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Evidence for effective falls prevention interventions in acute wards is limited. One reason for this may be suboptimal program implementation. This study aimed to identify perceived barriers and enablers of the implementation of the 6-PACK falls prevention program to inform the implementation in a randomised controlled trial. Strategies to optimise successful implementation of 6-PACK were also sought. A mixed-methods approach was applied in 24 acute wards from 6 Australian hospitals. Participants were nurses working on participating wards and senior hospital staff including Nurse Unit Managers; senior physicians; Directors of Nursing; and senior personnel involved in quality and safety or falls prevention. Information on barriers and enablers of 6-PACK implementation was obtained through surveys, focus groups and interviews. Questions reflected the COM-B framework that includes three behaviour change constructs of: capability, opportunity and motivation. Focus group and interview data were analysed thematically, and survey data descriptively. The survey response rate was 60% (420/702), and 12 focus groups (n = 96 nurses) and 24 interviews with senior staff were conducted. Capability barriers included beliefs that falls could not be prevented; and limited knowledge on falls prevention in patients with complex care needs (e.g. cognitive impairment). Capability enablers included education and training, particularly face to face case study based approaches. Lack of resources was identified as an opportunity barrier. Leadership, champions and using data to drive practice change were recognised as opportunity enablers. Motivation barriers included complacency and lack of ownership in falls prevention efforts. Motivation enablers included senior staff articulating clear goals and a commitment to falls prevention; and use of reminders, audits and feedback. The information gained from this study suggests that regular practical face-to-face education and training for nurses; provision of equipment; audit, reminders and feedback; leadership and champions; and the provision of falls data is key to successful falls prevention program implementation in acute hospitals.

Background Falls are a major cause of injury and death among older people. Evidence suggests that people with osteoarthritis (OA) are at a higher risk of falls and fall-related injuries including fractures. While studies demonstrate a link between OA and falls, little is known about the pathways that link falls with demographic factors, OA impairments, activity limitations and participation restrictions. The aim of this study was to identify risk factors for falls and fractures among people with OA or at high risk of developing OA using the International Classification of Functioning, Disability and Health (ICF) framework. Methods A longitudinal analysis of data from the Osteoarthritis Initiative (OAI) dataset was undertaken. Participants were considered to have OA if they reported they had been diagnosed with knee or hip OA by a medical practitioner. Outcomes were self-reported falls and fractures. Potential predictors were classified using the ICF framework. Poisson regression models were used to determine the risk factors for falls and fractures. Results Of the 4796 participants, 2270 (47%) were diagnosed with knee and/or hip OA. A higher proportion of participants with OA reported having had falls (72% vs 63%; p  < 0.0001) and fractures (17% vs 14%; p  = 0.012) than those without OA. Personal factors were found to be stronger predictors of falls and fractures compared to OA impairments, activity limitations and participation restrictions in this sample of participants. After adjusting for potential covariates, self-reported history of falls was a significant predictor of both increased falls (incidence rate ratio [IRR] 1.50; 95% confidence interval [CI] 1.40, 4.60) and fracture risk (IRR 1.38; 95% CI 1.13, 1.69). Conclusions By applying the ICF framework, we have shown that personal factors were more likely to predict falls and fractures rather than OA impairments, environmental factors, activity limitations and participation restrictions in people with OA or at high risk of developing OA. This highlights the importance of questioning patients about their previous falls and past medical history, and using this information to focus our assessment and clinical decision-making processes.

There is limited evidence to support the effectiveness of falls prevention interventions in the acute hospital setting. The 6-PACK falls prevention program includes a fall-risk tool; 'falls alert' signs; supervision of patients in the bathroom; ensuring patients' walking aids are within reach; toileting regimes; low-low beds; and bed/chair alarms. This study explored the acceptability of the 6-PACK program from the perspective of nurses and senior staff prior to its implementation in a randomised controlled trial. A mixed-methods approach was applied involving 24 acute wards from six Australian hospitals. Participants were nurses working on participating wards and senior hospital staff including: Nurse Unit Managers; senior physicians; Directors of Nursing; and senior personnel involved in quality and safety or falls prevention. Information on program acceptability (suitability, practicality and benefits) was obtained by surveys, focus groups and interviews. Survey data were analysed descriptively, and focus group and interview data thematically. The survey response rate was 60%. Twelve focus groups (n = 96 nurses) and 24 interviews with senior staff were conducted. Falls were identified as a priority patient safety issue and nurses as key players in falls prevention. The 6-PACK program was perceived to offer practical benefits compared to current practice. Nurses agreed fall-risk tools, low-low beds and alert signs were useful for preventing falls (>70%). Views were mixed regarding positioning patients' walking aid within reach. Practical issues raised included access to equipment; and risk of staff injury with low-low bed use. Bathroom supervision was seen to be beneficial, however not always practical. Views on the program appropriateness and benefits were consistent across nurses and senior staff. Staff perceived the 6-PACK program as suitable, practical and beneficial, and were open to adopting the program. Some practical concerns were raised highlighting issues to be addressed by the implementation plan.

Background When tested in a randomized controlled trial (RCT) of 31,411 patients, the nurse-led 6-PACK falls prevention program did not reduce falls. Poor implementation fidelity (i.e., program not implemented as intended) may explain this result. Despite repeated calls for the examination of implementation fidelity as an essential component of evaluating interventions designed to improve the delivery of care, it has been neglected in prior falls prevention studies. This study examined implementation fidelity of the 6-PACK program during a large multi-site RCT. Methods Based on the 6-PACK implementation framework and intervention description, implementation fidelity was examined by quantifying adherence to program components and organizational support. Adherence indicators were: 1) falls-risk tool completion; and for patients classified as high-risk, provision of 2) a ‘Falls alert’ sign; and 3) at least one additional 6-PACK intervention. Organizational support indicators were: 1) provision of resources (executive sponsorship, site clinical leaders and equipment); 2) implementation activities (modification of patient care plans; training; implementation tailoring; audits, reminders and feedback; and provision of data); and 3) program acceptability. Data were collected from daily bedside observation, medical records, resource utilization diaries and nurse surveys. Results All seven intervention components were delivered on the 12 intervention wards. Program adherence data were collected from 103,398 observations and medical record audits. The falls-risk tool was completed each day for 75% of patients. Of the 38% of patients classified as high-risk, 79% had a ‘Falls alert’ sign and 63% were provided with at least one additional 6-PACK intervention, as recommended. All hospitals provided the recommended resources and undertook the nine outlined program implementation activities. Most of the nurses surveyed considered program components important for falls prevention. Conclusions While implementation fidelity was variable across wards, overall it was found to be acceptable during the RCT. Implementation failure is unlikely to be a key factor for the observed lack of program effectiveness in the 6-PACK trial. Trial registration The 6-PACK cluster RCT is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000332921 (29 March 2011).

Background The 12-item Short-Form Health Survey version 2 (SF-12v2), a widely used, generic patient-reported measure of health status that provides summary scores of physical and mental health. No study to date has examined the measurement properties of the SF-12v2 in patients with lung cancer using Rasch analysis. The aim of this study was to extend the psychometric evaluations of the SF-12 within the lung cancer population to ensure its validity and reliability to assess the health status in this population. Methods Participants in the Victorian Lung Cancer Registry (VLCR) who completed the SF-12v2 between 2012 and 2016 were included in this study. The structural validity of the SF-12v2 was assessed using Rasch analysis. Overall fit to the Rasch measurement model was examined as well as five key measurement properties: uni-dimensionality, response thresholds, internal consistency, measurement invariance and targeting. Results A total of 342 participants completed the SF-12v2 three months following their lung cancer diagnosis. The SF-12 Physical Component Score (PCS-12) did not fit the overall Rasch measurement model (χ 2 107.0; p  < 0.001). Three items deviated significantly from the Rasch model (item fit residual beyond ± 2.5) with signs of dependency between item responses and disordered thresholds. Nevertheless, the PCS-12 was uni-dimensional with good internal consistency (person separation index [PSI] 0.83) and reasonable targeting. In contrast, the SF-12 Mental Component Score (MCS-12) had good overall model fit (χ 2 35.1; p  = 0.07), reasonable targeting and good internal consistency (PSI 0.81). Conclusions Rasch analysis suggests that there is general support for the reliability of the SF-12v2 as a measure of physical and mental health in people with lung cancer. However, the appropriateness of some items (e.g. pain) in the PCS-12 is questionable and further refinement of the scale including changing the response options may be required to improve the ability of the SF-12v2 to more appropriately assess the health status of this population.

Objective To evaluate the effect of the 6-PACK programme on falls and fall injuries in acute wards. Design Cluster randomised controlled trial. Setting Six Australian hospitals. Participants All patients admitted to 24 acute wards during the trial period. Interventions Participating wards were randomly assigned to receive either the nurse led 6-PACK programme or usual care over 12 months. The 6-PACK programme included a fall risk tool and individualised use of one or more of six interventions: “falls alert” sign, supervision of patients in the bathroom, ensuring patients’ walking aids are within reach, a toileting regimen, use of a low-low bed, and use of a bed/chair alarm. Main outcome measures The co-primary outcomes were falls and fall injuries per 1000 occupied bed days. Results During the trial, 46 245 admissions to 16 medical and eight surgical wards occurred. As many people were admitted more than once, this represented 31 411 individual patients. Patients’ characteristics and length of stay were similar for intervention and control wards. Use of 6-PACK programme components was higher on intervention wards than on control wards (incidence rate ratio 3.05, 95% confidence interval 2.14 to 4.34; P<0.001). In all, 1831 falls and 613 fall injuries occurred, and the rates of falls (incidence rate ratio 1.04, 0.78 to 1.37; P=0.796) and fall injuries (0.96, 0.72 to 1.27; P=0.766) were similar in intervention and control wards. Conclusions Positive changes in falls prevention practice occurred following the introduction of the 6-PACK programme. However, no difference was seen in falls or fall injuries between groups. High quality evidence showing the effectiveness of falls prevention interventions in acute wards remains absent. Novel solutions to the problem of in-hospital falls are urgently needed. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12611000332921.

Falls are a leading reason for older people presenting to the emergency department (ED), and many experience further falls. Little evidence exists to guide secondary prevention in this population. This randomised controlled trial (RCT) investigated whether a 6-month telephone-based patient-centred program-RESPOND-had an effect on falls and fall injuries in older people presenting to the ED after a fall. Community-dwelling people aged 60-90 years presenting to the ED with a fall and planned for discharge home within 72 hours were recruited from two EDs in Australia. Participants were enrolled if they could walk without hands-on assistance, use a telephone, and were free of cognitive impairment (Mini-Mental State Examination > 23). Recruitment occurred between 1 April 2014 and 29 June 2015. Participants were randomised to receive either RESPOND (intervention) or usual care (control). RESPOND comprised (1) home-based risk assessment; (2) 6 months telephone-based education, coaching, goal setting, and support for evidence-based risk factor management; and (3) linkages to existing services. Primary outcomes were falls and fall injuries in the 12-month follow-up. Secondary outcomes included ED presentations, hospital admissions, fractures, death, falls risk, falls efficacy, and quality of life. Assessors blind to group allocation collected outcome data via postal calendars, telephone follow-up, and hospital records. There were 430 people in the primary outcome analysis-217 randomised to RESPOND and 213 to control. The mean age of participants was 73 years; 55% were female. Falls per person-year were 1.15 in the RESPOND group and 1.83 in the control (incidence rate ratio [IRR] 0.65 [95% CI 0.43-0.99]; P = 0.042). There was no significant difference in fall injuries (IRR 0.81 [0.51-1.29]; P = 0.374). The rate of fractures was significantly lower in the RESPOND group compared with the control (0.05 versus 0.12; IRR 0.37 [95% CI 0.15-0.91]; P = 0.03), but there were no significant differences in other secondary outcomes between groups: ED presentations, hospitalisations or falls risk, falls efficacy, and quality of life. There were two deaths in the RESPOND group and one in the control group. No adverse events or unintended harm were reported. Limitations of this study were the high number of dropouts (n = 93); possible underreporting of falls, fall injuries, and hospitalisations across both groups; and the relatively small number of fracture events. In this study, providing a telephone-based, patient-centred falls prevention program reduced falls but not fall injuries, in older people presenting to the ED with a fall. Among secondary outcomes, only fractures reduced. Adopting patient-centred strategies into routine clinical practice for falls prevention could offer an opportunity to improve outcomes and reduce falls in patients attending the ED. Australian New Zealand Clinical Trials Registry (ACTRN12614000336684).

Purpose To determine the effectiveness of patient safety culture strategies to improve hospital patient safety climate. Data sources Electronic search of the Cochrane Library, OVID Medline, Embase, CINAHL, proQuest and psychinfo databases, with manual searches of quality and safety websites, bibliographies of included articles and key journals. Study selection English language studies published between January 1996 and April 2011 that measured the effectiveness of patient safety culture strategies using a quantitative measure of patient safety climate in a hospital setting. Studies included were randomised controlled trials (RCTs), non-RCTs, controlled before and after studies, interrupted time series and historically controlled studies. Data extraction Data extraction and critical appraisal were conducted by two independent reviewers. Study design, intervention, level of application, setting, study participants, safety climate outcome measures and implementation lessons were extracted from each article. Results of data synthesis Over 2000 articles were screened, with 21 studies meeting the inclusion criteria, one cluster RCT, seven controlled before and after studies, and 13 historically controlled studies. There was marked methodological heterogeneity amongst studies. Impacts of 11 different strategies were reported. There was some evidence to support that leadership walk rounds (p=0.02) and multi-faceted unit-based programmes (p < 0.05) may have a positive impact on patient safety climate. Conclusions Despite strong face validity for a variety of patient safety culture strategies, there is limited evidence to support definitive impacts on patient safety climate outcomes. Organisations are advised to consider robust evaluation designs when implementing these potentially resource intensive strategies.

Measuring patient reported outcomes can improve the quality and effectiveness of healthcare interventions. The aim of this study was to identify the final set of items that can be included in a patient-reported outcome measure to assess recovery of patients following percutaneous coronary interventions. A consecutive sample of 200 patients registered in the Victorian Cardiac Outcomes Registry participated in a telephone survey 30 days following their percutaneous cardiac procedure. Rasch analysis was used to select the best set of items to form a concise and psychometrically sound patient-reported outcome measure. Key measurement properties assessed included overall fit to the Rasch measurement model, unidimensionality, response formats (thresholds), targeting, internal consistency and measurement invariance. Five items were identified as being reliable and valid measures of patient-reported outcomes: pain or discomfort, shortness of breath, confidence in performing usual activities, feeling unhappy and having trouble sleeping. Data showed overall fit to a Rasch model of expected item functioning (χ2 16.99; p = 0.07) and all items demonstrated unidimensionality (t-test less than 0.05 threshold value). Internal consistency was acceptable (equivalent Cronbach's α 0.65) given there are only five items, but there was a ceiling effect (mean logit score -1.24) with compromised score precision for patients with better recovery. We identified a succinct set of items that can be used in a patient-reported outcome measure following percutaneous coronary interventions. This patient-report outcome measure has good structural validity and acceptable internal consistency. While further psychometric evaluations are recommended, the items identified capture the patient's perspective of their recovery following a percutaneous coronary intervention.