NCT06738316

Brief Summary

The key purpose of the study is to establish what the barriers to preventing accidental falls in hospital are, what interventions are perceived to work best in preventing falls and what could help. The study will attempt to disprove the null hypothesis that "there is no universal clinical experience of accidental fall prevention in hospitals with patients who have impaired cognitive function". To gather an evidence base for the co-created design and testing of fall prevention interventions as part of the longer term PhD project.This is a multi-centre qualitative study utilising a purposive sampling strategy. Healthcare workers directly involved in preventing falls in hospital will be invited to contribute to the study via an email from their ward manager or clinical lead. Participants will be asked to respond directly to the investigator to indicate their interest in the study. They will be selected to ensure both Medical and Surgical wards are represented. Overall aim will be for up to 16 participants from the nursing team, registered and unregistered, up to 8 therapist participants and up to 8 doctors.This will provide 2 nurses, 1 therapist, 1 doctor in each simulation. This will provide 4 datasets for analysis and this process will be repeated at up to 4 Hospitals to deliver up to 16 datasets. Each group will participate in a 30 minute simulation followed by a semi structured focus group where critical decision method will be used to extract themes and codes to inductively generate a questionnaire for a further study. Patient and Public Involvement (PPI) representatives will be consulted on the outcomes of the focus groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

January 9, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

December 12, 2024

Last Update Submit

November 20, 2025

Conditions

Keywords

Patient SafetyFall prevention in hospitalshealthcare workerssimulationfocus groupcritical decision method

Outcome Measures

Primary Outcomes (1)

  • To disprove the null hypothesis that "there is no universal clinical experience of accidental fall prevention in hospitals with patients who have impaired cognitive function".

    Up to 32 multidisciplinary participants in each of 3 NHS Trusts will take part in a simulation of a ward based patient safety incident. They will then debate how closely this resembles their lived experience of managing patient safety in a ward environment. From this themes and codes will be analysed and the outcomes tested via questionnaire feedback from a larger broader population of healthcare workers. the questionnaire will be distributed to 4000 healthcare workers across the country. Statistical analysis of both quantitative and qualitative data will disprove or prove the null hypothesis.

    September 2025

Secondary Outcomes (2)

  • To inductively generate a questionnaire to be distributed to healthcare professionals and care workers in a future study.

    September 2025

  • To gather an evidence base for the co-created design and testing of fall prevention interventions as part of the longer term PhD project

    April 2026

Study Arms (1)

Healthcare Worker Focus Groups

Self nominated participants from various healthcare worker professions and jobs. Doctors, Nurses, Therapists and Support Staff

Behavioral: Simulation

Interventions

SimulationBEHAVIORAL

Simulation of a patient safety incident in practice. The simulation closely replicates the workplace experience.

Healthcare Worker Focus Groups

Eligibility Criteria

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

Healthcare professionals involved in the management or care of patients who are at risk of accidental falls in hospitals.

You may qualify if:

  • Any healthcare professional or associated support staff involved in the fall risk assessment of patients on admission to a standard care ward environment in hospital
  • Any healthcare professional or associated support staff involved in the multifactorial assessment of patients in an acute ward environment
  • Any healthcare professional or associated support staff involved in putting fall prevention measures in place in an acute ward environment
  • Any healthcare professional or associated support staff involved in caring for patients and their relatives after an accidental fall in an acute ward environment
  • Ability to give informed consent

You may not qualify if:

  • Any healthcare worker with no medical or surgical ward experience
  • Any healthcare worker under the age of 18 years old
  • Any healthcare worker working exclusively in Critical Care or high dependency units or Paediatrics as countermeasures and levels of observation are different in these areas and have separate guidance and policies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospitals of Leicester

Leicester, LE1 5WW, United Kingdom

Location

Nottingham University Hospitals

Nottingham, NG7 2UH, United Kingdom

Location

Northern Care Alliance, Rochdale Care Organisation

Salford, M6 8HD, United Kingdom

Location

Study Design

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

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 17, 2024

Study Start

January 9, 2025

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

November 26, 2025

Record last verified: 2024-11

Locations