Dosage regimens and interrupted treatment in heart failure: a national retrospective cohort study in primary care.

Study type
Protocol
Date of Approval
Study reference ID
18_053
Lay Summary

Heart failure occurs when the heart does not pump blood as well as it should. Nearly one million people in the United Kingdom have heart failure. These patients experience debilitating symptoms, frequent hospitalisations, and an increased risk of death because of this condition.

Medical guidelines recommend several medications to relieve symptoms in patients with heart failure, avoid the need for hospitalisation, and help them to live longer. However, it is unclear if patients in the UK are given these medications in ways that maximise the possible benefits. We must therefore examine how many patients have an adequate supply of pills (enough for each day) and whether the doses they are given are appropriate. We must then determine the extent to which supply of pills and doses are related to better health outcomes. We will use the Clinical Practice Research Datalink and Hospital Episode Statistics databases to complete this study. The results could be used to improve prescribing of heart failure medications in UK primary care and improve health outcomes for patients.

Technical Summary

Heart failure (HF) is a leading cause of morbidity and mortality globally, and a major financial burden on health systems. Current medical guidelines recommend use of several medications to help manage patients with heart failure and a reduced ejection fraction. Studies have shown that the use of these medications in recommended doses improves survival, reduces hospital admissions, and can reduce health costs. However, it is unclear if patients in UK primary care receive adequate supplies of medications and whether target doses are being achieved. Patients may not receive or take medications correctly or at all, for various reasons related to the patient, the prescriber, or the healthcare system:
- they may not adhere to treatment, for example because of forgetfulness or adverse reactions;
- they may receive conflicting advice from carers;
- they may have limited access to health care, owing to geography or cost;
- repeat prescriptions may not be requested or issued.
However, before studying these factors in UK primary care we must first determine the extent to which interruptions in treatment occur and if they are associated with patient outcomes.

We shall therefore describe the proportion of patients with reduced ejection fractions experiencing interrupted treatment (days without pills) and determine the extent to which their prescribed doses meet guideline recommendations. We will then examine the association between interrupted treatment and prescribed dosage regimens and important patient outcomes (emergency hospital admissions and mortality) using Cox proportional hazards modelling adjusted for key co-variates. We will also examine if patient characteristics are associated with interrupted treatment and dosage regimens using Cox proportional hazards modelling and logistic regression. The results of this study could be used to inform quality improvement initiatives and improved management of patients with heart failure in UK primary care.

Health Outcomes to be Measured

Primary:
- Mortality
- All-cause emergency hospital admissions
- Cardiovascular-related emergency hospital admissions
Secondary:
- Treatment interruptions in heart failure medication
- Defined daily dose of heart failure medication

Collaborators

Carl Heneghan - Chief Investigator - University of Oxford
Niklas Bobrovitz - Corresponding Applicant - University of Oxford
Jeffrey Aronson - Collaborator - University of Oxford
Kamal Mahtani - Collaborator - University of Oxford
Margaret Smith - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of Oxford

Linkages

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