Trial Outcomes & Findings for Improving Comprehensive Cancer Screening Among Vulnerable Patients Using Patient Navigation (NCT NCT02553538)
NCT ID: NCT02553538
Last Updated: 2018-03-26
Results Overview
The primary outcome was the overall cancer screening test completion rate over the follow-up period for each eligible patient, with all eligible cancers combined in intention to treat analyses. For example, a patient who was eligible for a total of 3 screening tests at a given time could have a completion rate of 0% (none of the 3 tests completed) 33%, 67%, or 100% (all 3 tests completed). By assessing each patient's completion rate over the 8-month follow-up period, the average completion rate over time was estimated from the area under the curve. We also calculated the completion rate for each individual cancer as the percentage of time screening was up to date among eligible patients during follow-up.
COMPLETED
NA
1612 participants
8 months
2018-03-26
Participant Flow
Participant milestones
| Measure |
Patient Navigation Intervention
Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
|
Standard of Care - No Intervention
Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
|
|---|---|---|
|
Overall Study
STARTED
|
792
|
820
|
|
Overall Study
COMPLETED
|
605
|
764
|
|
Overall Study
NOT COMPLETED
|
187
|
56
|
Reasons for withdrawal
| Measure |
Patient Navigation Intervention
Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
|
Standard of Care - No Intervention
Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
|
|---|---|---|
|
Overall Study
Could Not Reach by Telephone
|
133
|
0
|
|
Overall Study
Died or Left Network
|
54
|
56
|
Baseline Characteristics
Improving Comprehensive Cancer Screening Among Vulnerable Patients Using Patient Navigation
Baseline characteristics by cohort
| Measure |
Patient Navigation Intervention
n=792 Participants
Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
|
Standard of Care - No Intervention
n=820 Participants
Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
|
Total
n=1612 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
57.1 years
STANDARD_DEVIATION 9.4 • n=107 Participants
|
57.0 years
STANDARD_DEVIATION 9.35 • n=206 Participants
|
|
Sex: Female, Male
Female
|
479 Participants
n=99 Participants
|
496 Participants
n=107 Participants
|
975 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
313 Participants
n=99 Participants
|
324 Participants
n=107 Participants
|
637 Participants
n=206 Participants
|
|
Race
Asian
|
61 participants
n=99 Participants
|
82 participants
n=107 Participants
|
143 participants
n=206 Participants
|
|
Race
Black
|
94 participants
n=99 Participants
|
83 participants
n=107 Participants
|
177 participants
n=206 Participants
|
|
Race
Hispanic
|
104 participants
n=99 Participants
|
71 participants
n=107 Participants
|
175 participants
n=206 Participants
|
|
Race
Other/Unknown
|
44 participants
n=99 Participants
|
42 participants
n=107 Participants
|
86 participants
n=206 Participants
|
|
Race
White
|
489 participants
n=99 Participants
|
542 participants
n=107 Participants
|
1031 participants
n=206 Participants
|
|
Language
English
|
565 participants
n=99 Participants
|
608 participants
n=107 Participants
|
1173 participants
n=206 Participants
|
|
Language
Not English
|
227 participants
n=99 Participants
|
212 participants
n=107 Participants
|
439 participants
n=206 Participants
|
|
Insurance
Commercial
|
430 participants
n=99 Participants
|
410 participants
n=107 Participants
|
840 participants
n=206 Participants
|
|
Insurance
Medicaid
|
174 participants
n=99 Participants
|
200 participants
n=107 Participants
|
374 participants
n=206 Participants
|
|
Insurance
Medicare
|
147 participants
n=99 Participants
|
169 participants
n=107 Participants
|
316 participants
n=206 Participants
|
|
Insurance
Self-Pay
|
41 participants
n=99 Participants
|
41 participants
n=107 Participants
|
82 participants
n=206 Participants
|
|
Patient-Physician Connectedness Status
Physician-connected
|
670 participants
n=99 Participants
|
674 participants
n=107 Participants
|
1344 participants
n=206 Participants
|
|
Patient-Physician Connectedness Status
Practice-connected
|
122 participants
n=99 Participants
|
146 participants
n=107 Participants
|
268 participants
n=206 Participants
|
|
Clinic Visits in Prior 3-Year
|
6.9 visits
STANDARD_DEVIATION 7.0 • n=99 Participants
|
6.8 visits
STANDARD_DEVIATION 6.5 • n=107 Participants
|
6.85 visits
STANDARD_DEVIATION 6.75 • n=206 Participants
|
PRIMARY outcome
Timeframe: 8 monthsThe primary outcome was the overall cancer screening test completion rate over the follow-up period for each eligible patient, with all eligible cancers combined in intention to treat analyses. For example, a patient who was eligible for a total of 3 screening tests at a given time could have a completion rate of 0% (none of the 3 tests completed) 33%, 67%, or 100% (all 3 tests completed). By assessing each patient's completion rate over the 8-month follow-up period, the average completion rate over time was estimated from the area under the curve. We also calculated the completion rate for each individual cancer as the percentage of time screening was up to date among eligible patients during follow-up.
Outcome measures
| Measure |
Patient Navigation Intervention
n=792 Participants
Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
|
Standard of Care - No Intervention
n=820 Participants
Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
|
|---|---|---|
|
Percentage of Cancer Screening Tests Completed - Intention to Treat
All Cancers Combined
|
10.2 percentage of screening visits completed
Interval 8.7 to 11.7
|
6.8 percentage of screening visits completed
Interval 5.5 to 8.1
|
|
Percentage of Cancer Screening Tests Completed - Intention to Treat
Breast
|
14.7 percentage of screening visits completed
Interval 12.0 to 17.4
|
11.0 percentage of screening visits completed
Interval 8.5 to 13.4
|
|
Percentage of Cancer Screening Tests Completed - Intention to Treat
Cervical
|
11.1 percentage of screening visits completed
Interval 8.4 to 13.9
|
5.7 percentage of screening visits completed
Interval 3.7 to 7.7
|
|
Percentage of Cancer Screening Tests Completed - Intention to Treat
Colorectal
|
7.6 percentage of screening visits completed
Interval 5.9 to 9.2
|
4.6 percentage of screening visits completed
Interval 3.2 to 5.9
|
PRIMARY outcome
Timeframe: 8 MonthsThe primary outcome was the average cancer screening test completion rate over the follow-up period for each eligible patient, with all eligible cancers combined in as treated analyses - excluding patients who either left the network or died during follow-up. The cancer screening test completion rate for each subject was calculated daily, then averaged across the 8-month study period. On any given day, the screening test completion rate was calculated as the number of tests completed divided by the number of eligible tests.
Outcome measures
| Measure |
Patient Navigation Intervention
n=605 Participants
Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
|
Standard of Care - No Intervention
n=764 Participants
Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
|
|---|---|---|
|
Percentage of Cancer Screening Tests Completed - As Treated
All Cancers Combined
|
13.1 percentage of completed screening visits
Interval 11.8 to 15.6
|
7.2 percentage of completed screening visits
Interval 5.9 to 8.6
|
|
Percentage of Cancer Screening Tests Completed - As Treated
Breast
|
18.8 percentage of completed screening visits
Interval 15.6 to 22.4
|
11.7 percentage of completed screening visits
Interval 9.0 to 14.3
|
|
Percentage of Cancer Screening Tests Completed - As Treated
Cervical
|
14.1 percentage of completed screening visits
Interval 11.0 to 18.2
|
6.2 percentage of completed screening visits
Interval 4.0 to 8.3
|
|
Percentage of Cancer Screening Tests Completed - As Treated
Colorectal
|
9.9 percentage of completed screening visits
Interval 8.0 to 12.3
|
4.9 percentage of completed screening visits
Interval 3.4 to 6.3
|
SECONDARY outcome
Timeframe: 8 MonthsThe percentage of patients completing any cancer screening during follow-up among those who were eligible and overdue for at least one cancer screening at baseline in intention to treat analyses, as the percentage of patients completing each type of cancer screening among those who were eligible and overdue at baseline in intention to treat analyses.
Outcome measures
| Measure |
Patient Navigation Intervention
n=792 Participants
Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
|
Standard of Care - No Intervention
n=820 Participants
Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
|
|---|---|---|
|
Percentage of Patients Completing Any Cancer Screening Test (Intention to Treat)
Any Screening
|
25.5 percentage of patients
|
17.0 percentage of patients
|
|
Percentage of Patients Completing Any Cancer Screening Test (Intention to Treat)
Breast
|
23.4 percentage of patients
|
16.6 percentage of patients
|
|
Percentage of Patients Completing Any Cancer Screening Test (Intention to Treat)
Cervical
|
14.4 percentage of patients
|
8.6 percentage of patients
|
|
Percentage of Patients Completing Any Cancer Screening Test (Intention to Treat)
Colorectal
|
13.7 percentage of patients
|
7.0 percentage of patients
|
SECONDARY outcome
Timeframe: 8 MonthsThe percentage of patients completing any cancer screening during follow-up among those who were eligible and overdue for at least one cancer screening at baseline in intention to treat analyses, as the percentage of patients completing each type of cancer screening among those who were eligible and overdue at baseline, removing patients who left our primary care network or who died during follow-up from both intervention and control arms, and also removed patients the navigators were not able to contact from the intervention arm.
Outcome measures
| Measure |
Patient Navigation Intervention
n=605 Participants
Patients randomized to the intervention arm were transferred to a navigator roster within the TopCare application for the 8-month study period. Navigators utilized TopCare to track these patients, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
|
Standard of Care - No Intervention
n=764 Participants
Patients randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the patient a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.
|
|---|---|---|
|
Percentage of Patients Completing Any Cancer Screening Test (As Treated)
Any Screening
|
32.9 percentage of patients
|
18.1 percentage of patients
|
|
Percentage of Patients Completing Any Cancer Screening Test (As Treated)
Breast
|
29.6 percentage of patients
|
17.6 percentage of patients
|
|
Percentage of Patients Completing Any Cancer Screening Test (As Treated)
Cervical
|
18.0 percentage of patients
|
9.3 percentage of patients
|
|
Percentage of Patients Completing Any Cancer Screening Test (As Treated)
Colorectal
|
18.1 percentage of patients
|
7.6 percentage of patients
|
Adverse Events
Patient Navigation Intervention
Standard of Care - No Intervention
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