Hospital Onset Diarrhoea Investigation

NCT ID: NCT03321578

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-08-31

Brief Summary

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This service evaulation aims to investigate how common diarrhoea is in hospital patients on medical, surgical and elderly care wards, what it is due to and how it is managed.

Detailed Description

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Latest National Health Service (NHS) England guidelines for the assessment of Clostridium difficile infection (CDI) cases recommend that acute hospitals collect data on the prevalence of hospital-onset diarrhoea in their organisations, and how it is managed, including if patients are appropriately tested for CDI.

The aims of this multi-centre service evaluation are therefore to:

* Determine the prevalence of hospital-onset diarrhoea on adult medical, surgical and care of the elderly wards in the NHS
* Investigate how hospital-onset diarrhoea is managed, including whether patients are tested for CDI according to Department of Health (DoH) England standards
* Investigate the aetiology of hospital-onset diarrhoea on adult medical, surgical and care of the elderly wards in the NHS, based on previously described causes

Data will be collected at participating centres on two days, one between 11-15/Jan/2016 and one between 6-10/Jun/2016. Hospitals will be able to choose locally which two days. On those days investigators from the local Microbiology and/or Infection Prevention teams will screen all patients on pre-identified wards, who have been admitted for ≥72 hours, for hospital-onset diarrhoea. For all patients that meet the definition of hospital-onset diarrhoea their medical notes and charts will be reviewed, to ascertain potential causes and how they have been managed.

This service evaluation should help participating hospitals to investigate hospital-onset diarrhoea in their own institutions, as well as generating a dataset that is representative of the problem across the NHS, and therefore of use to other centres.

Conditions

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Diarrhea

Keywords

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nosocomial hospital acquired clostridium difficile

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Admitted to hospital for ≥72 hours at the time of data collection for the service evaluation
* Presence of hospital-onset diarrhoea (defined as ≥ 2 episodes of unformed stools (Bristol Stool Chart type 5-7) during the day before the service evaluation, with the onset of the diarrhoea being more than 48 hours after admission to hospital)

Exclusion Criteria

* Patients admitted to the ward for ≤72hour at the time of data collection for the service evaluation
* Patients with diarrhoea since admission or in whom it developed within the first 48 hours of admission
* Patients receiving end of life care
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aneurin Bevan University Health Board

OTHER

Sponsor Role collaborator

Northern Health and Social Care Trust

OTHER_GOV

Sponsor Role collaborator

Barnsley Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

East Lancashire Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role collaborator

Hampshire Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Harrogate & District NHS Foundation Trust

OTHER

Sponsor Role collaborator

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role collaborator

Mid Yorkshire Teaching NHS Trust

OTHER

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role collaborator

NHS Lothian

OTHER_GOV

Sponsor Role collaborator

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

South Tees Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

The Royal Wolverhampton Hospitals NHS Trust

OTHER_GOV

Sponsor Role collaborator

Torbay and South Devon NHS Foundation Trust

OTHER

Sponsor Role collaborator

South Eastern Health and Social Care Trust

OTHER

Sponsor Role collaborator

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role collaborator

George Eliot Hospital NHS Trust

OTHER

Sponsor Role collaborator

University Hospitals, Leicester

OTHER

Sponsor Role collaborator

York Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Kirby, MBBS

Role: STUDY_DIRECTOR

Leeds Teaching Hospitals NHS Trust

Jonathan AT Sandoe, MBChB

Role: STUDY_DIRECTOR

Leeds Teaching Hospitals NHS Trust

Locations

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Antrim Area Hospital (Northern Health and Social Care Trust)

Antrim, , United Kingdom

Site Status

Barnsley Hospital NHS Foundation Trust

Barnsley, , United Kingdom

Site Status

East Lancashire Hospitals NHS Trust

Blackburn, , United Kingdom

Site Status

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Site Status

University Hospitals Coventry and Warwickshire + George Eliot Hospital NHS Trust

Coventry, , United Kingdom

Site Status

Ulster Hospital (South Eastern Health and Social Care Trust)

Dundonald, , United Kingdom

Site Status

NHS Lothian and NHS Fife

Edinburgh, , United Kingdom

Site Status

NHS Greater Glasgow and Clyde

Glasgow, , United Kingdom

Site Status

Harrogate and District NHS Foundation Trust

Harrogate, , United Kingdom

Site Status

Hull and East Yorkshire Hospitals NHS Trust

Hull, , United Kingdom

Site Status

University Hospitals of Leicester NHS Trust

Leicester, , United Kingdom

Site Status

Guy's & St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

The Royal Free London NHS Foundation Trust

London, , United Kingdom

Site Status

South Tees Hospitals NHS Foundation Trust

Middlesbrough, , United Kingdom

Site Status

Aneurin Bevan University Health Board

Newport, , United Kingdom

Site Status

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Site Status

Oxford University Hospitals NHS Trust

Oxford, , United Kingdom

Site Status

Papworth Hospital NHS Foundation Trust

Papworth Everard, , United Kingdom

Site Status

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , United Kingdom

Site Status

Torbay and South Devon Healthcare NHS Foundation Trust

Torbay, , United Kingdom

Site Status

Mid Yorkshire NHS Trust

Wakefield, , United Kingdom

Site Status

Hampshire Hospitals NHS Foundation Trust

Winchester, , United Kingdom

Site Status

The Royal Wolverhampton NHS Trust

Wolverhampton, , United Kingdom

Site Status

York Teaching Hospital NHS Foundation Trust

York, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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v10.5

Identifier Type: -

Identifier Source: org_study_id