THE CAPTURED TRIAL: CAN ALGORITHMS AND QUALITY IMPROVEMENT SUPPORT FOR PRIMARY CARE LEAD TO EARLIER DIAGNOSIS FOR SPECIFIC RARE DISEASE PATIENTS?
Author(s)
Ursie Smith, MBChB, MSc, PhD1, Siddharth Banka, MBBS, MRCPCH, PhD2, Kris Bennett, MSc, MBBS3, Videha Sharma, PhD, MRCS, BMBS4, David Zemmel, MBBS5, Francis Appiagyei, BA1, Chris Price, LLB1, Pedro Avila, BSc1, Sophie Harriman, LLB1, Victoria Carter, BSc1, David Price, FRCGP1.
1Optimum Patient Care, Cambridge, United Kingdom, 2Manchester Centre for Genomic Medicine, Manchester, United Kingdom, 3University Hospitals Plymouth NHS Trust, Plymouth, United Kingdom, 4University of Manchester, Manchester, United Kingdom, 5Attenborough Surgery, London, United Kingdom.
1Optimum Patient Care, Cambridge, United Kingdom, 2Manchester Centre for Genomic Medicine, Manchester, United Kingdom, 3University Hospitals Plymouth NHS Trust, Plymouth, United Kingdom, 4University of Manchester, Manchester, United Kingdom, 5Attenborough Surgery, London, United Kingdom.
OBJECTIVES: Rare conditions collectively affect 3.5-5.9% of the UK population, with patients often experiencing long diagnostic delays due to non-specific symptoms and multi-system involvement. Algorithms applied to electronic health record data can identify patients at high-risk of certain rare diseases. CAPTURED is a cluster-randomised clinical trial to evaluate the efficacy of algorithm technology combined with quality improvement support in getting patients diagnostic testing for ten treatable conditions. CAPTURED aims to evaluate whether the intervention improves the recognition, investigation and diagnosis of rare or difficult-to-diagnose conditions, and to understand patient engagement with related quality-improvement activities.
METHODS: CAPTURED began recruiting GP practices in January 2026 and runs until 2031. For each ‘rare disease algorithm’: Practices are identified where there are patients at high probability of disease and randomised into clusters for quality improvement delivery in a stepped wedge design. The quality improvement support includes patient review and testing or referral; with the patient and practice updated throughout the process. Optimum Patient Care (OPC) will support implementation at participating GP sites through the OPC Quality Improvement & Research Support Services. Results from all projects under CAPTURED will be combined for analysis at the end of the 5-year period. CAPTURED commenced with an algorithm for X-linked hypophosphataemia (XLH), a form of rickets.
RESULTS: 111 general practices covering a population of >2.2 million patients, have enrolled in the CAPTURED trial. Quality improvement activities for the first programme are progressing as follows: 100% of patients identified as high-risk have had a full electronic health record review with 50% considered suitable for further follow-up. 80% of these have been successfully contacted, and all patients contacted have accepted the intervention. Patients are expected to complete the pathway from July 2026.
CONCLUSIONS: This unique study design provides an opportunity to combine multiple rare disease programmes for statistical power for clinical outcomes.
METHODS: CAPTURED began recruiting GP practices in January 2026 and runs until 2031. For each ‘rare disease algorithm’: Practices are identified where there are patients at high probability of disease and randomised into clusters for quality improvement delivery in a stepped wedge design. The quality improvement support includes patient review and testing or referral; with the patient and practice updated throughout the process. Optimum Patient Care (OPC) will support implementation at participating GP sites through the OPC Quality Improvement & Research Support Services. Results from all projects under CAPTURED will be combined for analysis at the end of the 5-year period. CAPTURED commenced with an algorithm for X-linked hypophosphataemia (XLH), a form of rickets.
RESULTS: 111 general practices covering a population of >2.2 million patients, have enrolled in the CAPTURED trial. Quality improvement activities for the first programme are progressing as follows: 100% of patients identified as high-risk have had a full electronic health record review with 50% considered suitable for further follow-up. 80% of these have been successfully contacted, and all patients contacted have accepted the intervention. Patients are expected to complete the pathway from July 2026.
CONCLUSIONS: This unique study design provides an opportunity to combine multiple rare disease programmes for statistical power for clinical outcomes.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
SA98
Topic
Study Approaches
Disease
Rare & Orphan Diseases