Optimizing Participation In Colorectal Cancer Screening By Direct Invitation Of Non Responders By General Practitionners: A Randomized Controlled Cluster Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Number of patients who completed the colorectal cancer screening in each arms
研究概览
简要总结
The goal of this randomized trial is to assess the effectiveness of a targeted telephone reminder strategy, implemented by the patient's general practitioner, in enhancing participation in colorectal cancer screening among individuals who are not up to date. The participants are patients between 50 and 74 years old, as they are the target population for colorectal cancer screening. The main questions are:
- What is the percentage of patients who completed the colorectal cancer screening test during the intervention year, within the patient population of general practitioners participating in the study and identified as not up to date with their screening?
- Identifying potential factors influencing the effectiveness of the intervention, based on various characteristics of the patient, the geographical area, the general practitioner, and the caller.
Researchers will compare these patients with other patients who are not up to date and did not receive the telephone reminder intervention from their general practitioner.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 筛查
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- for general practitioners:
- Practice in one of the four departments of the Franche-Comté region;
- Practice in a solo practice, group practice, multidisciplinary primary care centre, or community health centre;
- Are engaged in general medical practice;
- Have agreed to participate in the study.
- Inclusion Criteria for patients:
- Patients within the practice population of general practitioners selected to participate in the study;
- Aged between 50 and 75 years inclusive;
- Affiliated with the French general health insurance scheme or the agricultural social insurance scheme.
排除标准
- for general practitioners:
- Practice exclusively in a specialty other than general practice (e.g., osteopathy, allergology, vascular medicine).
- Non-inclusion Criteria for patients:
- Objection expressed by the patient to the change in the purpose of data processing for research purposes.
研究组 & 干预措施
Intervention Arm : phone-based outreach to promote colorectal cancer screening
In year n, the 50 selected general practitioners will receive a list of patients who are not up to date with colorectal cancer screening from the national health insurance. Each patient's screening status will be verified by the clinical research associate through a review of the medical records. A telephone call will then be made by a member of the patient's primary care team.
干预措施: Intervention (Other)
Control arm
In year n, the 50 selected general practitioners will receive from the national health insurance a list of patients who are not up to date with colorectal cancer screening. Each patient's screening status will be verified by the clinical research associate through a review of the medical records. There will be no intervention.
结局指标
主要结局
Number of patients who completed the colorectal cancer screening in each arms
时间窗: 6 months after inclusion
Patients who completed the colorectal cancer screening test during the intervention year (year n), within the patient population of general practitioners participating in the study, and who were identified from the national health insurance list as not up to date with screening, a status that was confirmed by reviewing their medical records. Completion of the screening will be confirmed by the presence of the test result in the patient's medical record within the general practitioner's practice software, no later than three months after the end of the intervention. This measure will be applied in each arm
次要结局
- Percentage of patients whose colorectal cancer screening status was updated according to the National Health Insurance database(1 year after enrollment)
- Number of patients who completed the colorectal cancer screening in the intervention arm according differents variables(3 months after the end of enrollment)
- Number of participants per stage of the intervention process(3 months after the end of enrollment)
- quantifying the time required to carry out the intervention(3 months after the end of the enrollment)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07639554
- 其他研究编号
- 2025-A01370-49
日期
- 首次提交
- (去年)
- 首次发布
- (3个月前)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否