Colorectal Cancer
Conditions
Keywords
neoplasm, colorectal, cancer, uninsured, FIT, Fecal Immunochemical Test
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.
Interventions
OTHERFIT 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.
OTHERFIT plus $5 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.
OTHERFIT plus $10 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.
Sponsors
Cancer Prevention Research Institute of Texas
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year | Each year for three years | Primary outcome was analyzed using an intent-to-screen approach where a 2-sided P-value \<0.05 was considered statistically significant. Patients were randomly assigned to one of 3 groups: outreach only, outreach + $5 incentive upon FIT return, and outreach + $10 incentive upon FIT return. For analysis, incentive groups were combined and compared to outreach alone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive | Each year for three years | Patients were randomly assigned to one of 3 groups: outreach only, outreach + $5 incentive upon FIT return, and outreach + $10 incentive upon FIT return. In year 4, use of financial incentives were discontinued and all patients with a normal result in year 3 were invited to complete a FIT using outreach only, regardless of their original intervention group. |
Participant flow
Pre-assignment details
18,700 age-eligible patients with qualifying outpatient clinic visits were identified for invitation. 10,135 patients were excluded from participation due to the following: primary language not English or Spanish, missing contact information, incarceration, screen up-to-date, and prior history of colorectal cancer or inflammatory bowel disease.
Participants by arm
| Arm | Count |
|---|---|
| FIT Invitation Only Fecal Immunochemical Test (FIT) mailed to patient homes free of charge. 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.
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. | 6,565 |
| FIT Plus $5 Incentive Fecal Immunochemical Test (FIT) mailed to patient homes, plus an incentive to complete the test. 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.
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. | 1,000 |
| FIT Plus $10 Incentive Fecal Immunochemical Test (FIT) mailed to patient homes, plus an incentive to complete the test. 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.
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. | 1,000 |
| Total | 8,565 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Year 1 | Did not return FIT kit | 4,186 | 608 | 654 |
| Year 2 | Did not return FIT kit | 803 | 131 | 115 |
| Year 3 | Did not return FIT kit | 288 | 43 | 30 |
Baseline characteristics
| Characteristic | FIT Invitation Only | FIT Plus $5 Incentive | FIT Plus $10 Incentive | Total |
|---|---|---|---|---|
| Age, Continuous | 56 years | 56 years | 56 years | 56 years |
| Race/Ethnicity, Customized Asian | 127 Participants | 19 Participants | 23 Participants | 169 Participants |
| Race/Ethnicity, Customized Black | 1578 Participants | 270 Participants | 245 Participants | 2093 Participants |
| Race/Ethnicity, Customized Hispanic | 1951 Participants | 257 Participants | 293 Participants | 2501 Participants |
| Race/Ethnicity, Customized Other | 405 Participants | 59 Participants | 54 Participants | 518 Participants |
| Race/Ethnicity, Customized Unknown | 76 Participants | 14 Participants | 17 Participants | 107 Participants |
| Race/Ethnicity, Customized White | 2428 Participants | 381 Participants | 368 Participants | 3177 Participants |
| Sex: Female, Male Female | 4042 Participants | 610 Participants | 644 Participants | 5296 Participants |
| Sex: Female, Male Male | 2523 Participants | 390 Participants | 356 Participants | 3269 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6,565 | 0 / 1,000 | 0 / 1,000 |
| other Total, other adverse events | 0 / 6,565 | 0 / 1,000 | 0 / 1,000 |
| serious Total, serious adverse events | 0 / 6,565 | 0 / 1,000 | 0 / 1,000 |
Outcome results
Primary
FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year
Primary outcome was analyzed using an intent-to-screen approach where a 2-sided P-value \<0.05 was considered statistically significant. Patients were randomly assigned to one of 3 groups: outreach only, outreach + $5 incentive upon FIT return, and outreach + $10 incentive upon FIT return. For analysis, incentive groups were combined and compared to outreach alone.
Time frame: Each year for three years
Population: If FIT is positive, patients are routed to appropriate treatment. If FIT is negative, patients mailed invitations in the following year.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Invite | FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year | Year 1 Screening Rate | 2391 Participants |
| Standard Invite | FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year | Year 2 Screening Rate | 1255 Participants |
| Standard Invite | FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year | Year 3 Screening Rate | 856 Participants |
| Incentive Invite | FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year | Year 1 Screening Rate | 738 Participants |
| Incentive Invite | FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year | Year 2 Screening Rate | 394 Participants |
| Incentive Invite | FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year | Year 3 Screening Rate | 281 Participants |
p-value: 0.59Chi-squared
p-value: 0.75Chi-squared
p-value: 0.08Chi-squared
Secondary
FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive
Patients were randomly assigned to one of 3 groups: outreach only, outreach + $5 incentive upon FIT return, and outreach + $10 incentive upon FIT return. In year 4, use of financial incentives were discontinued and all patients with a normal result in year 3 were invited to complete a FIT using outreach only, regardless of their original intervention group.
Time frame: Each year for three years
Population: Patients were re-invited after participation in previous year and had a negative FIT result.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Invite | FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive | Year 2 Repeat Screening Rate | 210 Participants |
| Standard Invite | FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive | Year 1 Initial Screening Rate | 392 Participants |
| Standard Invite | FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive | Year 3 Repeat Screening Rate | 141 Participants |
| Incentive Invite | FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive | Year 2 Repeat Screening Rate | 184 Participants |
| Incentive Invite | FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive | Year 1 Initial Screening Rate | 346 Participants |
| Incentive Invite | FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive | Year 3 Repeat Screening Rate | 140 Participants |
| Outreach Alone | FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive | Year 1 Initial Screening Rate | 2379 Participants |
| Outreach Alone | FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive | Year 3 Repeat Screening Rate | 856 Participants |
| Outreach Alone | FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive | Year 2 Repeat Screening Rate | 1248 Participants |
p-value: 0.82Chi-squared
p-value: 0.033Chi-squared
p-value: 0.033Chi-squared
p-value: >0.99Chi-squared
p-value: 0.184Chi-squared
p-value: 0.07Chi-squared
p-value: 0.8Chi-squared
p-value: 0.6Chi-squared
p-value: 0.31Chi-squared