PROSPR Project 1: Identifying and Tracking Personalized CRC Screening Regimens for Patients in Clinical Settings



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:25 - 64
Updated:10/17/2018
Start Date:August 2013
End Date:August 2021
Contact:Celette Skinner, PhD
Email:celette.skinner@utsouthwestern.edu
Phone:214-648-5499

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The overall goal of the Parkland-UT Southwestern Population-based Research Optimizing
Screening through Personalized Regimens (PROSPR) Center is to optimize colon cancer screening
through personalized regimens in the integrated safety-net clinical provider network, which
serves a large and diverse population of under- and un-insured patients in Dallas. Together,
three research projects will assess clinic, system, and organizational factors associated
with over-, under- and guideline-based screening among this important population and will
compare benefits, harms, and costs of strategies for facilitating optimized screening
regimens. The theme of optimizing colorectal cancer screening in a safety-net clinical
provider network brings together several components. Its focus on colorectal cancer (CRC)
screening which is important, because CRC is the second cancer killer in the US while being
the only major cancer for which optimized screening results in primary prevention. Despite
this strong potential benefit, CRC screening remains suboptimal overall, and especially among
low-income and minority individuals served by safety-nets. Safety-net networks therefore
offer tremendous potential for CRC prevention and control, but numerous factors at the
clinics-, system-, and organization-level influence their ability to provide optimized care.

Each of the Population-based Research Optimizing Screening through Personalized Regimens
(PROSPR) Center's projects is innovative and addresses the continuum of care. Project 1
addresses transitions 1 and 3, employing novel, algorithmically driven tools in clinics to
determine personalized optimized screening regimens for individual patients and track whether
each has received the indicated guideline-based screening. Project 2 addresses all three
transitions through a novel comparative effectiveness study of benefits, risks, and costs of
two outreach strategies for promoting screening completion and guideline-appropriate
follow-up. Project 3 addresses transitions 2 and 3 by focusing on organizational culture,
structure, and protocols, using both quantitative and qualitative methods to elucidate
factors influencing completion of effective screening processes. These projects address
research priorities identified through a recent National Institute of Health (NIH) State of
the Science Conference, including: implementing interventions proven effective at increasing
colorectal cancer (CRC) screening (Projects 1 & 2), conducting research to assess
effectiveness of tailoring programs to match characteristics and preferences of target
populations (Project 1), implementing systems to ensure follow up of positive CRC screening
results (Projects 1, 2 & 3), and conducting studies to determine comparative effectiveness of
CRC screening methods in usual practice (Project 2).

PROSPR Center's goals are to:

1. Develop a Parkland-UT Southwestern PROSPR Center to promote coordinated,
transdisciplinary research to evaluate and improve the CRC screening process in a large
population-based safety-net.

2. Conduct three projects that address the continuum of care for CRC screening and address
these goals:

Project 1- Employ innovative methods for assessing personalized guideline-based
screening in the clinic setting to evaluate guideline-based, over- and under-screening;
Project 2 - Compare benefits, harm, and costs of three system-level strategies for
inviting patients to screening and promoting guideline-based follow up, with particular
focus on completing an effective screening process.

Project 3 - Examine specific organizational factors that contribute to completion of
guideline-based screening processes and examine which organizational factors modify
relationships between social disadvantage and completion of guideline-based repeat
screening and follow up of abnormal test results.

3. Contribute to a national PROSPR network by actively participating in network activities,
including:

1. collaborating with the National Data Coordinating Center regarding approaches for
measuring screening effectiveness, (b) sharing algorithmically driven tools
facilitating personalized screening regimes, (c) sharing electronic medical record
(EMR) capabilities with other Epic institutions, and (d) becoming a leader in
cancer screening processes in safety-net systems. While the SPDU will be
exclusively responsible for all required PROSPR network data collection, processing
and transfer activities, our complementary Shared Research Resources Core (SRRC)
will serve as the local "data coordinating center" of our PROSPR center. The SRRC
will work with Projects 1-3 to identify patients for recruitment; track study
accrual; and manage, process, and analyze all Project data. The SRRC will also help
assure consistent data definitions and terminology for harms, benefits, and other
common domains across the screening process documentation unit (SPDU) and Projects.
The SRRC and SPDU will work closely together as much of the required SPDU screening
process data will be used by the SRRC to identify eligible patients for Projects
1-3, and ascertain the processes and outcomes of the CRC screening process for
study participants. An innovative activity of the SRRC will be to extract from Epic
a novel set of electronically derived measures of social disadvantage previously
developed by the Parkland Center for Innovation.27 This will empower Projects 1 and
2 to examine the influence of these factors on the in-reach and out-reach programs,
as well as provide Project 3 with critical explanatory variables to understand the
impact of clinic-level organizational factors on the CRC screening process.

Inclusion Criteria:

- Male or female patients, ages 25-64, presenting for appointment will be eligible to
participate.

- Patients 25-49 must also have family hx of CRC or personal hx of inflammatory bowel
disease or adenomatous polyps.

- No racial or ethnic group will be excluded from participation.

- Both English and Spanish speakers will be eligible for participation.

Exclusion Criteria:

- Patients with a personal history of CRC are not eligible to participate.

- Patients who do not speak Spanish or English or have severely impaired hearing or
speech or do not give informed consent will also be excluded from participation.
We found this trial at
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Phone: 214-648-5499
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