PROSPR Project 1: Identifying and Tracking Personalized CRC Screening Regimens for Patients in Clinical Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,264
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving appropriate screening regimen.
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Screening
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.
干预措施: Computerized Risk Stratification Tool (Other)
Screening
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.
干预措施: Algorithmic Risk Stratification Tool (Other)
Screening
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.
干预措施: Step completion assessment (Other)
结局指标
主要结局
Proportion of patients achieving appropriate screening regimen.
时间窗: Three years
Proportion of patients achieving appropriate screening regimen.
次要结局
未报告次要终点
研究者
Celette Skinner
Professor of Medicine
University of Texas Southwestern Medical Center