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Increasing Access and Developing Predictors for Colorectal Cancer Screening for Minority and Medicaid Clients

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA232824-01A1
Agency Tracking Number: R41CA232824
Amount: $351,546.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA18-576
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-04-19
Award End Date (Contract End Date): 2020-03-31
Small Business Information
Buffalo, NY 14215-3137
United States
DUNS: 080431366
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (716) 845-2927
Business Contact
Phone: (716) 253-1847
Research Institution
BUFFALO, NY 14263-0001
United States

 Domestic Nonprofit Research Organization

African Americans have 22% higher incidence and 49% higher death rates from CRC than any other
ethnic/racial group. Similarly, lower socioeconomic status (SES) is also associated with higher CRC incidence
and mortality. Both of these groups are overrepresented in Medicaid populations. Screening colonoscopy is a
cost-effective cancer prevention and control strategy, leading to CRC prevention (e.g., removal of
precancerous polyps), earlier CRC detection and therefore higher survival rates. For patients preferring or
needing alternatives, fecal tests are reliable alternatives (e.g., FIT). However, numerous individual and
structural barriers often reduce client adherence to screening guidelines resulting in “gaps in care,” increasing
costs of treatment and lower quality metrics (e.g., Medicare Star and HEDIS® scores) for the health insurance
companies and providers. Insured, non-adherent patients are considered a strategic priority for insurers. The
mission of Witness CARES, LLC, is to help improve peopleandapos;s lives by facilitating use of health care. The
product to be developed in this STTR Phase I study is a specialized set of services and electronic prototype
tool (i.e., WC Services) to optimize and predict CRC screening for Medicaid clients based on our behavioral
research, intervention development and delivery through a not-for-profit organization. We will provide
personalized, culturally/racially-customized services for insured client end-users while improving national
metrics and cost-effective access for the health insurance company and health care provider customers. The
technological innovation is development of a computer-based assessment tool (i.e., Screening Engagement
Model) allowing us to tailor messaging and type of screening test (FIT or colonoscopy) to client preferences,
with the goal of increasing rates of screening for these clients and reducing colonoscopy no-shows for GI
facilities. Successful creation of this product will reduce gaps in care for health insurers and reduce disparities
in CRC mortality. To move forward, we need to 1) prove that this product can be delivered outside an
individual clinical setting and significantly reduce gaps in care; and 2) develop a predictive model for
determining which patients are best served by navigation to colonoscopy versus a stool test. The goal of this
Phase I application is to prove the feasibility and small scale pilot efficacy of WC Services to increase CRC
screening. We propose the following specific aims: Aim 1: Test the feasibility of WC Services to achieve CRC
screening for non-adherent Medicaid clients. Milestone 1a: Achieve either colonoscopy or stool screening by a
minimum of 130 of 200 (65%) patients contacted. Milestone 1b: Produce a new prototype to test in Phase II.
Aim 2: Develop an algorithm for predicting CRC screening outcomes. Milestone 2a: Develop models based on
existing R01 data to predict intent and CRC screening behaviors. Milestone 2b: Revise this R01 model with
new measures collected prospectively from 80% of clients contacted (n=160) to identify likelihood of stool test
v. colonoscopy completion. Milestone 2c: Develop a revised prototype into a complete WC Services product.NARRATIVE
The proposed study is relevant to public health because it studies the feasiblity of developing a business model
to increase colorectal cancer (CRC) screening for African Americans and lower income Medicaid/Medicare
patients who have an excess incidence and mortality rate from this disease. The proposed study is relevant to
the NIH mission pertaining to support of knowledge and research that will help reduce CRC health disparities.
Moreover, demonstrating the commercial potential for these services provides the opportunity to significantly
increase dissemination of effective, evidence-based outreach and navigation to reduce CRC disparities.

* Information listed above is at the time of submission. *

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