Trial Outcomes & Findings for Evidence-Based Colorectal Cancer Screening for the Uninsured (NCT NCT01946282)
NCT ID: NCT01946282
Last Updated: 2020-03-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8565 participants
Primary outcome timeframe
Each year for three years
Results posted on
2020-03-19
Participant Flow
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.
Participant milestones
| Measure |
FIT Invitation Only, No Incentive
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 1 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 Plus $5 Incentive
Fecal Immunochemical Test (FIT) mailed to patient homes, plus an $5 gift card incentive to complete the test. FIT kits and invitation letter with a gift card incentive to complete screening are mailed to the homes of 1000 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 1 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 $10 Incentive
Fecal Immunochemical Test (FIT) mailed to patient homes, plus an $10 gift card incentive to complete the test. FIT kits and invitation letter with a gift card incentive to complete screening are mailed to the homes of 1000 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 1 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.
|
|---|---|---|---|
|
Year 1
STARTED
|
6565
|
1000
|
1000
|
|
Year 1
COMPLETED
|
2379
|
392
|
346
|
|
Year 1
NOT COMPLETED
|
4186
|
608
|
654
|
|
Year 2
STARTED
|
2051
|
341
|
299
|
|
Year 2
COMPLETED
|
1248
|
210
|
184
|
|
Year 2
NOT COMPLETED
|
803
|
131
|
115
|
|
Year 3
STARTED
|
1144
|
184
|
170
|
|
Year 3
COMPLETED
|
856
|
141
|
140
|
|
Year 3
NOT COMPLETED
|
288
|
43
|
30
|
Reasons for withdrawal
| Measure |
FIT Invitation Only, No Incentive
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 1 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 Plus $5 Incentive
Fecal Immunochemical Test (FIT) mailed to patient homes, plus an $5 gift card incentive to complete the test. FIT kits and invitation letter with a gift card incentive to complete screening are mailed to the homes of 1000 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 1 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 $10 Incentive
Fecal Immunochemical Test (FIT) mailed to patient homes, plus an $10 gift card incentive to complete the test. FIT kits and invitation letter with a gift card incentive to complete screening are mailed to the homes of 1000 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 1 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.
|
|---|---|---|---|
|
Year 1
Did not return FIT kit
|
4186
|
608
|
654
|
|
Year 2
Did not return FIT kit
|
803
|
131
|
115
|
|
Year 3
Did not return FIT kit
|
288
|
43
|
30
|
Baseline Characteristics
Evidence-Based Colorectal Cancer Screening for the Uninsured
Baseline characteristics by cohort
| Measure |
FIT Invitation Only
n=6565 Participants
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.
|
FIT Plus $5 Incentive
n=1000 Participants
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.
|
FIT Plus $10 Incentive
n=1000 Participants
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.
|
Total
n=8565 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
56 years
n=7 Participants
|
56 years
n=5 Participants
|
56 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4042 Participants
n=5 Participants
|
610 Participants
n=7 Participants
|
644 Participants
n=5 Participants
|
5296 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2523 Participants
n=5 Participants
|
390 Participants
n=7 Participants
|
356 Participants
n=5 Participants
|
3269 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
2428 Participants
n=5 Participants
|
381 Participants
n=7 Participants
|
368 Participants
n=5 Participants
|
3177 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
1578 Participants
n=5 Participants
|
270 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
2093 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1951 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
2501 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
127 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
169 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
405 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
518 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
76 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Each year for three yearsPopulation: If FIT is positive, patients are routed to appropriate treatment. If FIT is negative, patients mailed invitations in the following 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.
Outcome measures
| Measure |
Standard Invite
n=6565 Participants
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.
|
Incentive Invite
n=2000 Participants
The denominator population for evaluating baseline and end of Year 3 screening rates will consist of patients meeting the following criteria: 1) Age 50-64, 2) Uninsured, but participants in JPS's medical assistance program for the uninsured, 3) One or more visits to a JPS primary care clinic within a year, 4) Address and phone number on file, 5) No history of CRC or colon resection, 6) Not incarcerated
|
Outreach Alone
The outreach included: (i) a mailed invitation to complete and return the FIT in English and Spanish; (ii) a 1-sample Polymedco OC Sensor FIT test; (iii) 2 automated telephone reminders in English and Spanish at the time invitations were mailed and 1 week later, encouraging test completion; and (iv) up to 2 live telephone reminders within 3 weeks of the invitation mailing, if the FIT was not returned or if the patient had not been reached during earlier attempts.
|
|---|---|---|---|
|
FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year
Year 1 Screening Rate
|
2391 Participants
|
738 Participants
|
—
|
|
FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year
Year 2 Screening Rate
|
1255 Participants
|
394 Participants
|
—
|
|
FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year
Year 3 Screening Rate
|
856 Participants
|
281 Participants
|
—
|
SECONDARY outcome
Timeframe: Each year for three yearsPopulation: Patients were re-invited after participation in previous year and had a negative FIT result.
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.
Outcome measures
| Measure |
Standard Invite
n=1000 Participants
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.
|
Incentive Invite
n=1000 Participants
The denominator population for evaluating baseline and end of Year 3 screening rates will consist of patients meeting the following criteria: 1) Age 50-64, 2) Uninsured, but participants in JPS's medical assistance program for the uninsured, 3) One or more visits to a JPS primary care clinic within a year, 4) Address and phone number on file, 5) No history of CRC or colon resection, 6) Not incarcerated
|
Outreach Alone
n=6565 Participants
The outreach included: (i) a mailed invitation to complete and return the FIT in English and Spanish; (ii) a 1-sample Polymedco OC Sensor FIT test; (iii) 2 automated telephone reminders in English and Spanish at the time invitations were mailed and 1 week later, encouraging test completion; and (iv) up to 2 live telephone reminders within 3 weeks of the invitation mailing, if the FIT was not returned or if the patient had not been reached during earlier attempts.
|
|---|---|---|---|
|
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
|
184 Participants
|
1248 Participants
|
|
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
|
140 Participants
|
856 Participants
|
|
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
|
346 Participants
|
2379 Participants
|
Adverse Events
FIT Invitation Only, No Incentive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FIT Plus $5 Incentive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FIT Plus $10 Incentive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Keith Argenbright, Director, Moncrief Cancer Institute
University of Texas Southwestern Medical Center, Moncrief Cancer Institute
Phone: 817-288-0070
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place