Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits
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|ClinicalTrials.gov Identifier: NCT03718221|
Recruitment Status : Enrolling by invitation
First Posted : October 24, 2018
Last Update Posted : October 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Other: Usual Care FIT Screening Strategy Other: GeoMail FIT Screening Strategy||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits on Colorectal Cancer Screening|
|Actual Study Start Date :||August 30, 2018|
|Estimated Primary Completion Date :||August 30, 2021|
|Estimated Study Completion Date :||August 30, 2021|
Active Comparator: Usual Care FIT Screening Strategy
Mailed outreach invitation to complete FIT include: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage). Up to three "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion. Centralized processes to promote guideline-based follow-up.
Other: Usual Care FIT Screening Strategy
Patients in usual care neighborhoods will receive FIT kits randomly throughout the year.
Experimental: GeoMail FIT Screening Strategy
The experimental arm differs from the active comparator in one way: patients living in treated ZIP codes will receive the mailed outreach at the same time.
Other: GeoMail FIT Screening Strategy
Patients in treated neighborhoods will receive kits at the same time.
- Patient-level Colorectal Cancer (CRC) Screening [ Time Frame: Assessed after 12 months of mailings are complete (i.e., 18 months after start of GeoMail). ]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.
- Neighborhood-level Screening [ Time Frame: Assessed after 12 months of mailings are complete (i.e., 18 months after start of GeoMail). ]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.
- FIT Kit Completed [ Time Frame: Assessed after 6 and 12 months of mailings. ]Defined as FIT completed within 6 months of when the FIT kit is mailed.
- FIT Kit Returned Unopened [ Time Frame: Assessed after 6 and 12 months of mailings. ]Defined as FIT kit returned unopened within 6 months of when the FIT kit is mailed.
- Patient-level CRC Screening [ Time Frame: Assessed 2 and 3 years after completion of mailings. ]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.
- Neighborhood-level Screening [ Time Frame: Assessed 2 and 3 years after completion of mailings. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718221
|United States, Texas|
|Parkland Health & Hospital System|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Sandi Pruitt, PhD||UT Southwestern|