Applying the International Classification of Functioning, Disability and Health framework to determine the predictors of falls and fractures in people with osteoarthritis or at high risk of developing osteoarthritis: data from the Osteoarthritis Initiative.

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.

Symptoms and feelings valued by patients after a percutaneous coronary intervention: a discrete-choice experiment to inform development of a new patient-reported outcome.

OBJECTIVE: To inform the development of a patient-reported outcome measure, the aim of this study was to identify which symptoms and feelings following percutaneous coronary intervention (PCI) are most important to patients. DESIGN: Discrete-choice experiment consisting of two hypothetical scenarios of 10 symptoms and feelings (pain or discomfort; shortness of breath; concern/worry about heart problems; tiredness; confidence to do usual activities; ability to do usual activities; happiness; sleep disturbance; dizziness or light-headedness and bruising) experienced after PCI, described by three levels (never, some of the time, most of the time). Preference weights were estimated using a conditional logit model. SETTING: Four Australian public hospitals that contribute to the Victorian Cardiac Outcomes Registry (VCOR) and a private insurer's claim database. PARTICIPANTS: 138 people aged >18 years who had undergone a PCI in the previous 6 months. MAIN OUTCOME MEASURES: Patient preferences via trade-offs between 10 feelings and symptoms. RESULTS: Of the 138 individuals recruited, 129 (93%) completed all 16 choice sets. Conditional logit parameter estimates were mostly monotonic (eg, moving to worse levels for each individual symptom and feeling made the option less attractive). When comparing the magnitude of the coefficients (based on the coefficient of the worst level relative to best level in each item), feeling unhappy was the symptom or feeling that most influenced perception of a least-preferred PCI outcome (OR 0.42, 95% CI 0.34 to 0.51, p<0.0001) and the least influential was bruising (OR 0.81, 95% CI 0.67 to 0.99, p=0.04). CONCLUSION: This study provides new insights into how patients value symptoms and feelings they experience following a PCI.

Implementation fidelity of a nurse-led falls prevention program in acute hospitals during the 6-PACK trial.

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).

Acceptability of the 6-PACK falls prevention program: A pre-implementation study in hospitals participating in a cluster randomized controlled trial.

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.

Barriers and enablers to the implementation of the 6-PACK falls prevention program: A pre-implementation study in hospitals participating in a cluster randomised controlled trial.

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.

Development of an implementation plan for the 6-PACK falls prevention programme as part of a randomised controlled trial: protocol for a series of preimplementation studies.

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.

6-PACK programme to decrease fall injuries in acute hospitals: cluster randomised controlled trial.

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.

Jumping into the deep-end: results from a pilot impact evaluation of a community-based aquatic exercise program.

This multi-center quasi-experimental pilot study aimed to evaluate changes in pain, joint stiffness, physical function, and quality of life over 12 weeks in adults with musculoskeletal conditions attending 'Waves' aquatic exercise classes. A total of 109 adults (mean age, 65.2 years; range, 24-93 years) with musculoskeletal conditions were recruited across 18 Australian community aquatic centers. The intervention is a peer-led, 45 min, weekly aquatic exercise class including aerobic, strength, flexibility, and balance exercises (n = 67). The study also included a control group of people not participating in Waves or other formal exercise (n = 42). Outcomes were measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and EuroQoL five dimensions survey (EQ-5D) at baseline and 12 weeks. Satisfaction with Waves classes was also measured at 12 weeks. Eighty two participants (43 Waves and 39 control) completed the study protocol and were included in the analysis. High levels of satisfaction with classes were reported by Waves participants. Over 90 % of participants reported Waves classes were enjoyable and would recommend classes to others. Waves participants demonstrated improvements in WOMAC and EQ-5D scores however between-group differences did not reach statistical significance. Peer-led aquatic exercise classes appear to improve pain, joint stiffness, physical function and quality of life for people with musculoskeletal conditions. The diverse study sample is likely to have limited the power to detect significant changes in outcomes. Larger studies with an adequate follow-up period are needed to confirm effects.

Feasibility of Pilates exercise to decrease falls risk: a pilot randomized controlled trial in community-dwelling older people.

OBJECTIVE: To evaluate the feasibility of Pilates exercise in older people to decrease falls risk and inform a larger trial. DESIGN: Pilot Randomized controlled trial. SETTING: Community physiotherapy clinic. PARTICIPANTS: A total of 53 community-dwelling people aged ⩾60 years (mean age, 69.3 years; age range, 61-84). INTERVENTIONS: A 60-minute Pilates class incorporating best practice guidelines for exercise to prevent falls, performed twice weekly for 12 weeks. All participants received a letter to their general practitioner with falls risk information, fall and fracture prevention education and home exercises. MAIN OUTCOME MEASURES: Indicators of feasibility included: acceptability (recruitment, retention, intervention adherence and participant experience survey); safety (adverse events); and potential effectiveness (fall, fall injury and injurious fall rates; standing balance; lower limb strength; and flexibility) measured at 12 and 24 weeks. RESULTS: Recruitment was achievable but control group drop-outs were high (23%). Of the 20 participants who completed the intervention, 19 (95%) attended ⩾75% of the classes and reported classes were enjoyable and would recommend them to others. The rate of fall injuries at 24 weeks was 42% lower and injurious fall rates 64% lower in the Pilates group, however, was not statistically significant (P = 0.347 and P = 0.136). Standing balance, lower-limb strength and flexibility improved in the Pilates group relative to the control group (P < 0.05). Estimates suggest a future definitive study would require 804 participants to detect a difference in fall injury rates. CONCLUSION: A definitive randomized controlled trial analysing the effect of Pilates in older people would be feasible and is warranted given the acceptability and potential positive effects of Pilates on fall injuries and fall risk factors. TRIAL REGISTRATION: The protocol for this study is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN1262000224820).

A Telephone Support Program to Reduce Costs and Hospital Admissions for Patients at Risk of Readmissions: Lessons from an Evaluation of a Complex Health Intervention.

This study aimed to evaluate the effectiveness of a telephone health coaching and support service provided to members of an Australian private health insurance fund-Telephonic Complex Care Program (TCCP)-on hospital use and associated costs. A case-control pre-post study design was employed using propensity score matching. Private health insurance members (n=273) who participated in TCCP between April and December 2012 (cases) were matched (1:1) to members who had not previously been enrolled in the program or any other disease management programs offered by the insurer (n=232). Eligible members were community dwelling, aged ≥65 years, and had 2 or more hospital admissions in the 12 months prior to program enrollment. Preprogram variables that estimated the propensity score included: participant demographics, diagnoses, and hospital use in the 12 months prior to program enrollment. TCCP participants received one-to-one telephone support, personalized care plan, and referral to community-based services. Control participants continued to access usual health care services. Primary outcomes were number of hospital admission claims and total benefits paid for all health care utilizations in the 12 months following program enrollment. Secondary outcomes included change in total benefits paid, hospital benefits paid, ancillary benefits paid, and total hospital bed days over the 12 months post enrollment. Compared with matched controls, TCCP did not appear to reduce health care utilization or benefits paid in the 12 months following program enrollment. However, program characteristics and implementation may have impacted its effectiveness. In addition, challenges related to evaluating complex health interventions such as TCCP are discussed. (Population Health Management 2016;19:187-195).

The extra resource burden of in-hospital falls: a cost of falls study.

OBJECTIVE: To quantify the additional hospital length of stay (LOS) and costs associated with in-hospital falls and fall injuries in acute hospitals in Australia. DESIGN, SETTING AND PARTICIPANTS: A multisite prospective cohort study conducted during 2011-2013 in the control wards of a falls prevention trial (6-PACK). The trial included all admissions to 12 acute medical and surgical wards of six Australian hospitals. In-hospital falls data were collected from medical record reviews, daily verbal reports by ward nurse unit managers, and hospital incident reporting and administrative databases. Clinical costing data were linked for three of the six participating hospitals to calculate patient-level costs. OUTCOME MEASURES: Hospital LOS and costs associated with in-hospital falls and fall injuries for each patient admission. RESULTS: We found that 966 of a total of 27 026 hospital admissions (3.6%) involved at least one fall, and 313 (1.2%) at least one fall injury, a total of 1330 falls and 418 fall injuries. After adjustment for age, sex, cognitive impairment, admission type, comorbidity and clustering by hospital, patients who had an in-hospital fall had a mean increase in LOS of 8 days (95% CI, 5.8-10.4; P < 0.001) compared with non-fallers, and incurred mean additional hospital costs of $6669 (95% CI, $3888-$9450; P < 0.001). Patients with a fall-related injury had a mean increase in LOS of 4 days (95% CI, 1.8-6.6; P = 0.001) compared with those who fell without injury, and there was also a tendency to additional hospital costs (mean, $4727; 95% CI, -$568 to $10 022; P = 0.080). CONCLUSION: Patients who experience an in-hospital fall have significantly longer hospital stays and higher costs. Programs need to target the prevention of all falls, not just the reduction of fall-related injuries.

A review of hospital characteristics associated with improved performance.

PURPOSE: The objective of this review was to critically appraise the literature relating to associations between high-level structural and operational hospital characteristics and improved performance. DATA SOURCES: The Cochrane Library, MEDLINE (Ovid), CINAHL, proQuest and PsychINFO were searched for articles published between January 1996 and May 2010. Reference lists of included articles were reviewed and key journals were hand searched for relevant articles. STUDY SELECTION: and data extraction Studies were included if they were systematic reviews or meta-analyses, randomized controlled trials, controlled before and after studies or observational studies (cohort and cross-sectional) that were multicentre, comparative performance studies. Two reviewers independently extracted data, assigned grades of evidence according to the Australian National Health and Medical Research Council guidelines and critically appraised the included articles. Data synthesis Fifty-seven studies were reported within 12 systematic reviews and 47 observational articles. There was heterogeneity in use and definition of performance outcomes. Hospital characteristics investigated were environment (incentives, market characteristics), structure (network membership, ownership, teaching status, geographical setting, service size) and operational design (innovativeness, leadership, organizational culture, public reporting and patient safety practices, information technology systems and decision support, service activity and planning, workforce design, staff training and education). The strongest evidence for an association with overall performance was identified for computerized physician order entry systems. Some evidence supported the associations with workforce design, use of financial incentives, nursing leadership and hospital volume. CONCLUSION: There is limited, mainly low-quality evidence, supporting the associations between hospital characteristics and healthcare performance. Further characteristic-specific systematic reviews are indicated.