DiarrheaHOODININCT03321578
Hospital Onset Diarrhoea Investigation
An observational study of Diarrhea, run by The Leeds Teaching Hospitals NHS Trust at 24 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Diarrhea
- How many people
- 230 participants
- Where
- 24 sitesUnited Kingdom
- Study dates
- Jan 2016to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cases (patients with hospital-onset diarrhoea)
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United Kingdom24 sites
Antrim Area Hospital (Northern Health and Social Care Trust)
Antrim
Barnsley Hospital NHS Foundation Trust
Barnsley
East Lancashire Hospitals NHS Trust
Blackburn
Cambridge University Hospitals NHS Foundation Trust
Cambridge
University Hospitals Coventry and Warwickshire + George Eliot Hospital NHS Trust
Coventry
Ulster Hospital (South Eastern Health and Social Care Trust)
Dundonald
NHS Lothian and NHS Fife
Edinburgh
NHS Greater Glasgow and Clyde
Glasgow
Harrogate and District NHS Foundation Trust
Harrogate
Hull and East Yorkshire Hospitals NHS Trust
Hull
University Hospitals of Leicester NHS Trust
Leicester
Guy's & St Thomas' NHS Foundation Trust
London
The Royal Free London NHS Foundation Trust
London
South Tees Hospitals NHS Foundation Trust
Middlesbrough
Aneurin Bevan University Health Board
Newport
Nottingham University Hospitals NHS Trust
Nottingham
Oxford University Hospitals NHS Trust
Oxford
Papworth Hospital NHS Foundation Trust
Papworth Everard
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Torbay and South Devon Healthcare NHS Foundation Trust
Torbay
Mid Yorkshire NHS Trust
Wakefield
Hampshire Hospitals NHS Foundation Trust
Winchester
The Royal Wolverhampton NHS Trust
Wolverhampton
York Teaching Hospital NHS Foundation Trust
York
About this study
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
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.
Read the 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.
- Conditions
- Diarrhea
- Keywords
- nosocomial, hospital acquired, clostridium difficile
- Medical subject headings
- Diarrhea
What is being measured
The primary outcome is the main question the study is designed to answer.
Point-prevalence of hospital-onset diarrhoea
Measured: At enrollment
Secondary outcomes (2)
• The proportion of patients with hospital-onset diarrhoea who have been assessed for the problem by a member of the clinical team.
Measured: 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).
Measured: Up to 72 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study startJan 2016
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Aneurin Bevan University Health Board, Northern Health and Social Care Trust, Barnsley Hospital NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, East Lancashire Hospitals 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, Nottingham University Hospitals NHS Trust, Oxford University Hospitals NHS Trust, Papworth Hospital NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, The Royal Wolverhampton Hospitals NHS Trust, Torbay and South Devon NHS Foundation Trust, South Eastern Health and Social Care Trust, University Hospitals Coventry and Warwickshire NHS Trust, George Eliot Hospital NHS Trust, University Hospitals, Leicester, York Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Andrew Kirby, MBBS, Study director, Leeds Teaching Hospitals NHS TrustJonathan AT Sandoe, MBChB, Study director, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321578
- Sponsor's protocol ID
- v10.5
- Acronym
- HOODINI
- Status last verified
- Oct 2017
- First submitted
- 23 Oct 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03321578
- Acronym / sponsor ID
- HOODINI / v10.5
- Conditions
- Diarrhea
- Keywords
- nosocomial, hospital acquired, clostridium difficile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Aneurin Bevan University Health Board, Northern Health and Social Care Trust, Barnsley Hospital NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, East Lancashire Hospitals 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, Nottingham University Hospitals NHS Trust, Oxford University Hospitals NHS Trust, Papworth Hospital NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, The Royal Wolverhampton Hospitals NHS Trust, Torbay and South Devon NHS Foundation Trust, South Eastern Health and Social Care Trust, University Hospitals Coventry and Warwickshire NHS Trust, George Eliot Hospital NHS Trust, University Hospitals, Leicester, York Teaching Hospitals NHS Foundation Trust
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases (patients with hospital-onset diarrhoea)
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Point-prevalence of hospital-onset diarrhoea
Time frame: At enrollment
2 secondary outcomes
• 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
• 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Kirby, MBBS study director
Leeds Teaching Hospitals NHS Trust
Jonathan AT Sandoe, MBChB study director
Leeds Teaching Hospitals NHS Trust
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea, run by The Leeds Teaching Hospitals NHS Trust at 24 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point-prevalence of hospital-onset diarrhoea (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.