PROSPR Project 2: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies

ColoRectal Cancer Clinical Trial

Official title:

PROSPR Project 2: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03404973
• Other study ID #: SCCC-12311
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2012
• Est. completion date: January 2019

Study information

• Verified date: May 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal of the Parkland-UT Southwestern Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) is to optimize colon cancer screening through personalized regimens in our 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. Our 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.

Description:

Each of our Parkland-UT Southwestern 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. Our 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6000
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 64 Years

Eligibility

Inclusion Criteria:

• Patients (names and contact information selected from the Parkland-UT Southwestern PROSPR Center database IRB #082011-040) who are not up-to-date with CRC screening.

• Age 50-64 years.

• Seen one or more times at a Parkland primary care clinic

• Participants in Parkland's medical assistance program for the uninsured

• Participants in Parkland Health Plus (Parkland Health Plus insurance and greater than 1 primary care visit within one year (Index Year)).

• Patients who obtain coverage through the Affordable Care Act's Health Insurance Marketplace after randomization will not be removed from the study.

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

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

Exclusion Criteria:

• Ip-to-date with CRC screening, defined by: a) Colonoscopy in the last 10 years, b) Sigmoidoscopy in the last 5 years, or c) Stool blood test (FIT) in the last year.

• Patients with a prior history of CRC, inflammatory bowel disease, or colon polyps, or who do not have an address or phone number on file.

• Incarcerated individuals will also be excluded.

Related Conditions & MeSH terms

• ColoRectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Outreach invitation
Annual mailed outreach invitation.
• FIT Kit
Fecal immunochemical testing.
• Usual Care
Usual care.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FIT vs. Colonoscopy	Compare benefits, harms, and costs of a FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with screening.	2 years
Primary	FIT vs. Usual Care	Compare benefits, harms, and cost of a) the FIT strategy versus Usual Care and b) the Colo strategy versus Usual Care.	2 years