Accidental FallsTechSIMPAFiHNCT07355556
Technology Supported Improvement, Management and Prevention of Accidental Falls in Hospitals
An observational study of Accidental Falls and Fall Prevention, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The student will observe fall prevention systems in practice in 2 different hospitals considering how fall prevention technology influences staff behaviour and patients safety in the context of accidental falls in hospital. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Fall Prevention
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2026to 31 Mar 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare professionals working as a clinical team in practice
Who may be able to join
- Any member of the ward team as defined by the ward manager including students. All healthcare professional groups, ancillary and administrative staff who work on the selected study ward and any temporary staff from agency or other wards who consent to participate.
Who cannot join
- Any staff under 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University Hospitals of Leicester
Leicester, LE1 5WW
Dylan Donnelly, +44 116 2584761, dylan.donnelly@nhs.net
About this study
The student will observe fall prevention systems in practice in 2 different hospitals considering how fall prevention technology influences staff behaviour and patients safety in the context of accidental falls in hospital. Accidental falls in hospital are rare but can be life changing for those that suffer them as they are often frail patients who are already vulnerable. Current research shows little improvement with any interventions tested which leaves patient facing clinicians with few resources to assist in the prevention of falls. The investigator believes this is because the measure of accidental falls in hospital is not sensitive enough to calibrate for the different contexts in which patients fall. The student would posit that it is the context that is most influential and addressing the context may lead to improved measures so progress can be made in finding solutions.
Read the detailed description
The multi-centre study will involve up to 2 wards on each of the 2 Trust sites. The study wards will be randomly selected from a group of wards that have indicated they are happy to be considered as potential research wards. An ethnographic case study with contextual enquiry design will be used to allow a contextual analysis of fall prevention in practice and consider how staff decisions and behaviour contribute to this. Hierarchical task analysis (HTA) will be utilised to inform this and to identify differences between 'work as imagined' compared to 'work as done' . The study will use observations of the staff in clinical practice using their current system of fall prevention measures assisted by their existing technology and will illustrate outcomes with specific and transparent definitions. Calculations of falls occurring measured with local live data will compare with current standard measurements (Falls/1000 occupied bed days) as calculated with central occupancy data. The ward team, patients and relatives attending the wards will have an opportunity to complete a questionnaire about the use of fall prevention technology advertised in the ward environment on fliers and posters as permitted by policy. Recommendations for future technology design, research and use of technology in fall prevention will be provided on conclusion of the study.
- Conditions
- Accidental Falls, Fall Prevention
- Keywords
- ethnographic case study, contextual enquiry, observation of clinical staff, The use of technology to prevent falls, mixed methods research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| clinical ward team UHL1 | A clinical ward team in a NHS acute care Trust | |
| clinical ward team UHL2 | A clinical ward team in a NHS acute care Trust |
What is being measured
The primary outcome is the main question the study is designed to answer.
To discover how work practice and behaviour adheres or varies from policy
Data will be gathered by observing staff in their usual work environment over a 12 month period to determine how fall prevention practice is shaped by technology. Up to 200 staff will be observed by the researcher on various shifts. Hierarchical task analysis will be used to compare how work varies from the policy/protocol and any workarounds that have been developed (Work as done will be compared to work as imagined). Adherence to policy/protocol or variance from policy/protocol will be recorded and collated as a count of deviations.
Measured: 12 months
To collate evidence of the context of falls in a context log to identify potential contributory factors to accidental falls in hospital.
A thematic analysis of accidental fall incident forms will be undertaken comparing contextual details at the time of the accidental fall to identify common themes. Previously uncollated facts such as the exact location of fall (bedside or bathroom), lighting at the time and ability to alter the lighting (automatic switch on /off versus dimmer switch), footwear (own or provided in hospital) and whether walking aids in place or not etc. These will be compared before the implementation of fall prevention alarms versus after implementation to see if the implementation of fall prevention alarms has impacted on falls in any specific contextual category. This will identify if there is a specific context in which fall prevention alarms prevents falls. This will allow more accurate measurement of success of technology as there may be a specific type of fall that can be prevented by the technology.
Measured: 12 months
To discover how accidental falls are being measured and recorded in hospital by observation and comparing live data measurement against standard data measurement.
The current way of calculating falls/1000 bed days is flawed. Occupancy rate and number of admissions are not considered. The outcome will compare standard falls/1000 OBD's versus a contextual measurement that better represents outcomes. Instead of taking average hospital occupancy data the calculation of the number of falls/1000 occupied bed days will be calculated using actual data from ward level occupancy. If the hospital uses an electronically generated occupancy measurement it can give falsely high measurements of falls on a specific ward as it reports empty beds at midnight. These empty beds at midnight are often an electronic delayed transfer rather than actual empty beds. measurement according to stafff reported figures will be compared.
Measured: 12 months
Secondary outcomes (2)
To identify through thematic analysis using Nvivo 15 task critical attributes and user requirements for future fall prevention technology design
The observation of the use of technology in practice will provide themes where practice is impeded or enhanced by the use of technology. This will be identified by the themes identified during observation of staff. These themes will be analysed and recommendations for future fall prevention alarms will be deduced.
Measured: 12 months
Staff interviews
Staff will be questioned during their shift with 'go along questions' (quick questions in between work tasks) to record their rationale for completing fall prevention tasks in the way they have. Answers will be anonymously recorded to provide themes to be analysed using Nvivo 15.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester, Northern Care Alliance NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- James Reid, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355556
- Sponsor's protocol ID
- 25057
- Acronym
- TechSIMPAFiH
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 21 Jan 2026
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Supported Improvement, Management and Prevention of Accidental Falls in Hospitals
- ClinicalTrials.gov ID
- NCT07355556
- Acronym / sponsor ID
- TechSIMPAFiH / 25057
- Conditions
- Accidental Falls, Fall Prevention
- Keywords
- ethnographic case study, contextual enquiry, observation of clinical staff, The use of technology to prevent falls, mixed methods research
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester, Northern Care Alliance NHS Foundation Trust
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Jan 2026 (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.
The student will observe fall prevention systems in practice in 2 different hospitals considering how fall prevention technology influences staff behaviour and patients safety in the context of accidental falls in hospital. Accidental falls in hospital are rare but can be life changing for those that suffer them as they are often frail patients who are already vulnerable. Current research shows little improvement with any interventions tested which leaves patient facing clinicians with few resources to assist in the prevention of falls. The investigator believes this is because the measure of accidental falls in hospital is not sensitive enough to calibrate for the different contexts in which patients fall. The student would posit that it is the context that is most influential and addressing the context may lead to improved measures so progress can be made in finding solutions.
Detailed description
The multi-centre study will involve up to 2 wards on each of the 2 Trust sites. The study wards will be randomly selected from a group of wards that have indicated they are happy to be considered as potential research wards. An ethnographic case study with contextual enquiry design will be used to allow a contextual analysis of fall prevention in practice and consider how staff decisions and behaviour contribute to this. Hierarchical task analysis (HTA) will be utilised to inform this and to identify differences between 'work as imagined' compared to 'work as done' . The study will use observations of the staff in clinical practice using their current system of fall prevention measures assisted by their existing technology and will illustrate outcomes with specific and transparent definitions. Calculations of falls occurring measured with local live data will compare with current standard measurements (Falls/1000 occupied bed days) as calculated with central occupancy data. The ward team, patients and relatives attending the wards will have an opportunity to complete a questionnaire about the use of fall prevention technology advertised in the ward environment on fliers and posters as permitted by policy. Recommendations for future technology design, research and use of technology in fall prevention will be provided on conclusion of the study.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clinical ward team UHL1 | – | –A clinical ward team in a NHS acute care Trust |
| clinical ward team UHL2 | – | –A clinical ward team in a NHS acute care Trust |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare professionals working as a clinical team in practice
Key inclusion criteria (1 listed)
- Any member of the ward team as defined by the ward manager including students. All healthcare professional groups, ancillary and administrative staff who work on the selected study ward and any temporary staff from agency or other wards who consent to participate.
Key exclusion criteria (1 listed)
- Any staff under 18 years old
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
To discover how work practice and behaviour adheres or varies from policy
Time frame: 12 months
Data will be gathered by observing staff in their usual work environment over a 12 month period to determine how fall prevention practice is shaped by technology. Up to 200 staff will be observed by the researcher on various shifts. Hierarchical task analysis will be used to compare how work varies from the policy/protocol and any workarounds that have been developed (Work as done will be compared to work as imagined). Adherence to policy/protocol or variance from policy/protocol will be recorded and collated as a count of deviations.
To collate evidence of the context of falls in a context log to identify potential contributory factors to accidental falls in hospital.
Time frame: 12 months
A thematic analysis of accidental fall incident forms will be undertaken comparing contextual details at the time of the accidental fall to identify common themes. Previously uncollated facts such as the exact location of fall (bedside or bathroom), lighting at the time and ability to alter the lighting (automatic switch on /off versus dimmer switch), footwear (own or provided in hospital) and whether walking aids in place or not etc. These will be compared before the implementation of fall prevention alarms versus after implementation to see if the implementation of fall prevention alarms has impacted on falls in any specific contextual category. This will identify if there is a specific context in which fall prevention alarms prevents falls. This will allow more accurate measurement of success of technology as there may be a specific type of fall that can be prevented by the technology.
To discover how accidental falls are being measured and recorded in hospital by observation and comparing live data measurement against standard data measurement.
Time frame: 12 months
The current way of calculating falls/1000 bed days is flawed. Occupancy rate and number of admissions are not considered. The outcome will compare standard falls/1000 OBD's versus a contextual measurement that better represents outcomes. Instead of taking average hospital occupancy data the calculation of the number of falls/1000 occupied bed days will be calculated using actual data from ward level occupancy. If the hospital uses an electronically generated occupancy measurement it can give falsely high measurements of falls on a specific ward as it reports empty beds at midnight. These empty beds at midnight are often an electronic delayed transfer rather than actual empty beds. measurement according to stafff reported figures will be compared.
2 secondary outcomes
To identify through thematic analysis using Nvivo 15 task critical attributes and user requirements for future fall prevention technology design
Time frame: 12 months
Staff interviews
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- 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.
James Reid principal investigator
University Hospitals, Leicester
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 Accidental Falls and Fall Prevention, run by University of Nottingham 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: opening soon, as of the sponsor's last update on 21 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Christian, RN, Ba(hons) (+447900180643, janice.christian@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To discover how work practice and behaviour adheres or varies from policy (time frame: 12 months). The study lists 3 primary outcomes in all. 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 21 Jan 2026.