Injury Prevention · 2011 · 19 citations · 28 references
Public HealthGeriatric MedicineInjury PreventionFalls PreventionOlder Adult Injury PreventionPatient SafetyClinical TrialsFall RiskInjury RiskRandomized Controlled TrialsElderly Fall PreventionIncreased Risk Of HarmMechanical Safety TestingMixed Methods AnalysisPilot Study DesignPilot Study PlanningRandomized Controlled Trial BaselineStudy Area Design
UNLABELLED: Falls are an issue disproportionately affecting older people who are at increased risk of falls and injury. This protocol describes a pilot study investigating 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 study uses mixed methods a pilot cluster randomised controlled trial, observation via mechanical testing and interviews. Eight participating wards (clusters) are randomised using a computer-generated list. No blinding is incorporated into the study. Each site has a baseline period of approximately 6 months. Then, four sites receive the intervention floor, while four continue using standard floors. Sites are then followed up for approximately 1 year. PARTICIPANTS: Any person admitted to a bed in the 'study area' of a participating ward can be entered into the trial. Orientated patients, visitors and any hospital staff who use the floor in a study area are eligible for inclusion in an interview. INTERVENTION: An 8.3 mm thick vinyl floor covering with polyvinyl chloride 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) are also being assessed.
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Consort 2010 statement: extension to cluster randomised trials
Marion Campbell, Gilda Piaggio, Diana R Elbourne et al. · BMJ · 2012 · 3.6K citations · Full text
CONSORT statement: extension to cluster randomised trials
Marion Campbell, Diana R Elbourne, Douglas G. Altman · BMJ · 2004 · 2.6K citations · Full text
Matthias Egger, Peter Jüni, C. J. Bartlett et al. · Health Technology Assessment · 2003 · 1.2K citations · Full text
Public Affairs, Pharmacoeconomics, Cost-effectiveness Analysis +16