A qualitative study exploring the barriers and facilitators of implementing a cardiovascular disease risk reducing intervention for people with severe mental illness into primary care contexts across England: the 'PRIMROSE' trial.

BACKGROUND: People with severe mental illness (SMI) are at greater risk of earlier mortality due to physical health problems including cardiovascular disease (CVD). There is limited work exploring whether physical health interventions for people with SMI can be embedded and/or adopted within specific healthcare settings. This information is necessary to optimise the development of services and interventions within healthcare settings. This study explores the barriers and facilitators of implementing a nurse-delivered intervention ('PRIMROSE') designed to reduce CVD risk in people with SMI in primary care, using Normalisation Process Theory (NPT), a theory that explains the dynamics of embedding or 'normalising' a complex intervention within healthcare settings. METHODS: Semi-structured interviews were conducted between April-December 2016 with patients with SMI at risk of CVD who received the PRIMROSE intervention, and practice nurses and healthcare assistants who delivered it in primary care in England. Interviews were audio recorded, transcribed and analysed using thematic analysis. Emergent themes were then mapped on to constructs of NPT. RESULTS: Fifteen patients and 15 staff participated. The implementation of PRIMROSE was affected by the following as categorised by the NPT domains: 1) Coherence, where both staff and patients expressed an understanding of the purpose and value of the intervention, 2) Cognitive participation, including mental health stigma and staff perceptions of the compatibility of the intervention to primary care contexts, 3) Collective action, including 3.1. Interactional workability in terms of lack of patient engagement despite flexible appointment scheduling. The structured nature of the intervention and the need for additional nurse time were considered barriers, 3.2. Relational integration i.e. whereby positive relationships between staff and patients facilitated implementation, and access to 'in-house' staff support was considered important, 3.3. Skill-set workability in terms of staff skills, knowledge and training facilitated implementation, 3.4. Contextual integration regarding the accessibility of resources sometimes prevented collective action. 4) Reflexive monitoring, where the staff commonly appraised the intervention by suggesting designated timeslots and technology may improve the intervention. CONCLUSIONS: Future interventions for physical health in people with SMI could consider the following items to improve implementation: 1) training for practitioners in CVD risk prevention to increase practitioners knowledge of physical interventions 2) training in SMI to increase practitioner confidence to engage with people with SMI and reduce mental health stigma and 3) access to resources including specialist services, additional staff and time. Access to specialist behaviour change services may be beneficial for patients with specific health goals. Additional staff to support workload and share knowledge may also be valuable. More time for appointments with people with SMI may allow practitioners to better meet patient needs

Evaluating the clinical and cost effectiveness of a behaviour change intervention for lowering cardiovascular disease risk for people with severe mental illnesses in primary care (PRIMROSE study):study protocol for a cluster randomised controlled trial

BACKGROUND: People with severe mental illnesses die up to 20 years earlier than the general population, with cardiovascular disease being the leading cause of death. National guidelines recommend that the physical care of people with severe mental illnesses should be the responsibility of primary care; however, little is known about effective interventions to lower cardiovascular disease risk in this population and setting. Following extensive peer review, funding was secured from the United Kingdom National Institute for Health Research (NIHR) to deliver the proposed study. The aim of the trial is to test the effectiveness of a behavioural intervention to lower cardiovascular disease risk in people with severe mental illnesses in United Kingdom General Practices. METHODS/DESIGN: The study is a cluster randomised controlled trial in 70 GP practices for people with severe mental illnesses, aged 30 to 75 years old, with elevated cardiovascular disease risk factors. The trial will compare the effectiveness of a behavioural intervention designed to lower cardiovascular disease risk and delivered by a practice nurse or healthcare assistant, with standard care offered in General Practice. A total of 350 people will be recruited and followed up at 6 and 12 months. The primary outcome is total cholesterol level at the 12-month follow-up and secondary outcomes include blood pressure, body mass index, waist circumference, smoking status, quality of life, adherence to treatments and services and behavioural measures for diet, physical activity and alcohol use. An economic evaluation will be carried out to determine the cost effectiveness of the intervention compared with standard care. DISCUSSION: The results of this pragmatic trial will provide evidence on the clinical and cost effectiveness of the intervention on lowering total cholesterol and addressing multiple cardiovascular disease risk factors in people with severe mental illnesses in GP Practices. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13762819 . Date of Registration: 25 February 2013. Date and Version Number: 27 August 2014 Version 5

Adult mental health provision in England : a national survey of acute day units

Background Acute Day Units (ADUs) exist in some English NHS Trusts as an alternative to psychiatric inpatient admission. However, there is a lack of information about the number, configuration, and functioning of such units, and about the extent to which additional units might reduce admissions. This cross-sectional survey and cluster analysis of ADUs aimed to identify, categorise, and describe Acute Day Units (ADUs) in England. Methods English NHS Mental Health Trusts with ADUs were identified in a mapping exercise, and a questionnaire was distributed to ADU managers. Cluster analysis was used to identify distinct models of service, and descriptive statistics are given to summarise the results of the survey questions. Results Two types of service were identified by the cluster analysis: NHS (n = 27; and voluntary sector services (n = 18). Under a third of NHS Trusts have access to ADUs. NHS services typically have multi-disciplinary staff teams, operate during office hours, offer a range of interventions (medication, physical checks, psychological interventions, group sessions, peer support), and had a median treatment period of 30 days. Voluntary sector services had mostly non-clinically qualified staff, and typically offered supportive listening on a one-off, drop-in basis. Nearly all services aim to prevent or reduce inpatient admissions. Voluntary sector services had more involvement by service users and carers in management and running of the service than NHS services. Conclusions The majority of NHS Trusts do not provide ADUs, despite their potential to reduce inpatient admissions. Further research of ADUs is required to establish their effectiveness and acceptability to service users, carers, and staff

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

Background: people with severe mental illnesses, including psychosis, have an increased risk of cardiovascular disease. We aimed to evaluate the effects of a primary care intervention on decreasing total cholesterol concentrations and cardiovascular disease risk in people with severe mental illnesses.Methods: we did this cluster randomised trial in general practices across England, with general practices as the cluster unit. We randomly assigned general practices (1:1) with 40 or more patients with severe mental illnesses using a computer-generated random sequence with a block size of four. Researchers were masked to allocation, but patients and general practice staff were not. We included participants aged 30–75 years with severe mental illnesses (schizophrenia, bipolar disorder, or psychosis), who had raised cholesterol concentrations (5·0 mmol/L) or a total:HDL cholesterol ratio of 4·0 mmol/L or more and one or more modifiable cardiovascular disease risk factors. Eligible participants were recruited within each practice before randomisation. The Primrose intervention consisted of appointments (≤12) with a trained primary care professional involving manualised interventions for cardiovascular disease prevention (ie, adhering to statins, improving diet or physical activity levels, reducing alcohol, or quitting smoking). Treatment as usual involved feedback of screening results only. The primary outcome was total cholesterol at 12 months and the primary economic analysis outcome was health-care costs. We used intention-to-treat analysis. The trial is registered with Current Controlled Trials, number ISRCTN13762819.Findings: between Dec 10, 2013, and Sept 30, 2015, we recruited general practices and between May 9, 2014, and Feb 10, 2016, we recruited participants and randomly assigned 76 general practices with 327 participants to the Primrose intervention (n=38 with 155 patients) or treatment as usual (n=38 with 172 patients). Total cholesterol concentration data were available at 12 months for 137 (88%) participants in the Primrose intervention group and 152 (88%) participants in the treatment-as-usual group. The mean total cholesterol concentration did not differ at 12 months between the two groups (5·4 mmol/L [SD 1·1] for Primrose vs 5·5 mmol/L [1·1] for treatment as usual; mean difference estimate 0·03, 95% CI −0·22 to 0·29; p=0·788). This result was unchanged by pre-agreed supportive analyses. Mean cholesterol decreased over 12 months (−0·22 mmol/L [1·1] for Primrose vs −0·36 mmol/L [1·1] for treatment as usual). Total health-care costs (£1286 [SE 178] in the Primrose intervention group vs £2182 [328] in the treatment-as-usual group; mean difference −£895, 95% CI −1631 to −160; p=0·012) and psychiatric inpatient costs (£157 [135] vs £956 [313]; −£799, −1480 to −117; p=0·018) were lower in the Primrose intervention group than the treatment-as-usual group. Six serious adverse events of hospital admission and one death occurred in the Primrose group (n=7) and 23, including three deaths, occurred in the treatment-as-usual group (n=18).Interpretation: total cholesterol concentration at 12 months did not differ between the Primrose and treatment-as-usual groups, possibly because of the cluster design, good care in the treatment-as-usual group, short duration of the intervention, or suboptimal focus on statin prescribing. The association between the Primrose intervention and fewer psychiatric admissions, with potential cost-effectiveness, might be important.Funding: National Institute of Health Research Programme Grants for Applied Research

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

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