Hospital Onset Diarrhoea Investigation (HOODINI)

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

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.

Study Overview

• Status: Completed
• Conditions: Diarrhea

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 Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cases (patients with hospital-onset diarrhoea)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Point-prevalence of hospital-onset diarrhoea	At enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust
• Collaborators: Cambridge University Hospitals NHS Foundation Trust; Nottingham University Hospitals NHS Trust; Guy's and St Thomas' NHS Foundation Trust; Sheffield Teaching Hospitals NHS Foundation Trust; Royal Free Hospital NHS Foundation Trust; University Hospitals, Leicester; NHS Lothian; South Eastern Health and Social Care Trust; Papworth Hospital NHS Foundation Trust; Hull University Teaching Hospitals NHS Trust; Oxford University Hospitals NHS Trust; East Lancashire Hospitals NHS Trust; NHS Greater Glasgow and Clyde; The Royal Wolverhampton Hospitals NHS Trust; University Hospitals Coventry and Warwickshire NHS Trust; Aneurin Bevan University Health Board; South Tees Hospitals NHS Foundation Trust; Hampshire Hospitals NHS Foundation Trust; Mid Yorkshire Hospitals NHS Trust; George Eliot Hospital NHS Trust; Northern Health and Social Care Trust; Barnsley Hospital NHS Foundation Trust; Harrogate & District NHS Foundation Trust; Torbay and South Devon NHS Foundation Trust; York Teaching Hospitals NHS Foundation Trust
• Investigators: Study Director: Andrew Kirby, MBBS, Leeds Teaching Hospitals NHS Trust; Study Director: Jonathan AT Sandoe, MBChB, Leeds Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (ACTUAL): October 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 23, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: clostridium difficile; nosocomial; hospital acquired
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: v10.5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO