NCT03718221

Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits

Effect of Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits on Colorectal Cancer Screening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8,653 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 50 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Colorectal cancer (CRC) screening can save lives but is under-used, especially among minority and low-income patients in urban safety-net systems. Interventions among safety-net patients have improved screening but require additional refinement. For example, the investigators demonstrated that mailing free home fecal immunochemical tests (FIT) to urban safety-net patients doubled screening uptake (59% vs. 30%, p\<.001); however a full 41% who received FIT kits still did not complete screening. Drawing from economics, behavioral science, and healthcare delivery science, the investigators propose a spatially informed randomized intervention to further improve screening uptake. By targeting all patients in a single neighborhood at one time using waves of mailed invitations, the GeoMail intervention is designed to amplify social contagion among neighbors (i.e., positive communications and reinforcement among neighbors to complete screening) thereby increasing screening uptake. GeoMail will be live for 12 months. This intervention will not change the content of FIT kits that are already to be mailed under usual care conditions at Parkland, it will only change the timing of mailing. The aims of this study are to: Aim 1: Conduct and evaluate outcomes from a GeoMail intervention - a geographically clustered randomized trial comparing geographically clustered mailed screening invitations (treatment) to non-clustered invitations (usual care). Hypotheses (H): H1.1: Patient-level and H1.2: Neighborhood-level screening will be higher in the treatment neighborhoods, compared to usual-care neighborhoods. Aim 2: Evaluate whether patient-level or neighborhood-level indicators of patient density, race/ethnicity, and socioeconomic disadvantage moderate GeoMail impact on CRC screening. H2.1-3: All three types of factors will moderate the GeoMail intervention impact

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	Usual Care FIT Screening Strategy	Patients in usual care neighborhoods will receive FIT kits randomly throughout the year.
OTHER	GeoMail FIT Screening Strategy	Patients in treated neighborhoods will receive kits at the same time.

Timeline

• Start date: 2018-08-30
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2018-10-24
• Last updated: 2021-11-30

Locations

1 site across 1 country: United States