Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits

NCT03718221 | Completed

• 2 other identifiers: 21985STU 082016-060
• Study Type: interventional
• Target: 8,653
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Patient-level Colorectal Cancer (CRC) Screening

  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.

  Assessed after 12 months of mailings are complete (i.e., 18 months after start of GeoMail).

Secondary Outcomes (5)

• Neighborhood-level Screening

  Assessed after 12 months of mailings are complete (i.e., 18 months after start of GeoMail).

• FIT Kit Completed

  Assessed after 6 and 12 months of mailings.

• FIT Kit Returned Unopened

  Assessed after 6 and 12 months of mailings.

• Patient-level CRC Screening

  Assessed 2 and 3 years after completion of mailings.

• Neighborhood-level Screening

  Assessed 2 and 3 years after completion of mailings.

Study Arms (2)

Usual Care FIT Screening Strategy

ACTIVE COMPARATOR

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

GeoMail FIT Screening Strategy

EXPERIMENTAL

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

Interventions

Usual Care FIT Screening Strategy OTHER

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

Usual Care FIT Screening Strategy

GeoMail FIT Screening Strategy OTHER

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

GeoMail FIT Screening Strategy

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Up-to-date with CRC screening, defined by:
• Colonoscopy in the last 10 years
• Sigmoidoscopy in the last 5 years
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Cancer Prevention Research Institute of Texas: collaborator
• Parkland Health and Hospital System: collaborator

Study Sites (1)

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Sandi Pruitt, PhD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 24, 2018
• Study Start: August 30, 2018
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)