Pre-hospital ECG in Acute Coronary Syndromes (PHECG2)

April 2, 2020 updated by: Kingston University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

420048

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Devon
      • Exeter, Devon, United Kingdom, EX2 7HY
        • South Western Ambulance Service NHS Foundation Trust
    • Wales
      • Cardiff, Wales, United Kingdom, CF11 8PL
        • Welsh Ambulance Services NHS Trust
    • West Midlands
      • Brierley Hill, West Midlands, United Kingdom, DY5 1LX
        • West Midlands Ambulance Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Two types of study populations:

  1. - Patients with confirmed diagnosis of ACS in MINAP database as per inclusion and exclusion criteria
  2. - Emergency Medical Service personnel who have been trained to perform 12 lead ECG.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases with confirmed ACS
Cases with confirmed diagnosis of acute coronary syndrome in the MINAP database (national registry of ACS patients). No interventions apply to this group as this is an observational study.
Other: No interventions
No interventions
EMS personnel
Emergency Medical Service (EMS) personnel will take part in the focus group. No intervention applies to this group in this qualitative component of the study.
Other: No interventions
No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WP1: 30-day mortality
Time Frame: 30 days
Proportion of patients who die within 30 days of the date of their event
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kingston University

Collaborators

University of Leeds
Swansea University
London Ambulance Service
West Midlands Ambulance Service NHS Foundation Trust
South West Ambulance Service NHS Foundation Trust

Investigators

  • Principal Investigator: Tom Quinn, FESC FAHA FACC, Kingston University & St George's, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECCCR_PHECG2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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