About the study

Prediction and management of cardiovascular disease risk for people with severe mental illnesses: A research programme and trial in primary care (Primrose)

Summary

We have shown that people with severe mental illness die 10-20 years early, particularly from Cardio Vascular Disease (CVD) due to excess modifiable risk factors. This is a priority in the NHS Long term plan.

The NIHR Primrose trial showed that a nurse/HCA intervention to reduce CVD risk factors in people with SMI was deliverable and acceptable nationally. The trial showed a decrease in psychiatric relapse for people who received the intervention over six months, with decreased costs. Although cholesterol went down in both arms of the trial, there was no difference between trial arms. We know why, through fidelity work which showed the intervention was well delivered and adhered to, but interventions such as statins were under-utilised. Social support improved the intervention uptake.

PRIMROSE-A (Adapted) is now being delivered to people with SMI in Camden NHS general practices. The funding is through HEE and partners include MIND and the local NHS organisations. The adaptations include increased focus on medication adherence (eg statins) and recovery work alongside peer support workers.

CVD Risk score work findings in SMI

We created new risk scores for CVD in 38,824 people with SMI and showed that standard risk scores for the general population underestimate risk in SMI.

• Results From the Prediction and Management of Cardiovascular Risk in People With Severe Mental Illnesses (PRIMROSE) Research Program, Osborn et al JAMA Psychiatry 2017
• Effectiveness and cost-effectiveness of a cardiovascular risk prediction algorithm for people with severe mental illness (PRIMROSE), Zomer et al, BMJ 2017

QRisk 3 now includes SMI in its algorithm, albeit with a different definition- including depression.

• Development and validation of QRISK3 risk prediction algorithms to estimate future risk of cardiovascular disease: prospective cohort study

Evaluating the effectiveness of statins in SMI

We evaluated statin prescriptions in 25,246 people with SMI and found that they do receive statins in primary care although statin prescribing is less frequent in older people with SMI. Further work in 16,854 people with SMI showed that statins are effective and cost effective in reducing cholesterol and reducing CVD risk.

• Blackburn et al 2017 https://pubmed.ncbi.nlm.nih.gov/28599749/
• Blackburn et al 2017 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5353294/

The PRIMROSE intervention and Trial

Primrose included a specific training package and manualised intervention for use in UK primary care.

The intervention was evaluated over one year in 76 English GPs and involved collaborative work with SMI patients to address cardiovascular risk factors such as cholesterol, smoking, weight and blood pressure.

• Trial protocol

Content of PRIMROSE intervention

• The intervention was delivered by primary care nurses and HCAs over a year.
• They followed latest evidence on managing CVD risk factors in people with SMI.
• Training in the manualised intervention including two day sessions incorporating BCTs and working with people with SMI. The training was delivered by health psychologists/peer experts with SMI, a nurse and research psychologist.
• Behaviour Change Techniques to manage risk factors (co-I Michie).
• Involvement of supportive others including family/carers/professionals (PhD complete Burton UCL).

PRIMROSE Trial Findings

The intervention ran successfully in a trial involving  76 UK general practices. There were significantly fewer relapses for psychiatric reasons in the people who received PRIMROSE and significantly lower health costs. Cholesterol decreased in both arms of the trial but there was no difference between arms.

Trial results paper in Lancet Psychiatry

There was fair fidelity to BCTs in the post-trial analysis of audiotaped PRIMROSE appointments. People had very good attendance at the intervention appointments over the year.

However Statin therapy was rarely discussed and this is the main target for improvement of the PRIMROSE intervention along with better supervision for HCAs/Nurses/workforce delivering Primrose .

Implementation research post-trial

We studied the implementation of the PRIMROSE intervention in a primary care-qualitative study. Barriers and facilitators. - Hassan 2020. The study recommendations were- provide flexible appointments (including phone), provide more support for staff in managing SMI, provide more staff supervision.

Involving other support in the PRIMROSE intervention

The involvement of supportive others in the PRIMROSE intervention increased attendance at appointments and adherence (Burton et al UCL 2020)