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Background: Falls are common among older people, and General Practitioners (GPs) could play an important role in implementing strategies to manage fall risk. Despite this, fall prevention is not a routine activity in general practice settings. The iSOLVE cluster randomised controlled trial aimed to evaluate implementation of a fall prevention decision tool in general practice. This paper sought to describe the strategies used and reflect on the enablers and barriers relevant to successful recruitment of general practices, GPs and their patients.Methods: Recruitment was conducted within the geographical area of a Primary Health Network in Northern Sydney, Australia. General practices and GPs were engaged via online surveys, mailed invitations to participate, educational workshops, practitioner networks and promotional practice visits. Patients 65 years or older were recruited via mailed invitations, incorporating the practice letterhead and the name(s) of participating GP(s). Observations of recruitment strategies, results and enabling factors were recorded in field notes as descriptive and narrative data, and analysed using mixed-methods.Results: It took 19 months to complete recruitment of 27 general practices, 75 GPs and 560 patients. The multiple strategies used to engage general practices and GPs were collectively useful in reaching the targeted sample size. Practice visits were valuable in engaging GPs and staff, establishing interest in fall prevention and commitment to the trial. A mix of small, medium and large practices were recruited. While some were recruited as a whole-practice, other practices had few or half of the number of GPs recruited. The importance of preventing falls in older patients, simplicity of research design, provision of resources and logistic facilitation of patient recruitment appealed to GPs. Recruitment of older patients was successfully achieved by mailed invitations which was a strategy that was familiar to practice staff and patients. Patient response rates were above the expected 10% for most practices. Many practices (n = 17) achieved the targeted number of 20 or more patients.Conclusions: Recruitment in general practice settings can be successfully achieved through multiple recruitment strategies, effective communication and rapport building, ensuring research topic and design suit general practice needs, and using familiar communication strategies to engage patients.Trial Registration: The trial was prospectively registered on 29 April 2015 with the Australian New Zealand Clinical Trial Registry www.anzctr.org.au (trial ID: ACTRN12615000401550). [ABSTRACT FROM AUTHOR]

Background: Despite strong evidence giving guidance for effective fall prevention interventions in community-residing older people, there is currently no clear model for engaging general medical practitioners in fall prevention and routine use of allied health professionals in fall prevention has been slow, limiting widespread dissemination. This protocol paper outlines an implementation-effectiveness study of the Integrated Solutions for Sustainable Fall Prevention (iSOLVE) intervention which has developed integrated processes and pathways to identify older people at risk of falls and engage a whole of primary care approach to fall prevention.Methods/design: This protocol paper presents the iSOLVE implementation processes and change strategies and outlines the study design of a blended type 2 hybrid design. The study consists of a two-arm cluster randomized controlled trial in 28 general practices and recruiting 560 patients in Sydney, Australia, to evaluate effectiveness of the iSOLVE intervention in changing general practitioner fall management practices and reducing patient falls and the cost effectiveness from a healthcare funder perspective. Secondary outcomes include change in medications known to increase fall risk. We will simultaneously conduct a multi-methodology evaluation to investigate the workability and utility of the implementation intervention. The implementation evaluation includes in-depth interviews and surveys with general practitioners and allied health professionals to explore acceptability and uptake of the intervention, the coherence of the proposed changes for those in the work setting, and how to facilitate the collective action needed to implement changes in practice; social network mapping will explore professional relationships and influences on referral patterns; and, a survey of GPs in the geographical intervention zone will test diffusion of evidence-based fall prevention practices. The project works in partnership with a primary care health network, state fall prevention leaders, and a community of practice of fall prevention advocates.Discussion: The design is aimed at providing clear direction for sustainability and informing decisions about generalization of the iSOLVE intervention processes and change strategies. While challenges exist in hybrid designs, there is a potential for significant outcomes as the iSOLVE pathways project brings together practice and research to collectively solve a major national problem with implications for policy service delivery.Trial Registration: Australian New Zealand Clinial Trials Registry ACTRN12615000401550. [ABSTRACT FROM AUTHOR]

Background: Pre-discharge home visits aim to maximise independence in the community. These visits involve assessment of a person in their own home prior to discharge from hospital, typically by an occupational therapist. The therapist may provide equipment, adapt the home environment and/or provide education. The aims of this study were to investigate the feasibility of a randomised controlled trial in a clinical setting and the effect of pre-discharge home visits on functional performance in older people undergoing rehabilitation. Methods: Ten patients participating in an inpatient rehabilitation program were randomly assigned to receive either a pre-discharge home visit (intervention), or standard practice in-hospital assessment and education (control), both conducted by an occupational therapist. The predischarge home visit involved assessment of the older person's function and environment, and education, and took an average of 1.5 hours. The hospital-based interview took an average of 40 minutes. Outcome data were collected by a blinded assessor at 0, 2, 4, 8 and 12 weeks. Outcomes included performance of activities of daily living, reintegration to community living, quality of life, readmission and fall rates. Results: Recruitment of 10 participants was slow and took three months. Observed performance of functional abilities did not differ between groups due to the small sample size. Difference in activities of daily living participation, as recorded by the Nottingham Extended Activities of Daily Living scale, was statistically significant but wide confidence intervals and low statistical power limit interpretation of results. Conclusion: Evaluation of pre-discharge home visits by occupational therapists in a rehabilitation setting is feasible, but a more effective recruitment strategy for a main study is favored by application of a multi-centre setting. [ABSTRACT FROM AUTHOR]

Background: Falls reflect sentinel events in older adults, with significant negative consequences. Although fall risk factors have been identified as intrinsic (e.g., muscle weakness, balance problems) and extrinsic (e.g., home hazards), most prevention programs target only intrinsic factors. We present the rationale and design of a home-based multicomponent fall prevention program-the LIVE LiFE program-for community-living older adults. The program adapts and expands the successful Lifestyle Intervention Functional Exercise (LiFE) program by adding home safety, vision contrast screening, and medication review. The specific aims of the study are to (1) adapt the LiFE program to a US context and expand it into a multicomponent program (LIVE LiFE) addressing intrinsic and extrinsic fall risks, (2) examine feasibility and acceptability, and (3) estimate program impact on multiple outcome measures to prepare for an efficacy trial.Methods: The study involves two phases: an open-label pilot, followed by a two-group, single-blinded randomized pilot trial. Eligible participants are community-living adults 70+ years reporting at least one injurious fall or two non-injurious falls in the previous year. Participants are randomized in a 2:1 ratio to the program group (LIVE LiFE, n = 25) or the control group (written fall risk assessment, n = 12). The open-label pilot participants (n = 3) receive the program without randomization and are assessed based on their experience, resulting in a stronger emphasis on the participant's personal goals being integrated into LIVE LiFE. Fall risk and balance outcomes are assessed by the Timed Up and Go and the 4-Stage Balance Test at 16 weeks. Additional outcomes are incidence of falls and near falls, falls efficacy, fear of falling, number of home hazards, and medications assessed at 16 weeks. Incidence of falls and near falls, program adherence, and satisfaction are assessed again at 32 weeks.Discussion: By expanding and adapting the evidence-based LiFE program, our study will help us understand the feasibility of conducting a multicomponent program and estimate its impact on multiple outcome measures. This will support moving forward with an efficacy trial of the LIVE LiFE program for older adults who are at risk of falling.Trial Registration: ClinicalTrials.gov, NCT03351413 . Registered on 22 November 2017. [ABSTRACT FROM AUTHOR]

Background: A nested process evaluation, within a randomised controlled trial, will explore relationships between program outcomes and quality of intervention implementation of the Lifestyle-Integrated Functional Exercise Program in older people with vision impairment. The Lifestyle-Integrated Functional Exercise Program is a home-based strength and balance program that has been shown to reduce falls in high risk populations. A pilot study showed positive trends in improvements in physical function in older people with vision impairment after participation in the program. The program will be delivered by Orientation and Mobility Specialists, who are experienced in working with people with vision impairment.Methods: The process evaluation has a mixed methods design. This includes quantitative (fidelity checklist score, number of completed sessions, survey data and a habit formation scale), as well as qualitative (open responses from program staff and semi-structured interviews with study participants) data. Process evaluation measures include program adherence (fidelity), complete delivery (dose delivered), participant receipt (dose received) and participant enactment. Using the Behaviour Change Wheel, a logic model was built to explain the intended inputs, outputs, outcomes and relationships to the behaviour change techniques in the Lifestyle-Integrated Functional Exercise Program in older people with vision impairment.Discussion: The findings of the process evaluation will inform the provision of fall prevention programs in older people with vision impairment by Orientation and Mobility Specialists. To date, there are no proven falls prevention programs which aim to improve physical function and reduce falls in older people with vision impairment. This process evaluation will contribute new knowledge about the implementation of a strength and balance program in this population.Trial Registration: ACTRN12616001186448 . Registered 29 August 2016. [ABSTRACT FROM AUTHOR]

Background Restorative home care services help older people maximise their independence using a multi-dimensional approach. They usually include an exercise program designed to improve the older person's strength, balance and function. The types of programs currently offered require allocation of time during the day to complete specific exercises. This is not how the majority of home care clients prefer to be active and may be one of the reasons that few older people do the exercises regularly and continue the exercises post discharge. This paper describes the study protocol to test whether a Lifestyle Functional Exercise (LiFE) program: 1) is undertaken more often; 2) is more likely to be continued over the longer term; and, 3) will result in greater functional gains compared to a standard exercise program for older people receiving a restorative home care service. Methods/Design Design: A pragmatic randomised controlled trial (RCT) design was employed with two study arms: LiFE program (intervention) and the current exercise program (control). Setting: Silver Chain, a health and community care organisation in Perth, Western Australia. Participants: One hundred and fifty restorative home care clients, aged 65 years and older. Measurements: The primary outcome is a composite measure incorporating balance, strength and mobility. Other outcome measures include: physical functioning, falls efficacy, and levels of disability and functioning. Discussion If LiFE is more effective than the current exercise program, the evidence will be presented to the service management accompanied by the recommendation that it be adopted as the generic exercise program to be used within the restorative home care service. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12611000788976. [ABSTRACT FROM AUTHOR]

Background: The 'Lifestyle-integrated Functional Exercise' (LiFE) program successfully reduced risk of falling via improvements in balance and strength, additionally increasing physical activity (PA) in older adults. Generally being delivered in an individual one-to-one format, downsides of LiFE are considerable human resources and costs which hamper large scale implementability. To address this, a group format (gLiFE) was developed and analyzed for its non-inferiority compared to LiFE in reducing activity-adjusted fall incidence and intervention costs. In addition, PA and further secondary outcomes were evaluated. Methods: Older adults (70 + years) at risk of falling were included in this multi-center, single-blinded, randomized non-inferiority trial. Balance and strength activities and means to enhance PA were delivered in seven intervention sessions, either in a group (gLiFE) or individually at the participant's home (LiFE), followed by two "booster" phone calls. Negative binomial regression was used to analyze non-inferiority of gLiFE compared to LiFE at 6-month follow-up; interventions costs were compared descriptively; secondary outcomes were analyzed using generalized linear models. Analyses were carried out per protocol and intention-to-treat. Results: Three hundred nine persons were randomized into gLiFE (n = 153) and LiFE (n = 156). Non-inferiority of the incidence rate ratio of gLiFE was inconclusive after 6 months according to per protocol (mean = 1.27; 95% CI: 0.80; 2.03) and intention-to-treat analysis (mean = 1.18; 95% CI: 0.75; 1.84). Intervention costs were lower for gLiFE compared to LiFE (-€121 under study conditions; -€212€ under "real world" assumption). Falls were reduced between baseline and follow-up in both groups (gLiFE: -37%; LiFE: -55%); increases in PA were significantly higher in gLiFE (+ 880 steps; 95% CI 252; 1,509). Differences in other secondary outcomes were insignificant. Conclusions: Although non-inferiority of gLiFE was inconclusive, gLiFE constitutes a less costly alternative to LiFE and it comes with a significantly larger enhancement of daily PA. The fact that no significant differences were found in any secondary outcome underlines that gLiFE addresses functional outcomes to a comparable degree as LiFE. Advantages of both formats should be evaluated in the light of individual needs and preferences before recommending either format. Trial registration: The study was preregistered under clinicaltrials.gov (identifier: NCT03462654) on March 12th 2018 [ABSTRACT FROM AUTHOR]

Background: Reablement has potential for enhancing function and independence in people with dementia. In order to enhance the use of evidence-based reablement in this population, this study sought to understand the current practices and needs of the sector around these interventions.Methods: A purposive sample of 22 Australian aged and community-care providers participated in a semi-structured interview. Qualitative content analysis was applied to the data, with key themes interpreted within the context of the study aims: to explore (1) what reablement interventions are currently being offered to people living with dementia in Australia, and (2) what are key factors that will contribute to enhanced uptake of reablement interventions in dementia practice.Results: Four themes emerged: (1) 'what reablement interventions are being offered', outlined a range of exercise and cognitive/social interventions, with only a proportion generated from a clear evidence-base, (2) 'what's in a name', illustrated the range of terms used to describe reablement, (3) 'whose role is it', highlighted the confusion around the range of health professionals involved in providing reablement interventions, and (4) 'perceived barriers and enablers to providing reablement to people living with dementia', described a range of factors that both hinder and support current reablement practice.Conclusions: Reablement interventions currently provided for people living with dementia in Australia are variable, with confusion around the definition of reablement, and apparently limited use of evidence-informed interventions. A multifaceted approach involving an evidence-informed and freely-accessible resource, and taking into account the varied levels of influence within the aged care sector would support uptake and implementation of reablement interventions for people living with dementia. [ABSTRACT FROM AUTHOR]

Background: The Lifestyle-integrated Functional Exercise (LiFE) programme is a fall prevention programme originally taught in a resource-intensive one-to-one format with limited feasibility for large-scale implementation. The aim of this paper is to present the conceptual framework and initial feasibility evaluation of a group-based LiFE (gLiFE) format developed for large-scale implementation. Methods: The conceptual gLiFE framework (part I) is based on three pillars, LiFE Activities and Principles, Theory of Behaviour Change and Behaviour Change Techniques, and Instruction. The feasibility of gLiFE was tested (part II) within a multimodal approach including quantitative questionnaires measuring safety, acceptability (1 = best to 7 = insufficient), and adherence to the LiFE activities (range = 0–14) as well as a focus group interview. Exploratory self-reported measures on behaviour change including self-determined motivation (range = 1–5), intention, planning, action control, and habit strength (range = 1–6) were assessed pre and post intervention. Data analyses were performed using descriptive statistics and qualitative content analysis. Results: The development process resulted in a manualised gLiFE concept containing standardised information on gLiFE's content and structure. Feasibility testing: Six older adults (median = 72.8 years, 5 female) completed the feasibility study and rated safety (median = 7.0, IQR = 0.3) and acceptability as high (median = 1, IQR = 1). Participants implemented 9.5 LiFE activities (IQR = 4.0) into their daily routines. No adverse events occurred during the study. In the focus group, the group format and LiFE activities were perceived as positive and important for maintaining strength and balance capacity. Self-determined motivation intention, planning, and habit strength were rated higher post intervention. Conclusion: The developed conceptual gLiFE framework represents the basis for a gLiFE format with potential for standardised large-scale implementation. Proof-of-concept could be demonstrated in a group of community-dwelling older adults at risk of falling. The public health potential of gLiFE in terms of (cost-)effectiveness is currently being evaluated in a large trial. Trial registration: ClinicalTrials.gov NCT03412123. Registered on January 26, 2018 [ABSTRACT FROM AUTHOR]

Background: While there is strong evidence that fall prevention interventions can prevent falls in people aged 65 and over, translating evidence into routine practice is challenging. Research regarding how allied health professionals (AHPs) respond to this challenge is limited. As part of the Integrated Solutions for Sustainable Fall Prevention (iSOLVE) project, this study aimed to explore how AHPs were making fall prevention practice routine in primary care and the factors that influenced their fall prevention practice.Methods: In-depth qualitative interviews were conducted with fifteen AHPs who had attended evidence-based workshops associated with the iSOLVE project. AHPs had backgrounds in physiotherapy, occupational therapy, exercise physiology and podiatry. Interviews explored how fall prevention was being incorporated into routine practice and the factors that influenced routinisation, including the project workshops. Thematic analysis was used to analyse the data.Results: We found fall prevention was valued in practice and recognised as complex. AHPs worked through challenges relating to clients (multi-morbidity, complex living situations, client motivation), challenges working alongside other health professionals (understanding respective roles/overlapping roles, sense of competition, communication) and challenges associated with funding systems perceived as complicated and constantly changing. Despite these challenges, AHPs were adopting strategies for integrating fall prevention routinely. The iSOLVE workshops were perceived as important in supporting existing practice and in providing strategies to enhance practice.Conclusions: Policy makers, program managers, educators and AHPs can adopt strategies identified in this research for routinising fall prevention such as being alert that falls are common, asking every client about falls, having processes for assessing clients for fall risk, and having structured and evidence-based programs to work with clients on fall prevention. Adapting and streamlining funding systems are also important for facilitating fall prevention work. [ABSTRACT FROM AUTHOR]

Background: This study investigates the use of an information and communication technology (Elder Tree) designed for older adults and their informal caregivers to improve older adult quality of life and address challenges older adults face in maintaining their independence (for example, loneliness and isolation, falling, managing medications, driving and transportation). Methods/Design: This study, an unblinded randomized controlled trial, will evaluate the effectiveness and cost of Elder Tree. Older adults who are at risk for losing their independence - along with their informal caregivers, if they name them - are randomized to two groups. The intervention group has access to their usual sources of information and communication as well as to Elder Tree for 18 months while the control group uses only their usual sources of information and communication. The primary outcome of the study is older adult quality of life. Secondary outcomes are cost per Quality-Adjusted Life Year and the impact of the technology on independence, loneliness, falls, medication management, driving and transportation, and caregiver appraisal and mastery. We will also examine the mediating effect of self-determination theory. We will evaluate the effectiveness of Elder Tree by comparing intervention- and control-group participants at baseline and months 6, 12, and 18. We will use mixed-effect models to evaluate the primary and secondary outcomes, where pretest score functions as a covariate, treatment condition is a between-subjects factor, and the multivariate outcome reflects scores for a given assessment at the three time points. Separate analyses will be conducted for each outcome. Cost per Quality-Adjusted Life Year will be compared between the intervention and control groups. Additional analyses will examine the mediating effect of self-determination theory on each outcome. Discussion: Elder Tree is a multifaceted intervention, making it a challenge to assess which services or combinations of services account for outcomes in which subsets of older adults. If Elder Tree can improve quality of life and reduce healthcare costs among older adults, it could suggest a promising way to ease the burden that advancing age can place on older adults, their families, and the healthcare system. Trial registration: ClinicalTrials.govNCT02128789. Registered on 26 March 2014. [ABSTRACT FROM AUTHOR]

Background: Restorative home care services help older people maximise their independence using a multi-dimensional approach. They usually include an exercise program designed to improve the older person's strength, balance and function. The types of programs currently offered require allocation of time during the day to complete specific exercises. This is not how the majority of home care clients prefer to be active and may be one of the reasons that few older people do the exercises regularly and continue the exercises post discharge.This paper describes the study protocol to test whether a Lifestyle Functional Exercise (LiFE) program: 1) is undertaken more often; 2) is more likely to be continued over the longer term; and, 3) will result in greater functional gains compared to a standard exercise program for older people receiving a restorative home care service.Methods/design: Design: A pragmatic randomised controlled trial (RCT) design was employed with two study arms: LiFE program (intervention) and the current exercise program (control).Setting: Silver Chain, a health and community care organisation in Perth, Western Australia.Participants: One hundred and fifty restorative home care clients, aged 65 years and older.Measurements: The primary outcome is a composite measure incorporating balance, strength and mobility. Other outcome measures include: physical functioning, falls efficacy, and levels of disability and functioning.Discussion: If LiFE is more effective than the current exercise program, the evidence will be presented to the service management accompanied by the recommendation that it be adopted as the generic exercise program to be used within the restorative home care service.Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12611000788976. [ABSTRACT FROM AUTHOR]

Background: Many interventions designed to meet physical activity guideline recommendations focus on a single component (e.g., walking), to the detriment of other elements of a healthy lifestyle, such as reducing prolonged sitting and doing balance and strength exercises (i.e., bundled multiple behaviors). Adopting these multiple health behaviors within daily life routines may facilitate uptake and support longer-term behavior change. We tested feasibility for a three-part lifestyle intervention to support older women to sit less, move more, and complete balance and strength exercises. Methods: We used a convergent parallel mixed-methods, single-arm study design to test feasibility for a 6-week lifestyle intervention: Return to Everyday Activities in the Community and Home (REACH). We collected information at baseline, 3 and 6 weeks (final), and 6 months (follow-up) using questionnaires, semi-structured interviews, and performance-based measures. We describe three key elements: (1) implementation factors such as recruitment, retention, program delivery, and adherence; (2) participants' acceptability and experience with the program; and (3) health outcomes, including participants' global mobility, activity, and perceptions of their physical activity identity, and habit strength for (i) physical activity, (ii) breaking up sitting time, and (iii) balance and strength exercises. Results: We were able to recruit enough participants in the allotted time to conduct one cycle of the REACH group-based program. There were 10 community-dwelling women, median (p25, p75) age 61 (57.5, 71) years, who completed the study. The program was feasible to deliver, with high attendance (mean 5/6 sessions) and positive overall ratings (8/10). Participants rated session content and length high, and educational materials as highly acceptable and understandable. Although participants were active walkers at baseline, few were breaking up prolonged sitting or participating in any balance and strength exercises. At final and follow-up assessments, participants reported developing habits for all three health behaviors, without diminishing physical activity. Conclusion: These results show acceptability of the program and its materials, and feasibility for bundling multiple health behaviors within the REACH program. It also provides confirmation to advance to testing feasibility of this three-part lifestyle intervention with older, less active, adults. Trial registration: ClinicalTrials.gov Identifier, NCT02786394; May 18, 2016. [ABSTRACT FROM AUTHOR]

Background: This study investigates the use of an information and communication technology (Elder Tree) designed for older adults and their informal caregivers to improve older adult quality of life and address challenges older adults face in maintaining their independence (for example, loneliness and isolation, falling, managing medications, driving and transportation).Methods/design: This study, an unblinded randomized controlled trial, will evaluate the effectiveness and cost of Elder Tree. Older adults who are at risk for losing their independence - along with their informal caregivers, if they name them - are randomized to two groups. The intervention group has access to their usual sources of information and communication as well as to Elder Tree for 18 months while the control group uses only their usual sources of information and communication. The primary outcome of the study is older adult quality of life. Secondary outcomes are cost per Quality-Adjusted Life Year and the impact of the technology on independence, loneliness, falls, medication management, driving and transportation, and caregiver appraisal and mastery. We will also examine the mediating effect of self-determination theory. We will evaluate the effectiveness of Elder Tree by comparing intervention- and control-group participants at baseline and months 6, 12, and 18. We will use mixed-effect models to evaluate the primary and secondary outcomes, where pretest score functions as a covariate, treatment condition is a between-subjects factor, and the multivariate outcome reflects scores for a given assessment at the three time points. Separate analyses will be conducted for each outcome. Cost per Quality-Adjusted Life Year will be compared between the intervention and control groups. Additional analyses will examine the mediating effect of self-determination theory on each outcome.Discussion: Elder Tree is a multifaceted intervention, making it a challenge to assess which services or combinations of services account for outcomes in which subsets of older adults. If Elder Tree can improve quality of life and reduce healthcare costs among older adults, it could suggest a promising way to ease the burden that advancing age can place on older adults, their families, and the healthcare system.Trial Registration: ClinicalTrials.gov NCT02128789 . Registered on 26 March 2014. [ABSTRACT FROM AUTHOR]