Hospital Onset Diarrhoea Investigation

Diarrhea Clinical Trial

— HOODINI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03321578
• Other study ID #: v10.5
• Status: Completed
• Phase: N/A
• First received: October 23, 2017
• Last updated: October 23, 2017
• Start date: January 2016
• Est. completion date: August 2016

Study information

• Verified date: October 2017
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea

Locations

Country	Name	City	State
United Kingdom	Antrim Area Hospital (Northern Health and Social Care Trust)	Antrim
United Kingdom	Barnsley Hospital NHS Foundation Trust	Barnsley
United Kingdom	East Lancashire Hospitals NHS Trust	Blackburn
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	University Hospitals Coventry and Warwickshire + George Eliot Hospital NHS Trust	Coventry
United Kingdom	Ulster Hospital (South Eastern Health and Social Care Trust)	Dundonald
United Kingdom	NHS Lothian and NHS Fife	Edinburgh
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	Harrogate and District NHS Foundation Trust	Harrogate
United Kingdom	Hull and East Yorkshire Hospitals NHS Trust	Hull
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London
United Kingdom	The Royal Free London NHS Foundation Trust	London
United Kingdom	South Tees Hospitals NHS Foundation Trust	Middlesborough
United Kingdom	Aneurin Bevan University Health Board	Newport
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Oxford University Hospitals NHS Trust	Oxford
United Kingdom	Papworth Hospital NHS Foundation Trust	Papworth
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	Torbay and South Devon Healthcare NHS Foundation Trust	Torbay
United Kingdom	Mid Yorkshire NHS Trust	Wakefield
United Kingdom	Hampshire Hospitals NHS Foundation Trust	Winchester
United Kingdom	The Royal Wolverhampton NHS Trust	Wolverhampton
United Kingdom	York Teaching Hospital NHS Foundation Trust	York

Sponsors (26)

Lead Sponsor

Collaborator

The Leeds Teaching Hospitals NHS Trust

Aneurin Bevan University Health Board, Barnsley Hospital NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, East Lancashire Hospitals NHS Trust, George Eliot Hospital NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Hampshire Hospitals NHS Foundation Trust, Harrogate & District NHS Foundation Trust, Hull and East Yorkshire Hospitals NHS Trust, Mid Yorkshire Hospitals NHS Trust, NHS Greater Glasgow and Clyde, NHS Lothian, Northern Health and Social Care Trust, Nottingham University Hospitals NHS Trust, Oxford University Hospitals NHS Trust, Papworth Hospital NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, South Devon Healthcare NHS Foundation Trust, South Eastern Health and Social Care Trust, South Tees Hospitals NHS Foundation Trust, The Royal Wolverhampton Hospitals NHS Trust, University Hospitals Coventry and Warwickshire NHS Trust, University Hospitals, Leicester, York Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point-prevalence of hospital-onset diarrhoea		At enrollment
Secondary	• The proportion of patients with hospital-onset diarrhoea who have been assessed for the problem by a member of the clinical team.		At enrollment
Secondary	• 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).		Up to 72 hours after enrollment