ISRCTN - ISRCTN87130712: Evaluation and refinement of pandemic inFLUenza Community Assessment Tools

Plain English Summary

Background and study aims
Flu pandemics occurs when a new flu virus emerges, rapidly spreads and causes widespread disease in many communities in many continents. Fortunately severe pandemics are rare events. When they occur health care capacity both in the community and hospitals can be overwhelmed. When this happens doctors need to make difficult decisions about who should be admitted to hospital and who can safely be allowed to stay at home. To do this fairly, most doctors feel that the same types of patient assessments and questions should be used across the wider community. This process is called triage. The ethical principle of "triage" is to do most for most in a fair way. This does not mean treating everybody equally. It means using scarce resources for those people most likely to benefit from treatment. Triage tools should help doctors identify which people are most likely to benefit from treatments only available in hospital and which people can safely be managed at home.The difficulty in designing triage tools for a future flu pandemic is that the exact nature of disease caused by a pandemic virus is generally unknown until that pandemic occurs. A further difficulty is that flu can affect children and adults quite differently. A one-size-fits-all tool is unlikely to work. This study will develop processes that will test how parts of a general practitioner's questions and assessment of children and adults with flu like illness can predict who: can safely be kept at home; need hospital admission; need high dependency or intensive care; are most at-risk of dying. The study uses the General Practitioner's (GP's) routine electronic record to capture most of the information and links to the hospital record if the patient is admitted to hospital. These records are be accessed by researchers without revealing people's identities at the Clinical Practice Research Datalink, which is part of the Medicines and Healthcare products Regulatory Authority (MHRA). We will develop technology that allows records from about 600 GP surgeries across the UK to be studied automatically every week. This is quite complicated and needs to be set up in advance by working closely with the GPs that will ultimately use these tools. This first part of the study is called feasibility and pilot work. In the event of a pandemic, the processes that have been developed will "go-live" and allow us to refine triage tools and check that they are "fit-for-purpose" in readiness for use should a pandemic become severe.

Who can participate?
People of all ages presenting to General Practitioners with Influenza Like Illness.

What does the study involve?
The study will be invisible to patients. GPs will be asked to record their routine consultations in a structured manner.

What are the possible benefits and risks of participating?
There are no immediate benefits or risks to patients. It would be reasonable to expect that participating GPs will develop a more structured approach to the assessment of patients presenting with Influenza Like Illness, and this may benefit patients. The knowledge and tools that evolve from this study will allow GPs and others to make better decisions about managing people with influenza like illness, particularly if the event of a severe influenza pandemic.

Where is the study run from?
This is a collaboration between researchers working at The University of Liverpool, The University of Nottingham, and the Clinical Practice Research Datalink, MHRA, London.

When is the study starting and how long is it expected to run for?
We anticipate that the study will start in January 2013 and run for a total of 30 months.

Who is funding the study?
The study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme.

Who is the main contact?
Dr MG (Calum) Semple
m.g.semple@liverpool.ac.uk

Trial website

http://www.nottingham.ac.uk/research/groups/healthprotection/projects/flu-cats.aspx

Contact information

Type

Scientific

Primary contact

Dr Malcolm Semple

ORCID ID

Contact details

Institute of Child Health
University of Liverpool
Alder Hey Children's Hospital
Eaton Road
Liverpool
L12 2AP
United Kingdom
+44 (0)151 252 5440
m.g.semple@liverpool.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 11/46/22

Study information

Scientific title

Real time refinement and validation of criteria and tools used in primary care to aid hospital referral decisions for patients of all ages in the event of surge during an influenza pandemic

Acronym

FLU-CATs

Study hypothesis

Assessment, refinement and validation of triage tools to guide GP referral of patients with influenza like illness during a pandemic in readiness for use should widespread illness exceed health care capacity (surge).

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=12827 and http://www.nets.nihr.ac.uk/projects/hta/114622
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/81777/PRO-11-46-22.pdf

On 13/07/2015 the overall trial end date was changed from 01/07/2015 to 01/01/2018.

Ethics approval

Independent Scientific Advisory Committee for MHRA database research (ISAC), 29/05/2012, ref: 12_043R

Study design

Prospective observational analysis

Primary study design

Observational

Secondary study design

Non-randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

There is no patient information leaflet. There is no requirement for consent on recruitment. The study uses anonymised data harvested from routine consultations recorded by GPs in electronic health care records.

Condition

Influenza like illness, influenza, seasonal influenza, pandemic influenza

Intervention

This is an observational study using anonymised data harvested from the electronic records of routine general practice consultations.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Hospital admission within 24 hours of GP assessment
2. Death within 30 days of GP assessment (all causes)

Secondary outcome measures

1. GP's decision to refer for hospital admission
2. Any need for augmented level of care during hospital admission i.e. level 2 - High Dependency and level 3 - Intensive/Critical Care, accepting that there are minor differences between paediatric and adult definitions of levels of care
3. Length of hospital stay (stratified >48 hours, ≥6 days & ≥12 days)

Overall trial start date

01/01/2013

Overall trial end date

01/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

All people of all ages presenting to primary care general practitioners with influenza like illness

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2013

Recruitment end date

01/07/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Child Health
Liverpool
L12 2AP
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor type

University/education

Website

http://www.liv.ac.uk/translational-medicine/departmentsandgroups/womens-and-childrens-health/