EmergenciesNCT03209375
Identification of the Sick Patient in the ED
An observational study of Emergencies, run by Lancashire Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Emergencies
- How many people
- 503 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 May 2017to 14 Jul 2017
- 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: As above.
Who may be able to join
- Presenting to Royal Preston Hospital Emergency Department
Who cannot join
- Trauma, purely psychiatric or obstetric presentation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Preston Hospital
Preston, Lancashire, PR2 9HT
About this study
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.
Read the 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
- Conditions
- Emergencies
- Keywords
- triage, early warning system
- Medical subject headings
- Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Life-saving intervention
Composite outcome measure
Measured: 48 hours
Secondary outcomes (1)
Death
All cause mortality
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start30 May 2017
- Primary completion14 Jul 2017
- Study completion14 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsty Challen, PhD, Principal investigator, Lancashire Teaching Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209375
- Sponsor's protocol ID
- 217746
- Status last verified
- Sep 2017
- First submitted
- 28 Jun 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Sick Patient in the ED
- ClinicalTrials.gov ID
- NCT03209375
- Acronym / sponsor ID
- 217746
- Conditions
- Emergencies
- Keywords
- triage, early warning system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 May 2017 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 6 Jul 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 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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- As above.
Key inclusion criteria (1 listed)
- Presenting to Royal Preston Hospital Emergency Department
Key exclusion criteria (1 listed)
- Trauma, purely psychiatric or obstetric presentation
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
Life-saving intervention
Time frame: 48 hours
Composite outcome measure
1 secondary outcome
Death
Time frame: 48 hours
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 14 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
Kirsty Challen, PhD principal investigator
Lancashire Teaching Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies, run by Lancashire Teaching Hospitals NHS Foundation Trust at 1 site 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 1 inclusion and 1 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 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Life-saving intervention (time frame: 48 hours). 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 14 Sep 2017.