Background: Falls are an issue disproportionately affecting older people who are at increased risk of both falls and injury. This pilot study investigates shock-absorbing flooring for fall-related injuries in wards for older people.
Objectives: To inform future research by: evaluating fall-related injuries on the intervention and existing flooring; assessing the sustainability of the flooring in ward environments; estimating the cost-effectiveness of the floor; and assessing how the floor affects patients and other users.
Design: This pilot study utilises mixed methods: a pilot cluster randomised controlled trial; observation via mechanical testing; and interviews. Eight participating wards (clusters) were randomised using a computer generated list. No blinding is incorporated into the study. Each site allocated one (4-8 bed) bay as the ‘Study Area’. Sites had a baseline period of two to five months. Then, four sites received the intervention floor, whilst four continued using standard floors. Sites were then followed up for approximately one year.
Participants: Any person admitted to a bed in the Study Area of a participating ward could be entered into the trial. Orientated patients, visitors, and any hospital staff who use the floor in a Study Area were eligible for inclusion in an interview.
Intervention: An 8.3mm thick vinyl floor covering with PVC foam backing (Tarkett Omnisports EXCEL).
Outcomes: The primary outcome is fall-related injuries. Severity of injuries, falls, cost-effectiveness, user views, and mechanical performance (shock absorbency and slip resistance) were also assessed.
Results: As this is a pilot study the results are indicative and we are not claiming statistical significance (note the confidence intervals). The findings indicate that the flooring may help reduce fall-related injuries (there were no moderate-major injuries in the intervention group but 6 in the control group, and the overall incident rate ratio for any injury was 0.46 (95% CI = 0.11 to 1.97); however there is a risk that the flooring may also increase falls (IRR = 1.33, 95% CI = 0.44 to 4.03). It is unclear as to whether the observation of increased falls is due to chance (random error), potential performance or detection bias (systematic error), an inherent property of the floor itself (adverse effect). Staff using the intervention floor raised concerns about pushing wheeled equipment, and one pulled back was documented but which did not require medical attention. The mechanical testing undertaken on the floors in the study indicated that there was no deterioration over time, and although more shock-absorbent, the intervention floor was no more slippery than the control floors (and slightly less slippery when wet). The cost-effectiveness of the floor hinges on whether or not it increases the falls risk; should the risk of falling remain the same, then the estimated injuries avoided would be very likely to lead to the flooring representing a dominant economic strategy (that is, it would be cost saving and would lead to health-related quality of life benefits). However should the flooring increase the risk of falls (even if the risk of injuries are reduced) the morbidity and mortality associated with falling would lead to health-related quality of life losses (and therefore would not be a viable option). Interviews with staff provided some impetus for assuming that performance bias has an influence on the study findings, and highlighted concerns about manoeuvring wheeled equipment on the intervention flooring. Patients were generally positive or neutral about the floor (in intervention and control sites).
Conclusions: Future research should seek a floor with better ‘push/pull’ properties, consider ways to further minimise risk of bias, and determine the risk of increased falls. It is estimated that a future trial will need approximately 10 - 12 sites (each with 2 bays) in each arm, followed up for 2 years.
|Commissioning body||The Dunhill Medical Trust |
|Number of pages||195|
|Publication status||Published - Dec 2011|