A Pragmatic, Stepped Wedge, Multi-centre, Cluster Randomised Trial Evaluating the Efficiency of Algorithm Technology and Tailored Primary Care Quality Improvement Support to Identify, Diagnose and Refer Patients With Rare and Difficult to Diagnose Disease (Defined by the NHS as Those Suffering From Significant Diagnostic Odyssey)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- Rate of patients given diagnosis for rare or difficult to diagnose disease
研究概览
简要总结
Rare diseases affect over 3.5 million people in the UK. It can take years of multiple referrals, inconclusive tests or incorrect diagnoses, for patients to get a final diagnosis. We call this diagnostic odyssey, and GPs are often the first point of call for patients at the start.
Algorithms can be used to help identify patients with rare diseases faster, who may benefit from testing. They also help healthcare professionals in decision making. Healthcare providers also recognise the value of quality improvement (QI) activities, but practices are often reluctant to participate in non-QOF QI initiatives.
CAPTURED aims to help reduce the diagnostic odyssey patients face by evaluating the efficiency of algorithms and tailored primary care QI support to identify, diagnose and refer patients with rare and difficult to diagnose disease. It will contribute towards these aspects of the UK Rare Disease Framework: (Priority 1) helping patients get a final diagnosis faster; and (Priority 2) increasing awareness of rare diseases among healthcare professionals.
CAPTURED will run as a stepped wedge, cluster randomised trial. Practices are the participants, and not individual patients. Practices will be randomly allocated to undertake quality improvement programmes (QIP) to help evaluate up to 10 rare disease algorithms. Practices will undertake QIPs at specific times, but at the end, all practices would undertake all the QIPs they have at-risk patients for. Practices will invite at-risk patients for testing/screening, and refer newly diagnosed patients for appropriate care. Practices will be supported with the QIPs by OPC Quality Improvement and Research Support Service, at no cost to practices.
CAPTURED will run for 5 years and will enrol 500 practices. The trial does not involve any medicine, drug or equipment. The trial will use anonymised patient data collected from all participating practices into the Optimum Patient Care Research Database (OPCRD).
详细描述
The aim of CAPTURED is to evaluate the efficiency of algorithm technology and tailored primary care quality improvement support in identifying, testing and referring patients at high probability of specific rare or difficult to diagnose disease.
The trial aims to reduce the diagnostic odyssey for rare and difficult to diagnose disease patients and facilitate quicker access to appropriate treatment, utilising algorithms designed to identify patients that are at high probability.
CAPTURED is a series of quality improvement programs (QIPs) that are each delivered in a stepped wedge model, to enable comparison between the QI intervention and standard care. Each QIP, under CAPTURED, will utilise a specific algorithm for rare or difficult to diagnose disease, and a specific diagnostic testing/quality improvement support package. It is planned to run for 5 years (2025-2030). Each QIP will run for a defined period.
CAPTURED is UK-wide multicentre study. All participating practices should be able to accept the intervention (diagnostic test/screening and tailored quality improvement support package) as part of their patient care. CAPTURED will be conducted at an estimated 500 GP practices in the UK. Only practices with patients identified as at high probability of specific rare or difficult to diagnose disease will participate in each project. The algorithms use digital biomarkers in patients electronic medical record data such as symptoms, diagnoses and healthcare utilisation to identify patients who would benefit from specific diagnostic testing. Individual projects will have specific cut-offs to determine high probability of disease but typically it is a likelihood of 60% or more.
Practices with patients with high probability of disease will be randomised into clusters. Randomisation will occur individually for each QIP. The intervention (diagnostic testing/screening and quality improvement support package) will be given at different time-points defined by the stepped wedge design.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General practice in the United Kingdom (England, Scotland, Wales, Northern Ireland) participating in Optimum Patient Care services and contributing deidentified data to OPCRD.
- •At least 1 patient identified as high probability of rare or difficult to diagnose disease by one of the quality improvement program algorithms.
排除标准
- •General practices hosting or affected by research, or other aspects of care, which might significantly influence the implementation of CAPTURED.
结局指标
主要结局
Rate of patients given diagnosis for rare or difficult to diagnose disease
时间窗: Each individual QIP will have a defined time-frame as per the stepped-wedge design. Anonymised data of patients will be collected throughout the project for each participating practice. Results will be analysed at the end of the 5-year trial period.
Rate of patients given diagnosis for rare or difficult to diagnose disease in intervention population compared to rate of patients given diagnosis for rare or difficult to diagnose disease in control population, in a comparable time frame who receive delayed roll out, by way of a step wedge implementation . Definition: Direct comparison between (1) Total number of patients who are positively diagnosed as a direct result of the intervention in the intervention population/whole patient population for intervention population and (2) Total number of patients who are positively diagnosed in the control population/whole patient population for the control population.
次要结局
- Rate of patients successfully completing diagnostic testing/screening(Each individual QIP will have a defined time-frame as per the stepped-wedge design. Anonymised data of patients will be collected throughout the project for each participating practice. Results will be analysed at the end of the 5-year trial period.)
- Rate that patients are successfully contacted about testing/screening.(Each individual QIP will have a defined time-frame as per the stepped-wedge design. Anonymised data of patients will be collected throughout the project for each participating practice. Results will be analysed at the end of the 5-year trial period.)
- Rate that patients are agreeing to testing/screening for rare or difficult to diagnose disease.(Each individual QIP will have a defined time-frame as per the stepped-wedge design. Anonymised data of patients will be collected throughout the project for each participating practice. Results will be analysed at the end of the 5-year trial period.)