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. 2020 Jun:93:106007.
doi: 10.1016/j.cct.2020.106007. Epub 2020 Apr 17.

Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborative

Tracy A Battaglia  1 , Karen M Freund  2 , Jennifer S Haas  3 , Nicole Casanova  4 , Sharon Bak  5 , Howard Cabral  6 , Rachel A Freedman  7 , Karen Burns White  8 , Stephenie C Lemon  9 ; TRIP Consortium
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Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborative

Tracy A Battaglia et al. Contemp Clin Trials. 2020 Jun.

Abstract

Background: Racial and socioeconomic disparities in breast cancer mortality persist. In Boston, MA, Black, Non-Hispanic women and Medicaid-insured individuals are 2-3 times more likely to have delays in treatment compared to White or privately insured women. While evidence-based care coordination strategies for reducing delays exist, they are not systematically implemented across healthcare settings.

Methods: Translating Research Into Practice (TRIP) utilizes community engaged research methods to address breast cancer care delivery disparities. Four Massachusetts Clinical and Translational Science Institute (CTSI) hubs collaborated with the Boston Breast Cancer Equity Coalition (The Coalition) to implement an evidence-based care coordination intervention for Boston residents at risk for delays in breast cancer care. The Coalition used a community-driven process to define the problem of care delivery disparities, identify the target population, and develop a rigorous pragmatic approach. We chose a cluster-randomized, stepped-wedge hybrid type I effectiveness-implementation study design. The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care. Primary clinical outcomes include time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction. We will use mixed methods to collect the secondary implementation outcomes of acceptability, adoption/penetration, fidelity, sustainability and cost.

Conclusion: TRIP utilizes an innovative community-driven research strategy, focused on interdisciplinary collaborations, to design and implement a translational science study that aims to more efficiently integrate proven health services interventions into clinical practice.

Keywords: Breast cancer disparities; Implementation science; Patient navigation; Social determinants of health; Stepped-wedge design.

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Conflict of interest statement

Declaration of Competing Interest Sharon Bak: The author has no competing interests to disclose. Karen Burns White: The author has no competing interests to disclose. Nicole Casanova: The author has no competing interests to disclose. Jennifer S Haas: The author has no competing interests to disclose. Stephenie C Lemon: The author has no competing interests to disclose. Tracy A Battaglia: Chair, National Navigation Roundtable (no honorarium, travel to meetings support by the American Cancer Society); Executive Committee Member, Boston Breast Cancer Equity Coalition (volunteer, no honorarium); PI, UO1TR002070 NIH/NCATS “Translating Research into Practice” a multisite patient navigation intervention study. Karen M Freund: Policy Task Force Chair – National Navigation Roundtable (no honorarium, travel to meetings support by the American Cancer Society); Consultant and travel to a national meeting, support by the National Minority Quality Forum. Rachel A Freedman: Institutional funding from Eisai and Puma, no personal funding.

Figures

Figure 1
Figure 1
TRIP Organizational Chart
Figure 2
Figure 2
Stepped-wedge study design: Schedule of events for site roll out in the intervention.
See this image and copyright information in PMC

References

    1. Flaherty. More work to do. Boston Herald; 2016.
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    1. Abdel-Rahman O. Impact of timeliness of adjuvant chemotherapy and radiotherapy on the outcomes of breast cancer; a pooled analysis of three clinical trials. Breast. 2018; 38:175–80. - PubMed

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