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
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
Scientific
Oxford University Hospitals NHS Trust
John Radcliffe Hospital
Kadoorie Research Centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0003-1023-3927 |
|---|
Study information
| Study design | Single-centre randomised stepped wedge interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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' |
| Study acronym | OTEST |
| Study objectives | 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(s) | Cambridgeshire 2 Research Ethics Committee, 17/02/2011, ref: 11/HO308/11 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 31/08/2011 |
| Completion date | 01/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2000 |
| Key inclusion criteria | All patients over 16 years of age admitted to two trauma wards over an eight month period |
| Key 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 |
| Date of first enrolment | 31/08/2011 |
| Date of final enrolment | 01/07/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
OX3 9DU
United Kingdom
Sponsor information
Hospital/treatment centre
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
England
United Kingdom
| Website | http://ouh.nhs.uk |
|---|---|
"ROR" |
https://ror.org/03h2bh287 |
Funders
Funder type
Research council
No information available
Results and Publications
| Intention to publish date | 08/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The 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.
