Clinical and cost-effectiveness of an intervention for reducing cholesterol and cardiovascular risk for people with severe mental illness in English primary care: a cluster randomised controlled trial

Osborn, David; Burton, Alexandra; Hunter, Rachael; Marston, Louise; Atkins, Lou; Barnes, Thomas R. E.; Blackburn, Ruth; Craig, T. K. J.; Gilbert, Hazel; Heinkel, Samira; Holt, Richard; King, Michael; Michie, Susan; Morris, Richard; Morris, Steve; Nazareth, Irwin; Omar, Rumana; Petersen, Inge; Peveler, Robert; Pinfold, Vanessa; Walters, Kate

doi:10.1016/s2215-0366(18)30007-5

Cited by 78 publications

(110 citation statements)

References 25 publications

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“…Furthermore, although effective for common mental disorders, the evidence for CC models in people with long-standing SMI is equivocal, and optimal models of integrated care in this group have yet to be refined. [366][367][368] One example of this provided by the PRIMROSE study; 368 which compared integrated primary care to usual care in 327 people with SMI, finding no significant benefits for HDL cholesterol over 12 months. However, The PRIMROSE integrated care did show a 12 month mean health care cost difference of -£824 (95% CI -£568 to £1079) compare to usual care, and proved to be cost-effective due to fewer of hospital readmissions over a 12-month period; thus indicating the enhanced continuity of care afforded by integrated care approaches can confer important benefits even in the absence of changes in cardiometabolic health.…”

Section: Panel 52 Examples and Evaluations: Integrated Care For Phymentioning

confidence: 99%

“…However, The PRIMROSE integrated care did show a 12 month mean health care cost difference of -£824 (95% CI -£568 to £1079) compare to usual care, and proved to be cost-effective due to fewer of hospital readmissions over a 12-month period; thus indicating the enhanced continuity of care afforded by integrated care approaches can confer important benefits even in the absence of changes in cardiometabolic health. 368 Nonetheless, in aiming to improve physical health outcomes of SMI, future studies must evaluate benefits of earlier implementation of integrated care for SMI (i.e. providing CC from illness onset), along with providing CC referral to evidence-based lifestyle programs based on DPP principles (See Figure 3).…”

Section: Panel 52 Examples and Evaluations: Integrated Care For Phymentioning

confidence: 99%

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The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness

Firth

Siddiqi

Koyanagi

et al. 2019

The Lancet Psychiatry

973

1,093

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Executive SummaryThe poor physical health of people with mental illness is a multi-faceted, transdiagnostic, and global problem. Physical health disparities are observed across the entire spectrum of mental illnesses, in low, middle-and high-income countries. This stems from both a heightened risk of physical diseases in people with mental illness, along with their reduced access to adequate healthcare. The high rates of physical comorbidities (and typically-poor clinical management of this) drastically reduces life expectancy, and also increases the personal, social and economic burden of illness across the lifespan.This Commission has brought together an international team of researchers, clinicians, and key stakeholders from various backgrounds and professionally / personally-relevant experience, in order to summarize advances in understanding on this topic, and present clear directions for health promotion, clinical care and future research. The breadth and multifactorial nature of physical health disparities across the range of mental health diagnoses poses an almost limitless number of potential considerations. Therefore, rather than attempting to cover all of the different possible combinations of physical-mental comorbidities individually, the aim of this Commission was to: (i) establish highlypertinent aspects of physical health-related morbidity and mortality which apply transdiagnostically, (ii) highlight the common modifiable factors driving these disparities, (iii) present actions and initiatives for health policy and clinical services to address these issues, and (iv) identify promising areas for future research towards discovering novel solutions. This was addressed across 5 different Parts of the Commission: Parts 1 and 2 determined the scope, priorities and key targets for physical health improvement across multiple mental illnesses. Parts 3, 4 and 5 discussed emerging strategies and produced recommendations for improving physical health outcomes in people with mental illness. Leaders and contributors for each Part are shown in the Appendix (pg.1) . Part 1: 'Its more than premature mortality'Part 1 identified almost 100 systematic reviews/meta-analyses examining the prevalence of physical comorbidities in mental illness. Around 70% of the meta-research focused on cardiometabolic diseases; consistently reporting that mental illnesses were associated with 1.4-to 2-fold increased risk for obesity, diabetes and cardiovascular diseases compared to the general population. Although mostly studied in 'severe mental illness' ('SMI', and particularly psychotic disorders), the prevalence of cardiometabolic diseases was similarly elevated across a broad range of other diagnoses, including substance use disorders (SUDs), and 'common mental disorders' ('CMDs', such as depression and anxiety). Part 2: Key modifiable factors in health behaviours and health servicesPart 2 built on the findings of Part 1 with a hierarchal evidence synthesis of modifiable risk factors for physical diseases in mental illness. The bu...

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Section: Panel 52 Examples and Evaluations: Integrated Care For Phymentioning

confidence: 99%

Section: Panel 52 Examples and Evaluations: Integrated Care For Phymentioning

confidence: 99%

The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness

Firth

Siddiqi

Koyanagi

et al. 2019

The Lancet Psychiatry

973

1,093

View full text Add to dashboard Cite

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“…107 The link to this paper can be found in Appendix 3, Work package 3. 107 The methods and results from the analysis of the cluster randomised trial in terms of clinical effectiveness are summarised below.…”

Section: Clinical Effectiveness Of An Intervention For Lowering Levelmentioning

confidence: 99%

“…106 The full cost-effectiveness analysis was published as supplementary material to the trial in the journal Lancet Psychiatry in 2018. 107 The link to this paper can be found in Appendix 3, Work package 3. 107 The methods and preliminary results from this paper are summarised below.…”

Section: Cost-effectiveness Of An Intervention For Lowering Levels Ofmentioning

confidence: 99%

Primary care management of cardiovascular risk for people with severe mental illnesses: the Primrose research programme including cluster RCT

Osborn

Burton

Walters

et al. 2019

Programme Grants Appl Res

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Background Effective interventions are needed to prevent cardiovascular disease (CVD) in people with severe mental illnesses (SMI) because their risk of CVD is higher than that of the general population. Objectives (1) Develop and validate risk models for predicting CVD events in people with SMI and evaluate their cost-effectiveness, (2) develop an intervention to reduce levels of cholesterol and CVD risk in SMI and (3) test the clinical effectiveness and cost-effectiveness of this new intervention in primary care. Design Mixed methods with patient and public involvement throughout. The mixed methods were (1) a prospective cohort and risk score validation study and cost-effectiveness modelling, (2) development work (focus groups, updated systematic review of interventions, primary care database studies investigating statin prescribing and effectiveness) and (3) cluster randomised controlled trial (RCT) assessing the clinical effectiveness and cost-effectiveness of a new practitioner-led intervention, and fidelity assessment of audio-recorded appointments. Setting General practices across England. Participants All studies included adults with SMI (schizophrenia, bipolar disorder or other non-organic psychosis). The RCT included adults with SMI and two or more CVD risk factors. Interventions The intervention consisted of 8–12 appointments with a practice nurse/health-care assistant over 6 months, involving collaborative behavioural approaches to CVD risk factors. The intervention was compared with routine practice with a general practitioner (GP). Main outcome measures The primary outcome for the risk score work was CVD events, in the cost-effectiveness modelling it was quality-adjusted life-years (QALYs) and in the RCT it was level of total cholesterol. Data sources Databases studies used The Health Improvement Network (THIN). Intervention development work included focus groups and systematic reviews. The RCT collected patient self-reported and routine NHS GP data. Intervention appointments were audio-recorded. Results Two CVD risk score models were developed and validated in 38,824 people with SMI in THIN: the Primrose lipid model requiring cholesterol levels, and the Primrose body mass index (BMI) model with no blood test. These models performed better than published Cox Framingham models. In health economic modelling, the Primrose BMI model was most cost-effective when used as an algorithm to drive statin prescriptions. Focus groups identified barriers to, and facilitators of, reducing CVD risk in SMI including patient engagement and motivation, staff confidence, involving supportive others, goal-setting and continuity of care. Findings were synthesised with evidence from updated systematic reviews to create the Primrose intervention and training programme. THIN cohort studies in 16,854 people with SMI demonstrated that statins effectively reduced levels of cholesterol, with similar effect sizes to those in general population studies over 12–24 months (mean decrease 1.2 mmol/l). Cluster RCT: 76 GP practices were randomised to the Primrose intervention (n = 38) or treatment as usual (TAU) (n = 38). The primary outcome (level of cholesterol) was analysed for 137 out of 155 participants in Primrose and 152 out of 172 in TAU. There was no difference in levels of cholesterol at 12 months [5.4 mmol/l Primrose vs. 5.5 mmol/l TAU; coefficient 0.03; 95% confidence interval (CI) –0.22 to 0.29], nor in secondary outcomes related to cardiometabolic parameters, well-being or medication adherence. Mean cholesterol levels decreased over 12 months in both arms (–0.22 mmol/l Primrose vs. –0.39 mmol/l TAU). There was a significant reduction in the cost of inpatient mental health attendances (–£799, 95% CI –£1480 to –£117) and total health-care costs (–£895, 95% CI –£1631 to –£160; p = 0.012) in the intervention group, but no significant difference in QALYs (–0.011, 95% CI –0.034 to 0.011). A total of 69% of patients attended two or more Primrose appointments. Audiotapes revealed moderate fidelity to intervention delivery (67.7%). Statin prescribing and adherence was rarely addressed. Limitations RCT participants and practices may not represent all UK practices. CVD care in the TAU arm may have been enhanced by trial procedures involving CVD risk screening and feedback. Conclusions SMI-specific CVD risk scores better predict new CVD if used to guide statin prescribing in SMI. Statins are effective in reducing levels of cholesterol in people with SMI in UK clinical practice. This primary care RCT evaluated an evidence-based practitioner-led intervention that was well attended by patients and intervention components were delivered. No superiority was shown for the new intervention over TAU for level of cholesterol, but cholesterol levels decreased over 12 months in both arms and the intervention showed fewer inpatient admissions. There was no difference in cholesterol levels between the intervention and TAU arms, which might reflect better than standard general practice care in TAU, heterogeneity in intervention delivery or suboptimal emphasis on statins. Future work The new risk score should be updated, deployed and tested in different settings and compared with the latest versions of CVD risk scores in different countries. Future research on CVD risk interventions should emphasise statin prescriptions more. The mechanism behind lower costs with the Primrose intervention needs exploring, including SMI-related training and offering frequent support to people with SMI in primary care. Trial registration Current Controlled Trials ISRCTN13762819. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 7, No. 2. See the NIHR Journals Library website for further project information. Professor David Osborn is supported by the University College London Hospital NIHR Biomedical Research Centre and he was also in part supported by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Barts Health NHS Trust.

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“…Rates of metabolic syndrome are also higher in BD patients than in the general population , characterized by hypertension, impaired glucose metabolism, obesity and dyslipidemia, increasing the risk for type 2 diabetes and CVD mortality . However, the mechanisms implicated in these excessive and premature cardiometabolic events among BD patients are poorly understood .…”

Section: Introductionmentioning

confidence: 99%

Emotional hyper‐reactivity and cardiometabolic risk in remitted bipolar patients: a machine learning approach

Dargél

Roussel

Volant

et al. 2018

Acta Psychiatr Scand

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Clinical and cost-effectiveness of an intervention for reducing cholesterol and cardiovascular risk for people with severe mental illness in English primary care: a cluster randomised controlled trial

Abstract: National Institute of Health Research Programme Grants for Applied Research.

Cited by 78 publications

References 25 publications

The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness

The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness

Primary care management of cardiovascular risk for people with severe mental illnesses: the Primrose research programme including cluster RCT

Emotional hyper‐reactivity and cardiometabolic risk in remitted bipolar patients: a machine learning approach

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