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Improving Comprehensive Cancer Screening Among Vulnerable Patients Using Patient Navigation

Improving Comprehensive Cancer Screening Among Vulnerable Patients Using Patient Navigation as Part of a Population-Based Health IT System: A Randomized Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02553538
Enrollment
1612
Registered
2015-09-17
Start date
2014-04-30
Completion date
2014-12-31
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Compliance

Keywords

cancer screening, patient navigation

Brief summary

Patient navigation (PN) has been shown to improve rates of cancer screening in vulnerable populations. Most cancer PN programs are located in community health centers and focus on a single cancer. The investigators will evaluate the impact of PN program on breast, cervical, and/or colorectal cancer screening in vulnerable patients receiving care in a large, academic, primary care network using a population-based IT system.

Detailed description

It is important to note that the TopCare system is currently the standard of care in the MGPC-PBRN. As such, this proposal does not involve evaluating the TopCare system or the patients and providers using it. Rather, the study evaluates the part of the TopCare system that involves the automated identification and referral to PN of patients at increased risk of screening non-adherence. All eligible patients overdue for cancer screening tests will receive usual care that includes a reminder letter and referral to a scheduling delegate for follow-up. Since the TopCare system represents usual care for patients with the MGH primary care network, no patient contact will occur solely for research purposes. The study will involve randomly assigning participants overdue for screening and identified as high risk for not completing screening to early or delayed PN. The investigators believe this random assignment is ethical because PN is an extremely limited resource, and all patients in the investigators network identified as high risk for not completing screening could not be contacted by the investigators navigators in a short period of time. Thus, the investigators will randomly assign access to PN during the study period, and then allow all participants to be navigated after the study period is over. As a result, all overdue, high risk patients will be referred for PN, but the timing of the referral will be randomly assigned. In this study, the investigators objectives are to improve the algorithm to automatically identify patients who are more likely to benefit from PN (Specific Aim 1), and to evaluate the clinical impact of PN in a randomized controlled trial within the MGPC-PBRN (Specific Aim 2). Investigators will also survey all patients identified by the TopCare algorithm to assess their overall satisfaction with healthcare to determine whether PN impacts satisfaction with healthcare (Specific Aim 3). Revising and improving the current 'high risk' algorithm to automatically identify patients who may be helped by PN in Specific Aim 1 will help us to most effectively utilize limited PN resources. The current algorithm utilizes information about patient age, number of overdue tests, primary language, and no-show visit history. The investigators will investigate adding patient registration information about insurance and education status to better identify patients at high risk for not completing screening. In Specific Aim 2, investigators will randomize eligible patients from the MGPC-PBRN primary care practices to either Arm 1 - TopCare with PN: Patients identified as at high risk for not completing screening by the automated algorithm will be assigned to a PN list for contact to help schedule and complete screening (breast, cervical, and colon), or Arm 2 - TopCare without PN: These patients will benefit from the standard features of the TopCare system, including automated identification of overdue patients, patient reminder letters, and referral to a scheduling delegate. All high risk patients in this arm will be eligible for PN after the study period is over.

Interventions

BEHAVIORALPatient Navigation

Navigators utilized TopCare to track participants, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 21-75 * Seen in MGPC Practices within the Past 3 Years * Linked to a Specific PCP or to a Specific Practice

Exclusion criteria

* A PCP Outside of the MGPC-PBRN network * Greater Than 75 Years Old * MGH Chelsea Health Center Patients

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Cancer Screening Tests Completed - Intention to Treat8 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.
Percentage of Cancer Screening Tests Completed - As Treated8 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.

Secondary

MeasureTime frameDescription
Percentage of Patients Completing Any Cancer Screening Test (Intention to Treat)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.
Percentage of Patients Completing Any Cancer Screening Test (As Treated)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.

Participant flow

Participants by arm

ArmCount
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.
792
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.
820
Total1,612

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyCould Not Reach by Telephone1330
Overall StudyDied or Left Network5456

Baseline characteristics

CharacteristicStandard of Care - No InterventionTotalPatient Navigation Intervention
Age, Continuous57.1 years
STANDARD_DEVIATION 9.4
57.0 years
STANDARD_DEVIATION 9.35
56.9 years
STANDARD_DEVIATION 9.3
Clinic Visits in Prior 3-Year6.8 visits
STANDARD_DEVIATION 6.5
6.85 visits
STANDARD_DEVIATION 6.75
6.9 visits
STANDARD_DEVIATION 7
Insurance
Commercial
410 participants840 participants430 participants
Insurance
Medicaid
200 participants374 participants174 participants
Insurance
Medicare
169 participants316 participants147 participants
Insurance
Self-Pay
41 participants82 participants41 participants
Language
English
608 participants1173 participants565 participants
Language
Not English
212 participants439 participants227 participants
Patient-Physician Connectedness Status
Physician-connected
674 participants1344 participants670 participants
Patient-Physician Connectedness Status
Practice-connected
146 participants268 participants122 participants
Race
Asian
82 participants143 participants61 participants
Race
Black
83 participants177 participants94 participants
Race
Hispanic
71 participants175 participants104 participants
Race
Other/Unknown
42 participants86 participants44 participants
Race
White
542 participants1031 participants489 participants
Sex: Female, Male
Female
496 Participants975 Participants479 Participants
Sex: Female, Male
Male
324 Participants637 Participants313 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 7290 / 820
serious
Total, serious adverse events
0 / 7920 / 820

Outcome results

Primary

Percentage of Cancer Screening Tests Completed - As Treated

The 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.

Time frame: 8 Months

ArmMeasureGroupValue (MEAN)
Patient Navigation InterventionPercentage of Cancer Screening Tests Completed - As TreatedAll Cancers Combined13.1 percentage of completed screening visits
Patient Navigation InterventionPercentage of Cancer Screening Tests Completed - As TreatedBreast18.8 percentage of completed screening visits
Patient Navigation InterventionPercentage of Cancer Screening Tests Completed - As TreatedCervical14.1 percentage of completed screening visits
Patient Navigation InterventionPercentage of Cancer Screening Tests Completed - As TreatedColorectal9.9 percentage of completed screening visits
Standard of Care - No InterventionPercentage of Cancer Screening Tests Completed - As TreatedColorectal4.9 percentage of completed screening visits
Standard of Care - No InterventionPercentage of Cancer Screening Tests Completed - As TreatedAll Cancers Combined7.2 percentage of completed screening visits
Standard of Care - No InterventionPercentage of Cancer Screening Tests Completed - As TreatedCervical6.2 percentage of completed screening visits
Standard of Care - No InterventionPercentage of Cancer Screening Tests Completed - As TreatedBreast11.7 percentage of completed screening visits
p-value: <0.001Mixed Models Analysis
Primary

Percentage of Cancer Screening Tests Completed - Intention to Treat

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.

Time frame: 8 months

ArmMeasureGroupValue (MEAN)
Patient Navigation InterventionPercentage of Cancer Screening Tests Completed - Intention to TreatBreast14.7 percentage of screening visits completed
Patient Navigation InterventionPercentage of Cancer Screening Tests Completed - Intention to TreatCervical11.1 percentage of screening visits completed
Patient Navigation InterventionPercentage of Cancer Screening Tests Completed - Intention to TreatColorectal7.6 percentage of screening visits completed
Patient Navigation InterventionPercentage of Cancer Screening Tests Completed - Intention to TreatAll Cancers Combined10.2 percentage of screening visits completed
Standard of Care - No InterventionPercentage of Cancer Screening Tests Completed - Intention to TreatColorectal4.6 percentage of screening visits completed
Standard of Care - No InterventionPercentage of Cancer Screening Tests Completed - Intention to TreatAll Cancers Combined6.8 percentage of screening visits completed
Standard of Care - No InterventionPercentage of Cancer Screening Tests Completed - Intention to TreatBreast11.0 percentage of screening visits completed
Standard of Care - No InterventionPercentage of Cancer Screening Tests Completed - Intention to TreatCervical5.7 percentage of screening visits completed
p-value: <0.001Mixed Models Analysis
Secondary

Percentage of Patients Completing Any Cancer Screening Test (As Treated)

The 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.

Time frame: 8 Months

ArmMeasureGroupValue (NUMBER)
Patient Navigation InterventionPercentage of Patients Completing Any Cancer Screening Test (As Treated)Any Screening32.9 percentage of patients
Patient Navigation InterventionPercentage of Patients Completing Any Cancer Screening Test (As Treated)Breast29.6 percentage of patients
Patient Navigation InterventionPercentage of Patients Completing Any Cancer Screening Test (As Treated)Cervical18.0 percentage of patients
Patient Navigation InterventionPercentage of Patients Completing Any Cancer Screening Test (As Treated)Colorectal18.1 percentage of patients
Standard of Care - No InterventionPercentage of Patients Completing Any Cancer Screening Test (As Treated)Colorectal7.6 percentage of patients
Standard of Care - No InterventionPercentage of Patients Completing Any Cancer Screening Test (As Treated)Any Screening18.1 percentage of patients
Standard of Care - No InterventionPercentage of Patients Completing Any Cancer Screening Test (As Treated)Cervical9.3 percentage of patients
Standard of Care - No InterventionPercentage of Patients Completing Any Cancer Screening Test (As Treated)Breast17.6 percentage of patients
p-value: <0.001Regression, Logistic
Secondary

Percentage of Patients Completing Any Cancer Screening Test (Intention to Treat)

The 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.

Time frame: 8 Months

ArmMeasureGroupValue (NUMBER)
Patient Navigation InterventionPercentage of Patients Completing Any Cancer Screening Test (Intention to Treat)Any Screening25.5 percentage of patients
Patient Navigation InterventionPercentage of Patients Completing Any Cancer Screening Test (Intention to Treat)Breast23.4 percentage of patients
Patient Navigation InterventionPercentage of Patients Completing Any Cancer Screening Test (Intention to Treat)Cervical14.4 percentage of patients
Patient Navigation InterventionPercentage of Patients Completing Any Cancer Screening Test (Intention to Treat)Colorectal13.7 percentage of patients
Standard of Care - No InterventionPercentage of Patients Completing Any Cancer Screening Test (Intention to Treat)Colorectal7.0 percentage of patients
Standard of Care - No InterventionPercentage of Patients Completing Any Cancer Screening Test (Intention to Treat)Any Screening17.0 percentage of patients
Standard of Care - No InterventionPercentage of Patients Completing Any Cancer Screening Test (Intention to Treat)Cervical8.6 percentage of patients
Standard of Care - No InterventionPercentage of Patients Completing Any Cancer Screening Test (Intention to Treat)Breast16.6 percentage of patients
p-value: <0.001Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026