Prehospital critical care for out-of-hospital cardiac arrest
| ISRCTN | ISRCTN18375201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18375201 |
| Secondary identifying numbers | 31703 |
- Submission date
- 03/10/2016
- Registration date
- 12/10/2016
- Last edited
- 14/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Out-of-hospital cardiac arrest (OHCA, the heart of a person stops beating while they are not in a hospital) is a common problem in the developed world and survival rates remain low. The current standard of care for OHCA in most modern ambulance services is advanced life support (ALS), which involves a set of life-saving techniques designed to help keep the heart beating and a person breathing. A number of ambulance trusts in the UK send pre-hospital critical care teams (CCTs) to patients having an OHCA, in addition to ALS paramedics. CCTs can provide a similar level of care to that of an emergency department, but at the scene of illness or injury. While it seems likely that this higher level of care leads to better outcomes, research so far has not shown clear benefits from sending CCTs to OHCA. This study is made up of three parts. The aim of the first part of this study is to assess the effect of CCT care on survival from OHCA and to examine which CCT treatments are actually beneficial. The aim of the second part of this study is to analyse the costs of CCTs. The aim of the final part of this study is to find out the views of key stakeholders about prehospital research using focus groups.
Who can participate?
Adults having an OHCA can take part in the first part of the study, and members of patient and public involvement group, prehospital providers, researchers, charity staff or commissioners can take part in the final part of this study.
What does the study involve?
In this study, patients do not receive any additional treatment to what they would normally receive. All patients who suffer an OHCA are attended by paramedics trained in advanced life support (ALS). In addition, some patients also have a prehospital critical care team attending. While CCTs try to attend many cases of OHCA, this is often not possible due to distance, not being able to use the air ambulance due to bad weather or because the CCT is already attending another incident. Information about how many patients who are or are not attended by CCTs make it to hospital alive is collected, as well as how many of those patients later survive and are discharged from hospital.
The costs of CCTs are assessed by reviewing ambulance and charity financial records.
Information about the way that different people with an interest in pre-hospital care feel about research like this is collected using focus groups, which include members of the public and professionals.
What are the possible benefits and risks of participating?
There are no direct benefits or risks to those participating in this study.
Where is the study run from?
1. South Western Ambulance Service NHS Foundation Trust (UK)
2. North East Ambulance Service NHS Trust (UK)
3. West Midlands Ambulance Service NHS Trust (UK)
4. University Hospitals Bristol NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2016 to December 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Johannes von Vopelius-Feldt
johannes.vonvopelius-feldt@uwe.ac.uk
Contact information
Scientific
University Hospitals Bristol NHS Foundation Trust
Academic Department of Emergency Care
Level 3 Queen's Building
Upper Maudlin Street
Bristol
BS2 8HW
United Kingdom
 ORCID ID |
0000-0002-6389-289X |
|---|---|
| Phone | +44 117 342 0000 |
| johannes.vonvopelius-feldt@uwe.ac.uk |
Study information
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prehospital critical care for out-of-hospital cardiac arrest: Mechanism, effect on survival, costs and the barriers to high quality research. |
| Study hypothesis | Prehospital critical care improves survival after out-of-hospital cardiac arrest, but at an increased cost. Stakeholders in prehospital care will have different attitudes towards the value and ethical implications of randomised research in this area. The study aims to 1. Assess the effect of critical care team (CCT) care on survival from out-of-hospital cardiac arrest (OHCA) and to understand what interventions are delivered 2. Analyse the costs of CCTs 3. Examine barriers to high quality research in this area |
| Ethics approval(s) | Sheffield National Research Ethics Service Committee, York and Humber, 29/07/2016, ref: 16/YH/0300 |
| Condition | Specialty: Cardiovascular disease, Primary sub-specialty: Arrhythmia; UKCRC code/ Disease: Cardiovascular/ Other and unspecified disorders of the circulatory system |
| Intervention | Observational Study of OHCA Survival: All participating ambulance trusts collect data on OHCA which were treated by prehospital providers, for the purpose of quality assurance. This data is also forwarded to a national registry, the Out Of Hospital Cardiac Arrest Outcomes database (OHCAO), hosted at the University of Warwick. Data for this research is provided by OHCAO under a data sharing agreement and includes: 1. Ambulance trust identifying number 2. Date and time of event 3. Location of event (public place, private location or nursing home) 4. Postcode of event (district level) 5. Age-group and gender of patient 6. Do Not Attempt Resuscitation order in place 7. Suspected cause of OHCA 8. First recorded cardiac rhythm 9. Witnessed event 10. Bystander CPR 11. Public access defibrillator used by bystander 12. First EMS resource response time 13. EMS chest compressions 14. Receiving hospital (if transported to hospital) 15. Survival to hospital arrival 16. Survival to hospital discharge In addition, the following data will be collected from CCTs when attending cases of OHCA: 1. Medical identifying number 2. Stand down prior to arrival at patient 3. CCT members: Critical care paramedic and or doctor 4. A list of critical care interventions delivered Cost Analysis: Data will be collected in order to estimate the costs of providing advanced life support care for OHCA in one UK ambulance trust. In addition, the additional costs incurred by providing prehospital critical care will be described. These costs will include provision of an air ambulance provided by a regional charity. The cost analysis will be stakeholder-focused and as such only consider costs occurred for prehospital care. Qualitative Work On Research Attitudes: Public and patients, prehospital providers, prehospital researchers, charity staff and commissioners will be contacted to participate in focus group discussions about prehosptial research lasting 60-90 minutes. The attitudes of each of these groups towards ethical issues and value of research designs, particularly randomised controlled trials will then be analysed. |
| Intervention type | Other |
| Primary outcome measure | Observational Study of OHCA Survival: Survival to hospital discharge is measured by reviewing ambulance notes (in case of prehospital death) at the time of data submission by the attending prehospital provider, or through review of hospital notes of receiving hospitals (in case of survival to hospital admission) at 3 months. Cost Analysis: Cost of prehospital care (advanced life support and critical care) in pound sterling. Costs will be measured through review of ambulance and charity financial records. Qualitative Work On Research Attitudes: Themes of views about prehosptial research are assessed using information collected at focus groups. |
| Secondary outcome measures | Observational Study of OHCA Survival: Survival to hospital admission (patient arriving in hospital with return of spontaneous circulation) is measured by reviewing ambulance notes at the time of data submission by the attending prehospital provider. |
| Overall study start date | 01/01/2016 |
| Overall study end date | 31/12/2018 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Observational Study of OHCA Survival: Intervention group (prehospital critical care): 600 cases Control group (advanced life support care): 6,000 cases; Qualitative Work On Research Attitudes: Five focus groups with 4-10 participants each, 40 participants in total. |
| Participant inclusion criteria | Observational Study of OHCA Survival: 1. Aged 18 years and over 2. Non-traumatic out-of-hospital cardiac arrest where cardiopulmonary resuscitation is commenced by a prehospital provider Qualitative Work On Research Attitudes: Member of patient and public involvement group, prehospital provider, researcher, charity staff or commissioner. |
| Participant exclusion criteria | Observational Study of OHCA Survival: 1. Cardiac arrest due to trauma, asphyxia, electrocution or drowning 2. Paediatric cardiac arrest (under 18 years of age) |
| Recruitment start date | 01/09/2016 |
| Recruitment end date | 31/10/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Abbey Court
Eagle Way
Sowton Industrial Estate
Exeter
EX2 7HY
United Kingdom
Goldcrest Way
Newburn Riverside
Newcastle upon Tyne
NE15 8NY
United Kingdom
Waterfront Way
Brierley Hill
DY5 1LX
United Kingdom
Bristol
BS2 8HW
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Innovation, Education and Research Centre
Level 3
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom
"ROR" |
https://ror.org/04nm1cv11 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | This research will be published in relevant peer-reviewed journals and submitted for presentation at conferences relevant to prehospital and emergency medicine. Executive summaries will be provided to key figures in ambulance trusts and air ambulance operations. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from johannes.vonvopelius-feldt@uwe.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/12/2016 | Yes | No | |
| Results article | results | 24/07/2019 | 14/08/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
14/08/2019: Publication reference added.
05/10/2018: The recruitment end date was updated from 28/08/2018 to 31/10/2017.
20/12/2016: Publication reference added.
