Evaluation of COVID-19 assessment in emergency departments and ambulance services
| ISRCTN | ISRCTN28342533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28342533 |
| IRAS number | 101138 |
| Secondary identifying numbers | CPMS 12725, IRAS 101138 |
- Submission date
- 27/03/2020
- Registration date
- 04/05/2020
- Last edited
- 14/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Respiratory (lung) infections, such as influenza or the coronavirus, affect the lungs and airways, typically causing symptoms such as fever, sore throat, coughing and breathing difficulties. They have the potential to cause a pandemic if a new strain of the virus becomes widespread across many countries. This can result in increased numbers of patients attending hospital and needing investigation or admission, and can place a huge strain on the NHS.
Patients contacting NHS 111, calling for a 999 ambulance or attending a hospital emergency department with suspected pandemic respiratory infection need to be rapidly assessed to identify who has severe illness and needs hospital admission. This process is known as "triage" and often uses methods, such as scores or decision rules, which have been developed to assess the severity of illness and predict which patients are at risk of life-threatening complications. Triage methods have been developed and are ready for use in a pandemic, but it is not known how well they perform in terms of correctly predicting who needs hospital admission and who does not. The researchers plan to use patient data from the early phases of a pandemic to test how well existing triage methods predict serious complications, identify cases where the triage methods did not predict serious complications or recommended unnecessary hospital admission, and modify triage methods or develop new triage methods that predict serious complications better than existing methods. This will involve recording medical details in a standardised way from patients with a suspected respiratory infection and then using hospital records to follow patients up to find out if they die or suffer a life-threatening complication.
Who can participate?
All adults and children with suspected respiratory infection during a pandemic who present at the emergency department of a participating hospital, call 111 or 999 services or are attended by a 999 ambulance from a participating ambulance trust
What does the study involve?
The researchers plan to use routine electronic data collected from people using the emergency care system (via 111 and 999 calls, ambulance conveyance, or hospital emergency department) with suspected respiratory infections during a pandemic. Participating emergency departments will be provided with electronic and/or paper forms that can be integrated into the patient record and used to collect standardised triage assessment data. The form can be used at triage or at full patient assessment and will form part of the clinical record. It can also be used by the emergency department to guide triage assessment. For example, the data recorded can be used to recommend diversion away from the hospital if criteria are not met or admission to hospital if criteria are met. The form will include key variables used in recommended triage methods, such as PMEWS and the swine flu hospital pathway, and other variables considered to be potentially useful predictors of adverse outcome. The researchers will allow participating sites to adapt the form to their local circumstances, for example omitting variables that are already routinely collected. The electronic and/or paper forms can also be used by paramedics in participating ambulance services. The electronic form will be used to collect data as part on the electronic case report form (eCRF) and can be used to support decisions, such as a decision not to transport the patient to hospital if triage criteria are not met. Alternatively, for 111 and 999 triage calls ambulance services could provide the University of Sheffield with the routinely collected triage question of patients with suspected respiratory infection pandemic. Though this routine data would not match data collected from participating hospitals it would closer reflect the data ambulances are collecting with patients and lessen the workload placed on frontline staff. The researchers will work with participating ambulance trusts to choose a data collection approach that best fits their capacity. Participating emergency departments and ambulances could also provide regular datasets to the University of Sheffield. Sites' business intelligence units or equivalent would be handle file transfers through a secure file transfer system, such as a FTP server.
What are the possible benefits and risks of participating?
There are no direct benefits to a patient but there are potential benefits to the ability of emergency departments to prioritise pandemic cases appropriately, so those that most require care receive it in a timely manner. The results of the study could be used in subsequent phases of a pandemic to produce a guideline or rule to decide which patients require hospital admission. The findings can also be used by doctors and nurses to identify which individual patients are at risk of serious complications. The researchers may also be able to identify which patient characteristics are associated with an increased risk of serious complications in a particular pandemic. For example, in 2009 it was found that pregnant patients and those suffering from obesity were at higher risk. The risks to patients involved in the study are very low. The study will not involve any change to the way patients are investigated or treated. Data collection has been designed to assist medical staff so that it does not interfere with patient care, and has been tested during a winter flu season. Most personal details will be removed from information that leaves a hospital, the researchers are only recording NHS numbers and ambulance incident numbers so they can track how patients move through health services. More identifiable information, such as patient’s names, will only be available to local trained nurses who work alongside the care teams. The researchers do not plan to ask patients for written consent to use their data in the study because this would incur delays that could be harmful in a pandemic. However, they will inform patients of the study and ensure that they are able to remove their data from the study if they wish. This approach worked well in the 2009 study and was approved by an independent Research Ethics Committee and the National Information Governance Board.
Where is the study run from?
The study will be undertaken by experienced researchers in Sheffield, Manchester and London who will involve around 40 hospitals across the country. They include experts in emergency medicine, intensive care, public health, and statistics. The Clinical Trials Unit in Sheffield is registered to provide research support and will be responsible for collecting and analysing the data.
When is the study starting and how long is it expected to run for?
October 2012 to October 2021
Who is funding the study?
Health Research Health Technology Assessment (NIHR HTA) Programme (UK)
Who is the main contact?
Dr Ben Thomas, priest-study@sheffield.ac.uk
Contact information
Scientific
3023 Regent Court
211 Portobello Street
Sheffield
S1 4DP
United Kingdom
 ORCID ID |
0000-0003-0803-8444 |
|---|---|
| Phone | +44 (0)114 222 0842 |
| priest-study@sheffield.ac.uk |
Scientific
Clinical Trials Research Unit
ScHARR
University of Sheffield
Innovation Centr
217 Portobello
Sheffield
S1 4DP
United Kingdom
Study information
| Study design | Both; Design type: Other, Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Participant information sheets can be found at: https://www.sheffield.ac.uk/scharr/sections/hsr/cure/priestpages/priest |
| Scientific title | The PRIEST study: Pandemic Respiratory Infection Emergency System Triage |
| Study acronym | PRIEST |
| Study hypothesis | The aim of this study is to optimise the triage of people using the emergency care system (111 and 999 calls, ambulance conveyance, or hospital emergency department) with suspected respiratory infections during a pandemic and identify the most accurate triage method for predicting severe illness among patients attending the emergency department with a suspected respiratory infection. The specific objectives during the pandemic are: 1. To undertake continuous monitoring of the performance of the emergency care triage method (or methods) used for suspected respiratory infections during a pandemic. 2. To identify clinical characteristics and routine tests associated with under-triage (false negative assessent) or over-triage (false positive assessment) during a pandemic. 3. To determine the discriminant value of alternative triage methods for predicting severe illness in patients presenting with suspected respiratory infection during a pandemic. 4. To inform policymakers and practitioners during a pandemic of the study’s emerging findings. The specific objectives after the pandemic are: 1. To determine the discriminant value of emergency department triage methods for predicting severe illness in patients presenting with suspected pandemic respiratory infection. 2. To determine the discriminant value of presenting clinical characteristics and routine tests for identifying severe illness. 3. To determine the independent predictive value of presenting clinical characteristics and routine tests for severe illness. 4. To develop new triage methods based upon presenting clinical characteristics alone or presenting clinical characteristics, electrocardiogram (ECG), chest X-ray and routine blood test results, depending upon the data available and the predictive value of variables evaluated in objective 3. |
| Ethics approval(s) | Approved 25/06/2012, North West - Haydock Research Ethics Committee (3rd Floor - Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)2071048165; haydock.rec@hra.nhs.uk), REC ref: 12/NW/0303 |
| Condition | COVID-19 (SARS-CoV-2 infection) |
| Intervention | The researchers plan to undertake an observational cohort study using routine electronic data capture from people using the emergency care system (via 111 and 999 calls, ambulance conveyance, or hospital emergency department) with suspected respiratory infections during a pandemic. Participating emergency departments will be provided with electronic and/or paper forms that can be integrated into the patient record and used to collect standardised triage assessment data. The form can be used at triage or at full patient assessment, and will form part of the clinical record. It can also be used by the emergency department to guide triage assessment. For example, the data recorded can be used to recommend diversion away from the hospital if criteria are not met or admission to hospital if criteria are met. The form will include key variables used in recommended triage methods, such as PMEWS and the swine flu hospital pathway, and other variables considered to be potentially useful predictors of adverse outcome. We will allow participating sites to adapt the form to their local circumstances, for example omitting variables that are already routinely collected. The electronic and/or paper forms can also be used by paramedics in participating ambulance services. The electronic form will be used to collect data as part on the electronic case report form (eCRF) and can be used to support decisions, such as a decision not to transport the patient to hospital if triage criteria are not met. Alternatively, for 111 and 999 triage calls ambulance services could provide the University of Sheffield with the routinely collected triage question of patients with suspected respiratory infection pandemic. Though this routine data would not match data collected from participating hospitals it would a) closer reflect the data ambulances are collecting with patients and b) lesson the work load placed on front line staff. The researchers will work with participating Ambulance trusts to choose a data collection approach that best fits their capacity. Participating emergency departments and ambulances could also provide regular datasets of the study’s predictor variables to the University of Sheffield. Sites business intelligence units or equivalent would be handle file transfers through a secure file transfer system, such as a FTP server. |
| Intervention type | Other |
| Primary outcome measure | Patients who die or require respiratory, cardiovascular or renal support will be defined as having an adverse outcome. If patients survive to 30 days without requiring respiratory, cardiovascular or renal support they will be defined as having no adverse outcome. If a severe pandemic leads to hospital resources being overwhelmed the researchers will categorise patients as having an adverse outcome if they were deemed to have needed respiratory, cardiovascular or renal support but were denied this due to lack of resources; Timepoint(s): 30 days |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/10/2012 |
| Overall study end date | 31/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Planned Sample Size: 20,000; UK Sample Size: 20,000 |
| Total final enrolment | 22445 |
| Participant inclusion criteria | All adults and children with suspected respiratory infection during a pandemic who present at the emergency department of a participating hospital, call 111 or 999 services or are attended by a 999 ambulance from a participating ambulance trust. Patients will be eligible for inclusion if they meet the current clinical diagnostic criteria; 1. Fever (pyrexia ≥38°C) or a history of a fever 2. Influenza-like illness (two or more of cough, sore throat, rhinorrhoea, limb or joint pain, headache, vomiting or diarrhoea or severe and/or life-threatening illness suggestive of an infectious process. (Or if they meet any future clinical diagnostic criteria recommended by the Department of Health). |
| Participant exclusion criteria | Participants will only be excluded from the study if they request to be. |
| Recruitment start date | 26/03/2020 |
| Recruitment end date | 31/07/2020 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Herries Rd
Sheffield
S5 7AU
United Kingdom
Clarkson St
Broomhall
Sheffield
S10 2TH
United Kingdom
Stott Ln
Salford
M6 8HD
United Kingdom
Clifton
York
YO31 8HE
United Kingdom
Scarborough
YO12 6QL
United Kingdom
W Smithfield
London
EC1A 7BE
United Kingdom
Anlaby Rd
Hull
HU3 2JZ
United Kingdom
Derriford Rd
Plymouth
PL6 8DH
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
London Rd
Reading
RG1 5AN
United Kingdom
Williams Ave
Dorchester
DT1 2JY
United Kingdom
Great Western Rd
Gloucester
GL1 3NN
United Kingdom
Wolverhampton Rd
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Apley Castle
Telford
TF1 6TF
United Kingdom
Mytton Oak Rd
Shrewsbury
SY3 8XQ
United Kingdom
Newcastle Rd
Stoke-on-Trent
ST4 6QG
United Kingdom
Cramlington
NE23 6NZ
United Kingdom
Prittlewell Chase
Westcliff-on-Sea
Southend-on-Sea
SS0 0RY
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Lancaster Park Rd
Harrogate
HG2 7SX
United Kingdom
51 Little France Cres
Edinburgh
EH16 4SA
United Kingdom
Edinburgh
EH9 1LF
United Kingdom
Howden
Livingston
EH54 6PP
United Kingdom
Edinburgh
EH4 2XU
United Kingdom
Court Rd
Broomfield
Chelmsford
CM1 7ET
United Kingdom
Queen Victoria Rd
Newcastle upon Tyne
NE1 4LP
United Kingdom
Oxford Rd
Manchester
M13 9WL
United Kingdom
Manchester
M13 9WL
United Kingdom
Lower Ln
Liverpool
L9 7AL
United Kingdom
Hills Rd
Cambridge
CB2 0QQ
United Kingdom
Derby Rd
Lenton
Nottingham
NG7 2UH
United Kingdom
Portadown
Craigavon
BT63 5QQ
United Kingdom
Slough
SL2 4HL
United Kingdom
Gayton Rd
King's Lynn
PE30 4ET
United Kingdom
Cardiff Rd
Newport
NP20 2UB
United Kingdom
Brecon Rd
Abergavenny
NP7 7EG
United Kingdom
Marlborough Rd
Swindon
SN3 6BB
United Kingdom
Denmark Hill
Brixton
London
SE5 9RS
United Kingdom
London Rd
Stanwell
Ashford
TW15 3AA
United Kingdom
Guildford Rd
Lyne
Chertsey
KT16 0PZ
United Kingdom
Sharoe Green Ln
Fulwood
Preston
PR2 9HT
United Kingdom
Dorking Rd
Epsom
KT18 7EG
United Kingdom
Wrythe Ln
Sutton
Carshalton
SM5 1AA
United Kingdom
Hardwick Road
Stockton on Tees
Cleveland
TS19 8PE
United Kingdom
Westminster Bridge Rd
Bishop's
London
SE1 7EH
United Kingdom
Gawber Rd
Barnsley
S75 2EP
United Kingdom
Great George St
Leeds
LS1 3EX
United Kingdom
Beckett St
Harehills
Leeds
LS9 7TF
United Kingdom
Darlington
DL3 6HX
United Kingdom
North Rd
Durham
DH1 5TW
United Kingdom
St George's Hospital
Blackshaw Rd
Tooting
London
SW17 0QT
United Kingdom
Marton Rd
Middlesbrough
TS4 3BW
United Kingdom
Liverpool
L12 2AP
United Kingdom
Poplar Grove
Hazel Grove
Stockport
SK2 7JE
United Kingdom
Prescot St
Liverpool
L7 8XP
United Kingdom
Castle Ln E
Bournemouth
BH7 7DW
United Kingdom
Stockwell Gate
Mansfield
NG18 5QE
United Kingdom
The Ridge
Hastings
Saint Leonards-on-Sea
TN37 7RD
United Kingdom
Kings Dr
Eastbourne
BN21 2UD
United Kingdom
Minerva Rd
Farnworth
Bolton
BL4 0JR
United Kingdom
Canada Ave
Redhill
RH1 5RH
United Kingdom
Haslingden Rd
Blackburn
BB2 3HH
United Kingdom
Casterton Ave
Burnley
BB10 2PQ
United Kingdom
Stadium Rd
Woolwich
London
SE18 4QH
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Hallamshire Hospital
Glossop Road
Broomhall
Sheffield
S10 2JF
England
United Kingdom
| Phone | +44 (0)114 226 5935 |
|---|---|
| getinvolved@sth.nhs.uk |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Additional study documents including the study protocol can be found and downloaded at the study website: https://www.sheffield.ac.uk/scharr/sections/hsr/cure/priestpages/priest Publication and dissemination plan to be confirmed at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 01/06/2020 | 22/07/2020 | No | No | |
| Results article | post-exertion oxygen saturation sub-study results | 03/12/2020 | 07/12/2020 | Yes | No |
| Results article | results | 25/11/2020 | 15/01/2021 | Yes | No |
| Preprint results | non-peer-reviewed analysis of DNAR status in preprint | 27/01/2021 | 19/03/2021 | No | No |
| Results article | triage tool development results | 22/01/2021 | 19/03/2021 | Yes | No |
| Results article | secondary analysis results | 01/07/2021 | 10/05/2021 | Yes | No |
| Results article | 03/06/2021 | 07/06/2021 | Yes | No | |
| Preprint results | Prognostic accuracy study results | 29/07/2021 | 30/07/2021 | No | No |
| Preprint results | Observational cohort study results | 19/10/2021 | 21/10/2021 | No | No |
| Preprint results | Accuracy of telephone triage | 29/06/2021 | 03/12/2021 | No | No |
| Preprint results | Prognostic accuracy results for children | 10/09/2021 | 03/12/2021 | No | No |
| Dataset | 25/11/2020 | 14/06/2023 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN28342533_SAP_V1_Jun2020.pdf
- Uploaded 22/07/2020
Editorial Notes
14/06/2023: Dataset added.
03/12/2021: The following changes have been made:
1. Preprint references added.
2. The overall trial end date has been changed from 31/07/2020 to 31/10/2021 and the plain English summary has been updated to reflect this change.
21/10/2021: Preprint reference added.
30/07/2021: Publication reference added.
07/06/2021: Publication reference added.
10/05/2021: Publication reference added.
19/03/2021: Publication and preprint references added.
15/01/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
07/12/2020: Publication reference added.
22/07/2020: This study has superseded PAINTED (ISRCTN56149622).
22/07/2020: Uploaded statistical analysis plan.
09/06/2020: A study contact was added.
11/05/2020: The study contact email has been changed in the study contacts and the plain English summary.
27/03/2020: Trial's existence confirmed by the NIHR.
