Coronary heart disease

Coronary heart disease, especially when chest pain is present, often causes functional limitation, distressing symptoms, is often life-threatening and requires long-term management, mostly in primary care. Many patients with CHD have a documented history of myocardial infarction (MI) or coronary artery disease shown at angiography. CHD also causes 70% of heart failure with fatigue and shortness of breath. CHD mainly comprises three groups of patients with: chronic stable angina (with exertional chest pain), post MI, and heart failure with a hierarchy of physical and emotional effects. The researchers at Imperial College London, on behalf of the Public Health Observatories of England, have developed a prevalence model.⁸ They estimate the prevalence of CHD in primary care trusts and at local authority level to be 5.80%, although this number rises to 16.08% in people aged 65–74 years, and 21.91% in those ≥ 75 years. In the south London primary care trusts of Lambeth, Southwark and Lewisham, the prevalence is 3.30%, 3.50%, and 3.85%, respectively (≥ 15% in those aged 65–74 years and ≥ 22% in those ≥ 75 years).⁸

Depression

Depression is a major public health problem responsible for around 100 million lost working days in England and Wales each year and costing £9B per annum.⁹ In the UK, depression is a common reason for consulting a general practitioner (GP). Up to one-third of people who visit the GP have mental health problems, and 90% of those are treated only in primary care.¹⁰

Depression incurs a 50% increase in the cost of long-term medical care after controlling for the severity of the physical illness,¹¹ and this may relate to the link between depression and adverse health risk behaviours such as smoking, diet, lack of exercise and poor self-care. Depression may exacerbate the perceived severity of symptoms and this, in turn, can bring about an increase in health service utilisation. Treating depression and improving outcomes for depression has been shown to reduce health costs in people with physical illness.¹¹ Furthermore, collaborative care and individualised management of patients with depression and chronic conditions, such as diabetes and CHD, has shown to improve both medical outcomes and depression.¹²

Depression and coronary heart disease comorbidity

Depression occurs in up to 20% of patients with CHD and depression increases the incidence and recurrence of CHD, acute coronary syndromes and mortality.⁵ A systematic review by Nicholson et al.¹³ places the pooled relative risk (RR) of future CHD associated with depression at 1.81; however, the authors stop short of calling depression an independent risk factor for developing CHD, owing to the heterogeneity of studies.

The clear association that exists between these two conditions has led to a long discussion about the precise nature of the relationship. Ageing (which increases the odds of both conditions), lifestyle factors, inflammation pathways, heart rate variability, impaired arterial repair and several genes, are just some of the mechanisms that could play a role.¹⁴ Nevertheless, the link is well established. A review by the American Heart Association¹⁵ recently recommended that depression be considered an independent risk factor for adverse outcomes in patients with acute coronary syndrome, given the strength of the evidence in the current literature.

The presence of concurrent physical illness, such as CHD, is known to reduce the likelihood of major depression being recognised by GPs.¹⁶ Diagnosing depression in elderly primary care patients is hampered by conditions such as heart disease and the drugs to treat these conditions, which can have mood-destabilising effects.¹⁷ The natural history, morbidity and mortality of depression in primary care CHD populations are unknown.

As GP practices keep separate registers for their patients with heart failure, this programme of research is solely concerned with CHD and patients on CHD registers rather than patients on heart failure registers. This also means that the focus of research in terms of physical symptoms is purely on chest pain rather than on fatigue and dyspnoea.

Managing depression and coronary heart disease

Although there are several treatment options for managing depression in primary care that are endorsed by the National Institute for Health and Care Excellence (NICE)¹⁸ [e.g. antidepressant medication, supervised exercise, guided self-help, problem-solving, computerised cognitive–behavioural therapy (CBT), group or individual CBT or interpersonal therapy], the treatment preferences of CHD patients are unknown, as are primary care professional treatment preferences. A recent US working party on the management of depression in CHD concluded that RCTs comparing stepped depression care with treatment as usual (TAU) for patients with CHD and depression are needed.⁵

It remains unclear how GPs and practice nurses (PNs) should best manage patients with depression and CHD. Previous research, which has been largely from the USA, has focused on treating depression with antidepressant medication, psychological treatment, case management and collaborative care. Because of the absence of available evidence in this area, we decided to conduct a systematic review and metasynthesis of available evidence in work package 1.

Medication and psychological treatment

Two large US-based trials^19,20 have also provided an indication in post-hoc subgroup analyses that there may have been cardiovascular benefit from the management of the depression using antidepressant medication and it has been suggested that this may be owing to an effect on platelet activation.^21,22 Mortality seems to have been reduced in those whose depression improved or in those who took sertraline (Zoloft^®, Pfizer) in one study.^23,24 This evidence was influential in the introduction of financial incentive payments to English GPs for screening consecutive CHD patients for comorbid depressive disorder under the General Medical Services Quality and Outcomes Framework (QOF), although this was abandoned in 2013.

Case management

Case management has been shown to improve outcomes for depression in primary health-care settings,²⁵ but there has been no research to determine the cost-effectiveness in patients with CHD. Case management is ‘taking responsibility for following-up patients; determining whether patients were continuing the prescribed treatment as intended; assessing whether depressive symptoms were improving; taking action when patients were not adhering to guideline-based treatment or were not showing expected improvement’.²⁶ It consists of five essential components:²⁵

1. identification of patients in need of services
2. assessing individual patient’s needs
3. developing personalised treatment plans
4. co-ordination of care
5. monitoring outcomes and altering care when favourable outcomes are not achieved.

Collaborative care

An early, large US-based multicentre study of stepped collaborative depression care showed positive results regarding depression in older people as did another US trial of collaborative depression care in diabetics in motivated patients.^27,28 However, the latter trial did not improve diabetic outcome.²⁸ Subsequently, during the life of the UPBEAT-UK programme, Katon et al.,¹² using collaborative care, were able to demonstrate in a groundbreaking study the improvement of depression, systolic hypertension, glycosylated haemoglobin and blood lipids. As they applied rigorous nurse care to the depression, hypertension, diabetes and lipid abnormalities, it is not clear to what extent the management of depression contributed to the improvement of the physical outcome measures. Since then, and again in the lifetime of the UPBEAT-UK programme, it has been demonstrated that collaborative care as a model works in an English setting for depressive disorder, albeit with a modest effect size.²⁹ Collaborative care usually requires the collaboration of psychiatrists or other mental health professionals working together with their primary care colleagues to supervise case management by dedicated case workers. These care workers are usually mental health professionals brought in for the purpose of overseeing the case management and liaising with the patient’s primary and secondary care workers.

The overall design of the UPBEAT-UK programme led to a pilot RCT in order to inform a future definitive RCT of the cost-effectiveness of PN-led personalised case management in primary care for patients with CHD and depression. A pilot RCT was necessary to determine whether or not case management by PNs for this population would be a feasible and acceptable intervention compared with TAU in terms of both depression and cardiac outcomes.

The first step was to judge the acceptability, feasibility and likely effect of case management to inform whether or not to conduct a future definitive RCT. As any future potential definitive RCT would be a complex intervention, it was necessary to follow Medical Research Council (MRC) guidelines³⁰ for the development of a complex intervention using a programme of related work packages to develop and test a new nurse-led personalised case management practice for depression and CHD in primary care. The overall scientific framework for the UPBEAT-UK programme was the MRC framework for the development and testing of complex interventions.³⁰ This framework has four stages:

Stage 1: development concerns the identification of existing evidence in order to develop the intervention to a point where it can be expected to have a beneficial effect. Conducting a systematic literature review or metasynthesis is recommended if such a review does not already exist. This is followed by the identification and development of theory with a rationale for the proposed intervention and likely change process. The development of theory may build on existing evidence and be supplemented with new (often qualitative) research. This should then lead to a testable model with a specific intervention, process and likely outcomes.

Stage 2: feasibility and piloting involves assessing the feasibility and acceptability of the new complex intervention and of the evaluation methods, including acceptability, compliance, delivery, randomisation, recruitment, retention, and observed variability around changes in the primary outcome to inform the power calculation for a subsequent definitive RCT. The pilot RCT examines key criteria for a definitive RCT.

Stage 3: evaluation involves the evaluation of the intervention using appropriate design usually by a definitive RCT.

Stage 4: implementation involves the routine implementation of the new intervention, surveillance, monitoring and long-term follow-up.

Stages 1–4 should be seen as cyclical rather than linear, with results from any stage informing not just subsequent stages but previous stages in continuous improvement and increasingly higher-level evaluation.³⁰ The UPBEAT-UK programme mainly involves stages 1 and 2 outlined above.

The four inter-related UPBEAT-UK work packages are:

1. a review of previous work in the area and qualitative study of GP and PN treatment preferences for this patient group
2. a qualitative study of patients with CHD and comorbid depression treatment preferences
3. a pilot RCT of nurse-led case management for depressed primary care patients with CHD
4. a 4-year cohort study of patients with CHD.

In this introductory chapter, the detailed methods will be described in each work package chapter.

Work package 1

A review and metasynthesis of the existing literature and a qualitative study of health professionals’ perceptions of distress and depression in patients with CHD.

Work package 2

Study of patients’ perceptions of distress and depression in patients with CHD.

Work package 3

Pilot RCT of primary care case management for depressed patients with symptomatic CHD (sCHD).

Work package 4