Improving Comprehensive Cancer Screening Among Vulnerable Patients Using Patient Navigation

NCT02553538 | Completed Results

• 1 other identifier: 2013P000473
• Study Type: interventional
• Target: 1,612
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patient Compliance

Keywords

cancer screening; patient navigation

Outcome Measures

Primary Outcomes (2)

• 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.

  8 months

• 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.

  8 Months

Secondary Outcomes (2)

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

  8 Months

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

  8 Months

Study Arms (2)

Patient Navigation Intervention

EXPERIMENTAL

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.

Behavioral: Patient Navigation

Standard of Care - No Intervention

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.

Interventions

Patient Navigation 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.

Patient Navigation Intervention

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (8)

• 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.

  PMID: 25957378 BACKGROUND

• 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.

  PMID: 25678378 BACKGROUND

• 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.

  PMID: 24043318 BACKGROUND

• 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.

  PMID: 25002002 BACKGROUND

• 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.

  PMID: 24691564 BACKGROUND

• 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.

  PMID: 23686510 BACKGROUND

• 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.

  PMID: 19067085 BACKGROUND

• 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.

  PMID: 27273602 DERIVED

MeSH Terms

Conditions

Patient Compliance

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Dr. Sanja Percac-Lima
• Organization: Massachusetts General Hospital

spercaclima@partners.org

617-643-6980

Study Officials

• Sanja Percac-Lima, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Medicine at Harvard Medical School; Primary Care Physician at MGH Chelsea Community HealthCare Center

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 17, 2015
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 26, 2018
• Results First Posted: March 26, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share