System to avoid fall events
| ISRCTN | ISRCTN24617143 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24617143 |
| Secondary identifying numbers | 999 |
- Submission date
- 04/01/2018
- Registration date
- 25/01/2018
- Last edited
- 18/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
In-patient falls are the most commonly reported patient safety issue in the NHS. Elderly, frail patients are at a particularly high risk of suffering a fall while admitted to hospital. In 2015/2015, more than 247,000 patients suffered an in-patient fall event with more than 10,500 patients over the age of 65 suffered severe harm as the result of a fall. The combined cost to the NHS is £150 million just for this type of injuries. Therefore, this study aims to test a new technology to provide nurses and clinicians with an early warning of situations that are known to frequently cause falls.
Who can participate?
Patients admitted to the ward who are deemed by the ward clinicians to be at risk of falling from the bed
What does the study involve?
The technology uses a non-invasive thermal sensor to measure the patient's position inside the bed. When a patient moves to exit the bed, a notification is sent to a ward nurse, who can respond appropriately to the situation. Should a patient fall out of bed and onto the floor, the technology raises an alarm to the nurses. The study compares the number of fall events recorded in a control phase without the technology with the number of fall events recorded during a test phase with the technology. Each phase lasts 3 months, with a 3-month follow-up.
What are the possible benefits and risks of participating?
The benefit of the study is that the technology may enable nurses to potentially take pre-emptive action before a fall occurs rather than react when a fall has already happened. No direct risk to the participants has been identified. All the hardware is installed after stringent safety precautions to eliminate risks of both voluntary and involuntary misuse of the system during the study.
Where is the study run from?
Royal Lancaster Infirmary (UK)
When is the study starting and how long is it expected to run for?
January 2018 to November 2018
Who is funding the study?
Rinicare Ltd (UK)
Who is the main contact?
1. Søren Udby (public)
2. Margaret Cooper (scientific)
Contact information
Public
Riverway House
Morecambe Road
Lancaster
LA1 2RX
United Kingdom
 ORCID ID |
0000-0001-8711-2168 |
|---|
Scientific
Ashton Road
Lancaster
LA1 4RP
United Kingdom
| ORCID ID |
0000-0001-9103-6639 |
|---|
Study information
| Study design | Interventional non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | An investigation to explore the feasibility of thermal imaging technology to prevent frail, elderly, and vulnerable patients in hospital wards from suffering preventable, in-patient fall events causing moderate to severe damage |
| Study acronym | SAFE |
| Study objectives | The study aims to determine the feasibility, suitability, and acceptability of using thermal imaging analysis to produce early warning notifications to prevent at-risk patients from suffering a fall from a bed while in hospital. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Patients deemed to be at risk of suffering a fall from a bed due to physical frailty, medication, or mental issues |
| Intervention | The participants will have a SAFE sensor system installed above their hospital bed as part of this study. The SAFE sensor unit will monitor the participant's position relative to the edge of the bed in real-time. If a dangerous situation is detected by the system, e.g. a frail, elderly patient sitting on the edge of the bed in preparation to exit the bed, the SAFE system will notify a member of the ward staff to inform them of the situation and take appropriate actions to ensure that the patient exits the bed safely. The study will compare the number of fall events recorded in a control phase with the number of fall events recorded during the test phase. Each phase is planned for 3 months, with a 3-month follow-up. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | The number of fall events recorded during the test phase and the control phase |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 29/01/2018 |
| Completion date | 19/11/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | 1. Patients admitted to the ward for a duration of no less than 48 hours 2. Patients who are deemed by the ward clinicians to be at risk of falling from the bed due to one or more of the following reasons: 2.1. Frailty due to old age (e.g. 65 years or older) 2.2. Frailty due to medical conditions (e.g. hypotension) 2.3. Frailty due to mental conditions (e.g. dementia) 2.4. Frailty due to physical conditions (e.g. amputation) 2.5. Frailty due to medication(s) Patients who are able to give informed consent or individuals unable to consent to participation due to a lack of mental capacity their participation needs to be agreed by someone who is independent of the study and who can assess the potential participant’s interests in accordance with current legislation and guidance. This person may be a relative, a carer or an independent representative. These patients are a particularly vulnerable group and their interests must therefore be protected. They should be given the same opportunities to participate in ethically designed research projects as those who do not lack capacity but must not be put at unwarranted risk. |
| Key exclusion criteria | 1. Patients under 18 years of age 2. Patients in an unconscious state or otherwise unable to move under the own power |
| Date of first enrolment | 02/03/2018 |
| Date of final enrolment | 15/08/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Lancaster
LA1 4RP
United Kingdom
Sponsor information
Industry
Riverway Hourse
Morecambe Road
Lancaster
LA1 2RX
United Kingdom
| Website | www.rinicare.com |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 19/02/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | 1. A number of supporting documents have been prepared for this trial: 1.1. The study protocol, currently under review from senior management (due back on Monday 15/01/2018) 1.2. Participant consent form 1.3. Participant information sheet 1.4. Consultee information sheet 1.5. Participant data privacy and protection protocol (in compliance with Rinicare’s internal ISO27001 protocols) 1.6. A paper is planned to be published after the completion of the trial for a peer-reviewed journal 2. The plan is to set-up a sub-site for the trial on the www.rinicare.com website with all the publicly available documents. The intention is to publish an article for a relevant peer-reviewed journal within 3 months of the conclusion of the study. Furthermore, the outcome of the study will be published on Rinicare's website. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. |
Editorial Notes
18/12/2020: Internal review.
