Title: Prediction and management of cardiovascular risk for people with severe mental illnesses. A research programme and trial in primary care. (PRIMROSE)
Funder: Department of Health (England)

Abstract: • Aims and objectives We aim to develop a Cardiovascular Disease (CVD) risk score tool, specifically for people with Severe Mental Illness (SMI). We will develop, then test, the effectiveness and cost-effectiveness of an intervention with practice nurses working to reduce CVD risk in SMI, including reviews, prescription of statins & adherence • Background People with SMI, including schizophrenia, die early from CVD. They have increased CVD risk factors including abnormal lipids, diabetes, smoking and obesity. They make frequent contact with primary care, yet are less likely to be screened for risk factors or receive interventions such as statins. Primary care services are expected to address this health inequality and our programme will address two key areas highlighted by NICE for NHS research • Research plans Development (yrs 1-2) Work Package (WP) 1: A new predictive risk score for CVD risk in SMI. We will refining existing tools for the general population which are widely used in primary care. We will use data from the THIN database on over 20,000 people with SMI over 20 years to build a model which predicts new-onset CVD. We will compare how models perform in people with and without SMI. Our final predictive model will be validated and calibrated for performance. It will be developed into a web based tool for clinical use in the NHS at year 2. WP 2: We will consolidate our previous work including qualitative work and systematic reviews to develop a nurse-led intervention to reduce CVD risk in SMI in primary care. i) We will hold 4 focus groups with service users, 4 with practice nurses/GPs and 4 with other stakeholders and experts. The corner stones of the intervention will be statin therapy, adherence and monitoring of CVD risk over one year. ii) We will update a systematic review of interventions to reduce CVD risk in SMI. iii) We will explore inequalities in CVD risk reduction (eg prescription of statins) for people with SMI in primary care using THIN data from WP1 Synthesis of WP 1 and 2 findings will lead to WP3 WP3: Trial (years 3-5) A cluster randomised, clinical and cost effectiveness trial, comparing the intervention to treatment as usual in 40 practices on the MRC GP Research Framework. Intervention arm nurses will work with adults with SMI who have a raised CVD risk score (from WP1) or raised lipids. They will review risk, arrange for statin prescriptions and check adherence. We have 90% power to demonstrate a 0.4 standard deviation difference in cholesterol between the two arms (n=198 each) at 1 year follow-up. This is an achievable and clinically meaningful impact. • Research team We have a track record of publications and grant funding in physical health and severe mental illness, research with primary care databases and delivering mental health trials. This also includes qualitative, statistical and epidemiological work and evidence synthesis. Our work has influenced NHS policy including NICE. Many applicants belong to the Mental Health Research Network research group on the physical consequences of SMI, including Rethink. Convenor: DO Our team includes NHS clinicians Experts in risk models Cardiovascular experts Expert service users and Rethink NHS clinical managers Consultant endocrinologist Clinical and academic GPs Clinical academic psychiatrists Statisticians epidemiologists & health economists Qualitative researchers Trials experts Health psychology • Research environment The host NHS Trust has a strong record of research with UCL and the co-applicants have a history of collaboration. There is a cohesive team of statistical and epidemiological experts at UCL to support the database work involved in WP1. The design and delivery of the trial will be supported by the PRIMENT CTU, several co-applicants work in the CTU and the London Research Design Service. • Anticipated outputs, outcomes and impact of research on the health and the NHS Our deliverables address two NICE priorities for people with SMI: better prediction and management of CVD. The new web based CVD risk score tool for SMI will be available to NHS clinicicians after year 2. The effectiveness of the intervention will be disseminated across the NHS, especially primary care after year 5. We will link to clinical networks and policy makers to ensure effective uptake in the NHS. • Public involvement We collaborate with Rethink & JA is an expert service user co-applicant. We have input from a service user research forum. Service users will be involved in research, training, management and dissemination. There will be a service user reference group. • Ethical implications All research will confirm to best ethical practice with full IRAS approval. • Justification for resources Staff costs are programme manager, 2 statisticians for WP1-2, 0.6 health economist, 0.6 statistician for the trial and all applicants. PPI is fully costed, plus the database and trial work.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: MENTAL HEALTH;CARDIOVASCULAR