Trial Outcomes & Findings for Health Literacy Interventions to Overcome Disparities in CRC Screening (NCT NCT02360605)
NCT ID: NCT02360605
Last Updated: 2021-06-30
Results Overview
A patient will be considered screened initially for CRC if he/she completes a FIT within 6 months of study entry.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
620 participants
Primary outcome timeframe
6 months after receipt of FIT kit
Results posted on
2021-06-30
Participant Flow
Recruitment occurred from February 2015-October 2016 in four Federally Qualified Health Centers in rural South Louisiana. Clinic staff asked consecutive patients aged 50 to 75 presenting to the clinic for a scheduled routine primary care visit if they were interested in participating in a CRC screening study.
Participant milestones
| Measure |
Automated Telephone Reminder Arm
Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.
automated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.
Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1.
|
Prevention Coordinator Arm
Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.
Prevention coordinator: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT.
Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly reminder letter and then a FIT kit will be mailed the following week. Follow-up calls will follow year 1 procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
311
|
309
|
|
Overall Study
COMPLETED
|
300
|
291
|
|
Overall Study
NOT COMPLETED
|
11
|
18
|
Reasons for withdrawal
| Measure |
Automated Telephone Reminder Arm
Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.
automated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.
Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1.
|
Prevention Coordinator Arm
Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.
Prevention coordinator: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT.
Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly reminder letter and then a FIT kit will be mailed the following week. Follow-up calls will follow year 1 procedure.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
9
|
|
Overall Study
Lost to Follow-up
|
7
|
8
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Health Literacy Interventions to Overcome Disparities in CRC Screening
Baseline characteristics by cohort
| Measure |
Automated Telephone Reminder Arm
n=308 Participants
Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.
automated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.
Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1.
|
Prevention Coordinator Arm
n=306 Participants
Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.
Prevention coordinator: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT.
Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly reminder letter and then a FIT kit will be mailed the following week. Follow-up calls will follow year 1 procedure.
|
Total
n=614 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
210 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
406 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
95 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after receipt of FIT kitA patient will be considered screened initially for CRC if he/she completes a FIT within 6 months of study entry.
Outcome measures
| Measure |
Automated Telephone Reminder Arm
n=308 Participants
Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.
automated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.
Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1.
|
Prevention Coordinator Arm
n=306 Participants
Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.
prevention coordinator: patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed
|
|---|---|---|
|
Initial CRC Screening
|
213 Participants
|
205 Participants
|
PRIMARY outcome
Timeframe: between 12 and 18 months of previous screen, 2 years overallPopulation: 620 participants enrolled - 6 withdrew the day after enrollment - 614 participants at baseline. Of these, 44 had a positive FIT result and were excluded from the second FIT screening and 2 withdrew after year 1 resulting in a sample size of 568 for the 2nd year screening analysis. All participants who were enrolled were included in the final analysis with the exception of the 44 with a positive FIT test in Year 1 and the 2 lost-to-follow-up.
Patients in our study will be considered to have completed repeat annual CRC screening if they complete a FIT between 12 and 18 months of previous screen (or baseline interview, if initial FIT was not returned). Year 2 primary outcome is number of participants who return a FIT for 2 years.
Outcome measures
| Measure |
Automated Telephone Reminder Arm
n=285 Participants
Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.
automated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.
Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1.
|
Prevention Coordinator Arm
n=283 Participants
Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.
prevention coordinator: patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed
|
|---|---|---|
|
Repeat CRC Screening
|
104 Participants
|
95 Participants
|
PRIMARY outcome
Timeframe: between 12 and 18 months of previous screen, 2 years overallPopulation: 531 eligible for year 3 screening - 614 baseline minus \[Year 1 FIT positive (n=44) + Lost to follow-up in year 2 (n=2) + Year 2 FIT positive (n=17) =Lost to follow-up in year 3 (n=20)\]
Patients in our study will be considered to have completed repeat annual CRC screening if they complete a FIT between 12 and 18 months of previous screen (or baseline interview, if initial FIT was not returned). Year 3 primary outcome is number of participants who return a FIT all 3 years.
Outcome measures
| Measure |
Automated Telephone Reminder Arm
n=269 Participants
Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions. Patients will receive reminders to complete their FIT screening kits by an automated call.
automated telephone reminder: The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions.
Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a reminder letter and a FIT kit will be mailed the following week. Follow-up procedure will be the same as year 1.
|
Prevention Coordinator Arm
n=262 Participants
Patients will receive Health literacy appropriate education and demonstration of FIT kits with simplified instructions.Patients will receive reminders to complete their FIT screening kits by a prevention coordinator.
prevention coordinator: patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed
|
|---|---|---|
|
Repeat Screening
|
58 Participants
|
58 Participants
|
Adverse Events
Automated Telephone Reminder Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prevention Coordinator Arm
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