening-eligible patients who are up-to-date with screening guidelines (defined as FIT =18 months, sigmoidoscopy =5 years, or colonoscopy =10 years) divided by the total screening-eligible block group Parkland patient population. The analysis will determine GeoMail impact on treated block groups while differencing change in the outcome that occurs in usual care block groups using a difference-in-difference model (DID) to measure change in neighborhood level screening for each block group before and after GeoMail intervention at 2 time points: on the day prior to GeoMail going live and at 6 months after mailing the last GeoMail kit (i.e., 18 months after start of GeoMail). This outcome measures the population level impact of GeoMail across all patients in the block group, including those not mailed a FIT kit because they were already up-to-date and thus ineligible for the mailing. | Assessed after 12 months of mailings are complete (i.e., 18 months after start of GeoMail). | |
Secondary | FIT Kit Completed | Defined as FIT completed within 6 months of when the FIT kit is mailed. | Assessed after 6 and 12 months of mailings. | |
Secondary | FIT Kit Returned Unopened | Defined as FIT kit returned unopened within 6 months of when the FIT kit is mailed. | Assessed after 6 and 12 months of mailings. | |
Secondary | Patient-level CRC Screening | Defined as any recommended screening modality. Screening will be measured using electronic medical record procedure, result, and billing data and will be considered complete when satisfactory FIT or colonoscopy test results are received. | Assessed 2 and 3 years after completion of mailings. | |
Secondary | Neighborhood-level Screening | Defined for each neighborhood as the number of all screening-eligible patients who are up-to-date with screening guidelines divided by the total screening-eligible block group Parkland patient population. | Assessed 2 and 3 years after completion of mailings. |
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