Integrated care pathway for stroke and cardiovascular outcomes: A population-based cohort study

Study type
Protocol
Date of Approval
Study reference ID
22_002055
Lay Summary

Stroke, a disease that occurs when the blood vessels that carry blood to the brain are suddenly interrupted, is a leading cause of disability and death. The factors that make someone more likely to have a stroke, in most cases are the same for other diseases of the heart and blood vessels such as heart attack. Therefore, to reduce the likelihood of another stroke, heart attack, or even death in patients who have been diagnosed as having a stroke, experts have recently recommended a more complete care plan (“ABC” integrated-care-pathway):
A – Appropriate use of medications to prevent/reduce blood clot
B – Better functional and psychological status
C – Cardiovascular risk factors and comorbidity optimisation (including lifestyle changes)

Using electronic patient records from general practices across the UK, this study aims to find out the effect of an integrated care plan on a person’s possibility of having another stroke or other diseases of the heart and blood vessels or death in patients who have been diagnosed as having stroke for the very first time. Patients who have been treated based on the integrated-care-plan will be compared with patients who have not been treated based on that plan in whole or partially.

The findings of this study will provide evidence that could influence the care that is provided to patients who have been diagnosed as having stroke. Providing the appropriate care could reduce the number of patients who end up with heart and blood vessel diseases including stroke or death.

Technical Summary

Given the common shared risk factors for stroke and cardiovascular disease, an integrated care approach has recently been recommended to optimise the management of patients with stroke. This follows the success of the same approach for people with atrial fibrillation. However, the impact of an integrated care (ABC) approach on subsequent major cardiovascular morbidity and mortality outcomes in patients with an incident diagnosis of stroke has not been explored.

This study will use a cohort study design to evaluate the association between integrated care (ABC) approach compliance and incidence of new major cardiovascular morbidity and mortality outcomes after incident diagnosis of stroke.

Linked primary care (both CPRD GOLD and Aurum) and hospital records (HES Admitted Patient Care) in the UK will be used to define a cohort of patients aged 18 years and over, with the first diagnosis of stroke (intracerebral haemorrhage, ischaemic stroke, and stroke not otherwise specified) from January 1997 to December 2021. All eligible patients will be categorized into two groups: (i) those treated in compliance to the ABC integrated pathway after incident stroke and (ii) those who were not.

The cumulative incidence of the primary and secondary outcomes will be estimated using a Kaplan–Meier product-limit estimator for each group and survival curves will be compared using the log-rank test. The risk of subsequent cardiovascular morbidity and mortality outcomes between the groups will be assessed using the Fine and Gray competing risk models with death from all causes as a competing risk. The study will provide real-world evidence on the potential benefits of the integrated care (ABC) approach in the management of patients with an incident stroke diagnosis.

Health Outcomes to be Measured

The health-related outcomes that are expected to be assessed are:

Primary outcome: Major adverse cardiovascular event (MACE) is defined as a composite of coronary heart disease, recurrent stroke, peripheral vascular disease, heart failure, and cardiovascular mortality.

Secondary outcomes:
• Morbidity outcomes
o Coronary heart disease (defined as a diagnosis of either myocardial infarction, angina (stable or unstable), CHD not otherwise specified, or a record for coronary revascularisation [coronary bypass surgery or coronary angioplasty]).
o Recurrent stroke (including haemorrhagic stroke, ischaemic stroke and stroke not otherwise specified).
o Peripheral vascular disease
o Heart failure
o Dementia and cognitive impairment

• Mortality outcomes
o Cardiovascular-related mortality including sudden cardiac death
o All-cause mortality

Collaborators

Ralph Kwame Akyea - Chief Investigator - University of Nottingham
Ralph Kwame Akyea - Corresponding Applicant - University of Nottingham
Dimitrios Sagris - Collaborator - University of Liverpool
George Ntaios - Collaborator - University of Thessaly
Gregory Lip - Collaborator - University of Liverpool
Nadeem Qureshi - Collaborator - University of Nottingham

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation