NCT07355556

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Mar 2027

First Submitted

Initial submission to the registry

November 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

January 21, 2026

Status Verified

October 1, 2025

Enrollment Period

12 months

First QC Date

November 14, 2025

Last Update Submit

January 12, 2026

Conditions

Keywords

ethnographic case studycontextual enquiryobservation of clinical staffThe use of technology to prevent fallsmixed methods research

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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

    12 months

  • Staff interviews

    12 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthcare professionals working as a clinical team in practice

You may qualify if:

  • 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.

You may not qualify if:

  • Any staff under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leicester

Leicester, LE1 5WW, United Kingdom

Location

Study Officials

  • James Reid

    University Hospitals, Leicester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Christian, RN, Ba(hons)

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

January 21, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

January 21, 2026

Record last verified: 2025-10

Locations