Preventing Early-Onset Colorectal Cancer in the VA Using a Multilevel Screening Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 536
- 试验地点
- 2
- 主要终点
- Screening participation rate in groups that received vs. did not receive the patient intervention
研究概览
简要总结
Colorectal cancer is a leading cause of cancer death among Veterans. The starting age for colorectal cancer screening has been lowered from 50 to 45 years in response to the rising incidence of early-onset colorectal cancer (EOCRC), but how to best engage younger Veterans in screening is unclear. The investigators will 1) develop and validate a novel risk score for EOCRC derived from the VA electronic health record data, 2) conduct a multilevel screening intervention that targets individuals aged 45-49 years and informs high-risk individuals and their providers about their risk status for EOCRC, and 3) determine barriers and facilitators to implementing the intervention using a qualitative process evaluation. Aim 2 is the focus of the trial. The overall goal of this study is to create and test a risk stratification approach to prevent EOCRC, which may be especially useful for younger individuals who are less likely to participate in preventive care.
详细描述
Background: Incidence and mortality of early-onset colorectal cancer (EOCRC), defined as colorectal cancer (CRC) diagnosed before age 50 years, has been increasing in the US since the 1990s. In response to these concerning trends, in 2021 the US Preventive Services Task Force recommended lowering the age to initiate CRC screening from 50 to 45 years. Within the VA health care system, 60% of eligible individuals aged 50-75 years and only 42% of those aged 45-49 years were up-to-date with screening in May 2024. Younger individuals are less likely to perceive the need for screening, but informing individuals who are at higher risk about their status may increase their interest and participation in screening.
Significance: CRC is a leading cause of cancer death among Veterans. To maximize CRC screening benefit in individuals younger than 50 years, it is critical to 1) identify high-risk individuals in this age group who may be targeted for screening and 2) assess the effectiveness and implementation of interventions to promote screening in all younger individuals. Innovation & Impact: Currently there are no risk scores for EOCRC in clinical use, and risk scores developed for research often use genetic and survey data but omit more readily accessible information from the electronic health record (EHR) to identify individuals at increased risk. In addition to identifying high-risk individuals, it is also crucial to study interventions that will increase screening in the younger population. Otherwise, data show that younger adults are less likely to engage in screening and passive adoption of new clinical guidelines occurs slowly among physicians.
Specific Aims:
Aim 1: To develop and validate a risk score for EOCRC using EHR data Aim 2: To determine the effectiveness of a multilevel intervention to increase screening in individuals aged 45-49 years, using personal risk as a motivator for high-risk individuals. This aim is the focus of the trial.
Aim 3: To evaluate the implementation of the multilevel intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 45-49 years at screening
排除标准
- •Up-to-date with CRC screening based on the USPSTF guideline (e.g., colonoscopy within the past 10 years or FIT within the past year)
- •Prior CRC diagnosis
- •Prior total colectomy
- •Limited life expectancy (defined as terminal illness, hospice enrollment, or documented life expectancy <6 months on the medical problem list or a health factor in the EHR
- •Deactivated national CRC screening and surveillance reminder (due to risk level or comorbidities)
研究组 & 干预措施
Patient intervention
Only patients receive intervention
干预措施: Patient intervention (Behavioral)
Combined
Both patient and PCP receive intervention
干预措施: Patient intervention (Behavioral)
PCP intervention
Only PCP receives intervention
干预措施: PCP intervention (Behavioral)
Combined
Both patient and PCP receive intervention
干预措施: PCP intervention (Behavioral)
Control
Neither patient nor PCP receives intervention
结局指标
主要结局
Screening participation rate in groups that received vs. did not receive the patient intervention
时间窗: 6 months
For the patient intervention analysis, the investigators will compare the patient and combined arms vs. the PCP and control arms. Completion of FIT, colonoscopy, and any other USPSTF-recommended screening test will be considered to meet the outcome.
Screening participation rate in groups that received vs. did not receive the PCP intervention
时间窗: 6 months
For the PCP intervention analysis, the investigators will compare the PCP and combined arms vs. the patient and control arms. Completion of FIT, colonoscopy, and any other USPSTF-recommended screening test will be considered to meet the outcome.
次要结局
- Screening participation rate in high-risk vs. non-high-risk individuals(6 months)