Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits

NCT ID: NCT03718221

Last Updated: 2021-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8653 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-30
• Study Completion Date: 2021-08-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Usual Care FIT Screening Strategy

Intervention Type: OTHER

Patients in usual care neighborhoods will receive FIT kits randomly throughout the year.

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.

Group Type: EXPERIMENTAL

GeoMail FIT Screening Strategy

Intervention Type: OTHER

Patients in treated neighborhoods will receive kits at the same time.

Interventions

Usual Care FIT Screening Strategy

Patients in usual care neighborhoods will receive FIT kits randomly throughout the year.

Intervention Type: OTHER

GeoMail FIT Screening Strategy

Patients in treated neighborhoods will receive kits at the same time.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Prevention Research Institute of Texas

OTHER

Sponsor Role: collaborator

Parkland Health and Hospital System

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Amit Singal

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandi Pruitt, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Locations

Parkland Health & Hospital System

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU 082016-060

Identifier Type: OTHER

Identifier Source: secondary_id

21985

Identifier Type: -

Identifier Source: org_study_id