Trial Outcomes & Findings for Mailed FIT Outreach 2022 (NCT NCT05341622)
NCT ID: NCT05341622
Last Updated: 2024-07-24
Results Overview
Percent of patients who complete FIT
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5460 participants
Primary outcome timeframe
4 months
Results posted on
2024-07-24
Participant Flow
Participant milestones
| Measure |
Arm 1: Box + Text + Reminder
Box + Text + Reminder
Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging
Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
|
Arm 2: Box + Text + No Reminder
Box + Text + No Reminder
Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging
Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit.
|
Arm 3: Box + No Text + Reminder
Box + No Text + Reminder
Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging
No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
|
Arm 4: Box + No Text + No Reminder
Box + No Text + No Reminder
Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging
No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit.
|
Arm 5: Standard Mail + Text + Reminder
Standard Mail + Text + Reminder
Standard Mail: Patients will receive mailed FIT in a standard mailing envelope
Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
|
Arm 6: Standard Mail + Text + No Reminder
Standard Mail + Text + No Reminder
Standard Mail: Patients will receive mailed FIT in a standard mailing envelope
Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit.
|
Arm 7: Standard Mail + No Text + Reminder
Standard Mail: Patients will receive mailed FIT in a standard mailing envelope
No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
|
Arm 8: Standard Mail + No Text + No Reminder
Standard Mail + No Text + No Reminder
Standard Mail: Patients will receive mailed FIT in a standard mailing envelope
No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
682
|
683
|
681
|
685
|
685
|
687
|
681
|
676
|
|
Overall Study
COMPLETED
|
656
|
661
|
653
|
661
|
655
|
656
|
653
|
649
|
|
Overall Study
NOT COMPLETED
|
26
|
22
|
28
|
24
|
30
|
31
|
28
|
27
|
Reasons for withdrawal
| Measure |
Arm 1: Box + Text + Reminder
Box + Text + Reminder
Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging
Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
|
Arm 2: Box + Text + No Reminder
Box + Text + No Reminder
Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging
Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit.
|
Arm 3: Box + No Text + Reminder
Box + No Text + Reminder
Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging
No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
|
Arm 4: Box + No Text + No Reminder
Box + No Text + No Reminder
Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging
No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit.
|
Arm 5: Standard Mail + Text + Reminder
Standard Mail + Text + Reminder
Standard Mail: Patients will receive mailed FIT in a standard mailing envelope
Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
|
Arm 6: Standard Mail + Text + No Reminder
Standard Mail + Text + No Reminder
Standard Mail: Patients will receive mailed FIT in a standard mailing envelope
Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit.
|
Arm 7: Standard Mail + No Text + Reminder
Standard Mail: Patients will receive mailed FIT in a standard mailing envelope
No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
|
Arm 8: Standard Mail + No Text + No Reminder
Standard Mail + No Text + No Reminder
Standard Mail: Patients will receive mailed FIT in a standard mailing envelope
No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Invalid Address
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Ineligible
|
26
|
21
|
28
|
24
|
29
|
31
|
28
|
26
|
Baseline Characteristics
Mailed FIT Outreach 2022
Baseline characteristics by cohort
| Measure |
Arm 1: Box + Text + Reminder
n=656 Participants
Box + Text + Reminder
Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging
Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
|
Arm 2: Box + Text + No Reminder
n=661 Participants
Box + Text + No Reminder
Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging
Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit.
|
Arm 3: Box + No Text + Reminder
n=653 Participants
Box + No Text + Reminder
Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging
No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
|
Arm 4: Box + No Text + No Reminder
n=661 Participants
Box + No Text + No Reminder
Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging
No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit.
|
Arm 5: Standard Mail + Text + Reminder
n=655 Participants
Standard Mail + Text + Reminder
Standard Mail: Patients will receive mailed FIT in a standard mailing envelope
Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
|
Arm 6: Standard Mail + Text + No Reminder
n=656 Participants
Standard Mail + Text + No Reminder
Standard Mail: Patients will receive mailed FIT in a standard mailing envelope
Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit.
|
Arm 7: Standard Mail + No Text + Reminder
n=653 Participants
Standard Mail: Patients will receive mailed FIT in a standard mailing envelope
No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
|
Arm 8: Standard Mail + No Text + No Reminder
n=649 Participants
Standard Mail + No Text + No Reminder
Standard Mail: Patients will receive mailed FIT in a standard mailing envelope
No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit.
|
Total
n=5244 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 7.2 • n=99 Participants
|
60.0 years
STANDARD_DEVIATION 7.4 • n=107 Participants
|
59.7 years
STANDARD_DEVIATION 7.4 • n=206 Participants
|
59.6 years
STANDARD_DEVIATION 7.5 • n=157 Participants
|
59.8 years
STANDARD_DEVIATION 7.3 • n=390 Participants
|
59.1 years
STANDARD_DEVIATION 7.1 • n=16 Participants
|
59.9 years
STANDARD_DEVIATION 7.3 • n=3 Participants
|
59.5 years
STANDARD_DEVIATION 7.2 • n=6 Participants
|
59.6 years
STANDARD_DEVIATION 7.3 • n=114 Participants
|
|
Sex: Female, Male
Female
|
376 Participants
n=99 Participants
|
377 Participants
n=107 Participants
|
391 Participants
n=206 Participants
|
388 Participants
n=157 Participants
|
366 Participants
n=390 Participants
|
352 Participants
n=16 Participants
|
375 Participants
n=3 Participants
|
371 Participants
n=6 Participants
|
2996 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
280 Participants
n=99 Participants
|
284 Participants
n=107 Participants
|
262 Participants
n=206 Participants
|
273 Participants
n=157 Participants
|
289 Participants
n=390 Participants
|
304 Participants
n=16 Participants
|
278 Participants
n=3 Participants
|
278 Participants
n=6 Participants
|
2248 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
32 Participants
n=157 Participants
|
32 Participants
n=390 Participants
|
28 Participants
n=16 Participants
|
27 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
208 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
619 Participants
n=99 Participants
|
620 Participants
n=107 Participants
|
619 Participants
n=206 Participants
|
616 Participants
n=157 Participants
|
601 Participants
n=390 Participants
|
619 Participants
n=16 Participants
|
616 Participants
n=3 Participants
|
615 Participants
n=6 Participants
|
4925 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
13 Participants
n=157 Participants
|
22 Participants
n=390 Participants
|
9 Participants
n=16 Participants
|
10 Participants
n=3 Participants
|
19 Participants
n=6 Participants
|
111 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
4 Participants
n=16 Participants
|
4 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
21 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
22 Participants
n=157 Participants
|
29 Participants
n=390 Participants
|
26 Participants
n=16 Participants
|
26 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
220 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
15 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
226 Participants
n=99 Participants
|
221 Participants
n=107 Participants
|
241 Participants
n=206 Participants
|
242 Participants
n=157 Participants
|
239 Participants
n=390 Participants
|
238 Participants
n=16 Participants
|
242 Participants
n=3 Participants
|
229 Participants
n=6 Participants
|
1878 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
357 Participants
n=99 Participants
|
369 Participants
n=107 Participants
|
342 Participants
n=206 Participants
|
342 Participants
n=157 Participants
|
345 Participants
n=390 Participants
|
332 Participants
n=16 Participants
|
349 Participants
n=3 Participants
|
344 Participants
n=6 Participants
|
2780 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
39 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
52 Participants
n=157 Participants
|
40 Participants
n=390 Participants
|
56 Participants
n=16 Participants
|
30 Participants
n=3 Participants
|
44 Participants
n=6 Participants
|
330 Participants
n=114 Participants
|
|
Patient Portal Status
Active
|
549 Participants
n=99 Participants
|
555 Participants
n=107 Participants
|
544 Participants
n=206 Participants
|
557 Participants
n=157 Participants
|
553 Participants
n=390 Participants
|
556 Participants
n=16 Participants
|
555 Participants
n=3 Participants
|
542 Participants
n=6 Participants
|
4411 Participants
n=114 Participants
|
|
Patient Portal Status
Not Active
|
107 Participants
n=99 Participants
|
106 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
104 Participants
n=157 Participants
|
102 Participants
n=390 Participants
|
100 Participants
n=16 Participants
|
98 Participants
n=3 Participants
|
107 Participants
n=6 Participants
|
833 Participants
n=114 Participants
|
|
Prior Screening (Any)
|
188 Participants
n=99 Participants
|
195 Participants
n=107 Participants
|
212 Participants
n=206 Participants
|
192 Participants
n=157 Participants
|
194 Participants
n=390 Participants
|
187 Participants
n=16 Participants
|
210 Participants
n=3 Participants
|
178 Participants
n=6 Participants
|
1556 Participants
n=114 Participants
|
|
Insurance Type
Commercial
|
388 Participants
n=99 Participants
|
371 Participants
n=107 Participants
|
392 Participants
n=206 Participants
|
369 Participants
n=157 Participants
|
369 Participants
n=390 Participants
|
371 Participants
n=16 Participants
|
360 Participants
n=3 Participants
|
373 Participants
n=6 Participants
|
2993 Participants
n=114 Participants
|
|
Insurance Type
Medicare
|
175 Participants
n=99 Participants
|
208 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
197 Participants
n=157 Participants
|
191 Participants
n=390 Participants
|
186 Participants
n=16 Participants
|
185 Participants
n=3 Participants
|
177 Participants
n=6 Participants
|
1491 Participants
n=114 Participants
|
|
Insurance Type
Medicaid
|
77 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
80 Participants
n=157 Participants
|
84 Participants
n=390 Participants
|
84 Participants
n=16 Participants
|
91 Participants
n=3 Participants
|
84 Participants
n=6 Participants
|
644 Participants
n=114 Participants
|
|
Insurance Type
Unknown
|
16 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
15 Participants
n=157 Participants
|
11 Participants
n=390 Participants
|
15 Participants
n=16 Participants
|
17 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
116 Participants
n=114 Participants
|
|
Median Household Income
|
76973 dollars
n=99 Participants
|
77091 dollars
n=107 Participants
|
77091 dollars
n=206 Participants
|
76854 dollars
n=157 Participants
|
74349 dollars
n=390 Participants
|
77091 dollars
n=16 Participants
|
76610 dollars
n=3 Participants
|
73762 dollars
n=6 Participants
|
76875 dollars
n=114 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPercent of patients who complete FIT
Outcome measures
| Measure |
Box (Arms 1+2+3+4)
n=2631 Participants
All patients in this study arm received mailed FIT in a stylized box. This combined study arm combines all patients in Arms 1-4.
|
Envelope (Arms 5+6+7+8)
n=2613 Participants
All patients in this study arm received mailed FIT in a plain mailing envelope. This combined study arm includes all patients in arms 5, 6, 7, and 8)
|
Text (Arms 1+2+5+6)
n=2628 Participants
All patients in this study arm received text messaging related to completion of mailed FIT. This combined study arm includes all patients in study arms 1, 2, 5, and 6).
|
No Text (Arms 3+4+7+8)
n=2616 Participants
Patients in this study arm did NOT receive any text messaging related to completion of mailed FIT. This combined study arm includes all patients in study arms 3, 4, 7, and 8).
|
Reminder (Arms 1+3+5+7)
n=2617 Participants
Patients in this study arm did received a mailed reminder letter related to completion of mailed FIT. This combined study arm includes all patients in study arms 1, 3, 5, and 7.
|
No Reminder (Arms 2+4+6+8)
n=2627 Participants
Patients in this study arm did NOT receive any mailed reminder letters related to completion of mailed FIT. This combined study arm includes all patients in study arms 2, 4, 6, and 8.
|
|---|---|---|---|---|---|---|
|
FIT Completion
|
469 Participants
|
470 Participants
|
558 Participants
|
381 Participants
|
532 Participants
|
407 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPercent of patients who complete FIT
Outcome measures
| Measure |
Box (Arms 1+2+3+4)
n=2631 Participants
All patients in this study arm received mailed FIT in a stylized box. This combined study arm combines all patients in Arms 1-4.
|
Envelope (Arms 5+6+7+8)
n=2613 Participants
All patients in this study arm received mailed FIT in a plain mailing envelope. This combined study arm includes all patients in arms 5, 6, 7, and 8)
|
Text (Arms 1+2+5+6)
n=2628 Participants
All patients in this study arm received text messaging related to completion of mailed FIT. This combined study arm includes all patients in study arms 1, 2, 5, and 6).
|
No Text (Arms 3+4+7+8)
n=2616 Participants
Patients in this study arm did NOT receive any text messaging related to completion of mailed FIT. This combined study arm includes all patients in study arms 3, 4, 7, and 8).
|
Reminder (Arms 1+3+5+7)
n=2617 Participants
Patients in this study arm did received a mailed reminder letter related to completion of mailed FIT. This combined study arm includes all patients in study arms 1, 3, 5, and 7.
|
No Reminder (Arms 2+4+6+8)
n=2627 Participants
Patients in this study arm did NOT receive any mailed reminder letters related to completion of mailed FIT. This combined study arm includes all patients in study arms 2, 4, 6, and 8.
|
|---|---|---|---|---|---|---|
|
FIT Completion
|
506 Participants
|
492 Participants
|
593 Participants
|
405 Participants
|
559 Participants
|
439 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPercent of patients who complete any CRC screening
Outcome measures
| Measure |
Box (Arms 1+2+3+4)
n=2613 Participants
All patients in this study arm received mailed FIT in a stylized box. This combined study arm combines all patients in Arms 1-4.
|
Envelope (Arms 5+6+7+8)
n=2631 Participants
All patients in this study arm received mailed FIT in a plain mailing envelope. This combined study arm includes all patients in arms 5, 6, 7, and 8)
|
Text (Arms 1+2+5+6)
n=2628 Participants
All patients in this study arm received text messaging related to completion of mailed FIT. This combined study arm includes all patients in study arms 1, 2, 5, and 6).
|
No Text (Arms 3+4+7+8)
n=2616 Participants
Patients in this study arm did NOT receive any text messaging related to completion of mailed FIT. This combined study arm includes all patients in study arms 3, 4, 7, and 8).
|
Reminder (Arms 1+3+5+7)
n=2617 Participants
Patients in this study arm did received a mailed reminder letter related to completion of mailed FIT. This combined study arm includes all patients in study arms 1, 3, 5, and 7.
|
No Reminder (Arms 2+4+6+8)
n=2627 Participants
Patients in this study arm did NOT receive any mailed reminder letters related to completion of mailed FIT. This combined study arm includes all patients in study arms 2, 4, 6, and 8.
|
|---|---|---|---|---|---|---|
|
Colorectal Cancer (CRC) Screening Completion (Any)
|
650 Participants
|
640 Participants
|
739 Participants
|
551 Participants
|
700 Participants
|
590 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPercent of patients with FIT+ results that schedule a colonoscopy
Outcome measures
| Measure |
Box (Arms 1+2+3+4)
n=50 Participants
All patients in this study arm received mailed FIT in a stylized box. This combined study arm combines all patients in Arms 1-4.
|
Envelope (Arms 5+6+7+8)
All patients in this study arm received mailed FIT in a plain mailing envelope. This combined study arm includes all patients in arms 5, 6, 7, and 8)
|
Text (Arms 1+2+5+6)
All patients in this study arm received text messaging related to completion of mailed FIT. This combined study arm includes all patients in study arms 1, 2, 5, and 6).
|
No Text (Arms 3+4+7+8)
Patients in this study arm did NOT receive any text messaging related to completion of mailed FIT. This combined study arm includes all patients in study arms 3, 4, 7, and 8).
|
Reminder (Arms 1+3+5+7)
Patients in this study arm did received a mailed reminder letter related to completion of mailed FIT. This combined study arm includes all patients in study arms 1, 3, 5, and 7.
|
No Reminder (Arms 2+4+6+8)
Patients in this study arm did NOT receive any mailed reminder letters related to completion of mailed FIT. This combined study arm includes all patients in study arms 2, 4, 6, and 8.
|
|---|---|---|---|---|---|---|
|
FIT Positive Follow-up Scheduling
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPercent of patients with FIT+ results that complete a diagnostic colonoscopy
Outcome measures
| Measure |
Box (Arms 1+2+3+4)
n=50 Participants
All patients in this study arm received mailed FIT in a stylized box. This combined study arm combines all patients in Arms 1-4.
|
Envelope (Arms 5+6+7+8)
All patients in this study arm received mailed FIT in a plain mailing envelope. This combined study arm includes all patients in arms 5, 6, 7, and 8)
|
Text (Arms 1+2+5+6)
All patients in this study arm received text messaging related to completion of mailed FIT. This combined study arm includes all patients in study arms 1, 2, 5, and 6).
|
No Text (Arms 3+4+7+8)
Patients in this study arm did NOT receive any text messaging related to completion of mailed FIT. This combined study arm includes all patients in study arms 3, 4, 7, and 8).
|
Reminder (Arms 1+3+5+7)
Patients in this study arm did received a mailed reminder letter related to completion of mailed FIT. This combined study arm includes all patients in study arms 1, 3, 5, and 7.
|
No Reminder (Arms 2+4+6+8)
Patients in this study arm did NOT receive any mailed reminder letters related to completion of mailed FIT. This combined study arm includes all patients in study arms 2, 4, 6, and 8.
|
|---|---|---|---|---|---|---|
|
FIT Positive Follow-up Completion
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Arm 1: Box + Text + Reminder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Box + Text + No Reminder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3: Box + No Text + Reminder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 4: Box + No Text + No Reminder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 5: Standard Mail + Text + Reminder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Arm 6: Standard Mail + Text + No Reminder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 7: Standard Mail + No Text + Reminder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 8: Standard Mail + No Text + No Reminder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place