Clinical trial NCT01946282: Evidence-Based Colorectal Cancer Screening for the Uninsured
Official title: Evidence-Based Colorectal Cancer Screening for the Uninsured
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: neoplasm
colorectal
cancer
uninsured
FIT
Fecal Immunochemical Test
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
First posted: 2013-09-19
Enrollment: 8565
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Through this program, the investigators will test a systematic colon cancer screening outreach strategy for increasing screening completion among uninsured patients, not up-to-date with screening. The intervention will consist of mailed screening invitations, with processes such as phone reminders to promote screening and evidence based follow up. All patients will be randomly assigned to receive mailed invitations to complete a home fecal immunochemical test (FIT). Some patients will be randomly assigned to receive a small financial incentive on completion of FIT testing.

Detailed description: All patients meeting inclusion/exclusion criteria will receive mailed invitation and FIT kit to complete screening, with processes to promote screening completion. The list of eligible patients will be divided into 5 groups so that the expected group of 10,000 patients will receive invitations spread out in time, so as to avoid overwhelming the system. The invitation letters emphasize importance of colorectal cancer screening, encourage the patient to complete FIT screening with the enclosed FIT kit, and will be signed by John Pter Smith (JPS) investigators as representatives of JPS primary care physicians.

The invitation kit will include a 1-sample POLYMEDCO Sensor FIT, including simplified instructions on how to perform the test, as well as a return mailer with prepaid postage. Diet/medication restriction will not be required. Kits will be returned to JPS and processed per manufacturer recommendations.

Automated and "live" phone call reminders to encourage screening completion will be sent at time of invite and within week 1 of the invitation. Up to two "live" phone call reminders will be attempted 2 to 3 weeks post invitation, using English and Spanish standard scripts.

Follow up for patients with a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3 consistent with guideline recommended annual FIT for colorectal screening. Follow up for patients with an abnormal FIT will consist of navigation to complete a colonoscopy. Patients with abnormal FIT will be called by the screening team within 1 week to report the result and facilitate direct scheduling of colonoscopy or a pre-colonoscopy visit. Follow up of patients with a colorectal cancer will consist of navigation to first treatment consultation visit. A surgery or oncology clinic follow up will be scheduled for all patients with a colorectal cancer diagnosis if such follow up is not already scheduled by the colonoscopist who diagnosed the colorectal cancer. Reminder calls for these visits will be made daily for up to one week.

A group of 2,000 individuals will be randomly assigned to receive a modest financial incentive to complete screening, in addition to the organized outreach program. The incentive will consist of a gift card in one of two small dollar amounts to a local retailer. Incentives will be mailed by the JPS outreach team, in exchange for successful FIT completion, after the FIT has been returned.

Follow up for determining screening completion for all included patients will be through the end of Year 3 regardless of whether or not patients respond to screening invitations. Once included, patients will remain in the program unless they no longer meet age criteria. Patients in both the standard (non-incentive) and incentive invitation groups who do not respond to initial invitation will be followed for screening outcomes, but will not receive repeat invitations. For patients who die on follow up or who do not have additional health system encounters, follow up will be censored at time of death or last health encounter, respectively.

Each year, patients who newly meet our inclusion/exclusion criteria will be included in the program. For example, patients newly turning 50 in year 2 or 3 meeting all other inclusion/exclusion criteria will receive screening outreach. Similarly, a 60 year old patient new to the JPS system and meeting inclusion/exclusion criteria will also receive screening outreach.

Eligibility criteria: Inclusion Criteria:

* Age 50-64.
* Uninsured, but participants in John Peter Smith Health System (JPS) medical assistance program for the uninsured.
* One or more visits to a JPS primary care clinic within a year.
* Not up-to-date with colorectal cancer screening.

Exclusion Criteria:

* Patients with a history of Colorectal Cancer or colon resection, no address and/or phone number on file, or who are incarcerated will be excluded.

Primary outcomes:
measure: FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year
timeFrame: Each year for three years
Secondary outcomes:
measure: FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive
timeFrame: Each year for three years
Other outcomes:
Locations:
Study officials:
affiliation: UT Southwestern Medical Center
name: Keith Argenbright, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Samir Gupta, M.D.
role: STUDY_DIRECTOR
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