Clinical trial NCT03321578: Hospital Onset Diarrhoea Investigation
Official title: National Infection Trainees Collaborative for Audit and Research (NITCAR) Service Evaluation: The Prevalence, Aetiology and Management of Hospital-onset Diarrhoea on Medical, Surgical and Elderly Care Wards in the NHS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diarrhea
Keywords: nosocomial
hospital acquired
clostridium difficile
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Aneurin Bevan University Health Board
name: Northern Health and Social Care Trust
name: Barnsley Hospital NHS Foundation Trust
name: Cambridge University Hospitals NHS Foundation Trust
name: East Lancashire Hospitals NHS Trust
name: Guy's and St Thomas' NHS Foundation Trust
name: Hampshire Hospitals NHS Foundation Trust
name: Harrogate & District NHS Foundation Trust
name: Hull University Teaching Hospitals NHS Trust
name: Mid Yorkshire Teaching NHS Trust
name: NHS Greater Glasgow and Clyde
name: NHS Lothian
name: Nottingham University Hospitals NHS Trust
name: Oxford University Hospitals NHS Trust
name: Papworth Hospital NHS Foundation Trust
name: Sheffield Teaching Hospitals NHS Foundation Trust
name: South Tees Hospitals NHS Foundation Trust
name: Royal Free Hospital NHS Foundation Trust
name: The Royal Wolverhampton Hospitals NHS Trust
name: Torbay and South Devon NHS Foundation Trust
name: South Eastern Health and Social Care Trust
name: University Hospitals Coventry and Warwickshire NHS Trust
name: George Eliot Hospital NHS Trust
name: University Hospitals, Leicester
name: York Teaching Hospitals NHS Foundation Trust
First posted: 2017-10-25
Enrollment: 230
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases (patients with hospital-onset diarrhoea)

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Point-prevalence of hospital-onset diarrhoea
timeFrame: At enrollment
Secondary outcomes:
measure: • The proportion of patients with hospital-onset diarrhoea who have been assessed for the problem by a member of the clinical team.
timeFrame: At enrollment
measure: • The proportion of patients with hospital-onset diarrhoea that are tested for CDI (both overall and amongst those who do and do not have an alternative explanation for the diarrhoea).
timeFrame: Up to 72 hours after enrollment
Other outcomes:
Locations:
city: Antrim
country: United Kingdom
facility: Antrim Area Hospital (Northern Health and Social Care Trust)
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
city: Blackburn
country: United Kingdom
facility: East Lancashire Hospitals NHS Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire + George Eliot Hospital NHS Trust
city: Dundonald
country: United Kingdom
facility: Ulster Hospital (South Eastern Health and Social Care Trust)
city: Edinburgh
country: United Kingdom
facility: NHS Lothian and NHS Fife
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Harrogate
country: United Kingdom
facility: Harrogate and District NHS Foundation Trust
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Free London NHS Foundation Trust
city: Middlesborough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
city: Newport
country: United Kingdom
facility: Aneurin Bevan University Health Board
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
city: Papworth
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Torbay
country: United Kingdom
facility: Torbay and South Devon Healthcare NHS Foundation Trust
city: Wakefield
country: United Kingdom
facility: Mid Yorkshire NHS Trust
city: Winchester
country: United Kingdom
facility: Hampshire Hospitals NHS Foundation Trust
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
city: York
country: United Kingdom
facility: York Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: Leeds Teaching Hospitals NHS Trust
name: Andrew Kirby, MBBS
role: STUDY_DIRECTOR
affiliation: Leeds Teaching Hospitals NHS Trust
name: Jonathan AT Sandoe, MBChB
role: STUDY_DIRECTOR
References: