Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs

Summary

Colon cancer (CRC) is a leading cause of cancer death in the United States. Screening can prevent CRC death, but screening rates are suboptimal, especially for vulnerable populations such as those with limited or no health insurance. This striking public health challenge demands urgent implementation of evidence-based strategies to reduce avoidable CRC death.

Prior research has shown that a direct-to-consumer strategy of inviting patients by mail to complete CRC screening may result in increased rates of screening completion. However, this approach has not been tested extensively in vulnerable populations, such as the under/uninsured, and minority populations often cared for by safety-net health systems. Further, it is unclear whether patients are more likely to participate in one CRC screening test versus another. Knowing this is important to designing programs for increasing screening. For example, the planning and resources required for a screening program with colonoscopy--which is a sensitive but invasive and expensive test--are very different from a program with that uses stool testing to detect microscopic blood such as an immunochemical stool blood test--which is a less sensitive, but non-invasive and cheap test.

Also, it is possible designing a program with a less sensitive, but more acceptable test could prevent more CRC death if participation in screening is test specific. For example, if many more patients participate in an immunochemical stool blood test based program than a colonoscopy based program, even though the immunochemical stool blood test is less sensitive, the program may save more lives because more patients are reached.

The aims of this trial are to:

Aim 1. Deliver CRC screening services (mailed invitation to screening, telephone reminders, and systematic clinical follow up) to uninsured, unscreened patients cared for by the safety-net health system serving Tarrant County, Texas. Patients will be invited to either:

1. Complete a free home-based, non-invasive immunochemical stool blood test
2. Complete a free colonoscopy

Aim 2. Evaluate program outcomes, including screening rates, cancers detected, and program costs.

The primary outcome is screening completion.

Conditions

• Colorectal Cancer

Interventions

OTHER

Mailed invitations for FIT test kits

Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test.

OTHER

Mailed invitations for a colonoscopy

These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital.

OTHER

Visit Based Care

Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would.

Sponsors & Collaborators

• Cancer Prevention Research Institute of Texas

  collaborator OTHER

• Polymedco Corporation

  collaborator UNKNOWN

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• Keith E Argenbright, MD · University of Texas Southwestern Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

54 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2013-09-30

Completion

2013-09-30