NCT03321578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

October 23, 2017

Last Update Submit

October 23, 2017

Conditions

Diarrhea

Keywords

nosocomialhospital acquiredclostridium difficile

Outcome Measures

Primary Outcomes (1)

  • Point-prevalence of hospital-onset diarrhoea

    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.

    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

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cases (patients with hospital-onset diarrhoea)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Antrim Area Hospital (Northern Health and Social Care Trust)

Antrim, United Kingdom

Location

Barnsley Hospital NHS Foundation Trust

Barnsley, United Kingdom

Location

East Lancashire Hospitals NHS Trust

Blackburn, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

University Hospitals Coventry and Warwickshire + George Eliot Hospital NHS Trust

Coventry, United Kingdom

Location

Ulster Hospital (South Eastern Health and Social Care Trust)

Dundonald, United Kingdom

Location

NHS Lothian and NHS Fife

Edinburgh, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

Harrogate and District NHS Foundation Trust

Harrogate, United Kingdom

Location

Hull and East Yorkshire Hospitals NHS Trust

Hull, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

Location

The Royal Free London NHS Foundation Trust

London, United Kingdom

Location

South Tees Hospitals NHS Foundation Trust

Middlesbrough, United Kingdom

Location

Aneurin Bevan University Health Board

Newport, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, United Kingdom

Location

Papworth Hospital NHS Foundation Trust

Papworth Everard, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Location

Torbay and South Devon Healthcare NHS Foundation Trust

Torbay, United Kingdom

Location

Mid Yorkshire NHS Trust

Wakefield, United Kingdom

Location

Hampshire Hospitals NHS Foundation Trust

Winchester, United Kingdom

Location

The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

Location

York Teaching Hospital NHS Foundation Trust

York, United Kingdom

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew Kirby, MBBS

    Leeds Teaching Hospitals NHS Trust

    STUDY DIRECTOR

  • Jonathan AT Sandoe, MBChB

    Leeds Teaching Hospitals NHS Trust

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 25, 2017

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

October 25, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(24)