Hospital Onset Diarrhoea Investigation (HOODINI)

October 23, 2017 updated by: The Leeds Teaching Hospitals NHS Trust

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Point-prevalence of hospital-onset diarrhoea
Time Frame: At enrollment
At enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: At enrollment
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).
Time Frame: Up to 72 hours after enrollment
Up to 72 hours after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Leeds Teaching Hospitals NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Andrew Kirby, MBBS, Leeds Teaching Hospitals NHS Trust
  • Study Director: Jonathan AT Sandoe, MBChB, Leeds Teaching Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • v10.5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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