Clinical Experience of Maintaining Patient Safety in Hospital (CEMPSIH)

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.

Study Overview

• Status: Completed
• Conditions: Patient Safety
• Intervention / Treatment: Behavioral: Simulation

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 Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • University Hospitals of Leicester
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals
  • Salford, United Kingdom, M6 8HD
    • Northern Care Alliance, Rochdale Care Organisation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthcare Worker Focus Groups; Self nominated participants from various healthcare worker professions and jobs. Doctors, Nurses, Therapists and Support Staff	Behavioral: Simulation; Simulation of a patient safety incident in practice. The simulation closely replicates the workplace experience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	April 2026

Collaborators and Investigators

• Sponsor: University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2025
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: simulation; Patient Safety; focus group; healthcare workers; Fall prevention in hospitals; critical decision method
• Other Study ID Numbers: 24065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No