Improving Comprehensive Cancer Screening Among Vulnerable Patients Using Patient Navigation
Condition: Patient Compliance
Study type: Interventional

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.
    

Intervention name(s): Patient Navigation
Intervention type(s): Behavioral
Intervention description(s): Navigators utilized TopCare to track participants, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: cancer screening; patient navigation