Enhanced psychological care in cardiac rehabilitation services for patients with new-onset depression: the CADENCE feasibility study and pilot RCT.

BACKGROUND: Around 19% of people screened by UK cardiac rehabilitation programmes report having moderate or severe symptoms of depression. These individuals are at an increased risk of cardiac mortality and morbidity, reduced quality of life and increased use of health resources compared with their non-depressed counterparts. Maximising psychological health is a goal of cardiac rehabilitation, but psychological care is patchy. OBJECTIVE(S): To examine the feasibility and acceptability of embedding enhanced psychological care (EPC) within cardiac rehabilitation, we tested the feasibility of developing/implementing EPC and documented the key uncertainties associated with undertaking a definitive evaluation. DESIGN: A two-stage multimethods study; a feasibility study and a qualitative evaluation, followed by an external pilot cluster randomised controlled trial (RCT) with a nested qualitative study. SETTING: UK comprehensive cardiac rehabilitation teams. PARTICIPANTS: Adults eligible for cardiac rehabilitation following an acute coronary syndrome with new-onset depressive symptoms on initial nurse assessment. Patients who had received treatment for depression in the preceding 6 months were excluded. INTERVENTIONS: The EPC intervention comprised nurse-led mental health-care co-ordination and behavioural activation within cardiac rehabilitation. The comparator was usual cardiac rehabilitation care. MAIN OUTCOME MEASURES: Measures at baseline, and at the 5- (feasibility and pilot) and 8-month follow-ups (pilot only). Process measures related to cardiac team and patient recruitment, and participant retention. Outcomes included depressive symptoms, cardiac mortality and morbidity, anxiety, health-related quality of life and service resource use. Interviews explored participant and nurses' views and experiences. RESULTS: Between September 2014 and May 2015, five nurses from four teams recruited participants into the feasibility study. Of the 203 patients screened, 30 were eligible and nine took part (the target was 20 participants). At interview, participants and nurses gave valuable insights into the EPC intervention design and delivery. Although acceptable, the EPC delivery was challenging for nurses (e.g. the ability to allocate sufficient time within existing workloads) and the intervention was modified accordingly. Between December 2014 and February 2015, 8 out of 20 teams approached agreed to participate in the pilot RCT [five were randomised to the EPC arm and three were randomised to the usual-care (UC) arm]. Of the 614 patients screened, 55 were eligible and 29 took part (the target was 43 participants). At baseline, the trial arms were well matched for sex and ethnicity, although the EPC arm participants were younger, from more deprived areas and had higher depression scores than the UC participants. A total of 27 out of 29 participants were followed up at 5 months. Interviews with 18 participants (12 in the EPC arm and six in the UC arm) and seven nurses who delivered EPC identified that both groups acknowledged the importance of receiving psychological support embedded within routine cardiac rehabilitation. For those experiencing/delivering EPC, the intervention was broadly acceptable, albeit challenging to deliver within existing care. LIMITATIONS: Both the feasibility and the pilot studies encountered significant challenges in recruiting patients, which limited the power of the pilot study analyses. CONCLUSIONS: Cardiac rehabilitation nurses can be trained to deliver EPC. Although valued by both patients and nurses, organisational and workload constraints were significant barriers to implementation in participating teams, suggesting that future research may require a modified approach to intervention delivery within current service arrangements. We obtained important data informing definitive research regarding participant recruitment and retention, and optimal methods of data collection. FUTURE RESEARCH: Consideration should be given to the delivery of EPC by dedicated mental health practitioners, working closely with cardiac rehabilitation services. TRIAL REGISTRATION: Current Controlled Trials ISRCTN34701576. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 30. See the NIHR Journals Library website for further project information.

Cardiovascular screening of people with severe mental illness in England: views of service users and providers.

OBJECTIVE: In England national clinical guidelines recommend annual screening for cardiovascular risk factors among individuals with schizophrenia and bipolar disorder within primary care supported by efforts to promote healthy behaviors by secondary psychiatric services. This study elicited the views of primary and specialty mental health care staff and service users about such service arrangements and barriers to implementation. METHODS: Surveys were mailed to a representative cross-section of service users, community mental health team (CMHT) staff, and primary care staff in Western England and London. RESULTS: Surveys were completed by 227 service users, 143 primary care staff, and 166 CMHT staff. A majority of staff stated that cardiovascular disease screening and risk reduction work were important, felt that this work was best accomplished in primary care settings, and anticipated good uptake among service users. More than 80% of service users viewed cardiovascular screening favorably, but 30% had not been screened in the past year. The proportion of service users prepared to make healthy changes in their lifestyle varied from 37% to 51%, depending on the change contemplated, but many cited difficulty traveling (35%), time pressures (28%), and a distaste for courses or group work (23%) as barriers to attending courses in healthy living. CONCLUSIONS: The obstacles to service identified by this study reinforce the importance of providing incentives for both providers and users of services to improve implementation of national clinical guidelines on mental illness.

Impact of a nurse-led intervention to improve screening for cardiovascular risk factors in people with severe mental illnesses. Phase-two cluster randomised feasibility trial of community mental health teams.

BACKGROUND: People with severe mental illnesses (SMI) are at increased risk of cardiovascular disease (CVD). Clinical guidelines recommend regular screening for CVD risk factors. We evaluated a nurse led intervention to improve screening rates across the primary-secondary care interface. METHODS: Six community mental health teams (CMHTs) were randomised to receive either the nurse led intervention plus education pack (n = 3) or education pack only (n = 3). Intervention (6 months): The nurse promoted CVD screening in primary care and then in CMHTs. Patients who remained unscreened were offered screening by the nurse. After the intervention participants with SMI were recruited from each CMHT to collect outcome data. MAIN OUTCOME: Numbers screened during the six months, confirmed in General Practice notes. RESULTS: All six CMHTs approached agreed to randomisation. 121 people with SMI participated in outcome interviews during two waves of recruitment (intervention arm n = 59, control arm n = 62). Participants from both arms of the trial had similar demographic profiles and rates of previous CVD screening in the previous year, with less than 20% having been screened for each risk factor. After the trial, CVD screening had increased in both arms but participants from the intervention arm were significantly more likely to have received screening for blood pressure (96% vs 68%; adjusted Odds Ratio (OR) 13.6; 95% CI: 3.5-38.4), cholesterol (66.7% vs 26.9%, OR 6.1; 3.2-11.5), glucose (66.7% vs 36.5% OR 4.4; 2.7-7.1), BMI (92.5% vs 65.2% OR 6.5; 2.1-19.6), and smoking status (88.2% vs 57.8% OR 5.5; 3.2-9.5) and have a 10 year CVD risk score calculated (38.2% vs 10.9%) OR 5.2 1.8-15.3). Within the intervention arm approximately half the screening was performed in general practice and half by the trial nurse. CONCLUSIONS: The nurse-led intervention was superior, resulting in an absolute increase of approximately 30% more people with SMI receiving screening for each CVD risk factor. The feasibility of the trial was confirmed in terms of CMHT recruitment and the intervention, but the response rate for outcome collection was disappointing; possibly a result of the cluster design. The trial was not large or long enough to detect changes in risk factors. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Registration Number (ISRCTRN) 58625025.

Relative risk of diabetes, dyslipidaemia, hypertension and the metabolic syndrome in people with severe mental illnesses: systematic review and metaanalysis.

BACKGROUND: Severe mental illnesses (SMI) may be independently associated with cardiovascular risk factors and the metabolic syndrome. We aimed to systematically assess studies that compared diabetes, dyslipidaemia, hypertension and metabolic syndrome in people with and without SMI. METHODS: We systematically searched MEDLINE, EMBASE, CINAHL & PsycINFO. We hand searched reference lists of key articles. We employed three search main themes: SMI, cardiovascular disease, and each cardiovascular risk factor. We selected cross-sectional, case control, cohort or intervention studies comparing one or more risk factor in both SMI and a reference group. We excluded studies without any reference group. We extracted data on: study design, cardiovascular risk factor(s) and their measurement, diagnosis of SMI, study setting, sampling method, nature of comparison group and data on key risk factors. RESULTS: Of 14592 citations, 134 papers met criteria and 36 were finally included. 26 reported on diabetes, 12 hypertension, 11 dyslipidaemia, and 4 metabolic syndrome. Most studies were cross sectional, small and several lacked comparison data suitable for extraction. Meta-analysis was possible for diabetes, cholesterol and hypertension; revealing a pooled risk ratio of 1.70 (1.21 to 2.37) for diabetes and 1.11 (0.91 to 1.35) of hypertension. Restricting SMI to schizophreniform illnesses yielded a pooled risk ratio for diabetes of 1.87 (1.68 to 2.09). Total cholesterol was not higher in people with SMI (Standardized Mean Difference -0.10 (-0.55 to 0.36)) and there were inconsistent data on HDL, LDL and triglycerides with some, but not all, reporting lower levels of HDL cholesterol and raised triglyceride levels. Metabolic syndrome appeared more common in SMI. CONCLUSION: Diabetes (but not hypertension) is more common in SMI. Data on other risk factors were limited by poor quality or inconsistent research findings, but a small number of studies show greater prevalence of the metabolic syndrome in SMI.

Prevention of coronary heart disease in people with severe mental illnesses: a qualitative study of patient and professionals' preferences for care.

BACKGROUND: People with severe mental illness (SMI) are at increased risk of developing coronary heart disease (CHD) and there is growing emphasis on the need to monitor their physical health. However, there is little consensus on how services for the primary prevention of CHD should be organised for this patient group. We explored the views of people with SMI and health professionals from primary care and community mental health teams (CMHTs) on how best to provide these services. METHODS: In-depth interviews were conducted with a purposive sample of patients with SMI (n = 31) and staff from primary care (n = 10) and community mental health teams (n = 25) in North Central London. Transcripts of the qualitative interviews were analysed using a 'framework' approach to identify the main themes in opinions regarding various service models. RESULTS: Cardiovascular risk factors in people with SMI were of concern to participants. However, there was some disagreement about the best way to deliver appropriate care. Although staff felt that primary care should take responsibility for risk factor screening and management, patients favoured CHD screening in their CMHT. Problems with both approaches were identified. These included a lack of familiarity in general practice with SMI and antipsychotic side effects and poor communication of physical health issues to the CMHT. Lack of knowledge regarding CHD risk factor screening and difficulties in interpreting screening results and implementing appropriate interventions exist in secondary care. CONCLUSION: Management of physical health care for people with SMI requires complex solutions that cross the primary-secondary care interface. The views expressed by our participants suggest that neither primary nor secondary care services on their own can provide a comprehensive service for all patients. The increased risk of CHD associated with SMI and antipsychotic medications requires flexible solutions with clear lines of responsibility for assessing, communicating and managing CHD risks.