Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
420048 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-05-06
Study Completion Date
2020-04-01
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Acute Coronary Syndrome
STEMI
Non STEMI
Study Design
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Observational Model Type
OTHER
Study Time Perspective
RETROSPECTIVE
Study Groups
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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.
No interventions
Intervention Type
OTHER
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.
No interventions
Intervention Type
OTHER
No interventions
Interventions
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No interventions
No interventions
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* patients who self-presented at hospitals with suspected ACS
* patients who developed ACS whilst in hospital
Minimum Eligible Age
18 Years
Maximum Eligible Age
110 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Swansea University
OTHER
Sponsor Role
collaborator
University of Leeds
OTHER
Sponsor Role
collaborator
London Ambulance Service
OTHER
Sponsor Role
collaborator
West Midlands Ambulance Service NHS Foundation Trust
UNKNOWN
Sponsor Role
collaborator
South West Ambulance Service NHS Foundation Trust
UNKNOWN
Sponsor Role
collaborator
Kingston University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Tom Quinn, FESC FAHA FACC
Role: PRINCIPAL_INVESTIGATOR
Kingston University & St George's, University of London
Locations
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South Western Ambulance Service NHS Foundation Trust
Exeter, Devon, United Kingdom
Site Status
Welsh Ambulance Services NHS Trust
Cardiff, Wales, United Kingdom
Site Status
West Midlands Ambulance Service
Brierley Hill, West Midlands, United Kingdom
Site Status
Countries
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United Kingdom
References
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Welsford M, Nikolaou NI, Beygui F, Bossaert L, Ghaemmaghami C, Nonogi H, O'Connor RE, Pichel DR, Scott T, Walters DL, Woolfrey KG; Acute Coronary Syndrome Chapter Collaborators. Part 5: Acute Coronary Syndromes: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S146-76. doi: 10.1161/CIR.0000000000000274. No abstract available.
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O'Connor RE, Al Ali AS, Brady WJ, Ghaemmaghami CA, Menon V, Welsford M, Shuster M. Part 9: Acute Coronary Syndromes: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S483-500. doi: 10.1161/CIR.0000000000000263. No abstract available.
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BACKGROUND
Nikolaou NI, Arntz HR, Bellou A, Beygui F, Bossaert LL, Cariou A; Initial management of acute coronary syndromes section Collaborator. European Resuscitation Council Guidelines for Resuscitation 2015 Section 8. Initial management of acute coronary syndromes. Resuscitation. 2015 Oct;95:264-77. doi: 10.1016/j.resuscitation.2015.07.030. Epub 2015 Oct 15. No abstract available.
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BACKGROUND
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Reference Type
BACKGROUND
Quinn T, Johnsen S, Gale CP, Snooks H, McLean S, Woollard M, Weston C; Myocardial Ischaemia National Audit Project (MINAP) Steering Group. Effects of prehospital 12-lead ECG on processes of care and mortality in acute coronary syndrome: a linked cohort study from the Myocardial Ischaemia National Audit Project. Heart. 2014 Jun;100(12):944-50. doi: 10.1136/heartjnl-2013-304599. Epub 2014 Apr 14.
Reference Type
BACKGROUND
Curtis JP, Portnay EL, Wang Y, McNamara RL, Herrin J, Bradley EH, Magid DJ, Blaney ME, Canto JG, Krumholz HM; National Registry of Myocardial Infarction-4. The pre-hospital electrocardiogram and time to reperfusion in patients with acute myocardial infarction, 2000-2002: findings from the National Registry of Myocardial Infarction-4. J Am Coll Cardiol. 2006 Apr 18;47(8):1544-52. doi: 10.1016/j.jacc.2005.10.077. Epub 2006 Mar 29.
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BACKGROUND
Diercks DB, Kontos MC, Chen AY, Pollack CV Jr, Wiviott SD, Rumsfeld JS, Magid DJ, Gibler WB, Cannon CP, Peterson ED, Roe MT. Utilization and impact of pre-hospital electrocardiograms for patients with acute ST-segment elevation myocardial infarction: data from the NCDR (National Cardiovascular Data Registry) ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry. J Am Coll Cardiol. 2009 Jan 13;53(2):161-6. doi: 10.1016/j.jacc.2008.09.030.
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Ducas RA, Labos C, Allen D, Golian M, Jeyaraman M, Lys J, Mann A, Copstein L, Vokey S, Rabbani R, Zarychanski R, Abou-Setta AM, Menkis AH. Association of Pre-hospital ECG Administration With Clinical Outcomes in ST-Segment Myocardial Infarction: A Systematic Review and Meta-analysis. Can J Cardiol. 2016 Dec;32(12):1531-1541. doi: 10.1016/j.cjca.2016.06.004. Epub 2016 Jun 14.
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BACKGROUND
Surveillance report 2016 - Unstable angina and NSTEMI (2010) NICE guideline CG94 and Myocardial infarction with ST-segment elevation (2013) NICE guideline CG167 [Internet]. London: National Institute for Health and Care Excellence (UK); 2016 Sep 29. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK552026/
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Klerdal K, Varenhorst C, James S, Alfredsson L, Blomberg H, Moradi T. Sex as a determinant of prehospital ECG in ST- and non-ST elevation myocardial infarction patients. Heart. 2014 Nov;100(22):1817-8. doi: 10.1136/heartjnl-2014-306412. Epub 2014 Jul 24. No abstract available.
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O'Hara R, Johnson M, Siriwardena AN, Weyman A, Turner J, Shaw D, Mortimer P, Newman C, Hirst E, Storey M, Mason S, Quinn T, Shewan J. A qualitative study of systemic influences on paramedic decision making: care transitions and patient safety. J Health Serv Res Policy. 2015 Jan;20(1 Suppl):45-53. doi: 10.1177/1355819614558472.
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National Institute for Cardiovascular Outcomes Research. Myocardial Ischaemia National Audit Project. Heart attack in England, Wales and Northern Ireland. Annual Public Report April 2015 - March 2016. June 2017.
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Kaji AH, Schriger D, Green S. Looking through the retrospectoscope: reducing bias in emergency medicine chart review studies. Ann Emerg Med. 2014 Sep;64(3):292-8. doi: 10.1016/j.annemergmed.2014.03.025. Epub 2014 Apr 18. No abstract available.
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Schiele F, Gale CP, Bonnefoy E, Capuano F, Claeys MJ, Danchin N, Fox KA, Huber K, Iakobishvili Z, Lettino M, Quinn T, Rubini Gimenez M, Botker HE, Swahn E, Timmis A, Tubaro M, Vrints C, Walker D, Zahger D, Zeymer U, Bueno H. Quality indicators for acute myocardial infarction: A position paper of the Acute Cardiovascular Care Association. Eur Heart J Acute Cardiovasc Care. 2017 Feb;6(1):34-59. doi: 10.1177/2048872616643053. Epub 2016 Sep 20.
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Ji C, Quinn T, Gavalova L, Lall R, Scomparin C, Horton J, Deakin CD, Pocock H, Smyth MA, Rees N, Brace-McDonnell SJ, Gates S, Perkins GD. Feasibility of data linkage in the PARAMEDIC trial: a cluster randomised trial of mechanical chest compression in out-of-hospital cardiac arrest. BMJ Open. 2018 Jul 28;8(7):e021519. doi: 10.1136/bmjopen-2018-021519.
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Gavalova L, Halter M, Snooks H, Gale CP, Weston C, Watkins A, Munro S, Davies G, Hampton C, Driscoll T, Rosser A, Rees N, Black S, Quinn T. Use and impact of the prehospital 12-lead ECG in the primary PCI era (PHECG2): protocol for a mixed-method study. Open Heart. 2019 Dec 2;6(2):e001156. doi: 10.1136/openhrt-2019-001156. eCollection 2019.
Reference Type
DERIVED
Related Links
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Other Identifiers
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ECCCR_PHECG2
Identifier Type: -
Identifier Source: org_study_id
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