Plain English Summary
Background and study aims
In current practice, each time a set of observations (blood pressure, heart rate etc) are performed they are recorded on a paper chart. Each result is given a score. The scores for each observation are manually summed, and the total score is recorded on the paper chart. If the total score is too high, the nurse at the bedside will respond by asking for help from a doctor or senior nurse. This method for helping doctors and nurses to recognise when patients are becoming unwell is called an Early Warning System. In 2007 the National Institute of Clinical Excellence advised that wards use an Early Warning System and recommended that the use of electronic systems to facilitate the process should be investigated. The study will test whether recording medical observations electronically can help doctors and nurses to improve outcomes for patients.
Who can participate?
Any patient over 16 years of age admitted to the John Radcliffe Hospital (wards 2A and 3A) in Oxford over an eight month period.
What does the study involve?
Whilst a patient is in hospital their medical observations will be recorded either using the paper-based system or using the electronic system. This will depend on which part of the ward a patient is initially admitted to. The nursing staff are guided to perform exactly the same observations on the patients regardless of whether the results of those observations are being recorded on paper or electronically.
To investigate whether there are any differences between the paper-based and electronic methods of recording the observations we ask trained nursing staff to look at the patients' medical notes.
What are the possible benefits and risks of participating?
The implementation of an electronic based track and trigger system may improve relevant patient outcomes in comparison to an optimised paper based version. There are no known risks for this study. Only data collected from the patients stay will be used.
Where is the study run from?
The study is being carried out on the Trauma unit at the John Radcliffe Hospital (wards 2A and 3A)
When is study starting and how long is it expected to run for?
August 2011 to July 2012
Who is funding the study?
Biomedical Research Council (UK)
Who is the main contact?
The main contact for any questions regarding this study is the OTEST study research team, who can be contacted on 01865 572282.
Dr Peter Watkinson, Principal Investigator for the study and Intensive Care Consultant, can be contacted via The John Radcliffe Hospital, Headley Way, Oxford OX3 9DU. Tel: 01865 741166.
Trial website
Contact information
Type
Scientific
Primary contact
Dr Peter Watkinson
ORCID ID
http://orcid.org/0000-0003-1023-3927
Contact details
Oxford University Hospitals NHS Trust
John Radcliffe Hospital
Kadoorie Research Centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Oxford Track-&-Trigger Electronic System for Trauma (OTEST) - a randomised stepped wedge trial comparing the effects of an integrated electronic 'Track-and-Trigger' system and a paper-based 'Track-and-Trigger' system on the length of trauma patients stay from admission date to 'fit for discharge'
Acronym
OTEST
Study hypothesis
Will the implementation of an electronic based track and trigger system improve relevant patient outcomes in comparison to an optimised paper based version?
The null hypothesis in this trial is that the electronic 'Track-and-Trigger' system will not affect the time between admission to the ward and 'fit-to-discharge' in comparison to a paper-based system; the alternative hypothesis that the electronic 'Track-and-Trigger' system will affect the time between admission to the ward and 'fit-to-discharge' in comparison to a paper-based system.
Ethics approval
Cambridgeshire 2 Research Ethics Committee, 17/02/2011, ref: 11/HO308/11
Study design
Single-centre randomised stepped wedge interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Patients admitted to a trauma ward
Intervention
Control 'paper system' arm:
A paper evidence-based 'track-and-trigger' system on which physiological observations of blood pressure, pulse, oxygen saturation, temperature and conscious level are recorded is used. A score is manually assigned to each observed physiological value dependent on that value's position within the range of values seen in hospitalised patients. The scores for each physiological value are manually summed to provide a single (summary) measure of the patient's physiological status. The frequency of subsequent observations and the clinical response to a patient's physiological status are then set by following an algorithm based on the summary measure. The control arm is essential to allow comparison with the current standard system, a comparison recommended by the National Institute for Clinical Excellence. Observation time is no longer than the patient's hospital stay. No follow-up other than survival at 30 days after admission.
Intervention 'electronic system' arm:
Physiological observations will be entered onto a tablet personal computer or personal digital assistant both integrated with a central display station. Scores will be automatically assigned and summed. The time of the next observation set and the appropriate clinical response will be automatically displayed according to the escalation algorithm. Visual warnings will be displayed if an observation set or clinical response is delayed. This study will use the VitalPAC v 1.2 system (The Learning Clinic, UK) to provide this functionality. The product and its software will be fully localised to both trust standards and those specific to the trauma unit (and has already been deployed in several NHS Trusts). Observation time is no longer than the patient's hospital stay. No follow-up other than survival at 30 days after admission.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Time from ward admission to 'fit to discharge'. 'Fit to discharge' is defined as either discharged from the ward to home or alternative care or accepted by social services as a 'delayed discharge'. This primary outcome measure has been chosen instead of using length of stay as a significant number of patients have an extended length of stay whilst waiting for suitable support mechanisms to be put in place outside hospital.
Secondary outcome measures
Patient outcome measures:
1. Hospital length of stay
2. In hospital mortality
3. 30 day mortality following ward admission
4. Unplanned admissions to intensive care
5. Number of cardiac arrest calls
Compliance measures:
1. Appropriate escalation in observation frequency
2. Appropriate escalation in clinical intervention
Overall trial start date
31/08/2011
Overall trial end date
01/07/2012
Reason abandoned
Eligibility
Participant inclusion criteria
All patients over 16 years of age admitted to two trauma wards over an eight month period
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2000
Participant exclusion criteria
1. Patients whose treatment plan is palliative at admission to the trauma ward
2. Patients with a learning disability
3. Patients unable to speak English and without a suitable translator
4. Patients in the custody of HM Prison Service
Recruitment start date
31/08/2011
Recruitment end date
01/07/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford University Hospitals NHS Trust
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Oxford University Hospitals NHS Trust (UK)
Sponsor details
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
Biomedical Research Council (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
08/09/2018
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary