About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

General practices hosting or affected by research, or other aspects of care, which might significantly influence the implementation of CAPTURED.

Trial population

A total of 500 practices will be recruited into the CAPTURED trial. The proposed study population will be GP practices with patients identified by the algorithm(s) in the Optimum Patient Care Research Database (OPCRD) and the Optimum Patient Care Service Database (OPCSD). The OPCRD is a REC approved, longitudinal electronic medical record database of over 29 million patients in the UK that is established and managed by Optimum Patient Care Ltd (OPC). OPCSD is pseudonymised patient database used to provide ongoing quality improvement services and programmes to GP practices across the UK. A total of 500 practices will be recruited into the CAPTURED trial. CAPTURED will be delivered in collaboration with Optimum Patient Care Ltd (OPC), as part of quality improvement and research support services provided to each participating GP practices with data collection into OPCSD (for QI and patient care) and OPCRD(for ethically approved research).

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants

are grouped into 1 trial group

Group A: GP practices with patients identified by one of the QIP algorithms.

Trial outcomes

Primary outcomes

1

Rate of patients given diagnosis for rare or difficult to diagnose disease

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.

Time frame