Pre-hospital ECG in Acute Coronary Syndromes

Acute Coronary Syndrome Clinical Trial

— PHECG2  

Official title:

Use and Impact of the Pre-hospital 12-lead Electrocardiogram in the Primary PCI Era: Mixed Methods Study (PHECG2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699137
• Other study ID #: ECCCR_PHECG2
• Status: Completed
• Start date: May 6, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2020
• Source: Kingston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420048
• Est. completion date: April 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• Patients > 18 years of age

• Patients with ACS

• Patients who have been brought to hospital by Emergency Medical Service (EMS)

• Patients included in the MINAP registry

• First episode of ACS

• Patients with confirmed STEMI and NSTEMI

• EMS personnel trained in performing an ECG in the pre-hospital setting

• EMS personnel involved in care of patients with a suspected heart attack

Exclusion Criteria:

• patients < 18 years of age

• patients who self-presented at hospitals with suspected ACS

• patients who developed ACS whilst in hospital

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Non STEMI
• STEMI
• Syndrome

Intervention

Other:
• No interventions
No interventions

Locations

Country	Name	City	State
United Kingdom	West Midlands Ambulance Service	Brierley Hill	West Midlands
United Kingdom	Welsh Ambulance Services NHS Trust	Cardiff	Wales
United Kingdom	South Western Ambulance Service NHS Foundation Trust	Exeter	Devon

Sponsors (6)

Lead Sponsor	Collaborator
Kingston University	London Ambulance Service, South West Ambulance Service NHS Foundation Trust, Swansea University, University of Leeds, West Midlands Ambulance Service NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WP1: 30-day mortality	Proportion of patients who die within 30 days of the date of their event	30 days
Secondary	Time to death	Length of time in days from ACS event to death	Up to one year
Secondary	Hospital mortality	Proportion of patients in each group who die during the (initial) hospital stay following their event	Up to 90 days
Secondary	One year mortality	Proportion of patients in each group who die within one year of their ACS event.	One year
Secondary	Time under care of EMS	Length of time from EMS arrival on scene to patient arrives at hospital.	Up to 3 hours
Secondary	Use and type of reperfusion	Proportion of patients with STEMI who receive reperfusion treatment (pPCI or fibrinolytic).	24 hours
Secondary	Time to treatment	Time in minutes from initial EMS call to patients first recorded reperfusion treatment.(STEMI only)	24 hours

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