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Completed

NCT Number: NCT03321578

Hospital Onset Diarrhoea Investigation

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antrim Area Hospital (Northern Health and Social Care Trust), Antrim, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Point-prevalence of hospital-onset diarrhoea

    Time frame: At enrollment

Secondary outcomes

  1. • The proportion of patients with hospital-onset diarrhoea who have been assessed for the problem by a member of the clinical team.

    Time frame: At enrollment

  2. • 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).

    Time frame: Up to 72 hours after enrollment

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Collaborators

  • 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 University Teaching Hospitals NHS Trust
  • Mid Yorkshire Teaching 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 Eastern Health and Social Care Trust
  • South Tees Hospitals NHS Foundation Trust
  • The Royal Wolverhampton Hospitals NHS Trust
  • Torbay and South Devon NHS Foundation Trust
  • University Hospitals Coventry and Warwickshire NHS Trust
  • University Hospitals, Leicester
  • York Teaching Hospitals NHS Foundation Trust

Registry information

Official study 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

Acronym: HOODINI

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 25, 2017
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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