CAPTURED V1.0
Research type
Research Study
Full title
A pragmatic, stepped wedge, multi-centre, cluster randomised controlled 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).
IRAS ID
361770
Contact name
David Price
Contact email
Sponsor organisation
Observational and Pragmatic Research International Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
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 QIP 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).
REC name
East Midlands - Derby Research Ethics Committee
REC reference
25/EM/0231
Date of REC Opinion
2 Dec 2025
REC opinion
Further Information Favourable Opinion