Reducing risk of cardiovascular disease in people with severe mental illness: co-production, feasibility testing and trial of a peer supported group clinic intervention (PEGASUS)

Research question Can a peer-supported, group clinic intervention reduce risk of cardiovascular disease (CVD) in people with severe mental illness (SMI) at enhanced CVD risk?

Background People with SMI die approximately 15-years earlier than the general population, with CVD the largest cause of early death.

Despite being 50% more likely to develop CVD than the general population, CVD is under-recognised and under-treated in people with SMI at considerable cost to individuals, health services and society. Psychiatric medication can exacerbate CVD risk. People from racialised communities face healthcare inequalities and can be at elevated CVD risk.

Lifestyle interventions have failed to address specific challenges faced by people with SMI in reducing CVD risk.

Aims To co-produce, feasibility test and trial a multi-goal, peer-supported group clinic intervention to reduce CVD risk in people with SMI.

Methods In workpackage (WP) 1 a rapid evidence synthesis of behavioural change mechanisms in physical health interventions for people with SMI, plus focus groups with people with SMI at elevated CVD risk (n=32 participants), will inform an Experience Based Co-Design (EBCD) process, co-producing our intervention with people using mental health services, peer workers, and physical and mental healthcare clinicians.

A dedicated Equality, Diversity & Inclusion (EDI) workstream (WP2) will run through the programme, monitoring recruitment of people from marginalised communities, and informing data collection and analysis.

Health awareness workshops with community organisations will aim to improve uptake of physical health checks among people from marginalised communities.

A feasibility study (WP3) will test the intervention in each of four study sites (n=40), conducting focus groups with participants and interviewing clinical staff (n=24), refining intervention and trial procedures as necessary.

An individually-randomised controlled trial (WP4) will recruit 520 people with SMI using community mental health services at enhanced CVD risk (indicated by presence of metabolic syndrome), allocated 1:1 to intervention or care as usual (annual physical health check). Primary outcome will be reduced CVD risk - reversal of metabolic syndrome - 12-months post-randomisation.

Secondary outcomes include individual physical health indicators, self-efficacy, social connection and uptake of healthy lifestyle support. We will undertake a cost-comparison analysis, enabling a future full cost-effectiveness study with longer follow-up.

A mixed-method process evaluation (WP5) will interview participants offered the intervention (n=32), use implementation theory to evaluate implementation in interviews with peer workers and clinical staff (n=28), and use path analysis to examine mediators and moderators of effectiveness. Timelines for delivery Health awareness workshops will become available at end of year one.

We will deliver the intervention handbook following feasibility study at end of year two.

Trial and economic evaluation, and implementation guidance based on process evaluation will be delivered by end of programme.

Anticipated Impact and Dissemination Health awareness workshops will improve access to treatment among people with SMI from marginalised communities.

The intervention will have short-term (improved physical wellbeing) and long-term (reduced incidence of diabetes and CVD) benefits.

Dissemination will be through academic outputs, professional and survivor/EDI networks, social media, Applied Research Collaborations and policy makers in NHSE&I and HEE.