Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - 64 |
| Updated: | 10/26/2018 |
| Start Date: | August 30, 2018 |
| End Date: | August 30, 2021 |
Effect of Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits on Colorectal Cancer Screening
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.
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.
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
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
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
We found this trial at
1
site
Click here to add this to my saved trials
