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Identification of the Sick Patient in the ED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209375
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Lancashire Teaching Hospitals NHS Foundation Trust

Brief Summary:

This non-interventional study will test scoring systems used to identify high risk patients when they are triaged upon presentation in the Emergency Department (ED) in a single hospital in the Northwest of England between May and July 2017.E The study will involve collecting data only from a cohort of 500 consecutive patients who arrive at the ED. Patients who have a traumatic, purely obstetric or purely psychiatric condition will be excluded.

Patients will be triaged as is routine by nursing and medical staff using various scoring methods determine whether they are high risk and need urgent, life-saving treatment. In addition the impression (yes/no) of the triaging nurse and the treating clinician as to whether the patient will need a life-saving intervention will be collected. Patients will be followed up for 48 hours to see whether they needed any life-saving treatment, such as admission to ICU, life-saving surgery, cardiopulmonary resuscitation (CPR), or death.

Each patient's Manchester Triage category, NEWS at presentation, nurse and treating clinician impressions and a novel score calculated from NEWS data will be collected together with the outcome data in order to compare the predictive power of the five scoring systems. In this way the study will test which is the best scoring system for identifying high risk patients in a timely manner. This is important as it can allow life saving treatment to be delivered quickly to those patients who need it most and can prevent inappropriate interventions on patients who do not immediately need them. The study will collect minimal patient information and will not interfere with or alter their treatment in any way. Only patient data recorded as part of routine practice is required, which will be collected by members of the direct care team and will be anonymised prior to analysis.


Condition or disease
Emergencies

Detailed Description:

This is a single-centre, non-interventional, prospective observational cohort study collecting data from patients presenting to the ED of a large teaching hospital in the Northwest of England. The study is designed to gather information about the number of patients receiving life-saving intervention within 48 hours of presentation and the best of five proposed ways of identifying these patients when they present to the ED. This study is non-interventional and there will be no interference with treatment decisions or alteration in clinical practice.

A prospective observational approach is chosen as it will allow direct access to information and better capture of the systems being assessed in the ED. Information about each patient's perceived risk at presentation (in terms of the five proposed systems) will be collected at the time of presentation. Information will include rating on the five proposed systems and a number of outcome variables, all of which are recorded as part of routine clinical practice. All information will be captured directly into a specially designed database including a study number to preclude the need to record any personal identifiable information for the study.

Data will be collected for each patient on an anonymised database. Demographic details (age, gender, presenting condition) will be collected to identify if the sample is representative of a general ED population. Each patient's Manchester Triage category, NEWS at presentation and the novel score calculated from NEWS data will be included, as will the impression (yes/no) of the triaging nurse and the treating clinician as to whether the patient will need a lifesaving intervention. A number of outcome measures (death, admission to high dependency or intensive care, admission directly to the cardiac catheter laboratory or coronary care, emergency endoscopy, thrombolysis, life-saving surgery, intubation, emergency intravenous medication, CPR, DC cardioversion/external or internal cardiac pacing, massive transfusion for ongoing haemorrhage and non-invasive ventilatory support) will be extracted, having been defined a priori as being potentially life-saving. The demographic details and variables chosen are all recorded or calculated for each patient as part of routine practice on critical care. No additional tests or measurements will be required for this study.

Data will be anonymised by allocation of a study number and this figure will be cross-referenced to an electronic masterlist which will contain the patient name and hospital number. In this way the database can be linked back to the patient to continue data collection and entry. The masterlist will be an electronic spreadsheet which will be stored on a secure server at the hospital and accessed via password protected computers within the ED. The masterlist will be destroyed on completion of the study.

Patient information will be collected in a spreadsheet designed to collate the information and allow statistical analysis. No identifiable patient information will be inputted onto the spreadsheet

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Study Type : Observational
Actual Enrollment : 503 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of the Sick Patient in the ED
Actual Study Start Date : May 30, 2017
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : July 14, 2017



Primary Outcome Measures :
  1. Life-saving intervention [ Time Frame: 48 hours ]
    Composite outcome measure


Secondary Outcome Measures :
  1. Death [ Time Frame: 48 hours ]
    All cause mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
As above.
Criteria

Inclusion Criteria:

  • Presenting to Royal Preston Hospital Emergency Department

Exclusion Criteria:

  • Trauma, purely psychiatric or obstetric presentation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209375


Locations
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United Kingdom
Royal Preston Hospital
Preston, Lancashire, United Kingdom, PR2 9HT
Sponsors and Collaborators
Lancashire Teaching Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Kirsty Challen, PhD Lancashire Teaching Hospital NHS Trust
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Responsible Party: Lancashire Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03209375    
Other Study ID Numbers: 217746
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lancashire Teaching Hospitals NHS Foundation Trust:
triage
early warning system
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes