FallNCT03192384
A Service Intervention to Reduce Falls in Hospital
An observational study of Fall, run by University of Warwick at 1 site in United Kingdom.
Trial summary
The head of nursing at University Hospital Coventry and Warwickshire (UHCW) plans to roll out an intervention across groups of hospital wards over the next four months. The intervention is designed to reduce falls as part of quality improvement for the hospital. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- Educational programme
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 May 2017to 31 May 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients admitted to wards at the hospital
Who may be able to join
- All patients on ward
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Coventry and Warwickshire
Coventry, Warwickshire, CV2 2DX
About this study
Official title: Step Wedge Cluster Randomised Trial of a Service Intervention to Reduce Falls in Hospital
The head of nursing at University Hospital Coventry and Warwickshire (UHCW) plans to roll out an intervention across groups of hospital wards over the next four months. The intervention is designed to reduce falls as part of quality improvement for the hospital. However, the head of nursing has asked the University of Warwick to help with the scientific evaluation of the intervention - to find out whether and to what extent falls on the wards are reduced by the intervention. The University of Warwick will have two functions:
- To analyse data on falls to see if there has been a statistically significant drop in fall rates before and after the intervention has been implemented across these groups of wards
- To determine a random order in which the groups of wards receive the intervention as this will make it easier to distinguish cause and effect.
Read the detailed description
Falls are the most commonly reported patient safety incident with 240,000 recorded in NHS hospitals in England each year. The national mean rate of falls per 1000 occupied bed day (OBDs) is 6.6. The rate of harm per 1000 OBD is 0.19. The head of nursing at UHCW is responsible for quality and safety in nursing and recognises that falls are a problem at UHCW. Consequently she plans to implement an intervention (an educational programme for ward staff) to reduce the potential harm caused by falls, and wishes to know whether the intervention is effective. For logistical reasons it is not possible to introduce the intervention to all wards at the same time, so it is necessary to roll the intervention out across clusters of wards over time. These clusters will be the unit of study. Human Subjects Protection Review will be exempt as the intervention is taking place at ward level, not the patient level. The hypothesis is that fall rates will tend to decline after the intervention is introduced. Standards for prevention of falls have been published by the Healthcare Quality Improvement Partnership (Royal College of Physicians. National Audit of Inpatient Falls: audit report 2015. London: RCP, 2015). The intervention will consist of education to improve compliance with these standards.
NIHR CLAHRC West Midlands were approached to conduct an independent evaluation. However, the service imperative does not permit any delay in implementation of the intervention. Although the intervention must not be delayed, it cannot be implemented simultaneously across all hospital wards; it must be rolled out incrementally. The unit of roll-out is a cluster of wards. There are nine clusters of wards:
Cluster A:
- Ward 40 - Gerontology - Age
- Ward 20 - Gerontology
- Ward 21 - Gerontology
Cluster B:
- Ward 41 - Stroke
- Ward 42 - Neurology
- Ward 43 - Neurosurgery
Cluster C:
- Ward 30 - Respiratory
- Ward 31 - Medical ward
- Ward 34 - Clinical Haemotology
- Ward 35 - Oncology
Cluster D:
- Ward 50 - Renal
- Ward 52 - Orthopaedics
- Ward 53 - Orthopaedics
Cluster E:
- Ward 10 - Cardiology
- Ward 11 - Cardiothoracic Surgery
Cluster F:
- Cedar Ward - Orthopaedics
- Hoskyn Ward
- Mulberry Ward
- Oak Ward - Rehab
Cluster G:
- Ward 32 - Head \& Neck
- Ward 33 - Surgery
- Ward 33 - Gastro
- Ward 33 - Urology
Cluster H:
- Ward 21 - Short-stay - Gen Surgery
- Ward 22 - ECU
- Ward 22 - Surgical Assessment Unit
- Ward 22A - Vascular Surgery
- Ward 23 - Gynaecology Suite
Cluster I:
- Ward 12/CDU - AMU1
- Ward 3 (AMU3)
- Ward 12 - Observation / Assessment Unit (ED)
- Ward 1
- AMU 2
The phased introduction across wards evokes the possibility of step wedge cluster RCT (Hemming, et al. BMJ. 2015; 350:h391). However, clusters A and B must proceed first, and clusters H and I must proceed last as these are wards with very short stay. Five clusters (C to G) are therefore available for randomisation. Once clusters have been randomised to a given order, there are no foreseeable reasons to change the order. Accordingly, a list of the five eligible clusters was sent to the CLAHRC WM Director on 17/01/17 and were randomised independently (by Dr Mark Slater at the Dept of Physics, University of Birmingham) using Microsoft Excel (each cluster was assigned a random number, the numbers were then sorted from smallest to largest), as below:
E - F - G - C - D.
The primary outcome is fall rates, and we hypothesise that fall rates will decrease over the intervention period. Fall rates per 1000 bed days per month range from 0 to 34.48. Fall rates will be collated monthly over a one year period to provide a median of approximately six months pre- and six months post-intervention data points. The data will be expressed as falls per 1000 OBDs and will be harvested from the routine data system. The senior nurse on duty has a statutory requirement to collect data on falls and enter them on the hospital computer system. We will record the date at which the intervention team start working with a new cluster. The rate at which the intervention will be rolled out is uncertain at this stage.
For analysis, the raw data from the system will be sent to Dr Karla Hemming at the University of Birmingham for statistical analysis, including adjustment for calendar time. Primary analysis will be restricted to the five randomised clusters, and secondary analysis will include the four non-randomised clusters. The evaluation will take account of correlation within clusters and auto-correlation over time.
- Conditions
- Fall
- Being tested
- Educational programme
- Keywords
- Hospital falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programmeBehavioural
Educational programme for ward staff
| Study group | Role | What they receive |
|---|---|---|
| Before intervention | Data from clusters before educational programme intervention implemented. | |
| After intervention | Data from clusters after educational programme intervention implemented Receives: Behavioral: Educational programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of falls per thousand occupied bed days.
We hypothesize that fall rates will decrease per 1000 Occupied Bed Days
Measured: Fall rates will be collated monthly over a one year period to provide a median of approximately six months pre- and six months post-intervention data points.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start19 May 2017
- Primary completion31 May 2018 (estimated)
- Study completion31 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warwick
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust
- Responsible party
- Principal investigator, Professor Richard Lilford, University of Warwick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192384
- Sponsor's protocol ID
- UoW
- Status last verified
- Jun 2017
- First submitted
- 9 May 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step Wedge Cluster Randomised Trial of a Service Intervention to Reduce Falls in Hospital
- ClinicalTrials.gov ID
- NCT03192384
- Acronym / sponsor ID
- UoW
- Conditions
- Fall
- Keywords
- Hospital falls
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of WarwickUniversity, hospital or other
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust
- Study start
- 19 May 2017 (actual)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 31 May 2018 (estimated)
- First posted
- 20 Jun 2017 (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 head of nursing at University Hospital Coventry and Warwickshire (UHCW) plans to roll out an intervention across groups of hospital wards over the next four months. The intervention is designed to reduce falls as part of quality improvement for the hospital. However, the head of nursing has asked the University of Warwick to help with the scientific evaluation of the intervention - to find out whether and to what extent falls on the wards are reduced by the intervention. The University of Warwick will have two functions:
- To analyse data on falls to see if there has been a statistically significant drop in fall rates before and after the intervention has been implemented across these groups of wards
- To determine a random order in which the groups of wards receive the intervention as this will make it easier to distinguish cause and effect.
Detailed description
Falls are the most commonly reported patient safety incident with 240,000 recorded in NHS hospitals in England each year. The national mean rate of falls per 1000 occupied bed day (OBDs) is 6.6. The rate of harm per 1000 OBD is 0.19. The head of nursing at UHCW is responsible for quality and safety in nursing and recognises that falls are a problem at UHCW. Consequently she plans to implement an intervention (an educational programme for ward staff) to reduce the potential harm caused by falls, and wishes to know whether the intervention is effective. For logistical reasons it is not possible to introduce the intervention to all wards at the same time, so it is necessary to roll the intervention out across clusters of wards over time. These clusters will be the unit of study. Human Subjects Protection Review will be exempt as the intervention is taking place at ward level, not the patient level. The hypothesis is that fall rates will tend to decline after the intervention is introduced. Standards for prevention of falls have been published by the Healthcare Quality Improvement Partnership (Royal College of Physicians. National Audit of Inpatient Falls: audit report 2015. London: RCP, 2015). The intervention will consist of education to improve compliance with these standards.
NIHR CLAHRC West Midlands were approached to conduct an independent evaluation. However, the service imperative does not permit any delay in implementation of the intervention. Although the intervention must not be delayed, it cannot be implemented simultaneously across all hospital wards; it must be rolled out incrementally. The unit of roll-out is a cluster of wards. There are nine clusters of wards:
Cluster A:
- Ward 40 - Gerontology - Age
- Ward 20 - Gerontology
- Ward 21 - Gerontology
Cluster B:
- Ward 41 - Stroke
- Ward 42 - Neurology
- Ward 43 - Neurosurgery
Cluster C:
- Ward 30 - Respiratory
- Ward 31 - Medical ward
- Ward 34 - Clinical Haemotology
- Ward 35 - Oncology
Cluster D:
- Ward 50 - Renal
- Ward 52 - Orthopaedics
- Ward 53 - Orthopaedics
Cluster E:
- Ward 10 - Cardiology
- Ward 11 - Cardiothoracic Surgery
Cluster F:
- Cedar Ward - Orthopaedics
- Hoskyn Ward
- Mulberry Ward
- Oak Ward - Rehab
Cluster G:
- Ward 32 - Head \& Neck
- Ward 33 - Surgery
- Ward 33 - Gastro
- Ward 33 - Urology
Cluster H:
- Ward 21 - Short-stay - Gen Surgery
- Ward 22 - ECU
- Ward 22 - Surgical Assessment Unit
- Ward 22A - Vascular Surgery
- Ward 23 - Gynaecology Suite
Cluster I:
- Ward 12/CDU - AMU1
- Ward 3 (AMU3)
- Ward 12 - Observation / Assessment Unit (ED)
- Ward 1
- AMU 2
The phased introduction across wards evokes the possibility of step wedge cluster RCT (Hemming, et al. BMJ. 2015; 350:h391). However, clusters A and B must proceed first, and clusters H and I must proceed last as these are wards with very short stay. Five clusters (C to G) are therefore available for randomisation. Once clusters have been randomised to a given order, there are no foreseeable reasons to change the order. Accordingly, a list of the five eligible clusters was sent to the CLAHRC WM Director on 17/01/17 and were randomised independently (by Dr Mark Slater at the Dept of Physics, University of Birmingham) using Microsoft Excel (each cluster was assigned a random number, the numbers were then sorted from smallest to largest), as below:
E - F - G - C - D.
The primary outcome is fall rates, and we hypothesise that fall rates will decrease over the intervention period. Fall rates per 1000 bed days per month range from 0 to 34.48. Fall rates will be collated monthly over a one year period to provide a median of approximately six months pre- and six months post-intervention data points. The data will be expressed as falls per 1000 OBDs and will be harvested from the routine data system. The senior nurse on duty has a statutory requirement to collect data on falls and enter them on the hospital computer system. We will record the date at which the intervention team start working with a new cluster. The rate at which the intervention will be rolled out is uncertain at this stage.
For analysis, the raw data from the system will be sent to Dr Karla Hemming at the University of Birmingham for statistical analysis, including adjustment for calendar time. Primary analysis will be restricted to the five randomised clusters, and secondary analysis will include the four non-randomised clusters. The evaluation will take account of correlation within clusters and auto-correlation over time.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before intervention | – | –Data from clusters before educational programme intervention implemented. |
| After intervention | – | Behavioral: Educational programmeData from clusters after educational programme intervention implemented |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to wards at the hospital
Key inclusion criteria (1 listed)
- All patients on ward
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Educational programmeEducational programme for ward staff | Behavioural | After intervention |
Primary outcome
Rates of falls per thousand occupied bed days.
Time frame: Fall rates will be collated monthly over a one year period to provide a median of approximately six months pre- and six months post-intervention data points.
We hypothesize that fall rates will decrease per 1000 Occupied Bed Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Fall, run by University of Warwick 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: status not confirmed, as of the sponsor's last update on 20 Jun 2017. 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?
Results are not available in the source record.
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?
Rates of falls per thousand occupied bed days. (time frame: Fall rates will be collated monthly over a one year period to provide a median of approximately six months pre- and six months post-intervention data points.). 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 20 Jun 2017.