Condition category
Infections and Infestations
Date applied
27/03/2020
Date assigned
04/05/2020
Last edited
11/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 July 2020

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Steve Goodacre

ORCID ID

http://orcid.org/0000-0003-0803-8444

Contact details

3023 Regent Court
211 Portobello Street
Sheffield
S1 4DP
United Kingdom
+44 (0)114 222 0842
priest-study@sheffield.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 12725, IRAS 101138

Study information

Scientific title

The PRIEST study: Pandemic Respiratory Infection Emergency System Triage

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

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

Study design

Both; Design type: Other, Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Participant information sheets can be found at: https://www.sheffield.ac.uk/scharr/sections/hsr/cure/priestpages/priest

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

Phase

Drug names

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 trial start date

01/10/2012

Overall trial end date

31/07/2020

Reason abandoned (if study stopped)

Eligibility

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 or999 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 type

Patient

Age group

Mixed

Gender

Both

Target number of participants

Planned Sample Size: 20000; UK Sample Size: 20000

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

United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Northern General Hospital Herries Rd
Sheffield
S5 7AU
United Kingdom

Trial participating centre

Sheffield Children’s NHS Foundation Trust
Sheffield Children's Hospital Clarkson St Broomhall
Sheffield
S10 2TH
United Kingdom

Trial participating centre

Salford Royal NHS Foundation Trust
Salford Royal Hospital Stott Ln
Salford
M6 8HD
United Kingdom

Trial participating centre

York Teaching Hospital
Wigginton Rd Clifton
York
YO31 8HE
United Kingdom

Trial participating centre

Scarborough General Hospital
Woodlands Dr
Scarborough
YO12 6QL
United Kingdom

Trial participating centre

Barts Health NHS Trust
St Bartholomew’s Hospital W Smithfield
London
EC1A 7BE
United Kingdom

Trial participating centre

Hull University Teaching Hospitals NHS Trust
Hull Royal Infirmary Anlaby Rd
Hull
HU3 2JZ
United Kingdom

Trial participating centre

University Hospitals Plymouth NHS Trust
Derriford Hospital Derriford Rd
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Milton Keynes University Hospital
Standing Way Eaglestone
Milton Keynes
MK6 5LD
United Kingdom

Trial participating centre

Royal Berkshire NHS Foundation Trust
Royal Berkshire Hospital London Rd
Reading
RG1 5AN
United Kingdom

Trial participating centre

Dorset County Hospital NHS Foundation Trust
Dorset County Hospital Williams Ave
Dorchester
DT1 2JY
United Kingdom

Trial participating centre

Gloucestershire Hospitals NHS Foundation Trust
Gloucestershire Royal Hospital Great Western Rd
Gloucester
GL1 3NN
United Kingdom

Trial participating centre

The Royal Wolverhampton NHS Trust
New Cross Hospital Wolverhampton Rd Heath Town
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

The Shrewsbury & Telford Hospital NHS Trust
Princess Royal Hospital Apley Castle
Telford
TF1 6TF
United Kingdom

Trial participating centre

The Shrewsbury & Telford Hospital NHS Trust
Royal Shrewsbury Hospital Mytton Oak Rd
Shrewsbury
SY3 8XQ
United Kingdom

Trial participating centre

University Hospital North Midlands NHS Trust
Royal Stoke Hospital Newcastle Rd
Stoke-on-Trent
ST4 6QG
United Kingdom

Trial participating centre

Northumbria Specialist Emergency Care Hospital
Northumbria Way
Cramlington
NE23 6NZ
United Kingdom

Trial participating centre

Southend University Hospital NHS Foundation Trust
Southend Hospital Prittlewell Chase Westcliff-on-Sea
Southend-on-Sea
SS0 0RY
United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Harrogate District Hospital
Harrogate District Hospital Lancaster Park Rd
Harrogate
HG2 7SX
United Kingdom

Trial participating centre

NHS Lothian
Royal Infirmary of Edinburgh 51 Little France Cres
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

Royal Hospital for Sick Children
9 Sciennes Rd
Edinburgh
EH9 1LF
United Kingdom

Trial participating centre

St John's Hospital
Howden W Rd Howden
Livingston
EH54 6PP
United Kingdom

Trial participating centre

Western General Hospital
Crewe Rd S
Edinburgh
EH4 2XU
United Kingdom

Trial participating centre

Mid and South Essex NHS Foundation Trust
Broomfield Hospital Court Rd Broomfield
Chelmsford
CM1 7ET
United Kingdom

Trial participating centre

Newcastle Upon Tyne Hospitals NHS Trust
Royal Victoria Infirmary Queen Victoria Rd
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

Manchester University NHS Foundation Trust
Manchester Royal Infirmary Oxford Rd
Manchester
M13 9WL
United Kingdom

Trial participating centre

Royal Manchester Children’s Hospital
Oxford Rd
Manchester
M13 9WL
United Kingdom

Trial participating centre

Liverpool University Hospitals NHS Foundation Trust
Aintree University Hospital Lower Ln
Liverpool
L9 7AL
United Kingdom

Trial participating centre

Cambridge University Hospitals NHS Foundation Trust
Addenbrooke's Hospital Hills Rd
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Queens Medical Centre Derby Rd Lenton
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Craigavon Area Hospital
68 Lurgan Rd Portadown
Craigavon
BT63 5QQ
United Kingdom

Trial participating centre

Wexham Park Hospital
Wexham St
Slough
SL2 4HL
United Kingdom

Trial participating centre

The Queen Elizabeth Hospital King’s Lynn NHS Foundation Trust
Queen Elizabeth Hospital Gayton Rd
King's Lynn
PE30 4ET
United Kingdom

Trial participating centre

Aneurin Bevan University Health Board
Royal Gwent Hospital Cardiff Rd
Newport
NP20 2UB
United Kingdom

Trial participating centre

Aneurin Bevan University Health Board
Nevill Hall Hospital Brecon Rd
Abergavenny
NP7 7EG
United Kingdom

Trial participating centre

Great Western Hospitals NHS Foundation Trust
Great Western Hospital Marlborough Rd
Swindon
SN3 6BB
United Kingdom

Trial participating centre

King's College Hospital NHS Foundation Trust
King’s College Hospital Denmark Hill Brixton
London
SE5 9RS
United Kingdom

Trial participating centre

Ashford and St Peter's Hospitals NHS Foundation Trust
Ashford Hospital London Rd Stanwell
Ashford
TW15 3AA
United Kingdom

Trial participating centre

Ashford and St Peter's Hospitals NHS Foundation Trust
St Peter’s Hospital Guildford Rd Lyne
Chertsey
KT16 0PZ
United Kingdom

Trial participating centre

Lancashire Teaching Hospitals NHS Trust
Royal Preston Hospital Sharoe Green Ln Fulwood
Preston
PR2 9HT
United Kingdom

Trial participating centre

Epsom and St Helier University Hospitals NHS Trust
Epsom Hospital Dorking Rd
Epsom
KT18 7EG
United Kingdom

Trial participating centre

Epsom and St Helier University Hospitals NHS Trust
St Helier Hospital Wrythe Ln Sutton
Carshalton
SM5 1AA
United Kingdom

Trial participating centre

North Tees and Hartlepool NHS Foundation Trust
University Hospital of North Tees Hardwick Road Stockton on Tees
Cleveland
TS19 8PE
United Kingdom

Trial participating centre

Guys and St Thomas' NHS Foundation Trust
Evelina London Children’s Hospital Westminster Bridge Rd Bishop's
London
SE1 7EH
United Kingdom

Trial participating centre

Barnsley Hospital NHS Foundation Trust
Barnsley Hospital Gawber Rd
Barnsley
S75 2EP
United Kingdom

Trial participating centre

Leeds Teaching Hospitals NHS Trust
Leeds General Infirmary Great George St
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Leeds Teaching Hospitals NHS Trust
St James' University Hospital Beckett St Harehills
Leeds
LS9 7TF
United Kingdom

Trial participating centre

County Durham and Darlington NHS Foundation Trust
Hollyhurst Rd
Darlington
DL3 6HX
United Kingdom

Trial participating centre

County Durham and Darlington NHS Foundation Trust
University Hospital of North Durham North Rd
Durham
DH1 5TW
United Kingdom

Trial participating centre

St George’s University Hospital NHS Foundation Trust
St. James Wing St George's Hospital Blackshaw Rd Tooting
London
SW17 0QT
United Kingdom

Trial participating centre

South Tees Hospitals NHS Foundation Trust
The James Cook University Hospital Marton Rd
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

Alder Hey Children's Hospital
E Prescot Rd
Liverpool
L12 2AP
United Kingdom

Trial participating centre

Stockport NHS Foundation Trust
Stepping Hill Hospital Poplar Grove Hazel Grove
Stockport
SK2 7JE
United Kingdom

Trial participating centre

Liverpool University Hospitals NHS Foundation Trust
Royal Liverpool Hospital Prescot St
Liverpool
L7 8XP
United Kingdom

Trial participating centre

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Royal Bournemouth Hospital Castle Ln E
Bournemouth
BH7 7DW
United Kingdom

Trial participating centre

Sherwood Forest Hospital NHS Foundation Trust
Sutton Rd Stockwell Gate
Mansfield
NG18 5QE
United Kingdom

Trial participating centre

East Sussex Healthcare NHS Trust
Conquest Hospital The Ridge Hastings
Saint Leonards-on-Sea
TN37 7RD
United Kingdom

Trial participating centre

East Sussex Healthcare NHS Trust
Eastbourne District General Hospital Kings Dr
Eastbourne
BN21 2UD
United Kingdom

Trial participating centre

Bolton NHS Foundation Trust
Royal Bolton Hospital Minerva Rd Farnworth
Bolton
BL4 0JR
United Kingdom

Trial participating centre

Surrey and Sussex Healthcare Foundation Trust
East Surrey Hospital Canada Ave
Redhill
RH1 5RH
United Kingdom

Trial participating centre

East Lancashire Hospital NHS Trust
Royal Blackburn Teaching Hospital Haslingden Rd
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

East Lancashire Hospital NHS Trust
Burnley General Teaching Hospital Casterton Ave
Burnley
BB10 2PQ
United Kingdom

Trial participating centre

Lewisham and Greenwich NHS Trust
Queen Elizabeth Hospital Stadium Rd Woolwich
London
SE18 4QH
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust

Sponsor details

Royal Hallamshire Hospital
Glossop Road
Broomhall
Sheffield
S10 2JF
United Kingdom
+44 (0)114 226 5935
getinvolved@sth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 11/46/07

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/07/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.