The HIP-HOP Flooring Study: Helping Injury Prevention in Hospitalised Older People

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
The Dunhill Medical Trust
National Osteoporosis Society
University of Sheffield
Health & Safety Laboratory
National Patient Safety Agency
Department of Health, United Kingdom
Portsmouth Hospitals NHS Trust
University of Bath
Information provided by:
University of Portsmouth
ClinicalTrials.gov Identifier:
NCT00817869
First received: January 6, 2009
Last updated: July 13, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Aged
Accidental Falls
Other: New flooring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Cluster Randomised Controlled Trial of Flooring to Reduce Injuries From Falls in Elderly Care Units

Resource links provided by NLM:


Further study details as provided by University of Portsmouth:

Primary Outcome Measures:
  • fall-related injury [ Time Frame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of falls [ Time Frame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days). ] [ Designated as safety issue: Yes ]
  • Unexpected adverse events [ Time Frame: Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days). ] [ Designated as safety issue: Yes ]
  • Slip resistance of flooring [ Time Frame: Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months) ] [ Designated as safety issue: Yes ]
  • Shock-absorbency of flooring [ Time Frame: Measured at 4 time-points over 1.5 years (1 month; 6 months; 12 months; 18 months) ] [ Designated as safety issue: Yes ]
  • Place of residence (for cost-effectiveness analysis) [ Time Frame: Each patient followed-up 3 months post-discharge ] [ Designated as safety issue: No ]
  • Quality of life (for cost-effectiveness analysis) [ Time Frame: Each patient followed-up 3 months post-discharge ] [ Designated as safety issue: No ]
  • Number of hospital re-admissions (for cost-effectiveness analysis) [ Time Frame: Each patient followed-up 3 months post-discharge ] [ Designated as safety issue: No ]
  • User views (patients and staff) [ Time Frame: Collected during 1 year follow-up of intervention sites (months 6 to 18) ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: April 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New Flooring
Will receive 8.3mm thick floor covering (Omnisports EXCEL) to replace previous floor covering.
Other: New flooring
8.3mm thick vinyl floor covering with foam backing, manufactured by Tarkett and installed by Tyndale Flooring Ltd.
Other Name: Omnisports EXCEL
No Intervention: Standard Flooring
Ward will remain with standard floor covering. The overlay will have a comparable slip resistance rating to the new flooring. The sub-floor will also be comparable.

Detailed Description:

We will carry out the study in eight elderly care wards across England. We will first study the wards for 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817869

Locations
United Kingdom
Ward D1, Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Newchurch Ward, St Mary's Hospital
Newport, Isle of Wight, United Kingdom, PO30 5TG
Ruby Ward, Ellesmere Port Hospital
Ellesmere Port, Merseyside, United Kingdom, CH65 6SG
Ward C5, Diana Princess of Wales Hospital
Grimsby, North East Lincolnshire, United Kingdom, DN33 2BA
Granby Ward, Harrogate District Hospital
Harrogate, North Yorkshire, United Kingdom, HG2 7SX
Draycott Ward, Weston General Hospital
Weston-super-Mare, Somerset, United Kingdom, BS23 4TQ
Ward 15, Newcastle Freeman Hospital
Newcastle-upon-Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Ward 25, York District Hospital
York, Yorkshire, United Kingdom, YO31 8HE
Sponsors and Collaborators
University of Portsmouth
The Dunhill Medical Trust
National Osteoporosis Society
University of Sheffield
Health & Safety Laboratory
National Patient Safety Agency
Department of Health, United Kingdom
Portsmouth Hospitals NHS Trust
University of Bath
Investigators
Study Chair: Martin Severs University of Portsmouth
Study Director: Amy K Drahota University of Portsmouth
Principal Investigator: Derek Ward University of Portsmouth
Principal Investigator: Julie Udell University of Portsmouth
  More Information

No publications provided by University of Portsmouth

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Martin Severs, University of Portsmouth
ClinicalTrials.gov Identifier: NCT00817869     History of Changes
Other Study ID Numbers: 13247, UKCRN ID: 5735
Study First Received: January 6, 2009
Last Updated: July 13, 2010
Health Authority: United Kingdom: Department of Health
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University of Portsmouth:
Floors and Floorcoverings
Health Services for the Aged
Fractures, bone
Delirium, Dementia, Amnestic, Cognitive Disorders
Frail Elderly
Aged, 80 and over

ClinicalTrials.gov processed this record on September 16, 2014