A study comparing the effects of using an automated electronic system and a paper-based system of recording patients observations on the length of stay in a hospital for trauma patients

ISRCTN ISRCTN91040762
DOI https://doi.org/10.1186/ISRCTN91040762
Secondary identifying numbers N/A
Submission date
10/05/2012
Registration date
16/05/2012
Last edited
02/11/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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.

Contact information

Dr Peter Watkinson
Scientific

Oxford University Hospitals NHS Trust
John Radcliffe Hospital
Kadoorie Research Centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

ORCiD logoORCID ID 0000-0003-1023-3927

Study information

Study designSingle-centre randomised stepped wedge interventional study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleOxford 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'
Study acronymOTEST
Study objectivesWill 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(s)Cambridgeshire 2 Research Ethics Committee, 17/02/2011, ref: 11/HO308/11
Health condition(s) or problem(s) studiedPatients admitted to a trauma ward
InterventionControl '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 typeOther
Primary outcome measureTime 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 measuresPatient 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 study start date31/08/2011
Completion date01/07/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants2000
Key inclusion criteriaAll patients over 16 years of age admitted to two trauma wards over an eight month period
Key exclusion criteria1. 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
Date of first enrolment31/08/2011
Date of final enrolment01/07/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Oxford University Hospitals NHS Trust
Oxford
OX3 9DU
United Kingdom

Sponsor information

Oxford University Hospitals NHS Trust (UK)
Hospital/treatment centre

John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
England
United Kingdom

Website http://ouh.nhs.uk
ROR logo "ROR" https://ror.org/03h2bh287

Funders

Funder type

Research council

Biomedical Research Council (UK)

No information available

Results and Publications

Intention to publish date08/09/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 31/10/2018 Yes No

Editorial Notes

02/11/2018: Publication reference added.
08/03/2018: Publication and dissemination plan and IPD sharing statement added.