Trial Outcomes & Findings for mFOCUS (Multilevel FOllow-up of Cancer Screening) (NCT NCT03979495)
NCT ID: NCT03979495
Last Updated: 2024-05-10
Results Overview
Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11980 participants
Primary outcome timeframe
120 days
Results posted on
2024-05-10
Participant Flow
Recruitment started in August 2020 and ended in December of 2021
Unit of analysis: Primary Care Practices
Participant milestones
| Measure |
Standard of Care
Standard care/no changes to usual care
|
IT Platform
Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results
mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
IT Platform With Reminders
Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.
mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
IT Platform and Patient Navigation
the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.
mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2702 11
|
3254 11
|
2569 11
|
3455 11
|
|
Overall Study
COMPLETED
|
2702 11
|
3254 11
|
2569 11
|
3455 11
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
mFOCUS (Multilevel FOllow-up of Cancer Screening)
Baseline characteristics by cohort
| Measure |
Standard of Care
n=2702 Participants
standard of care
|
IT Platform
n=3254 Participants
Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results
mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
IT Platform With Reminders
n=2569 Participants
Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.
mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
IT Platform and Patient Navigation
n=3455 Participants
the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.
mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
Total
n=11980 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1828 Participants
n=5 Participants
|
2051 Participants
n=7 Participants
|
1557 Participants
n=5 Participants
|
2042 Participants
n=4 Participants
|
7478 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
874 Participants
n=5 Participants
|
1203 Participants
n=7 Participants
|
1012 Participants
n=5 Participants
|
1413 Participants
n=4 Participants
|
4502 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1772 Participants
n=5 Participants
|
2139 Participants
n=7 Participants
|
1680 Participants
n=5 Participants
|
2172 Participants
n=4 Participants
|
7763 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
930 Participants
n=5 Participants
|
1115 Participants
n=7 Participants
|
889 Participants
n=5 Participants
|
1283 Participants
n=4 Participants
|
4217 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
207 Participants
n=5 Participants
|
316 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
344 Participants
n=4 Participants
|
1095 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2310 Participants
n=5 Participants
|
2642 Participants
n=7 Participants
|
2137 Participants
n=5 Participants
|
2913 Participants
n=4 Participants
|
10002 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
185 Participants
n=5 Participants
|
296 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
198 Participants
n=4 Participants
|
883 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
90 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
357 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
139 Participants
n=5 Participants
|
265 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
789 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2241 Participants
n=5 Participants
|
2546 Participants
n=7 Participants
|
2051 Participants
n=5 Participants
|
2782 Participants
n=4 Participants
|
9620 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
226 Participants
n=5 Participants
|
346 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
357 Participants
n=4 Participants
|
1179 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2702 participants
n=5 Participants
|
3254 participants
n=7 Participants
|
2569 participants
n=5 Participants
|
3455 participants
n=4 Participants
|
11980 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 120 daysCompletion of follow-up test within 120 days of eligibility for mFOCUS (EHR)
Outcome measures
| Measure |
Standard of Care
n=2702 Participants
standard of care
|
IT Platform
n=3254 Participants
Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results
mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
IT Platform With Reminders
n=2569 Participants
Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.
mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
IT Platform and Patient Navigation
n=3455 Participants
the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.
mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
|---|---|---|---|---|
|
Completion of Follow-up Test
|
672 Participants
|
796 Participants
|
831 Participants
|
1062 Participants
|
SECONDARY outcome
Timeframe: up to 240 daysHow many participants completed the required diagnostic evaluation (EHR), 0-60, 61-120, 121-180, 181-240 day intervals were evaluated.
Outcome measures
| Measure |
Standard of Care
n=2702 Participants
standard of care
|
IT Platform
n=3254 Participants
Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results
mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
IT Platform With Reminders
n=2569 Participants
Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.
mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
IT Platform and Patient Navigation
n=3455 Participants
the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.
mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
|---|---|---|---|---|
|
Number of Participants Who Complete the Required Diagnostic Evaluation
0-60 days
|
423 Participants
|
464 Participants
|
514 Participants
|
653 Participants
|
|
Number of Participants Who Complete the Required Diagnostic Evaluation
61-120 days
|
249 Participants
|
332 Participants
|
317 Participants
|
409 Participants
|
|
Number of Participants Who Complete the Required Diagnostic Evaluation
121-180 days
|
170 Participants
|
215 Participants
|
191 Participants
|
255 Participants
|
|
Number of Participants Who Complete the Required Diagnostic Evaluation
181-240 days
|
113 Participants
|
159 Participants
|
100 Participants
|
153 Participants
|
|
Number of Participants Who Complete the Required Diagnostic Evaluation
Did not receive follow up
|
1747 Participants
|
2084 Participants
|
1447 Participants
|
1985 Participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IT Platform
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IT Platform With Reminders
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IT Platform and Patient Navigation
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place