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Patient Navigation and Time to Diagnostic Resolution: Results for a Cluster Randomized Trial Evaluating the Efficacy of Patient Navigation among Patients with Breast Cancer Screening Abnormalities, Tampa, FL

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  • Ji-Hyun Lee
  • William Fulp
  • Kristen J Wells
  • Cathy D Meade
  • Ercilia Calcano
  • Richard Roetzheim

Abstract

Objectives: The objective of this study was to evaluate a patient navigation (PN) program that attempts to reduce the time between a breast cancer screening abnormality and definitive diagnosis among medically underserved populations of Tampa Bay, Florida. Methods: The Moffitt Patient Navigation Research Program conducted a cluster randomized design with 10 primary care clinics. Patients were navigated from time of a breast screening abnormality to diagnostic resolution. This paper examined the length of time between breast abnormality and definitive diagnosis, using a shared frailty Cox proportional hazard model to assess PN program effect. Results: 1,039 patients were eligible for the study because of an abnormal breast cancer screening/clinical abnormality (494 navigated; 545 control). Analysis of PN effect by two time periods of resolution (0-3 months and > 3 months) showed a lagged effect of PN. For patients resolving in the first three months, the adjusted Hazard Ratio (aHR) was 0.85 (95% Confidence Interval [CI]: 0.64-1.13) suggesting that PN had no effect on resolution time during this period. Beyond three months, however, navigated patients resolved more quickly to diagnostic resolution compared with the control group (aHR 2.8, 95%CI: 1.30-6.13). The predicted aHR at 3 months was 1.2, which was not statistically significant, while PN had a significant positive effect beyond 4.7 months. Conclusions: PN programs may increase the timeliness of diagnostic resolution for patients with a breast cancer-related abnormality. PN did not speed diagnostic resolution during the initial three months of follow up but started to reduce time to diagnostic resolution after three months and showed a significant effect after 4.7 months. Trial Registration: ClinicalTrials.gov NCT00375024

Suggested Citation

  • Ji-Hyun Lee & William Fulp & Kristen J Wells & Cathy D Meade & Ercilia Calcano & Richard Roetzheim, 2013. "Patient Navigation and Time to Diagnostic Resolution: Results for a Cluster Randomized Trial Evaluating the Efficacy of Patient Navigation among Patients with Breast Cancer Screening Abnormalities, Ta," PLOS ONE, Public Library of Science, vol. 8(9), pages 1-1, September.
  • Handle: RePEc:plo:pone00:0074542
    DOI: 10.1371/journal.pone.0074542
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    References listed on IDEAS

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    1. Ji-Hyun Lee & Michael J Schell & Richard Roetzheim, 2009. "Analysis of Group Randomized Trials with Multiple Binary Endpoints and Small Number of Groups," PLOS ONE, Public Library of Science, vol. 4(10), pages 1-9, October.
    2. Richardson, L.C. & Royalty, J. & Howe, W. & Helsel, W. & Kammerer, W. & Benard, V.B., 2010. "Timeliness of breast cancer diagnosis and initiation of treatment in the national breast and cervical cancer early detection program, 1996-2005," American Journal of Public Health, American Public Health Association, vol. 100(9), pages 1769-1776.
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