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临床试验/NCT04293315
NCT04293315Unknown不适用

Evaluation of the Effectiveness of a Collaborative Strategy to Increase the Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina

Institute for Clinical Effectiveness and Health Policy1 个研究点 分布在 1 个国家目标入组 1,520 人开始时间: 2018年6月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,520
试验地点
1
主要终点
Effective Screening

研究概览

简要总结

Introduction: Early detection of certain types of cancer significantly increases the likelihood of successful treatment and reduces mortality from these causes. However, the use of screening and the early detection of selected tumors such as colorectal cancer (CRC) are lower than those expected in our country. The objective of this project is to evaluate the effectiveness of a multicomponent strategy that improves the screening and early detection of CRC in the population at risk of Primary Health Care Clinics (PCCs) of the public health system.

Population: people leaving in the catchment area of 10 selected primary care clinics from the public health system in the province of Mendoza, Argentina.

Design and methods: a Randomized clinical study by clusters. 10 PCCs will be included: 5 will be randomly assigned to receive an intervention to increase the CRC screening rates (improvement cycles) and 5 to the control arm (usual care). 150 participants will be included in each PCCs, in total, 1500 participants.

Intervention: An innovative vision is proposed, which combines a participatory and dynamic methodology based on improvement cycles. This approach includes the implementation of participatory learning sessions for health providers, involving the effectors of the design of the intervention. In the intervention branch at least 3 workshops (sessions) will be held with the members of the care system, in order to identify opportunities for improvement oriented to the design and application of an innovative intervention based on best practices. Each one of the sessions will constitute an analysis of the improvement cycle, following the following steps: 1) Selection of participants of the initial workshop; 2) Development of work model based on bibliographic review and initial qualitative phase; 3) Initial workshop with effectors for training in continuous improvement, objectives, interventions and data collection; 4) Learning workshops to discuss results, applicability of interventions and modifications to the work plan; 5) Closing session to evaluate preliminary results and discuss continuity of interventions beyond the project.

Outcomes: 1) Percentage of the population at risk that completes the screening; 2) Percentage of the population classified as at habitual risk or increased by risk factors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Subjects who have public health coverage
  • Age between 50 and 75 years old
  • Residence in the catchment area of the PCCs
  • With an indication to perform screening for CRC with FOBT
  • People who consent to participate

排除标准

  • People who are bedridden.
  • People who plan to move in the next 3 months.

结局指标

主要结局

Effective Screening

时间窗: 3 months

Proportion of participants who with known result of the FOBT within 90 days from recruitment. The investigators will review National Information System Registry to count the number of participants in each arm with a known result for their FOBT. The investigators will calculate the proportion of participants with known result (Effective Screening) in each arm of the study.

次要结局

  • Proportion of positive FOBT referred for colonoscopy(3 months)
  • Implementation outcomes according to the RE-AIM framework(3 months)
  • Proportion of participants with inadequate FOBT(3 months)

研究者

发起方
Institute for Clinical Effectiveness and Health Policy
申办方类型
Other
责任方
Sponsor

研究点 (1)

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