Patient SafetyCEMPSIHNCT06738316
Clinical Experience of Maintaining Patient Safety in Hospital
An observational study of Patient Safety, run by University of Nottingham at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Safety
- What is being tested?
- Simulation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 53 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 9 Jan 2025to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Healthcare professionals involved in the management or care of patients who are at risk of accidental falls in hospitals.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
University Hospitals of Leicester
Leicester, LE1 5WW
Nottingham University Hospitals
Nottingham, NG7 2UH
Northern Care Alliance, Rochdale Care Organisation
Salford, M6 8HD
About this study
Official title: What is the Clinical Experience of Maintaining Patient Safety in Hospital in Patients With Temporary or Permanent Loss of Cognitive Function? A Mixed Methods Study
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.
Read the detailed description
The National Institute for Health and Care Excellence clinical guidance CG161 recommends that all patients admitted to hospital over the age of 65 and those with specific underlying conditions between the age of 50 and 64 are considered at high risk of falls and a documented falls risk assessment is undertaken on admission. However, whilst advising the use of an appropriate multifactorial risk assessment (MFA) NICE also acknowledges that there is no evidence of the efficacy of most falls prevention methods in hospital and that high quality randomised controlled trials (RCT) conducted in the UK are required to improve the existing evidence base.
Falls are referred to as accidents but statistically they have been shown not to demonstrate a pattern of chance which suggests a causal process. Contributing factors leading to falls have been recognised as; postural stability, gait, sensory deficit, neuromuscular impairment, psychological conditions, impact of medications, environmental risks and medical risks such as stroke and cardiac issues. Significant research has been undertaken in relation to falls in the community and as such there are useful clinical guidelines published by both NICE and World Falls Guidelines for preventing and managing patients falls in their home. Whilst patients may be at less risk in their own environment, when admitted to hospital usually single or multiple risk factors apply, even if only for a limited period due to the nature of their presenting condition. It is therefore necessary to assess all patients who are admitted to hospital to establish the level of risk they face and to prescribe interventions with the goal of preventing an accidental fall.
In the UK, 30 - 50% of accidental falls in hospital lead to some injury and 1-3% of those sustain a fracture. In-patient falls are a significant cause of morbidity and mortality, with an estimated 247,000 occurring annually at a cost of £2.3billion to the NHS. In-patient falls have consistently been the biggest single category of reported incidents since the 1940's. Little has changed in the 39 years since the that paper and with falls accounting for 85% of all hospital acquired conditions in the USA it is safe to say this is a global issue. A recent Australian study estimated that the annual cost of attempts to prevent in-hospital falls across six health services consumed AU$590 million per year in resources. The areas of greatest investment were 18% physiotherapy, 14% 24 hour observation, 12% falls assessments and 11% falls prevention alarms and there is a lack of quality research to support their efficacy as falls prevention strategies. The generalisable level of success of these strategies is still not known. It seems that health services across the world are investing time and effort in strategies for which there is an absence of evidence. The recently published World Guidelines for Falls Prevention has confirmed there remains no research supporting the use of technology such as falls alarms or nonslip socks (NSS) in hospitals and as such recommends only standard falls prevention methods. As a result of increasing reimbursement costs for hospital treatments, in 2008 the Centres for Medicaid \& Medicare Services, health insurance companies in the United States of America (US), removed reimbursement to hospitals for costs incurred by patient falls and any associated trauma resulting in increasing financial burden to hospitals. The impact on staff suffering 'second victim phenomena' as a result of adverse incidents and the cost to patients who suffer pain, disability, and death is incalculable.
- Conditions
- Patient Safety
- Being tested
- Simulation
- Keywords
- Patient Safety, Fall prevention in hospitals, healthcare workers, simulation, focus group, critical decision method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationBehavioural
Simulation of a patient safety incident in practice. The simulation closely replicates the workplace experience.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare Worker Focus Groups | Self nominated participants from various healthcare worker professions and jobs. Doctors, Nurses, Therapists and Support Staff Receives: Behavioral: Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: September 2025
Secondary outcomes (2)
To inductively generate a questionnaire to be distributed to healthcare professionals and care workers in a future study.
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.
Measured: 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
To generate a cross NHS Trust research group of up to 8 participants that will work collaboratively to co-create interventional clinical trials that will result in a reduction in falls/1000 bed days for each unit in which the design is tested. Additional performance measures will be reported to demonstrate the importance of context such as number of admissions, discharges, high dependency patients and length of stay. Qualitative data will be collected to establish acceptability of the intervention to healthcare workers.
Measured: April 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start9 Jan 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738316
- Sponsor's protocol ID
- 24065
- Acronym
- CEMPSIH
- Status last verified
- Nov 2024
- First submitted
- 12 Dec 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The work is a collective experience and knowledge base. Any individual opinion will be shared within the focus group and a group perspective will be reported therefore individual participant data would be incomplete and therefore worthless. Demographics would not be relevant due to very small sample size. This will however be reconsidered once the questionnaire is designed and amended accordingly
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Clinical Experience of Maintaining Patient Safety in Hospital in Patients With Temporary or Permanent Loss of Cognitive Function? A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT06738316
- Acronym / sponsor ID
- CEMPSIH / 24065
- Conditions
- Patient Safety
- Keywords
- Patient Safety, Fall prevention in hospitals, healthcare workers, simulation, focus group, critical decision method
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 17 Dec 2024 (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 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.
Detailed description
The National Institute for Health and Care Excellence clinical guidance CG161 recommends that all patients admitted to hospital over the age of 65 and those with specific underlying conditions between the age of 50 and 64 are considered at high risk of falls and a documented falls risk assessment is undertaken on admission. However, whilst advising the use of an appropriate multifactorial risk assessment (MFA) NICE also acknowledges that there is no evidence of the efficacy of most falls prevention methods in hospital and that high quality randomised controlled trials (RCT) conducted in the UK are required to improve the existing evidence base.
Falls are referred to as accidents but statistically they have been shown not to demonstrate a pattern of chance which suggests a causal process. Contributing factors leading to falls have been recognised as; postural stability, gait, sensory deficit, neuromuscular impairment, psychological conditions, impact of medications, environmental risks and medical risks such as stroke and cardiac issues. Significant research has been undertaken in relation to falls in the community and as such there are useful clinical guidelines published by both NICE and World Falls Guidelines for preventing and managing patients falls in their home. Whilst patients may be at less risk in their own environment, when admitted to hospital usually single or multiple risk factors apply, even if only for a limited period due to the nature of their presenting condition. It is therefore necessary to assess all patients who are admitted to hospital to establish the level of risk they face and to prescribe interventions with the goal of preventing an accidental fall.
In the UK, 30 - 50% of accidental falls in hospital lead to some injury and 1-3% of those sustain a fracture. In-patient falls are a significant cause of morbidity and mortality, with an estimated 247,000 occurring annually at a cost of £2.3billion to the NHS. In-patient falls have consistently been the biggest single category of reported incidents since the 1940's. Little has changed in the 39 years since the that paper and with falls accounting for 85% of all hospital acquired conditions in the USA it is safe to say this is a global issue. A recent Australian study estimated that the annual cost of attempts to prevent in-hospital falls across six health services consumed AU$590 million per year in resources. The areas of greatest investment were 18% physiotherapy, 14% 24 hour observation, 12% falls assessments and 11% falls prevention alarms and there is a lack of quality research to support their efficacy as falls prevention strategies. The generalisable level of success of these strategies is still not known. It seems that health services across the world are investing time and effort in strategies for which there is an absence of evidence. The recently published World Guidelines for Falls Prevention has confirmed there remains no research supporting the use of technology such as falls alarms or nonslip socks (NSS) in hospitals and as such recommends only standard falls prevention methods. As a result of increasing reimbursement costs for hospital treatments, in 2008 the Centres for Medicaid \& Medicare Services, health insurance companies in the United States of America (US), removed reimbursement to hospitals for costs incurred by patient falls and any associated trauma resulting in increasing financial burden to hospitals. The impact on staff suffering 'second victim phenomena' as a result of adverse incidents and the cost to patients who suffer pain, disability, and death is incalculable.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare Worker Focus Groups | – | Behavioral: SimulationSelf nominated participants from various healthcare worker professions and jobs. Doctors, Nurses, Therapists and Support Staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare professionals involved in the management or care of patients who are at risk of accidental falls in hospitals.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimulationSimulation of a patient safety incident in practice. The simulation closely replicates the workplace experience. | Behavioural | Healthcare Worker Focus Groups |
Primary outcome
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".
Time frame: September 2025
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.
2 secondary outcomes
To inductively generate a questionnaire to be distributed to healthcare professionals and care workers in a future study.
Time frame: 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
Time frame: April 2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided. The work is a collective experience and knowledge base. Any individual opinion will be shared within the focus group and a group perspective will be reported therefore individual participant data would be incomplete and therefore worthless. Demographics would not be relevant due to very small sample size. This will however be reconsidered once the questionnaire is designed and amended accordingly
Related trials for Patient Safety
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Safety, run by University of Nottingham at 3 sites 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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". (time frame: September 2025). 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 19 May 2026.