Mental Illness In Primary Care Research Articles

Understanding the causes of preventable medication incidents for patients with mental illness in primary care

Abstract Introduction A recent scoping review has highlighted that whilst patients with mental illness are commonly affected by medication errors and preventable adverse drug events in primary care, there were limited data regarding their causes1. By understanding why these preventable events occur, targeted interventions can be developed. Aim To understand the nature and contributory factors that lead to medication errors and preventable adverse drug events amongst patients with mental illness in primary care. Methods This study used a qualitative design. A researcher remotely interviewed 26 healthcare professionals (14 pharmacists, 5 GPs, 5 nurses, 2 psychiatrists) working in primary care between June-November 2022, guided by the critical incident technique. Professionals were recruited via social media, research team networks, and snowballing. Data were analysed using the framework method and any data that involved speculation as to the causes of errors was not included. The data were organised into themes based on the London protocol error framework, which describes the contributory factors leading to care delivery problems2. Themes generated were validated by other members of the research team and a patient advisory group. This study was approved by the University of Manchester Ethics Committee 1 (reference 2022-13735-23555). Results Forty-three medication errors and twelve preventable adverse drug events were discussed during interview. Prescribing errors were discussed most commonly (n=24) and administration errors least commonly (n=4). Six contributory factors were identified which were: the individual (staff) (n=37); the work environment (n=31); the teams/interfaces (n=28); the organisation and management (n=24); the patient (n=23); and the task and technology (n=15). Primary care clinicians reported a lack of knowledge regarding psychotropics and mental illness which accompanied diffusion of responsibility. The responsibilities of staff were also confused by limited clinical information communicated between teams and across care interfaces. Service demand was reported to exceed capacity, creating stress for the staff, as well as limiting the time available for staff to undergo training. Complicated patient lifestyles and behavioural challenges were reported as unique contributory factors. Discussion/Conclusion Lack of knowledge amongst primary care clinicians regarding psychotropics and mental illness was a key issue. This was exacerbated by a mental health service structure placing considerable pressure on primary care leaving clinicians to support patients with needs perceived to be outside their areas of confidence and competence. There is a need to support this workforce by upskilling them to effectively manage patients by addressing the educational needs regarding neuropharmacology and communication skills. These changes may have a positive effect in reducing error rates for this patient group in primary care. Study limitations include recall bias, social desirability bias, as well as the majority errors discussed were made by another clinician within a chain therefore critical details may be missing in the series of events. This is the first study to identify the nature and contributory factors of preventable medication incidents for patients with mental illness in primary care. Future research should focus on exploring this topic from the perspective of patients to better understand the causes of preventable medication incidents.

HEAD-MIP–(HEAlth Dialogues for patients with Mental Illness in Primary care)—a feasibility study

BackgroundPatients with mental illness have an increased risk of cardiovascular morbidity and mortality compared to the rest of the population, which is partly related to unhealthy lifestyle habits. To individualise lifestyle counselling in primary care, the Swedish-developed Health Dialogue (HD) can be used as an educative tool at recurrent measurement points with the goal to improve non-healthy lifestyle habits. HD has not been aimed specifically at patients with mental illness, and the effect of a systematic approach with repeated HDs in patients with mental illness in primary care has not been previously studied. The aim of this pilot study was to assess the feasibility of the study design for a larger-scale cohort study using repeated HDs focused on the improvement of lifestyle habits in patients seeking primary care due to anxiety, depression, sleeping problems or stress-related symptoms.MethodsPatients were recruited after a visit to a Primary Health Care Center due to mental illness between October 2019 until November 2021 and received a Health Dialogue, including an assessment of cardiovascular risk factors through a Health Curve. Specific feasibility objectives measured were dropout rate, time to follow-up, and risk improvement rate for different lifestyle changes.ResultsA total of 64 patients were recruited and 29 (45%) attended a second HD, with a mean follow-up time of 15 months. All participants had at least one elevated cardiovascular risk level on the Health Curve for the assessed lifestyles. Risk level improvement rate was good except for tobacco use.ConclusionDespite a higher dropout rate than expected, we suggest that the proposed methodology for a full cohort study within general practice of patients with mental illness in primary care is both acceptable to practice and feasible.Trial registrationNCT05181254. Registered January 6th, 2022. Retrospectively registered.

Understanding the medication safety challenges for patients with mental illness in primary care: a scoping review

BackgroundMental illness and medication safety are key priorities for healthcare systems around the world. Despite most patients with mental illness being treated exclusively in primary care, our understanding of medication safety challenges in this setting is fragmented.MethodSix electronic databases were searched between January 2000-January 2023. Google Scholar and reference lists of relevant/included studies were also screened for studies. Included studies reported data on epidemiology, aetiology, or interventions related to medication safety for patients with mental illness in primary care. Medication safety challenges were defined using the drug-related problems (DRPs) categorisation.ResultsSeventy-nine studies were included with 77 (97.5%) reporting on epidemiology, 25 (31.6%) on aetiology, and 18 (22.8%) evaluated an intervention. Studies most commonly (33/79, 41.8%) originated from the United States of America (USA) with the most investigated DRP being non-adherence (62/79, 78.5%). General practice was the most common study setting (31/79, 39.2%) and patients with depression were a common focus (48/79, 60.8%). Aetiological data was presented as either causal (15/25, 60.0%) or as risk factors (10/25, 40.0%). Prescriber-related risk factors/causes were reported in 8/25 (32.0%) studies and patient-related risk factors/causes in 23/25 (92.0%) studies. Interventions to improve adherence rates (11/18, 61.1%) were the most evaluated. Specialist pharmacists provided the majority of interventions (10/18, 55.6%) with eight of these studies involving a medication review/monitoring service. All 18 interventions reported positive improvements on some medication safety outcomes but 6/18 reported little difference between groups for certain medication safety measures.ConclusionPatients with mental illness are at risk of a variety of DRPs in primary care. However, to date, available research exploring DRPs has focused attention on non-adherence and potential prescribing safety issues in older patients with dementia. Our findings highlight the need for further research on the causes of preventable medication incidents and targeted interventions to improve medication safety for patients with mental illness in primary care.

District nurses’ experiences of giving initial health care assessment to young adults applying for mental illness in primary care: a qualitative interview study

Mental illness among young adults is increasing both nationally and internationally. Primary care's mission is to be the hub of health care and to offer high-quality care regardless of age, patient group, or disease. The role of district nurse varies in terms of definition and scope of practice but has a central role through their health promotion mission and by being the first person these young adults meet in primary care. The aim of this study was to explore district nurses' experiences of meeting young adults with mental illness in primary care. The study was conducted with a qualitative inductive approach. Data were collected through semi-structured interviews with nine district nurses in primary care in Sweden. The data were analysed through qualitative content analysis. Three categories emerged in the results - The difficult meeting, The district nurse's ability to promote health, and A sense of inadequacy. The results show that district nurses can experience feelings of stress and frustration when time, resources, and knowledge are lacking. Continuous training in mental illness was desired by all district nurses. Listening, confirming, and daring to ask were highlighted as particularly important in the meeting with young adults. Cooperation between different professions and colleagues was highlighted as a prerequisite for the provision of good quality care. To meet the increasing number of young adults with mental health problems seeking care, district nurses in primary care need continuous training. By working in a person-centred and health-promoting manner, the district nurse's competence can be utilized. The district nurses perceive they could manage the important role being a resource and take a greater responsibility to guide young adults on the right path.

Prevalence and associated factors of common mental disorders in primary care settings in Sofala Province, Mozambique.

In Mozambique, the prevalence of common mental illness in primary care is not well established. This study aimed to assess the prevalence of, and associated factors for, common mental illness in patients accessing primary care services in three Ministry of Health clinics in Mozambique. Adult patients were recruited from the waiting rooms of prenatal, postpartum and general out-patient consultations. A mental health professional administered a diagnostic interview to examine prevalence of major depressive disorder (MDD), generalised anxiety disorder (GAD), post-traumatic stress disorder (PTSD) and any substance misuse or dependence. Generalised linear mixed models were used to examine the odds of each disorder and sociodemographic associations. Of 502 patients interviewed, 74.1% were female (n = 372) and the average age was 27.8 years (s.d. = 7.4). Of all participants, 23.9% (n = 120) met diagnostic criteria for at least one common mental disorder; 8.6% were positive for MDD (n = 43), 13.3% were positive for GAD (n = 67), 4.8% were positive for PTSD (n = 24) and 4.0% were positive for any substance misuse or dependence (n = 20). Patients attending prenatal or postpartum consultations had significantly lower odds of any common mental disorder than patients attending out-patient primary care. Age was negatively associated with MDD, but positively associated with substance misuse or dependence. Over 20% of patients attending primary care in Mozambique may have common mental disorders. A specific focus on patients attending general out-patient visits, young people for depression, and older people and men for substance misuse/dependence would provide a targeted response to high-risk demographics.

Engaging Veterans With Serious Mental Illness in Primary Care.

Veterans with serious mental illness (SMI) are at substantial risk for premature mortality. Engagement in primary care can mitigate these mortality risks. However, veterans with SMI often become disengaged from primary care. The US Department of Veterans Affairs (VA) measures and reports at VA facilities primary care engagement among enrolled veterans with SMI. This quarterly metric enables VA facilities to identify targets for quality improvement and track their progress. To inform quality improvement at our VA facility, we sought to identify promising practices for supporting engagement in primary care among veterans with SMI. We conducted semistructured telephone interviews from May 2019 through July 2019 with a purposeful sample of key informants at VA facilities with high levels of engagement in primary care among veterans with SMI. All interviews were recorded, summarized using a structured template, and summaries placed into a matrix. An interdisciplinary team reviewed and discussed matrices to identify and build consensus around findings. We interviewed 18 key informants from 11 VA facilities. The strategies used to engage veterans with SMI fell into 2 general categories: targeted outreach and routine practices. Targeted outreach included proactive, deliberate, systematic approaches for identifying and contacting veterans with SMI who are at risk of disengaging from care. In targeted outreach, veterans were identified and prioritized for outreach independent of any visits with mental health or other VA services. Routine practices included activities embedded in regular clinical workflows at the time of veterans' mental health visits, assessing, and connecting/reconnecting veterans with SMI into primary care. In addition, we identified extensive formal and informal ties between mental health and primary care that facilitated engaging veterans with SMI in primary care. VA facilities with high levels of primary care engagement among veterans with SMI used extensive engagement strategies, including a diverse array of targeted outreach and routine practices. Intentionally designed organizational structures and processes and facilitating extensive formal and informal ties between mental health and primary care teams supported these efforts. Additional organizational cultural factors were especially relevant to routine practice strategies. The practices we identified should be evaluated empirically for their effects on establishing and maintaining engagement in primary care among veterans with SMI.

Structured assessment of modifiable lifestyle habits among patients with mental illnesses in primary care

Patients with mental illness have an increased risk of cardiovascular morbidity. The Swedish-developed Health Dialogue is a pedagogical tool to individualize lifestyle counselling, used in specific age-groups to improve lifestyle habits and decrease mortality, but not tested specifically for patients with mental illness. Patients > 18 years old seeking primary care due to symptoms related to mental illness and diagnosed with depression, sleeping disorders, stress and anxiety, were included. A nurse-led health dialogue was conducted, focusing on lifestyle habits, anthropometric measurements, and blood samples, resulting in tailored advice regarding the individual’s risk profile. All 64 participants had lifestyle areas with increased risk level. Approximately 20% had elevated fasting glucose, blood pressure or cholesterol levels, and over 40% had highest risk level in Waist–Hip-Ratio. 30% were overweight, or physical inactive. The results suggest the need of a larger cohort study with long-term follow up, to establish potentially positive effects on wellbeing, and decreased cardiovascular risk in patients with mental illness.Clinical trial registration: The study was registered at ClinicalTrials.gov January 6th, 2022, registration number NCT05181254.

Evaluating the safety of mental health-related prescribing in UK primary care: a cross-sectional study using the Clinical Practice Research Datalink (CPRD)

BackgroundMost patients with mental illness are managed in primary care, yet there is a lack of data exploring potential prescribing safety issues in this setting for this population.ObjectivesExamine the prevalence...

Family engagement as part of managing patients with mental illness in primary care.

The family unit plays a crucial role in patients with mental illness. Mental health problems have been associated with an assortment of dysfunctional social and psychological processes in one's family of origin, yet families are now expected to be responsible for the care of the patient with mental illness. There are many short- and long-term benefits of engaging the families in the care of patients with mental illness. However, the implementation of family engagement in patients with mental illness is fraught with challenges. The primary care provider possesses several distinctive characteristics that lend an advantage to successfully engaging the families of patients with mental illness, such as better accessibility, better rapport, and being associated with less stigma. Primary care providers could engage the family in various ways, ranging from basic functions such as psychoeducation and supporting the family's needs, to more specialised interventions such as family assessment and family therapy.

Mental Health Services Provision in Primary Care and Emergency Department Settings: Analysis of Blended Fee-for-Service and Blended Capitation Models in Ontario, Canada.

Treating mental illnesses in primary care is increasingly emphasized to improve access to mental health services. Although family physicians (FPs) or general practitioners are in an ideal position to provide the bulk of mental health care, it is unclear how best to remunerate FPs for the adequate provision of mental health services. We examined the quantity of mental health services provided in Ontario's blended fee-for-service and blended capitation models. We evaluated the impact of FPs switching from blended fee-for-service to blended capitation on the provision of mental health services in primary care and emergency department using longitudinal health administrative data from 2007 to 2016. We accounted for the differences between those who switched to blended capitation and non-switchers in the baseline using propensity score weighted fixed-effects regressions to compare remuneration models. We found that switching from blended fee-for-service to blended capitation was associated with a 14% decrease (95% CI 12-14%) in the number of mental health services and an 18% decrease (95% CI 15-20%) in the corresponding value of services. This result was driven by the decrease in services during regular-hours. During after-hours, the number of services increased by 20% (95% CI 10-32%) and the corresponding value increased by 35% (95% CI 17-54%). Switching was associated with a 4% (95% CI 1-8%) decrease in emergency department visits for mental health reasons. Blended capitation reduced provision of mental health services without increasing emergency department visits, suggesting potential efficiency gain in the blended capitation model in Ontario.

Serious Mental Illness in Primary Care: a National Physician Survey

Serious Mental Illness in Primary Care: a National Physician Survey

Mixed method evaluation of Relational Team Development (RELATED) to improve team-based care for complex patients with mental illness in primary care

BackgroundPatients with mental illness are frequently treated in primary care, where Primary Care Providers (PCPs) report feeling ill-equipped to manage their care. Team-based models of care improve outcomes for patients with mental illness, but multiple barriers limit adoption. Barriers include practical issues and psychosocial factors associated with the reorganization of care. Practice facilitation can improve implementation, but does not directly address the psychosocial factors or gaps in PCP skills in managing mental illness. To address these gaps, we developed Relational Team Development (RELATED).MethodsRELATED is an implementation strategy combining practice facilitation and psychology clinical supervision methodologies to improve implementation of team-based care. It includes PCP-level clinical coaching and a team-level practice change activity. We performed a preliminary assessment of RELATED with a convergent parallel mixed method study in 2 primary care clinics in an urban Federally Qualified Health Center in Southwest, USA, 2017-2018. Study participants included PCPs, clinic staff, and patient representatives. Clinic staff and patients were recruited for the practice change activity only. Primary outcomes were feasibility and acceptability. Feasibility was assessed as ease of recruitment and implementation. Acceptability was measured in surveys of PCPs and staff and focus groups. We conducted semi-structured focus groups with 3 participant groups in each clinic: PCPs; staff and patients; and leadership. Secondary outcomes were change in pre- post- intervention PCP self-efficacy in mental illness management and team-based care. We conducted qualitative observations to better understand clinic climate.ResultsWe recruited 18 PCPs, 17 staff members, and 3 patient representatives. We ended recruitment early due to over recruitment. Both clinics developed and implemented practice change activities. The mean acceptability score was 3.7 (SD=0.3) on a 4-point Likert scale. PCPs had a statistically significant increase in their mental illness management self-efficacy [change = 0.9, p-value= <.01]. Focus group comments were largely positive, with PCPs requesting additional coaching.ConclusionsRELATED was feasible and highly acceptable. It led to positive changes in PCP self-efficacy in Mental Illness Management. If confirmed as an effective implementation strategy, RELATED has the potential to significantly impact implementation of evidence-based interventions for patients with mental illness in primary care.

Prevalence of mental illness in primary care and its association with deprivation and social fragmentation at the small-area level in England.

We aimed to spatially describe mental illness prevalence in England at small-area geographical level, as measured by prevalence of depression, severe mental illness (SMI) and antidepressant prescription volume in primary care records, and how much of their variation was explained by deprivation, social fragmentation and sociodemographic characteristics. Information on prevalence of depression and SMI was obtained from the Quality and Outcomes Framework (QOF) administrative dataset for 2015/16 and the national dispensing dataset for 2015/16. Linear regression models were fitted to examine ecological associations between deprivation, social fragmentation, other sociodemographic characteristics and mental illness prevalence. Mental illness prevalence varied within and between regions, with clusters of high prevalence identified across England. Our models explained 33.4-68.2% of variability in prevalence, but substantial variability between regions remained after adjusting for covariates. People in socially cohesive and socially deprived areas were more likely to be diagnosed with depression, while people in more socially fragmented and more socially deprived areas were more likely to be diagnosed with SMI. Our findings suggest that to tackle mental health inequalities, attention needs to be targeted at more socially deprived localities. The role of social fragmentation warrants further investigation, and it is possible that depression remains undiagnosed in more socially fragmented areas. The wealth of routinely collected data can provide robust evidence to aid optimal resource allocation. If comparable data are available in other countries, similar methods could be deployed to identify high prevalence clusters and target funding to areas of greater need.

Understanding barriers to women seeking and receiving help for perinatal mental health problems in UK general practice: development of a questionnaire.

To develop a questionnaire to measure quantitatively barriers and facilitators to women's disclosure of perinatal mental health problems in UK primary care. To pilot and evaluate the questionnaire for content validity and internal consistency. Around 15% of women develop a mental illness in the perinatal period, such as depression, anxiety or post-traumatic stress disorder. In the United Kingdom, 90% of these women will be cared for in primary care, yet currently in as many as 50% of cases, no discussion of this issue takes place. One reason for this is that women experience barriers to disclosing symptoms of perinatal mental illness in primary care. These have previously been explored qualitatively, but no tool currently exists with which to measure these barriers quantitatively. Questionnaire items, drawn from qualitative literature and accounts of women's experiences, were identified, refined iteratively and arranged in themes. The questionnaire was piloted using cognitive debriefing interviews to establish content validity. Women completed a refined version online. Responses were analysed using descriptive statistics. Internal consistency of subscales was calculated using Cronbach's alpha. Cognitive debriefing interviews with five women showed the majority of questionnaire items were relevant, appropriate and easy to understand. The final questionnaire was completed by 71 women, and the majority of subscales had good internal consistency. The barrier scoring most highly was fear and stigma, followed by willingness to seek help and logistics of attending an appointment. Family/partner support and general practitioners' (GPs) reaction were the lowest scoring barriers. Factors facilitating disclosure were GPs being empathetic and non-judgemental and listening during discussions. In the future, this questionnaire can be used to examine which barriers are most important for particular groups of women. This may enable the development of strategies to improve acknowledgement and discussion, and prevent under-recognition and under-treatment, of perinatal mental health problems in primary care.

Mental illness in primary care: a narrative review of patient, GP and population factors that affect prescribing rates.

Mental illness poses a large and growing disease burden worldwide. Its management is increasingly provided by primary care. The prescribing of psychotropic drugs in general practice has risen in recent decades, and variation in prescribing rates has been identified by a number of studies. It is unclear which factors lead to this variation. To describe the variables that cause variation in prescribing rates for psychotropic drugs between general practices. A narrative review was conducted in January 2018 by searching electronic databases using the PRISMA statement. Studies investigating causal factors for variation in psychotropic prescribing between at least two general practice sites were eligible for inclusion. Ten studies met the inclusion criteria. Prescribing rates varied considerably between practices. Positive associations were found for many variables, including social deprivation, ethnicity, patient age and gender, urban location, co-morbidities, chronic diseases and GP demographics. However studies show conflicting findings, and no single regression model explained more than 57% of the variation in prescribing rates. There is no consensus on the factors that most predict prescribing rates. Most research was conducted in countries with central electronic databases, such as the United Kingdom; it is unclear whether these findings apply in other healthcare systems. More research is needed to determine the variables that explain prescribing rates for psychotropic medications.

Evaluation of an electronic consultation service in psychiatry for primary care providers

BackgroundThis study explores the effectiveness of an electronic consultation (eConsult) service between primary care providers and psychiatry, and the types and content of the clinical questions that were asked.MethodsThis is a retrospective eConsult review study. All eConsults directed to Psychiatry from July 2011 to January 2015 by Primary care providers were reviewed. Response time and the amount of time reported by the specialist to answer each eConsult was analyzed. Each eConsult was also categorized by clinical topic and question type in predetermined categories. Mandatory post-eConsult surveys for primary care providers were analyzed to determine the number of traditional consults avoided and to gain insight into the perceived value of eConsults.ResultsOf the 5597 eConsults, 169 psychiatry eConsults were completed during the study period. The average response time for a specialist to a primary care provider was 2.3 days. Eighty-seven percent of clinical responses were completed by the psychiatrist in less than 15 min. The primary care providers most commonly asked clinical questions were about depressive and anxiety disorders. 88.7% of PCPs rated the eConsult service a 5 (excellent value) or 4.ConclusionsThis study indicates that an eConsult psychiatry service has tremendous potential to improve access to psychiatric advice and expand the capacity to treat mental illness in primary care. Future research may include follow-up with PCPs regarding the implementation of specialist advice.

Peer navigators to promote engagement of homeless African Americans with serious mental illness in primary care

Homeless African Americans with serious mental illness experience higher rates of morbidity and mortality than adults with severe mental illness alone. Peer navigators, individuals with similar lived experiences, may help these individuals navigate the healthcare system to improve healthcare utilization. This study examined whether the Peer Navigator Program (PNP) improved scheduling and achieving healthcare appointments compared to treatment as usual (TAU) over the course of 12 months, including three periods within that timeframe: engagement (first three months), impact (middle six months), and maintenance (final six months). Results indicated no change during the first three months of the study, a significantly greater improvement in scheduled and achieved appointments for PNP compared to TAU during the middle six months, and maintenance of appointment change improvements over the final three months of the study. This research suggests peer navigators may offer a promising solution to barriers in utilizing the healthcare system for people with severe mental illness, especially those who may be homeless or from minority racial groups.

Peer navigators to promote engagement of homeless African Americans with serious mental illness in primary care

Peer navigators to promote engagement of homeless African Americans with serious mental illness in primary care

Barriers, facilitators, and effective interventions for lowering cardiovascular disease risk in people with severe mental illnesses: evidence from a systematic review and focus group study

BackgroundPeople with severe mental illnesses die early from cardiovascular disease (CVD). They have increased CVD risk factors, yet are less likely to receive appropriate treatments. Little is known about effective interventions to reduce CVD risk in severe mental illness. This study aimed to consolidate the best available evidence on lowering CVD risk in severe mental illness in primary care. Methods75 participants took part in 14 focus groups. Participants included people with severe mental illness, general practitioners, practice nurses, community mental health staff, and carers. Staff were asked to identify the training, resources, and systems required to lower CVD risk in severe mental illness, while access to services, motivation, and capability to lower CVD risk were explored with people with severe mental illness. Effective interventions were identified through a systematic review. We searched the Cochrane Library for systematic reviews of randomised controlled trials (RCTs) and the Cochrane Schizophrenia and Cochrane Depression, Anxiety and Neurosis Group Trial Registers between 1966 and 2014 for additional RCTs. Search terms were (schizophrenia, severe mental illness, bipolar, mania, manic, hypomani*, psychos*, psychotic, rapid cycling, schizoaffective) AND (physical, cardio*, metabolic, weight, tobacco, smok, medical, alcohol, nutrition, diet, health, diabet*, blood pressure, hypertension, cholesterol, statin). Non-English language papers were excluded. Data from included studies were extracted with a template to record methodological and substantive characteristics. FindingsFocus groups identified five barriers: negative perceptions of severe mental illnesses, difficulties accessing services, difficulties managing a healthy lifestyle, not attending appointments, and lack of awareness of CVD risk. Five facilitators included social support, improving patient engagement, continuity of care, positive feedback, and goal setting. 15 systematic reviews and 28 additional RCTs were included. Effective pharmacological and behavioural interventions to manage weight and promote smoking cessation or reduction were identified. There was minimal evidence of effective interventions to reduce alcohol use and blood glucose and no evidence for interventions targeting cholesterol, hypertension, or diabetes. InterpretationCVD risk attributable to weight and smoking can be reduced in severe mental illness; other risk factors must currently be managed as for other populations. However we identified factors that can be incorporated in the design, delivery, and evaluation of services to reduce CVD risk for people with severe mental illness in primary care. New interventions should address these barriers and harness facilitating factors to reduce CVD risk in this population. FundingThis work was funded as part of a National Institute for Health Research Programme grant for applied research (ref RP-PG-0609-10156).

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.

BackgroundPeople 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/DesignThe 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.DiscussionThe 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 registrationCurrent Controlled Trials ISRCTN13762819. Date of Registration: 25 February 2013.Date and Version Number: 27 August 2014 Version 5.