Work Package 3 - The PRIMROSE Trial

In a cluster randomised controlled trial we will test the cost effectiveness of a practice-nurse led intervention to reduce cardiovascular disease (CVD) risk in people with severe mental illnesses over a 12-month period. 38 GP practices will be randomly allocated to the intervention or control group.  380 patients with severe mental illness, including people with schizophrenia and bipolar affective disorder, who are at increased risk of CVD will receive either:

1) A CVD risk reduction service for people with severe mental illnesses and CVD risk factors or

2) Standard care


We will approach GP practices in three waves of recruitment. The first wave of GP practices will be based in North London. Recruitment will then be extended to sites across the UK.

In each GP practice, people aged 30-75 years old with SMI will be invited to attend a CVD health check. The GP practice will identify 10 eligible patients to work with and will be randomly allocated to either receive training to deliver the intervention or to deliver usual care.

Inclusion/Exclusion Criteria

The following patient inclusion criteria will be applied:

  • Diagnosis of severe mental illness, i.e. schizophrenia, persistent delusional disorder, schizo-affective disorder, bipolar affective disorder
  • Aged between 30-75 years old
  • Able to give written informed consent
  • Total cholesterol >5.0 mmol/l or Total cholesterol/HDL cholesterol Ratio > 4 AND one of the following CVD risk factors:
  • BMI > 30 kg/m2
  • Current smoker
  • Blood pressure >140mm Hg systolic AND/OR >90 mm Hg diastolic
  • HbA1c range of 42- 47 mmol/mol (6.0-6.4%) or fasted glucose range of 5.5 - 6.9 mmol/mol
  • Diagnosis of diabetes

Exclusion criteria are:

  • Too acutely unwell defined as under acute psychiatric care
  • Primary diagnosis of an organic mental health problem and/or severe cognitive impairment
  • Life expectancy < 6 months
  • Pre-existing CVD 
  • Currently pregnant