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Objective: To determine whether multifactorial falls prevention interventions are effective in preventing falls, fall injuries, emergency department (ED) re-presentations and hospital admissions in older adults presenting to the ED with a fall., Design: Systematic review and meta-analyses of randomised controlled trials (RCTs)., Data Sources: Four health-related electronic databases (Ovid MEDLINE, CINAHL, EMBASE, PEDro and The Cochrane Central Register of Controlled Trials) were searched (inception to June 2018)., Study Selection: RCTs of multifactorial falls prevention interventions targeting community-dwelling older adults ( ≥ 60 years) presenting to the ED with a fall with quantitative data on at least one review outcome., Data Extraction: Two independent reviewers determined inclusion, assessed study quality and undertook data extraction, discrepancies resolved by a third., Data Synthesis: 12 studies involving 3986 participants, from six countries, were eligible for inclusion. Studies were of variable methodological quality. Multifactorial interventions were heterogeneous, though the majority included education, referral to healthcare services, home modifications, exercise and medication changes. Meta-analyses demonstrated no reduction in falls (rate ratio = 0.78; 95% CI: 0.58 to 1.05), number of fallers (risk ratio = 1.02; 95% CI: 0.88 to 1.18), rate of fractured neck of femur (risk ratio = 0.82; 95% CI: 0.53 to 1.25), fall-related ED presentations (rate ratio = 0.99; 95% CI: 0.84 to 1.16) or hospitalisations (rate ratio = 1.14; 95% CI: 0.69 to 1.89) with multifactorial falls prevention programmes., Conclusions: There is insufficient evidence to support the use of multifactorial interventions to prevent falls or hospital utilisation in older people presenting to ED following a fall. Further research targeting this population group is required., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Falls remain common for community-dwelling older people and impose a substantial economic burden to the healthcare system. RESPOND is a novel falls prevention programme that aims to reduce secondary falls and fall injuries among older people who present to a hospital emergency department (ED) with a fall. The present protocol describes a prospective economic evaluation examining the incremental cost-effectiveness of the RESPOND programme, compared with usual care practice, from the Australian health system perspective., Methods and Design: This economic evaluation will recruit 528 participants from two major tertiary hospital EDs in Australia and will be undertaken alongside a multisite randomised controlled trial. Outcome and costing data will be collected for all participants over the 12-month trial. It will compare the RESPOND falls prevention programme with usual care practice (current community-based falls prevention practices) to determine its incremental cost-effectiveness according to three intermediate clinical outcomes: (1) falls prevented, (2) fall injuries prevented and (3) injurious falls prevented. In addition, utilities will be derived from a generic quality-of-life measure (EQ-5D-5L) and used to calculate the 'incremental cost per quality-adjusted life years gained'., Discussion: The results of this study will provide healthcare decision makers with evidence to assist with setting spending thresholds for preventive health programmes and inform selection of emergency and community service models of care., Trial Registration Number: The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000336684); Pre-results., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Background: Inhospital falls cause morbidity, staff burden and increased healthcare costs. It is unclear if the persistent problem of inhospital falls is due to the use of ineffective interventions or their suboptimal implementation. The 6-PACK programme appears to reduce fall injuries and a randomised controlled trial (RCT) was undertaken to confirm effects. This paper describes the protocol for the preimplementation studies that aimed to identify moderators of the effective use of the 6-PACK programme to inform the development of an implementation plan to be applied in the RCT., Methods: The 6-PACK project included five preimplementation studies: (1) a profile of safety climate; (2) review of current falls prevention practice; (3) epidemiology of inhospital falls; (4) acceptability of the 6-PACK programme; and (5) barriers and enablers to implementation of the 6-PACK programme. The Theoretical Domain Framework that includes 12 behaviour change domains informed the design of these studies that involved 540 staff and 8877 patients from 24 wards from six Australian hospitals. Qualitative and quantitative methods were applied with data collected via: structured bedside observation; daily nurse unit manager verbal report of falls; audit of medical records, incident reporting and hospital administrative data; surveys of ward nurses; focus groups with ward nurses; and key informant interviews with senior staff., Discussion: Information on contextual, system, intervention, patient and provider level factors is critical to the development of an implementation plan. Information gained from these studies was used to develop a plan applied in the RCT that addressed the barriers and harnessed enablers., Trial Registration Number: The RCT is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000332921., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Background: Disability, mortality and healthcare burden from fractures in older people is a growing problem worldwide. Observational studies suggest that aspirin may reduce fracture risk. While these studies provide room for optimism, randomised controlled trials are needed. This paper describes the rationale and design of the ASPirin in Reducing Events in the Elderly (ASPREE)-Fracture substudy, which aims to determine whether daily low-dose aspirin decreases fracture risk in healthy older people., Methods: ASPREE is a double-blind, randomised, placebo-controlled primary prevention trial designed to assess whether daily active treatment using low-dose aspirin extends the duration of disability-free and dementia-free life in 19 000 healthy older people recruited from Australian and US community settings. This substudy extends the ASPREE trial data collection to determine the effect of daily low-dose aspirin on fracture and fall-related hospital presentation risk in the 16 500 ASPREE participants aged ≥70 years recruited in Australia. The intervention is a once daily dose of enteric-coated aspirin (100 mg) versus a matching placebo, randomised on a 1:1 basis. The primary outcome for this substudy is the occurrence of any fracture-vertebral, hip and non-vert-non-hip-occurring post randomisation. Fall-related hospital presentations are a secondary outcome., Discussion: This substudy will determine whether a widely available, simple and inexpensive health intervention-aspirin-reduces the risk of fractures in older Australians. If it is demonstrated to safely reduce the risk of fractures and serious falls, it is possible that aspirin might provide a means of fracture prevention., Trial Registration Number: The protocol for this substudy is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000347561)., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: Programme evaluations conducted alongside randomised controlled trials (RCTs) have potential to enhance understanding of trial outcomes. This paper describes a multi-level programme evaluation to be conducted alongside an RCT of a falls prevention programme (RESPOND)., Objectives: (1) To conduct a process evaluation in order to identify the degree of implementation fidelity and associated barriers and facilitators. (2) To evaluate the primary intended impact of the programme: participation in fall prevention strategies and the factors influencing participation. (3) To identify the factors influencing RESPOND RCT outcomes: falls, fall injuries and emergency department (ED) re-presentations., Methods/design: 528 community-dwelling adults aged 60-90 years presenting to two EDs with a fall will be recruited and randomly assigned to the intervention or standard care group. All RESPOND participants and RESPOND clinicians will be included in the evaluation. A mixed methods design will be used and a programme logic model will frame the evaluation. Data will be sourced from interviews, focus groups, questionnaires, clinician case notes, recruitment records, participant-completed calendars, hospital administrative datasets and audio-recordings of intervention contacts. Quantitative data will be analysed via descriptive and inferential statistics and qualitative data will be interpreted using thematic analysis., Discussion: The RESPOND programme evaluation will provide information about contextual and influencing factors related to the RESPOND RCT outcomes. The results will assist researchers, clinicians and policy makers regarding decisions about future falls prevention interventions. Insights gained may be applicable to a range of chronic conditions where similar preventive intervention approaches are indicated., Trial Registration Number: This programme evaluation is linked to the RESPOND RCT which is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000336684)., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Introduction: Participation in falls prevention activities by older people following presentation to the emergency department (ED) with a fall is suboptimal. This randomised controlled trial (RCT) will test the RESPOND programme, an intervention designed to improve older persons' participation in falls prevention activities through delivery of patient-centred education and behaviour change strategies., Design and Setting: A RCT at two tertiary referral EDs in Melbourne and Perth, Australia., Participants: 528 community-dwelling people aged 60-90 years presenting to the ED with a fall and discharged home will be recruited. People who require an interpreter or hands-on assistance to walk; live in residential aged care or >50 km from the trial hospital; have terminal illness, cognitive impairment, documented aggressive behaviour or a history of psychosis; are receiving palliative care or are unable to use a telephone will be excluded., Methods: Participants will be randomly allocated to the RESPOND intervention or standard care control group. RESPOND incorporates (1) a home-based risk factor assessment; (2) education, coaching, goal setting and follow-up telephone support for management of one or more of four risk factors with evidence of effective interventions and (3) healthcare provider communication and community linkage delivered over 6 months. Primary outcomes are falls and fall injuries per person-year., Discussion: RESPOND builds on prior falls prevention learnings and aims to help individuals make guided decisions about how they will manage their falls risk. Patient-centred models have been successfully trialled in chronic and cardiovascular disease; however, evidence to support this approach in falls prevention is limited., Trial Registration Number: The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000336684)., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: In-hospital falls are common and pose significant economic burden on the healthcare system. To date, few studies have quantified the additional cost of hospitalisation associated with an in-hospital fall or fall-related injury. The aim of this study is to determine the additional length of stay and hospitalisation costs associated with in-hospital falls and fall-related injuries, from the acute hospital perspective., Methods and Design: A multisite prospective study will be conducted as part of a larger falls-prevention clinical trial-the 6-PACK project. This study will involve 12 acute medical and surgical wards from six hospitals across Australia. Patient and admission characteristics, outcome and hospitalisation cost data will be prospectively collected on approximately 15 000 patients during the 15-month study period. A review of all in-hospital fall events will be conducted using a multimodal method (medical record review and daily verbal report from the nurse unit manager, triangulated with falls recorded in the hospital incident reporting and administrative database), to ensure complete case ascertainment. Hospital clinical costing data will be used to calculate patient-level hospitalisation costs incurred by a patient during their inpatient stay. Additional hospital and hospital resource utilisation costs attributable to in-hospital falls and fall-related injuries will be calculated using linear regression modelling, adjusting for a priori-defined potential confounding factors., Discussion: This protocol provides the detailed statement of the planned analysis. The results from this study will be used to support healthcare planning, policy making and allocation of funding relating to falls prevention within acute hospitals.