Acute Coronary Syndrome Clinical Trial
Official title:
Use and Impact of the Pre-hospital 12-lead Electrocardiogram in the Primary PCI Era: Mixed Methods Study (PHECG2)
The Pre-Hospital 12-lead electrocardiogram (PHECG) is a simple test that helps ambulance
clinicians assess patients with suspected acute coronary syndrome (heart attack), and
provides clinical data to inform ongoing care. This project builds on previous work by this
team, which found that one in three eligible patients did not receive a PHECG, but those that
did had a lowered risk of short-term death. In this study the investigators will update that
work, and explore reasons for variations in practice - highlighting opportunities to improve
care and outcomes.
Using routinely collected data and qualitative methods, the investigators will research
patient, practitioner and contextual factors contributing to the decision to administer a
PHECG. The aim is also to develop an intervention to increase the proportion of eligible
patients that receive a PHECG, and to produce a proposal for further funding to test this
intervention in a subsequent randomised trial.
This mixed methods design study consists of four work packages:
WP1 - Population-based, linked cohort study using MINAP data from 2010-2016
This work package will entail analysis of data from around 420,000 pseudonymised patient
records from the MINAP database, linking to the Office for National Statistics (ONS) in order
to determine mortality/vital status. No patients will be contacted to obtain consent for
inclusion of their records in the study as NICOR (custodian of MINAP data) hold section 251
exemption to hold and process patient data for clinical audit purposes without their explicit
consent. The data will be released to the research team, using established processes, in
pseudonymised format.
The study statisticians will analyse the data provided from MINAP to determine how many heart
attack patients who came by ambulance survive to 30 days, estimate time to death, and will
estimate from the data whether more people who had an ambulance ECG survive compared to those
who did not have the test.
The aim of the study is also to determine from the data whether patients who have an
ambulance ECG receive treatment in hospital faster than those who did not.
WP2 - Retrospective chart review of ambulance records
The study statisticians will generate from the larger sample discussed above, a smaller
sample (approximately 1800 patients in total) specific to three National Health Service (NHS)
ambulance services (Welsh, West Midlands and South West). The investigators will then work
with those ambulance services to review the records held by the ambulance service, to see
what other information over and above that is collected in the national MINAP audit (e.g.
presenting symptoms, severity of any chest pain, public place or home, patient preferences
including declining to have the test, ambulance clinician grade and gender). The
investigators have worked with a 'task and finish group' of paramedics and cardiology experts
to agree which data might be helpful and devised specific forms to collect these data. Data
collection from ambulance records will be undertaken by NHS paramedics in the three ambulance
services, seconded to work on this project. These paramedics will receive specific training
in study procedures to ensure accuracy and data quality. Anonymised data collected by these
'research paramedics' will be sent to the research team by secure electronic database.
WP3 - Ambulance clinician self-report on PHECG recording
In this work package, clinical staff from the three participating ambulance Trusts (48 in
total) will be invited to participate in focus group discussions led by an experienced
researcher. A semi-structured topic guide (developed beforehand with the help and advice of a
small group of paramedics and cardiac experts, and our knowledge of previous literature on
paramedic decision making) will be used to explore the view of consenting ambulance
clinicians about their perceptions of the role of the PHECG, their experiences of assessing
patients with suspected heart attack, and factors which might influence the decision to
record (or not) an ECG when assessing and treating a patient.
Focus group discussions will be audio-recorded and transcribed. A method called framework
analysis will be used to analyse the transcribed records of the focus group discussions to
see whether any particular themes arise, including consensus or disagreement of ambulance
staff views on recording an ECG, and consider them against any differences in the
characteristics of focus group participants (e.g. grade of clinician, employing ambulance
service's local practice).
WP4 - Synthesis of the findings
The investigators will bring together ambulance staff, patient representatives, cardiac
experts and researchers to consider the findings from the three work packages described
above, with aim to synthesise the study findings and present evidence addressing the study
research questions. This will be done with consideration of the investigators' work as
forming the 'development phase' for the design of a complex intervention for further testing
in a later study.
The project has been designed with input from patient and public representatives especially
around the importance of the research question(s), potential impact of the findings for
patients and the public. The study team includes three paramedics who have been instrumental
in the design of the study as well as supporting documentation particularly for WP3.
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