Condition category
Infections and Infestations
Date applied
27/10/2015
Date assigned
29/10/2015
Last edited
29/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There has been uncertainty over the effectiveness of drugs called neuraminidase inhibitors, such as oseltamivir (Tamiflu) for the treatment of influenza. Despite this their use is recommend by national guidelines providing certain conditions are met. Recently some studies run during the swine flu pandemic have been published and suggest large benefits from these drugs in unwell hospitalised patients with influenza. It is not known how often UK doctors prescribe neuraminidase inhibitors to patients with influenza or whether they use them in line with current guidelines. This questionnaire-based survey aims to find out how UK physicians are currently using these drugs in hospital and whether their practice is consistent with guidelines.

Who can participate?
Participants should be physicians based in a hospital in the UK that frequently manage patients that suffer from influenza and work in in infectious diseases, microbiology, respiratory medicine, acute medicine, emergency medicine or geriatric medicine. Recruitment of participants will be via relevant medical societies.

What does the study involve?
All participants are given access to an online questionnaire via a link sent out to them by the medical society that they belong to. They all have one month to complete the questionnaire and are sent a reminder after two weeks. Once all the questionnaires have been sent out and completed. Analysis is performed by the research team to investigate physicians neuraminidase inhibitor prescribing practices, whether these guidelines are consistent with current UK guidelines and why any differences may occur.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Southampton General Hospital (University Hospitals Southampton Foundation NHS trust) (UK)

When is the study starting and how long is it expected to run for?
July 2015 to September 2016

Who is funding the study?
University Hospitals Southampton Foundation NHS Trust (UK)

Who is the main contact?
Dr Tristan Clark

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tristan Clark

ORCID ID

Contact details

LF101
South Academic block
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RHM 1280

Study information

Scientific title

Neuraminidase inhibitor prescribing by physicians in the UK: a questionnaire-based survey of practice

Acronym

Study hypothesis

Given the controversy relating to the efficacy of neuraminidase inhibitors, UK guideline discrepancies and the recent published evidence from observational studies of hospitalized adults, data regarding current NAI prescribing practices among UK hospital-based physicians is urgently needed. This questionnaire based survey of practise aims to address this need.

Objectives:
1. To explore the neuraminidase inhibitor prescribing practices among UK hospital-based physicians using a questionnaire based survey of practice
2. To compare prescribing practise to current UK guidelines
3. To explore factors associated with deviation from guidelines

Ethics approval

Faculty of Medicine Ethics committee, University of Southampton, 25/09/2015, ref: 17321.

Study design

On-line questionnaire-based survey of UK hospital physicians

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Influenza

Intervention

The basis of this study is a online survey developed to explore current UK physician knowledge of existing neuraminidase inhibitor prescribing guidelines and self-reported prescribing practice for adults hospitalised with suspected influenza. The survey is electronic and uses the 'survey monkey' platform. The link is sent out via the listed professional societies to its physician members. The members have one month to respond following the initial email invitation and are sent a reminder after two weeks. One month after last society has sent it out we will close the survey and collate and analyse the results. The exact date of this will depend when the societies send it out which in turn depends on the speed at which it goes through their individual governance procedures.

Analysis will be performed by the research team in conjunction with a medical statistician. Prism (GraphPad Software Inc; La Jolla, California) and SPSS (SPSS, Inc; Chicago, Illinois) will be used for statistical analysis. Demographic details (including place of work, speciality and seniority), influenza testing method and guideline awareness will be described using proportions. For guideline compliance, assessed using the scenarios provided, compliance will be described for PHE and NICE guidelines using proportions and compared using Chi squared and Fisher’s exact test. Factors associated with guideline compliance will be explored using univariate and multivariate analysis. Subgroup analysis will be by scenario and by speciality of respondent.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Self reported neuraminidase inhibitor prescribing practice and adherence to National guidelines. Collected and analysed one month after last surveys have been sent out.

Secondary outcome measures

Differences in practice between specialities. Collected and analysed one month after last surveys have been sent out.

Overall trial start date

01/07/2015

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. A hospital-based physician (consultant or specialist registrar grade or equivalent)
2. Working in the UK and managing patient with suspected influenza
3. Working in infectious diseases, microbiology, respiratory medicine, acute medicine, emergency medicine or geriatric medicine

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

Not meeting any of the inclusion criteria

Recruitment start date

01/10/2015

Recruitment end date

30/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Southampton Foundation NHS trust
Southampton General Hospital Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University Hospitals Southampton Foundation NHS trust

Sponsor details

Research and Development
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospitals Southampton Foundation NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish the results of the study sometime in the autumn 2016.

Intention to publish date

01/10/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes