Evidence-Based Colorectal Cancer Screening for the Uninsured
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01946282|
Recruitment Status : Completed
First Posted : September 19, 2013
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Other: FIT Invitation Only Other: FIT plus Incentive||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15152 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||Evidence-Based Colorectal Cancer Screening for the Uninsured|
|Actual Study Start Date :||November 2013|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
Active Comparator: FIT Invitation Only
Fecal Immunochemical Test (FIT) mailed to patient homes free of charge.
Intervention: Fecal Immunochemical Test (FIT) kits and an invitation letter to complete colorectal cancer screening are mailed to the homes of study eligible patients. A postage paid return mailer is included. Automated and "live" phone call reminders are made at the time of invitation and within one week of invitation. Up to two "live" phone call reminders are attempted 2 to 3 weeks post invitation.
Follow up for patients who return 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 cancer screening. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy.
Other: FIT Invitation Only
Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes with instructions, followed up with live and TELEVOX reminder phone calls.
Active Comparator: FIT plus Incentive
Fecal Immunochemical Test (FIT) mailed to patient homes, plus an incentive to complete the test.
Intervention: FIT kits and invitation letter with a gift card incentive in one of two small dollar amounts to complete screening are mailed to the homes of 2000 (1000 per group) randomly assigned eligible patients. A postage paid return mailer is included. Automated and "live" phone call reminders are made at the time of invitation and within one week of invitation. Up to two "live" phone call reminders are attempted 2 to 3 weeks post invitation.
Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy.
Other: FIT plus Incentive
Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes with instructions, followed up with live and TELEVOX reminder phone calls. Patients are offered a small incentive to complete their screening.
- Screening rate improvement after expanding screening outreach to all unscreened patients. [ Time Frame: Each year for three years ]
The denominator population for our baseline and end of Year 3 follow comparisons of screening rates generally includes patients age-eligible for screening outreach. The numerator for calculation of screening rates will be the number of patients who are up-to-date with screening based on colonoscopy within 10 years, sigmoidoscopy within 5 years, or stool blood test (guaiac FOBT or FIT) within the last year, measured by HEDIS criteria. Thus, the screening rate at baseline and at end of Year 3 will be defined by:
Screening Rate = # up-to-date with screening
- patients eligible for screening
We will compare groups using a Chi-square test, and use a 2-sided p-value <0.05 to indicate a statistically significant difference between baseline and follow up screening rates.
- Compare rates of initial and repeat screening completion among 1) Patients offered a modest financial incentive to complete screening, in addition to outreach invitations, vs. 2) Patients offered outreach invitations alone. [ Time Frame: Each year for three years ]
The rate of initial screening completion will be defined by:
Initial Screening Completion Rate = # patients completing a FIT Year 1
- of patients sent FIT invitation Year 1
- of patients sent FIT invitation Year 1 We will compare the initial screening completion rate for patients offered the financial incentive, in addition to screening outreach, to the initial rate for patients offered screening outreach alone using a Chi-square test of proportions, with a 2-sided p value <0.05 considered statistically significant.
The rate of repeat screening for Years 2 and 3 will be defined by:
Year 2 Repeat Completion Rate = # patients completing FIT screening Year 2 Year 3 Repeat Completion Rate = # patients completing FIT screening Year 3
- patients completing FIT Year 1 with normal result # patients completing FIT Year 2 with normal result
- Change in early stage cancer detection from baseline. [ Time Frame: After three years. ]
To assess increase in early stage cancer detection from baseline investigators will compute proportion of colorectal cancer patients with early stage cancer at baseline and at end of Year 3. John Peter Smith Hospital Cancer Registry data will be used for this computation. Rate of early stage cancer will be defined as:
Early Stage Cancer Detection Rate =
# CRC patients with SEER Summary Stage 0 or Stage 1 / # CRC patients
We will use a Chi-square test of proportions for comparing groups, and a p value <0.05 to signify statistical significance.
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): NCT01946282
|Principal Investigator:||Keith Argenbright, M.D.||UT Southwestern Medical Center|
|Study Director:||Samir Gupta, M.D.||University of California, San Diego|