Improving the quality of care of patients with angina and heart attack
BACKGROUND
Unacceptable variations in care for patients with coronary disease are ubiquitous, but we do not have prospective large scale outcomes research linking general practice, specialist clinic, and in-patient hospital care. In order to evaluate explanations for these variations and test new interventions which are actionable in the NHS, we propose unique new observational research and a major randomized trial.
AIM
To evaluate important new opportunities for improving quality of care and outcomes for patients with chronic stable angina and acute coronary syndromes (ACS), integrated across the patient journey, and at different levels of care.
OBJECTIVES
(i) To determine the cumulative impact of missed opportunities for improving patient outcome, from the beginning to the end of the patient journey, across five of the most common symptomatic coronary presentations, assessing inequalities in care and outcome.
(ii) To determine at the level of the individual hospital the extent to which the organisation and processes of care have an impact on the patient journey.
(iii) To establish the effectiveness and cost-effectiveness of a multi-faceted intervention targeting initial specialist management at hospital chest pain clinics of patients early in the symptomatic phase of the patient journey.
(iv) To determine whether novel biomarkers are a cost-effective addition to existing clinical information in predicting the progression of chronic stable angina to acute fatal and non-fatal events.
RESEARCH PLANS
(i) We will identify patients presenting with coronary disease and reconstruct the longitudinal patient journey by establishing a linkage between primary care record datasets, the Myocardial Infarction National Audit Project, hospitalisation and death. We will examine missed opportunities for diagnosis, treatment and risk prediction, at multiple time points, and assess their relative impact on outcome.
(ii) We will determine how each of the 230 hospitals nationally differ in terms of patient outcomes after ACS, and identify explanations for variation which are amenable to action within the NHS, using quantitative surveys and an ethnographic study of hospital care.
(iii) We will develop the intervention (patient specific computerised decision support, coupled with training and support of clinicians) pilot it in 4 clinics, test its acceptability to clinicians and patients and the feasibility of a cluster randomized trial design. We will model the effectiveness and cost-effectiveness of the intervention with our pilot and external data, and use this for an expected value of information analysis to determine the need for a definitive trial powered on CVD events.
(iv) Clinical Cohorts in Coronary disease Collaboration (4C): This project involves phenotyping and genotyping people with suspected and confirmed stable coronary disease, with follow up for coronary endpoints. This study will allow a range of translational research questions to be addressed under different study designs appropriate to studying the causes of disease onset (case-control), disease progression (cohort) and pharmacogenetic effects.
STUDY DESIGN
Prospective, observational cohort study among 3000 consecutive patients with suspected and confirmed coronary disease recruited from rapid access chest pain clinics attending for investigation of their chest pain, or patients undergoing elective coronary angiography and non-invasive ischaemic testing or admitted to hospital with chest pain at four centres across England and Wales (Heart hospital (University College London Hospitals NHS Foundation Trust), the London Chest Hospital and Newham General Hospital (Barts NHS Trust) and the Bristol Heart Institute (University Hospitals Bristol NHS Foundation Trust).
Participant baseline assessment
Patients are consented for a research blood sample (21.5ml of blood is taken for biomarker and DNA analysis), completion of a short phenotyping questionnaire (quality of life, chest pain and symptoms and depression) and access to their medical records. Data on resting and exercise electrocardiography will be collected in addition to routine investigation (e.g. coronary angiogram) and blood results from the hospital and primary care electronic health record.
Follow up
Participants will be followed for primary outcome of all cardiovascular deaths and admissions for acute coronary syndrome events, stroke, peripheral vascular disease.