Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs
1 other identifier
interventional
5,970
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Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Oct 2010
Typical duration for not_applicable colorectal-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2010
CompletedFirst Posted
Study publicly available on registry
August 30, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
October 20, 2014
CompletedMay 23, 2017
April 1, 2017
2.9 years
August 27, 2010
October 13, 2014
April 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.
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.
1 year
Study Arms (3)
Mailed invitations for FIT test kits
ACTIVE COMPARATORFecal 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.
Mailed invitations for a colonoscopy
ACTIVE COMPARATORInvitation 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.
Visit Based Care
ACTIVE COMPARATORNo 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- to 64 year old men and women
- All races and ethnicities
- Patients that have been on JPS Connection in 2010 or JPS Connection in 2009 and have been seen at least once between September 1, 2009 and August 31, 2010 in any JPS setting
You may not qualify if:
- No address and phone number on file
- Incarcerated individuals
- Primary language other than English or Spanish
- Up to date with CRC screening, defined as any:
- Fecal Occult Blood Test (FOBT) in 2009
- Flexible Sigmoidoscopy 2005-09
- Barium Enema 2005-09
- Colonoscopy 2002-09\* Prior history of CRC, inflammatory bowel disease, or colorectal polyps.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Gupta S, Halm EA, Rockey DC, Hammons M, Koch M, Carter E, Valdez L, Tong L, Ahn C, Kashner M, Argenbright K, Tiro J, Geng Z, Pruitt S, Skinner CS. Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial. JAMA Intern Med. 2013 Oct 14;173(18):1725-32. doi: 10.1001/jamainternmed.2013.9294.
PMID: 23921906DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Keith E. Argenbright, MD
- Organization
- University of Texas Southwestern Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Keith E Argenbright, MD
University of Texas Southwestern Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2010
First Posted
August 30, 2010
Study Start
October 1, 2010
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
May 23, 2017
Results First Posted
October 20, 2014
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share