Specialist-led community-based cardio-kidney-metabolic-pulmonary care in high risk individuals: multi-centre pragmatic prospective randomised open label blinded endpoint trial

Abstract Background and Aims Pharmacological therapies that treat cardiovascular, kidney, metabolic and pulmonary (CKMP) risk factors reduce the risk of major adverse cardiovascular events, but community-dwelling individuals may not receive all treatments to which they are eligible from non-specialists. This trial investigated if specialist-led care in the community increases the utilisation of CKMP pharmacological interventions compared with usual care. Methods This pragmatic prospective randomised open label blinded endpoint trial included community-dwelling high risk adults aged ≥30 years from 15 primary care sites in England. Participants were randomised 1:1 to an intervention of two clinic appointments (at baseline and approximately 3 months) with a cardiology specialist at their primary care site to review and optimise CKMP risk factors in accordance with UK guidelines, or usual care. The primary outcome was the proportion of participants with initiation and/or increase in the dose of guideline-directed CKMP pharmacological therapies at 6 months after date of randomisation. Results Between March 2025 and July 2025, 138 participants were randomised (68 intervention, 70 control); the median age was 76.6 years, 52.9% were women. At 6 months after randomisation, in the intervention arm 42 of 68 (61.8%) patients received a CKMP pharmacological intervention compared with 16 of 70 patients (22.9%) in the control arm (odds ratio 5.4, 95% CI 2.5 to 12.3, p < 0.0001, absolute risk difference 38.9%, 95% CI 23.7% to 54.1%). Conclusions Specialist-led care in the community for high risk individuals increased the use of pharmacological interventions for CKMP risk factors compared to usual care.