ISRCTN22560297进行中（未招募）未知
A pragmatic cluster randomised controlled trial of electronic risk-assessment for cancer to help identify early stage cancer in patients in general practice (The ERICA trial)
niversity of Exeter0 个研究点目标入组 530 人开始时间: 2019年3月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 530
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36940950/ (added 21/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 23/01/2023:
- •We will not recruit participants to the main RCT. It is a cluster RCT with the clusters being GP practices across England.
- •Practices must host either EMIS, or SystmOne, principal clinical systems. Only practices completing an agreement to engage with the research processes and the intervention/control arms will be eligible; in a practice agreement the practice will confirm that a practice meeting has taken place and at least fifty per cent of their GPs have agreed to participate in the trial. Practices that are proposing a split or a merger are not eligible.
- •We will also run a series of nested studies which will involve the recruitment of patients:
- •1. Patient interviews to explore their experience of care following an eRAT trigger and
- •2. Patient use of health services and their quality of life following an eRAT trigger.
- •For 1. only intervention practices will participate, and we'll seek to recruit 12-18 patients for whom an eRAT triggered and the GP made a referral/order investigations.
- •For 2. intervention (N=28) and control (N=28) practices will be recruited, and we'll aim to recruit 140 patients from each arm. In the intervention arm this will be patients who received an eRAT trigger and for whom the GP made a referral/order investigations. In control practices, patients will be those for whom an eRAT would have trigger in the practice and for whom the GP made referral/order investigations. Patients will be invited to participate via the practice.
- •Previous participant inclusion criteria as of 13/01/2023 to 23/01/2023:
- •We will not recruit participants to the main RCT. It is a cluster RCT with the clusters being GP practices across England.
- •Practices must host either Microtest, or SystmOne, principal clinical systems. Only practices completing an agreement to engage with the research processes and the intervention/control arms will be eligible; in a practice agreement the practice will confirm that a practice meeting has taken place and at least fifty per cent of their GPs have agreed to participate in the trial. Practices that are proposing a split or a merger are not eligible.
- •We will also run a series of nested studies which will involve the recruitment of patients:
- •1. Patient interviews to explore their experience of care following an eRAT trigger and
- •2. Patient use of health services and their quality of life following an eRAT trigger.
- •For 1. only intervention practices will participate, and we'll seek to recruit 12-18 patients for whom an eRAT triggered and the GP made a referral/order investigations.
- •For 2. intervention (N=28) and control (N=28) practices will be recruited, and we'll aim to recruit 140 patients from each arm. In the intervention arm this will be patients who received an eRAT trigger and for whom the GP made a referral/order investigations. In control practices, patients will be those for whom an eRAT would have trigger in the practice and for whom the GP made referral/order investigations. Patients will be invited to participate via the practice.
- •Previous participant inclusion criteria:
- •We will not recruit participants to this RCT. It is a cluster RCT with the clusters being GP practices across England.
- •1. Practices must host either Microtest, SystmOne, or Vision principal clinical systems. Only practices completing an agreement to engage with the research processes and the intervention/control arms will be eligible; in a practice agreement
排除标准
- •1. If a practice is planning to merge or restructure over the course of the trial (to the extent that the practice size will change by at least 10%) they will not be permitted to participate
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