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

NCT03705897 | Active Not Recruiting DMC

• 1 other identifier: STU 102011-068
• Study Type: interventional
• Target: 9,865
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ColoRectal Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving appropriate screening regimen.

  Proportion of patients achieving appropriate screening regimen.

  Three years

Study Arms (1)

Screening

OTHER

Employ innovative methods for assessing personalized guideline-based screening in the clinic setting to evaluate guideline-based, over- and under-screening. Interventions include Computerized Risk Stratification Tool, Algorithmic Risk Stratification Tool, and Step completion assessment.

Other: Computerized Risk Stratification Tool; Other: Algorithmic Risk Stratification Tool; Other: Step completion assessment

Interventions

Computerized Risk Stratification Tool OTHER

Implement a novel computerized risk stratification tool in Parkland community-oriented primary-care clinics that collects data directly from patients and uses a computerized algorithm system to generate their personalized guideline-based next steps in the screening regimen

Screening

Algorithmic Risk Stratification Tool OTHER

Implement a novel algorithmic risk stratification system in Parkland's endoscopy clinics that, based on test findings entered by colonoscopists, generates personalized guideline-based next steps in the screening regimen for patients with colorectal polyps removed at olonoscopy

Screening

Step completion assessment OTHER

Assess completion of guideline-recommended steps in personalized screening regimens, under-screening, and over-screening

Screening

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Celette Skinner, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: October 15, 2018
• Study Start: August 1, 2013
• Primary Completion: December 27, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)