跳至主要内容
临床试验/NCT06401174
NCT06401174Enrolling By Invitation不适用

Bridging the Gap: Delivering Equitable Colorectal Cancer Screening

Medstar Health Research Institute29 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
1,800
试验地点
29
主要终点
Colorectal cancer screening completion

研究概览

简要总结

Patient navigation is an evidence-based strategy to increase screening rates among racial and ethnic minorities, but there is a gap in understanding the multi-level influences on implementation of such programs across primary care practices. The investigators will conduct a stepped-wedge, randomized trial to roll out patient navigation and patient and provider reminders across 15 clinics (3 clinics per step, 5 six-month steps). Implementation strategies will include assessing for readiness, audit and feedback, building a community coalition, engaging consumers, modifying referral tracking, and training and educating clinical stakeholders. The research team will use the electronic health record data with consideration for the Observational Medical Outcomes Partnership (OMOP) Common Data Model, additional patient-reported data, and study tracking logs to measure reach, effectiveness, adoption, implementation, and will use qualitative measures and site observations to document contextual factors, including examination of discrimination in patient experiences and provider referral patterns that may influence intervention delivery or colorectal cancer screening completion.

详细描述

Colorectal cancer (CRC) screening is recommended by the United States Preventative Services Task Force for adults age 45-75. Patient navigation is an evidence-based strategy to increase screening rates among racial and ethnic minorities. While patient navigation is an evidence-based approach to improve screening, there is a gap in understanding the multi-level influences on implementation of such programs across primary care practices, particularly using a health-equity focused, stakeholder-centered approach. Guided by the Practical, Robust Implementation and Sustainability Model (PRISM) and core health and racial equity principles, the investigative team aims to increase reach of patient navigation and show effectiveness through improvement in the percentage of Black and Hispanic patients completing CRC screening. Investigators will also utilize longitudinal tracking of implementation strategies to better track implementation or intervention adaptations navigation delivery in order to inform future scale up. The research team will conduct a stepped-wedged, randomized trial to roll out patient navigation and patient and provider reminders across 15 clinics (3 clinics per step, 5 six-month steps). Implementation strategies will include assessing for readiness, audit and feedback, building a community coalition, engaging consumers, modifying referral tracking, and training and educating clinical stakeholders. Researchers will use the electronic health record data with consideration for the Observational Medical Outcomes Partnership (OMOP) Common Data Model, additional patient-reported data, and study tracking logs to measure reach, effectiveness, adoption, implementation, and will use qualitative measures and site observations to document contextual factors, including examination of discrimination in patient experiences and provider referral patterns that may influence intervention delivery or CRC screening completion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 45-75
  • Due for colorectal cancer screening
  • Identify as Black or Hispanic/Latino
  • Attend primary care visit at one of the 15 selected clinics within the step time -period

排除标准

  • 未提供

结局指标

主要结局

Colorectal cancer screening completion

时间窗: 12 months

Completion of any USPSTF approved screening test

次要结局

  • Acceptability measured by the Acceptability of Intervention Measure (AIM)(12 months)
  • Sustainability measured by the clinical sustainability assessment tool(12 months)
  • Adoption(6 months)
  • Reach(6 months)
  • Appropriateness measured by the Intervention Appropriateness Measure (IAM)(12 months)
  • Feasibility measured by the Feasibility of Implementation Measure (FIM)(12 months)

研究者

发起方
Medstar Health Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (29)

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