Improving Comprehensive Cancer Screening Among Vulnerable Patients Using Patient Navigation

NCT ID: NCT02553538

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1612 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Patient Compliance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Patient Navigation Intervention

Participants 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 participants, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.

Group Type: EXPERIMENTAL

Patient Navigation

Intervention Type: BEHAVIORAL

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

Standard of Care - No Intervention

Participants randomized to the control arm received usual care within TopCare, which meant that clinicians and staff could elect to send the participant a reminder letter about their overdue cancer screening exams, reach out to schedule overdue exams, or document appropriate reasons for deferral or exclusion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sanja Percac-Lima, MD

Assistant Professor in Medicine at Harvard Medical School; Primary Care Physician at MGH Chelsea Community HealthCare Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sanja Percac-Lima, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

References

Beaber EF, Kim JJ, Schapira MM, Tosteson AN, Zauber AG, Geiger AM, Kamineni A, Weaver DL, Tiro JA; Population-based Research Optimizing Screening through Personalized Regimens Consortium. Unifying screening processes within the PROSPR consortium: a conceptual model for breast, cervical, and colorectal cancer screening. J Natl Cancer Inst. 2015 May 7;107(6):djv120. doi: 10.1093/jnci/djv120. Print 2015 Jun.

Reference Type: BACKGROUND

PMID: 25957378 (View on PubMed)

Berkowitz SA, Percac-Lima S, Ashburner JM, Chang Y, Zai AH, He W, Grant RW, Atlas SJ. Building Equity Improvement into Quality Improvement: Reducing Socioeconomic Disparities in Colorectal Cancer Screening as Part of Population Health Management. J Gen Intern Med. 2015 Jul;30(7):942-9. doi: 10.1007/s11606-015-3227-4. Epub 2015 Feb 13.

Reference Type: BACKGROUND

PMID: 25678378 (View on PubMed)

Zai AH, Kim S, Kamis A, Hung K, Ronquillo JG, Chueh HC, Atlas SJ. Applying operations research to optimize a novel population management system for cancer screening. J Am Med Inform Assoc. 2014 Feb;21(e1):e129-35. doi: 10.1136/amiajnl-2013-001681. Epub 2013 Sep 16.

Reference Type: BACKGROUND

PMID: 24043318 (View on PubMed)

Atlas SJ, Zai AH, Ashburner JM, Chang Y, Percac-Lima S, Levy DE, Chueh HC, Grant RW. Non-visit-based cancer screening using a novel population management system. J Am Board Fam Med. 2014 Jul-Aug;27(4):474-85. doi: 10.3122/jabfm.2014.04.130319.

Reference Type: BACKGROUND

PMID: 25002002 (View on PubMed)

Percac-Lima S, Lopez L, Ashburner JM, Green AR, Atlas SJ. The longitudinal impact of patient navigation on equity in colorectal cancer screening in a large primary care network. Cancer. 2014 Jul 1;120(13):2025-31. doi: 10.1002/cncr.28682. Epub 2014 Apr 1.

Reference Type: BACKGROUND

PMID: 24691564 (View on PubMed)

Percac-Lima S, Ashburner JM, Bond B, Oo SA, Atlas SJ. Decreasing disparities in breast cancer screening in refugee women using culturally tailored patient navigation. J Gen Intern Med. 2013 Nov;28(11):1463-8. doi: 10.1007/s11606-013-2491-4. Epub 2013 May 18.

Reference Type: BACKGROUND

PMID: 23686510 (View on PubMed)

Percac-Lima S, Grant RW, Green AR, Ashburner JM, Gamba G, Oo S, Richter JM, Atlas SJ. A culturally tailored navigator program for colorectal cancer screening in a community health center: a randomized, controlled trial. J Gen Intern Med. 2009 Feb;24(2):211-7. doi: 10.1007/s11606-008-0864-x.

Reference Type: BACKGROUND

PMID: 19067085 (View on PubMed)

Percac-Lima S, Ashburner JM, Zai AH, Chang Y, Oo SA, Guimaraes E, Atlas SJ. Patient Navigation for Comprehensive Cancer Screening in High-Risk Patients Using a Population-Based Health Information Technology System: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):930-7. doi: 10.1001/jamainternmed.2016.0841.

Reference Type: DERIVED

PMID: 27273602 (View on PubMed)

Other Identifiers

2013P000473

Identifier Type: -

Identifier Source: org_study_id