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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03699137
Other study ID # ECCCR_PHECG2
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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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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. Epub 2006 Mar 29. — View Citation

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. — View Citation

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. Review. — View Citation

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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. — View Citation

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. — View Citation

Kvale, S. InterViews: An introduction to qualitative research interviewing. Thousand Oaks, CA: Sage 1996.

McHugh ML. Interrater reliability: the kappa statistic. Biochem Med (Zagreb). 2012;22(3):276-82. — View Citation

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.

National Institute for Health and Care Excellence. Myocardial infarction with ST-segment elevation: acute management. Clinical guideline [CG167] July 2013

National Institute for Health and Clinical Excellence. Behaviour Change at Population, Community and Individual Levels. NICE Public Health Guidance. London: NICE, 2007

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. — View Citation

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. Review. — View Citation

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. — View Citation

Porter A, Snooks H, Youren A, Gaze S, Whitfield R, Rapport F, Woollard M. "Covering our backs": ambulance crews' attitudes towards clinical documentation when emergency (999) patients are not conveyed to hospital. Emerg Med J. 2008 May;25(5):292-5. doi: 10.1136/emj.2007.050443. — View Citation

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. — View Citation

Ritchie J, Lewis J, Nicholls CMN, et al. Qualitative research practice: A guide for social science students and researchers. Sage 2013.

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, Bøtker 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. — View Citation

Snooks HA, Kearsley N, Dale J, Halter M, Redhead J, Foster J. Gaps between policy, protocols and practice: a qualitative study of the views and practice of emergency ambulance staff concerning the care of patients with non-urgent needs. Qual Saf Health Care. 2005 Aug;14(4):251-7. — View Citation

Tubaro M, Danchin N, Goldstein P, Filippatos G, Hasin Y, Heras M, Jansky P, Norekval TM, Swahn E, Thygesen K, Vrints C, Zahger D, Arntz HR, Bellou A, De La Coussaye JE, De Luca L, Huber K, Lambert Y, Lettino M, Lindahl B, McLean S, Nibbe L, Peacock WF, Price S, Quinn T, Spaulding C, Tatu-Chitoiu G, Van De Werf F. Pre-hospital treatment of STEMI patients. A scientific statement of the Working Group Acute Cardiac Care of the European Society of Cardiology. Acute Card Care. 2011 Jun;13(2):56-67. doi: 10.3109/17482941.2011.581292. — View Citation

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* Note: There are 30 references in allClick 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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