Hospital Onset Diarrhoea Investigation

Completed

• Conditions: Diarrhea

• Registration Number: NCT03321578
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

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.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-06
• Study Completion: 2016-08
• Status Verified: 2017-10
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-23
• Last Update Submitted: 2017-10-23
• Study First Posted: 2017-10-25
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Point-prevalence of hospital-onset diarrhoea	At enrollment

Secondary Outcome Measures

Name	Time	Method
• 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
• The proportion of patients with hospital-onset diarrhoea who have been assessed for the problem by a member of the clinical team.	At enrollment

Trial Locations

Locations (24)

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

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