Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs
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|ClinicalTrials.gov Identifier: NCT01191411|
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : October 20, 2014
Last Update Posted : May 23, 2017
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:
- Complete a free home-based, non-invasive immunochemical stool blood test
- Complete a free colonoscopy
Aim 2. Evaluate program outcomes, including screening rates, cancers detected, and program costs.
The primary outcome is screening completion.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Other: Mailed invitations for FIT test kits Other: Mailed invitations for a colonoscopy Other: Visit Based Care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5970 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs.|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Active Comparator: Mailed invitations for FIT test kits
Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.
Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.
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 Name: Polymedco Fecal Immunochemical Test
Active Comparator: Mailed invitations for a colonoscopy
Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.
Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.
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.
Active Comparator: Visit Based Care
No invitation to complete colorectal cancer screening.
Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.
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.
- Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem. [ Time Frame: 1 year ]To compare participation rates for screening between those receiving (a) mailed invitation to screening (immunochemical stool blood test (MailFIT) or colonoscopy(MailColo)) and (b) traditional visit-based screening (VisitBased), rates for these groups will be contrasted via a Chi-squared test. A p value<0.025 will be considered statistically significant.
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): NCT01191411
|Principal Investigator:||Keith E Argenbright, MD||University of Texas Southwestern Medical Center|