Impact of Family History and Decision Support on High-risk Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 505
- 试验地点
- 4
- 主要终点
- Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening
研究概览
简要总结
Family health history can help identify patients at higher than average risk for disease. There is no standardized system for collecting and updating family health history, using this information to determine a patient's disease risk level, and providing screening recommendations to patients and providers. Patients will enter their family health history into MeTree, a family history software program. The program will produce screening recommendations tailored to the patient's family health history. The investigators will examine whether this process increases physician referrals for, and patient uptake of, guideline-recommended screening for colorectal cancer.
详细描述
Eligible patients are aged 40-65 years, enrolled in primary care, do not have a personal history of colorectal cancer, and have some knowledge of family health history. In Aim 1, a retrospective chart review will be conducted to determine the baseline rate of documenting family health history of colorectal cancer in the medical record for patients enrolled in the Aim 2 randomized trial. In Aim 2, consented patients will be randomized to provide patient-entered family health history and receive patient and provider decision support at enrollment or 12 months later (wait-list control). The primary outcome is risk-appropriate CRC screening/surveillance referral for patients 12 months post-enrollment. Secondary outcomes include patient uptake of recommendations and referral for genetic consultation 12 months post-enrollment. In Aim 3, qualitative interviews will be conducted with physicians and clinic leaders; data will be analyzed using conventional content analysis. In Aim 4, data will be obtained from the administrative databases and patient medical records to conduct a budget impact analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary care provider inclusion criteria:
- •primary care physician,
- •physician assistant, or nurse practitioner;
- •at least one half-day of primary care clinic per week.
- •Patient inclusion criteria:
- •assigned to an enrolled PCP;
- •English as preferred language;
- •no plans to relocate or leave the VA system in the next 12 months;
- •at least one primary care appointment in the 18 months prior to enrollment;
- •upcoming PCP appointment with assigned PCP;
- •aged 40-64 years; no previous history of colorectal cancer or adenomatous polyps or inflammatory bowel disease;
- •no endoscopy within previous 3 years; some knowledge of family health history
排除标准
- •n/a (contained within inclusion criteria)
结局指标
主要结局
Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening
时间窗: 12 months
Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform.
次要结局
- Number of Participants Who Received Recommended Colorectal Cancer Screening(12 months)
- Number of Patients Who Received Referral for Genetic Consultation(12 months)