Implementing Evidence Based Colorectal Cancer Screening in Rural Clinics
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Effectiveness and Maintenance
研究概览
简要总结
The goal of this implementation study is to support an evidence-based intervention to the improve colorectal cancer (CRC) screening and diagnostic colonoscopy rates in rural Indiana. The main questions the study aims to answer are:
- How does the implementation of an evidence based intervention to increase CRC screening in rural Indiana improve CRC screening and diagnostic colonoscopy rates, defined as completed screening episode?
- Will dose and type of implementation strategies contribute to differences in contextual factors and readiness as well as different levels of implementation outcomes (reach and implementation) in rural clinic?
- Will Contextual factors (innovation, recipient, inner and outer context) and implementation outcomes (reach, and implementation) vary with the levels of CRC screening and diagnostic colonoscopy following active implementation (effectiveness) and throughout maintenance compared to baseline (usual care)?
- What is the cost and budget impact of the deployment of implementation strategies and processes for rural clinics and evaluate the cost-effectiveness of implementing and sustaining the CRC screening intervention?
Approach: Participating clinics tasks consist of mailing FIT kits, sending text messages, phone reminders, and the use of a Patient Navigator to initiate a screening episode with eligible patients who are 45-75 (and have no colonoscopy in the last 10 years or FIT in the last 12 months) as identified from medical records.
详细描述
In Aim 1, the investigators will evaluate the ability of an implementation of an EBI to improve CRC screening and diagnostic colonoscopy rates, defined as completed screening episode (effectiveness) through implementation of an EBI for CRC screening in rural Indiana. The investigators hypothesize that a complete screening episode of CRC screening (FIT or screening colonoscopy), including diagnostic colonoscopy uptake following positive FIT, will be higher following implementation of an EBI and throughout maintenance compared to baseline (usual care). Resolution with diagnostic colonoscopy and repeat screening with FIT will be handled as exploratory outcomes.
In Aim 2, the investigators will evaluate the variation in contextual factors (innovation, recipient, inner and outer context), implementation strategies and implementation outcomes (reach and implementation) using mixed data (qualitative interviews and quantitative measures) to build implementation profiles of nine rural clinics.
In Aim 3, the investigators estimate the cost and budget impact of the deployment of implementation strategies and processes for rural clinics and evaluate the cost-effectiveness of implementing and sustaining the CRC screening intervention.
Study Overview: The investigators will partner with the IRHA, a not-for-profit organization, that was founded in 1997 to meet the healthcare needs of rural residents including Medicare and Medicaid recipients in underserved areas in Indiana. Nine IRHA with CRC screening rates below the state average of 68% were selected.
Approach and Design: The EBI for CRC screening consists of mailing an opportunity for patients not up to date with CRC screening to obtain a colonoscopy, Cologuard or FIT kit. Patients are provided with an opportunity to talk to a patient navigator and select screening options. Risk status for colorectal cancer is assessed. To initiate a screening episode, screening eligible patients who are 45-75 (no colonoscopy in the last 10 years or FIT in the last 12 months) will be identified from medical records
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
- None
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
- 是
入选标准
- •All participants will be staff employed at the respective clinics. Patients will be age 45 to 75 and either male or female. Age limitations are necessary because colorectal cancer screening doesn't start until 45 and ends at 75.
排除标准
- •Under surveillance (inherited familial syndromes),history of inflammatory bowel disease, and a previous adenomatous polyp, or previous colorectal cancer.
研究组 & 干预措施
Phase 1
Usual care and planning period.
Phase 2
Implementation period.
Clinics are randomized into clusters
干预措施: Colorectal Screen rates with implementation of evidence-based intervention (Behavioral)
Phase 3
Maintenance period.
干预措施: Colorectal Screen rates with implementation of evidence-based intervention (Behavioral)
结局指标
主要结局
Effectiveness and Maintenance
时间窗: Up to 12 months
The primary effectiveness measure will be the rate of uptake of a complete episode CRC screening, a rate that includes resolution of a positive FIT test with diagnostic colonoscopy.
Implementation outcomes
时间窗: Up to 36 months
Measured by CC tracking forms, clinic logs that record all PN calls, adaptations to the implementation plan, fidelity measures and costs. The Clinic Implementation Tracking Form contains all essential tasks in the implementation plan including the dose and quality of intervention delivery. Overall quality of implementation and responsiveness to facilitation will be rated on a scale of 1 to 3. At the end of Phase 3, the investigators will interview two staff/clinic about their perceptions of the implementation. The investigators will also measure responses to a validated Acceptability scale using two staff/clinic at each clinic. All adaptations to the implementation plan will be recorded including rationale for change. Cost-data will be collected in phase 1 for usual care CRC screening promotion/education activities and throughout Phase 2 and 3 of implementation.
Contextual factors
时间窗: Up to 12 months
Contextual factors will be measured at the beginning of Phase 2 and during the midpoint and end of Phase 3. Semi structured items are used for contextual factors and are guided by the iPARIHS framework. The final contextual factor construct assessed during the interview will be readiness to engage in implementation of the EBI, measured by the Organizational Readiness to Change Assessment (ORCA).
次要结局
未报告次要终点
研究者
Victoria L. Champion
Professor
Indiana University