Investigating the cost-effectiveness of interventions to reduce hazardous prescribing associated with antithrombotic drugs in primary care.

Study type
Protocol
Date of Approval
Study reference ID
18_235
Lay Summary

Blood thinners, such as aspirin and warfarin, are commonly used drugs to prevent strokes and heart attacks. Even though they are very effective bleedings are more likely, for instance bleeding in the stomach or brain, which can lead to death. We have developed a set of patient safety indicators representing potentially "hazardous prescribing events" (HPEs). The overall aim of this study is to get information for an evaluation of the value for money of programmes that try to reduce the number of HPEs. There is some evidence about how often HPEs occur, but we do not know how much harm they cause to patients. Therefore, we will use linked primary care, hospital and mortality records to investigate the relationship between HPEs and patient harm in England. HPEs are also likely to be associated with high costs due to events like hospital admissions for stomach bleeds. We plan to analyse the value for money of programmes targeting HPEs by combining information on harm and costs related to HPEs.

Technical Summary

Antithrombotic treatments, such as oral anticoagulants (OACs) and antiplatelets, are highly effective in reducing cardiovascular risk. However, due to the mechanism of action, bleedings are likely. Bleeding events, such as gastrointestinal (GI) bleeds or intracranial haemorrhages (ICH), are rare but have a huge impact on patient's quality of life and treatment costs. Hazardous or erroneous prescribing of antithrombotics, which will be referred to as hazardous prescribing events (HPEs), is associated with an increased risk of bleeding and mortality. This study will analyse specific HPEs defined by a set of patient safety indicators (PSIs). The PSIs are used in interventions that aim to reduce HPE. To analyse the cost-effectiveness of these interventions information on HPE prevalence, associated harm and costs are required. Evidence on harm for the patient and costs related to HPEs is sparse. Therefore, this study will undertake a retrospective cohort analysis to estimate the incidence of harm including bleeding events, mortality and NHS costs associated with HPEs using linked primary and secondary healthcare datasets. Probabilities of bleeding events, mortality and resource use will be used to generate input parameters for an economic model which will estimate the overall economic impact of hazardous prescribing in this context.

Health Outcomes to be Measured

Bleeding (primary outcome)
- Stroke
- Individual drug and regimen adherence and persistence
- Mortality
- Primary care utilisation
- Myocardial infarction
- Secondary care utilisation

Collaborators

Rachel Elliott - Chief Investigator - University of Manchester
Leonie Brinkmann - Corresponding Applicant - University of Manchester
- Collaborator -
Bruce Guthrie - Collaborator - University of Edinburgh
Daniel Morales - Collaborator - University of Dundee
Darren Ashcroft - Collaborator - University of Manchester
Elizabeth Camacho - Collaborator - University of Manchester
Georgios Gkountouras - Collaborator - University of Manchester
Jack Wilkinson - Collaborator - University of Manchester
Jill Stocks - Collaborator - University of Manchester
Niels Peek - Collaborator - University of Manchester
Sean Gavan - Collaborator - University of Manchester
Tjeerd van Staa - Collaborator - University of Manchester
Tony Avery - Collaborator - University of Nottingham

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation