Accidental Falls Clinical Trial
Official title:
Pilot Cluster Randomised Controlled Trial of Flooring to Reduce Injuries From Falls in Elderly Care Units
In hospitals, older people can fall and hurt themselves. The investigators want to see if a new type of flooring can help stop people hurting themselves as badly, if they accidentally fall.
Status | Completed |
Enrollment | 571 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - all patients admitted to the study area on a participating elderly care ward Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | Ruby Ward, Ellesmere Port Hospital | Ellesmere Port | Merseyside |
United Kingdom | Ward C5, Diana Princess of Wales Hospital | Grimsby | North East Lincolnshire |
United Kingdom | Granby Ward, Harrogate District Hospital | Harrogate | North Yorkshire |
United Kingdom | Ward 15, Newcastle Freeman Hospital | Newcastle-upon-Tyne | Tyne and Wear |
United Kingdom | Newchurch Ward, St Mary's Hospital | Newport | Isle of Wight |
United Kingdom | Ward D1, Queen Alexandra Hospital | Portsmouth | Hampshire |
United Kingdom | Draycott Ward, Weston General Hospital | Weston-super-Mare | Somerset |
United Kingdom | Ward 25, York District Hospital | York | Yorkshire |
Lead Sponsor | Collaborator |
---|---|
University of Portsmouth | Department of Health, United Kingdom, Health & Safety Laboratory, National Osteoporosis Society, National Patient Safety Agency, Portsmouth Hospitals NHS Trust, The Dunhill Medical Trust, University of Bath, University of Sheffield |
United Kingdom,
Drahota A, Gal D, Windsor J, Dixon S, Udell J, Ward D, Soilemezi D, Dean T, Severs M. Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in elderly care units: study protocol. Inj Prev. 2011 Dec;17(6):e7. doi: 10.1136/injuryprev-2011-040154. Epub 2011 Sep 2. — View Citation
Drahota AK, Ward D, Udell JE, Soilemezi D, Ogollah R, Higgins B, Dean TP, Severs M. Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in wards for older people. Age Ageing. 2013 Sep;42(5):633-40. doi: 10.1093/ageing/aft06 — View Citation
Latimer N, Dixon S, Drahota AK, Severs M. Cost--utility analysis of a shock-absorbing floor intervention to prevent injuries from falls in hospital wards for older people. Age Ageing. 2013 Sep;42(5):641-5. doi: 10.1093/ageing/aft076. Epub 2013 Jul 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fall-related injury | Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days). | Yes | |
Secondary | Number of falls | Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days). | Yes | |
Secondary | Unexpected adverse events | Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days). | Yes | |
Secondary | Slip resistance of flooring | Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months) | Yes | |
Secondary | Shock-absorbency of flooring | Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months) | Yes | |
Secondary | Place of residence (for cost-effectiveness analysis) | Each patient followed-up 3 months post-discharge | No | |
Secondary | Quality of life (for cost-effectiveness analysis) | Each patient followed-up 3 months post-discharge | No | |
Secondary | Number of hospital re-admissions (for cost-effectiveness analysis) | Each patient followed-up 3 months post-discharge | No | |
Secondary | User views (patients and staff) | Collected during 1 year follow-up of intervention sites (months 6 to 18) | No |
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