Clinical trial NCT00817869: The HIP-HOP Flooring Study: Helping Injury Prevention in Hospitalised Older People
Official title: Pilot Cluster Randomised Controlled Trial of Flooring to Reduce Injuries From Falls in Elderly Care Units
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: Floors and Floorcoverings
Health Services for the Aged
Fractures, bone
Delirium, Dementia, Amnestic, Cognitive Disorders
Frail Elderly
Aged, 80 and over
Lead sponsor: University of Portsmouth
Sponsor class: OTHER
Collaborators: name: The Dunhill Medical Trust
name: National Osteoporosis Society
name: University of Sheffield
name: Health & Safety Laboratory
name: National Patient Safety Agency
name: Department of Health, United Kingdom
name: Portsmouth Hospitals NHS Trust
name: University of Bath
First posted: 2009-01-07
Enrollment: 571
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: We will carry out the study in eight elderly care wards across England. We will first study the wards for up to 6 months. Then, half of the wards will have the new floor laid. Wards will be chosen to receive the new floor, or remain with a standard floor, by chance. The new floor has 'shock-absorbent' properties. We will study all the wards for another 12 months. This will allow us to compare the new flooring with the normal flooring.

Eligibility criteria: Inclusion Criteria:

* all patients admitted to the study area on a participating elderly care ward

Exclusion Criteria:

* none.

Primary outcomes:
measure: fall-related injury
timeFrame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).
Secondary outcomes:
measure: Number of falls
timeFrame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).
measure: Unexpected adverse events
timeFrame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).
measure: Slip resistance of flooring
timeFrame: Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months)
measure: Shock-absorbency of flooring
timeFrame: Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months)
measure: Place of residence (for cost-effectiveness analysis)
timeFrame: Each patient followed-up 3 months post-discharge
measure: Quality of life (for cost-effectiveness analysis)
timeFrame: Each patient followed-up 3 months post-discharge
measure: Number of hospital re-admissions (for cost-effectiveness analysis)
timeFrame: Each patient followed-up 3 months post-discharge
measure: User views (patients and staff)
timeFrame: Collected during 1 year follow-up of intervention sites (months 6 to 18)
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Ward D1, Queen Alexandra Hospital
state: Hampshire
city: Newport
country: United Kingdom
facility: Newchurch Ward, St Mary's Hospital
state: Isle of Wight
city: Ellesmere Port
country: United Kingdom
facility: Ruby Ward, Ellesmere Port Hospital
state: Merseyside
city: Grimsby
country: United Kingdom
facility: Ward C5, Diana Princess of Wales Hospital
state: North East Lincolnshire
city: Harrogate
country: United Kingdom
facility: Granby Ward, Harrogate District Hospital
state: North Yorkshire
city: Weston-super-Mare
country: United Kingdom
facility: Draycott Ward, Weston General Hospital
state: Somerset
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Ward 15, Newcastle Freeman Hospital
state: Tyne and Wear
city: York
country: United Kingdom
facility: Ward 25, York District Hospital
state: Yorkshire
Study officials:
affiliation: University of Portsmouth
name: Martin Severs
role: STUDY_CHAIR
affiliation: University of Portsmouth
name: Amy K Drahota
role: STUDY_DIRECTOR
affiliation: University of Portsmouth
name: Derek Ward
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Portsmouth
name: Julie Udell
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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/aft067. Epub 2013 Jul 17.
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.