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)

CAPTURED – Channelling Algorithm Proficiency To Understand, Recognise and Elucidate Disease.

Not applicable. No investigational medicinal product is involved in this trial.

Observational and Pragmatic Research International (OPRI UK)

United Kingdom (UK)

General practices in the UK receiving or willing to receive the free OPC quality improvement services and contribute deidentified data to the OPCRD.

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.

A pragmatic, multicentre, stepped wedge, cluster randomised control trial. CAPTURED trial will run for 5 years and evaluate up to 10 projects. Each project, under CAPTURED, will utilise a specific algorithm for rare or difficult to diagnose disease, and a specific diagnostic testing/quality improvement support package. The algorithms have been designed to reduce the diagnostic odyssey for rare and difficult to diagnose conditions. 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 quality improvement programs (QIPs) will have specific cut-offs to determine high probability of disease but typically it is a likelihood of 60% or more.

All practices are eligible to participate in CAPTURED but participation in an individual CAPTURED quality improvement project (QIP) will depend on whether the practice has patients identified as high probability by one of the disease-specific project algorithms.

For each project, practices will be randomised into clusters in a stepped wedge design. All practices will receive the intervention (diagnostic testing/screening and quality improvement support package). This means one practice may participate in more than one CAPTURED QIP at different time points.

Inclusion criteria:

• 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.

Exclusion Criteria:

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

Inclusion criteria:

• Patients at a participating practice.

Exclusion criteria:

• Patients who have opted out of data sharing for research.

500 GP practices

Five (5) years

2025 to 2030

• Rate of new diagnosis of rare or difficult to diagnose disease

Results for all projects (up to 10) will be combined for overall analysis of CAPTURED at the end of the 5-year planned trial period.

• Rate of tests/screening for rare for difficult to diagnose disease

• Rate of successful communication with patients regarding QI intervention

• Rate of patients’ acceptance of the QI intervention

• Proportion of patients identified by the algorithm as high probability for rare or difficult to diagnose disease, deemed clinically appropriate for testing by Medical professional judgement

• Alternative diagnoses derived from QI intervention

Results for all projects (up to 10) will be combined for overall analysis of CAPTURED at the end of the 5-year planned trial period.

Not applicable. No investigational medicinal product is involved in this trial.