Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

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
    

Intervention name(s): Usual Care FIT Screening Strategy; GeoMail FIT Screening Strategy
Intervention type(s): Other; Other
Intervention description(s): Patients in usual care neighborhoods will receive FIT kits randomly throughout the year.; Patients in treated neighborhoods will receive kits at the same time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening