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One-third of opioid (OPI) overdose deaths involve concurrent benzodiazepine (BZD) use. Little is known about concurrent opioid and benzodiazepine use (OPI-BZD) most associated with overdose risk. We aimed to examine associations between OPI-BZD dose and duration trajectories, and subsequent OPI or BZD overdose in US Medicare.Retrospective cohort study.US Medicare.Using a 5% national Medicare data sample (2013-16) of fee-for-service beneficiaries without cancer initiating OPI prescriptions, we identified 37 879 beneficiaries (age ≥ 65 = 59.3%, female = 71.9%, white = 87.6%, having OPI overdose = 0.3%).During the 6 months following OPI initiation (i.e. trajectory period), we identified OPI-BZD dose and duration patterns using group-based multi-trajectory models, based on average daily morphine milligram equivalents (MME) for OPIs and diazepam milligram equivalents (DME) for BZDs. To label dose levels in each trajectory, we defined OPI use as very low ( 25 MME), low (25-50 MME), moderate (51-90 MME), high (91-150 MME) and very high (150 MME) dose. Similarly, we defined BZD use as very low ( 10 DME), low (10-20 DME), moderate (21-40 DME), high (41-60 DME) and very high ( 60 DME) dose. Our primary analysis was to estimate the risk of time to first hospital or emergency department visit for OPI overdose within 6 months following the trajectory period using inverse probability of treatment-weighted Cox proportional hazards models.We identified nine distinct OPI-BZD trajectories: group A: very low OPI (early discontinuation)-very low declining BZD (n = 10 598; 28.0% of the cohort); B: very low OPI (early discontinuation)-very low stable BZD (n = 4923; 13.0%); C: very low OPI (early discontinuation)-medium BZD (n = 4997; 13.2%); D: low OPI-low BZD (n = 5083; 13.4%); E: low OPI-high BZD (n = 3906; 10.3%); F: medium OPI-low BZD (n = 3948; 10.4%); G: very high OPI-high BZD (n = 1371; 3.6%); H: very high OPI-very high BZD (n = 957; 2.5%); and I: very high OPI-low BZD (n = 2096; 5.5%). Compared with group A, five trajectories (32.3% of the study cohort) were associated with increased 6-month OPI overdose risks: E: low OPI-high BZD [hazard ratio (HR) = 3.27, 95% confidence interval (CI) = 1.61-6.63]; F: medium OPI-low BZD (HR = 4.04, 95% CI = 2.06-7.95); G: very high OPI-high BZD (HR = 6.98, 95% CI = 3.11-15.64); H: very high OPI-very high BZD (HR = 4.41, 95% CI = 1.51-12.85); and I: very high OPI-low BZD (HR = 6.50, 95% CI = 3.15-13.42).Patterns of concurrent opioid and benzodiazepine use most associated with overdose risk among fee-for-service US Medicare beneficiaries initiating opioid prescriptions include very high-dose opioid use (MME 150), high-dose benzodiazepine use (DME 40) or medium-dose opioid with low-dose benzodiazepine use.

Objectives: This evidence-based design clinical trial assessed the feasibility of a multisensory environment (MSE) using aromatherapy, color-changing lights, and music as a behavioral intervention to calm Veterans with dementia during assisted bathing to improve the patient experience. Background: The number of Veterans with dementia is growing rapidly, along with the associated debilitating behavior challenges. The severity of these distressed behaviors that predominantly occur at bath time often necessitates costly, dangerous sedatives. Feasibility studies of nonpharmacological behavioral interventions during bathing for people with dementia are urgently needed, and research supports MSE as a viable solution. Method: Using an A–B, multiple baselines across participants design, this study tracked operational behaviors of four Veterans with dementia during bathing without and with an MSE intervention. Sessions were provided and recorded by a dedicated team of five nurses, so the study team could analyze the Veterans’ operational behaviors to understand the impact of individualized MSE during both baseline and intervention phases. Results: The results support the feasibility of MSE as a helpful, nonpharmacological behavioral intervention for Veterans with dementia during bathing. All participants experienced an overall increase in duration of positive operational behaviors and an overall decrease in duration of negative operational behaviors. Conclusions: Healthcare environments are integral components in dementia care and the use of MSE within the bathing setting appears to improve not only operational behaviors but the overall bathing experience.

Objective: Falls are a significant problem for many older patients after hospital discharge. The purpose of this study was to evaluate the fidelity and impact of a tailored patient fall prevention education programme from the perspective of the educators who delivered the programme. Design: Qualitative sequential design. Setting: Three rehabilitation hospitals in Western Australia. Method: Three experienced physiotherapists trained as ‘educators’ to deliver a tailored fall prevention education programme to 195 older patients prior to hospital discharge, together with monthly telephone follow-up for 3 months after discharge. Educator–patient interactions were recorded in a standardised educator diary. Post-intervention, educators participated in a mini-focus group, providing their perspectives regarding education delivery and its impact on patient abilities to engage in fall prevention strategies. Data were analysed using deductive content analysis. Results: Educators followed up 184 (94%) patients, identifying multiple barriers and enablers affecting patient engagement in planned fall prevention strategies. Key barriers included unresolved medical conditions, reluctance to accept assistance on discharge, delays in assistive service provision, patient beliefs and perceptions about falls and, in some cases, patients’ absolving responsibility for recovery. Enablers were related to programme design, the completion of hospital discharge processes and support networks following discharge. Conclusion: Educators identified several barriers and enablers to programme delivery, receipt and enactment by older patients that contributed to the fidelity of the education programme. The consistent need for more patient support to enable improved enactment of plans and assist with safe recovery long after discharge warrants further attention at policy and health system levels.

Objective Our study examines how consistently fall prevention practices and implementation strategies are used by U.S. hospitals. Methods We conducted a cross-sectional, descriptive study of 60 general adult hospital units.We administered a survey measuring 5 domains of fall prevention practices: visibility and identification, bed modification, patient monitoring, patient safety, and education. We measured 4 domains of implementation strategies including quality management (e.g., providing data and support for quality improvement), planning (e.g., designating leadership), education (e.g., providing consultation and training), and restructuring (e.g., revising staff roles and modifying equipment). Results Of 60 units, 43% were medical units and 57% were medical-surgical units. The hospital units varied in fall prevention practices, with practices such as keeping a patient's bed in a locked position (73% strongly agree) being used more consistently than other practices, such as scheduled toileting (15% strongly agree). Our study observed variation in fall prevention implementation strategies. For example, publicly posting fall rates (60% strongly agree) was more consistently used than having a multidisciplinary huddle after a fall event (12% strongly agree). Conclusions There is substantial variation in the implementation of fall prevention practices and implementation strategies across inpatient units. Our study found that resource-intensive practices (e.g., scheduled toileting) are less consistently used than less resource-intensive practices and that interdisciplinary approaches to fall prevention are limited. Future studies should examine how units tailor fall prevention practices based on patient risk factors and how units decide, based on their available resources, which implementation strategies should be used.

Objectives: To evaluate the diffusion of multisensory environments (MSEs) as an innovation at the Veterans Health Administration (VHA) and gather feedback regarding staff perceptions of barriers to uptake and effectiveness of MSEs for Veterans with dementia. Background: Responding to the need for nonpharmacological behavioral interventions, VHA funded the first MSE for Veterans with dementia in 2010. The room incorporated LED color-changing lights, bubble tubes, vibroacoustic furniture, music, and aromatherapy, and the success of this patient-centered sensory room fueled national rollouts in 2013 and 2015. Method: A qualitative interview approach was used. Thirty-two staff members participated from 12 of the 53 sites producing 21 individual interviews and 1 group interview with 11 participants. Results were analyzed by a team of eight researchers using the rapid qualitative inquiry method to identify common themes and major insights. Results: Important insights emerged with regard to staff members’ perceptions about the effectiveness of MSE therapy as well as barriers to uptake and suggested strategies for overcoming those barriers (e.g., empowering a champion, developing a clear maintenance plan). Conclusions: The findings from this research indicate MSEs are perceived as effective in improving behavior for Veterans with dementia and represent an innovation that has been well-diffused within the VHA, with great potential for future clinical applications.

Older adults recently discharged from hospital are at high risk of functional decline and falls. A tailored fall prevention education provided at hospital discharge aimed to improve the capacity of older adults to engage in falls prevention activities. What remains unknown are the factors affecting behaviour change after hospital discharge. This study identified the perceived barriers and enablers of older adults to engagement in fall prevention activities during the 6-month period post-discharge. An exploratory approach using interpretative phenomenological analysis focused on the lived experience of a purposive sample (n = 30) of participants. All were recruited as a part of an RCT (n = 390) that delivered a tailored fall prevention education program at three hospital rehabilitation wards in Perth, Australia. Data were collected at 6-month post-discharge using semi-structured telephone surveys. Personal stories confirmed that some older adults have difficulty recovering functional ability after hospital discharge. Reduced physical capability, such as experiences of fatigue, chronic pain and feeling unsteady when walking were barriers for participants to safely return to their normal daily activities. Participants who received the tailored fall education program reported positive effects on knowledge and motivation to engage in fall prevention. Participants who had opportunities to access therapy or social supports described more positive experiences of recovery compared to individuals who persevered without assistance. A lack of physical and social support was associated with apprehension and fear toward adverse events such as falls, injuries, and hospital readmission. The lived experience of participants following hospital discharge strongly suggested that they required more supports from both healthcare professionals and caregivers to ensure that their needs were met. Further research that evaluates how to assist this population to engage in programs that will mitigate the high risk of falls and hospital readmissions is required.

BackgroundTo guide fall prevention efforts, United States organisations, such as the Joint Commission and the Agency for Healthcare Research and Quality, have recommended organisational-level implementation strategies: leadership support, interdisciplinary falls committees, electronic health record tools, and staff, family and patient education. It is unclear whether hospitals adhere to such strategies or how these strategies are operationalised.ObjectiveTo identify and describe the prevalence of specific hospital fall prevention implementation strategies.MethodsIn 2017, we surveyed 80 US hospitals participating in the National Database of Nursing Quality Indicators who volunteered for the study. We conducted descriptive statistics by calculating percentages for categorical variables and the median and IQR for count variables.ResultsA total of 60/80 (75%) of hospitals completed the survey. The majority of hospitals were not-for-profit (98%) and urban (90%); more than half were Magnet (53%), small (53%) and teaching (52%). Hospitals were more likely to use leadership strategies, such as updating fall policies in the past 3 years (98%) but less likely to reward staff (40%). Hospitals commonly used interdisciplinary falls committees (83%) but membership rarely included physicians. Hospitals lacked access to electronic health record tools, such as high-risk medication warnings (27%). Education strategies were commonly used; 100% of hospitals provided fall education at staff orientation, but only 22% educated all employees (not just nursing staff).ConclusionsOur study is the first to our knowledge to examine which expert-recommended implementation strategies are being used and how they are being operationalised in US hospitals. Future studies are needed to document fall prevention implementation strategies in detail and to test which implementation strategies are most effective at reducing falls. Additionally, research is needed to evaluate the quality of implementation (eg, fidelity) of fall prevention interventions.

Background/Objectives: We investigated the impact of ceasing routine falls risk assessment tool (FRAT) completion and instead used clinical reasoning to select fall mitigation strategies. Design: Two-group, multi-site cluster-randomized active-control non-inferiority trial. Setting: Hospital wards. Participants: Adult inpatients admitted to participating hospitals (n = 10 hospitals, 123,176 bed days). Intervention: Hospitals were randomly assigned (1:1) to a usual care control group that continued to use a historical FRAT to assign falls risk scores and accompanying mitigation strategies, or an experimental group whereby clinicians did not assign risk scores and instead used clinical reasoning to select fall mitigation strategies using a decision support list. Measurements: The primary measure was between-group difference in mean fall rates (falls/1000 bed days). Falls were identified from incident reports supplemented by hand searches of medical records over three consecutive months at each hospital. The incidence rate ratio (IRR) of monthly falls rates in control versus experimental hospitals was also estimated. Results: The experimental clinical reasoning approach was non-inferior to the usual care FRAT that assigned fall risk ratings when compared to a-priori stakeholder derived and sensitivity non-inferiority margins. The mean fall rates were 3.84 falls/1000 bed days for the FRAT continuing sites and 3.11 falls/1000 bed days for experimental sites. After adjusting for historical fall rates at each hospital, the IRR (95%CI) was 0.78 (0.64, 0.95), where IRR < 1.00 indicated fewer falls among the experimental group. There were 4 and 3 serious events in the control and experimental groups, respectively. Conclusion: Replacing a FRAT scoring system with clinical reasoning did not lead to inferior fall outcomes in the short term and may even reduce fall incidence.

BACKGROUND Patient falls are the most common adverse events reported in hospitals. Although it is well understood that the physical hospital environment contributes to nearly 40% of severe or fatal hospital falls, there are significant gaps in the knowledge about the relationship between inpatient unit design and fall rates. The few studies that have examined unit design have been conducted in a single hospital (non-Veterans Health Administration [VHA]) or a small number of inpatient units, limiting generalizability. The goal of this study is to identify unit design factors contributing to inpatient falls in the VHA. OBJECTIVE The first aim of the study is to investigate frontline and management perceptions of and experiences with veteran falls as they pertain to inpatient environmental factors. An iterative rapid assessment process will be used to analyze the data. Interview findings will directly inform the development of an environmental assessment survey to be conducted as part of aim 2 and to contribute to interpretation of aim 2. The second aim of this study is to quantify unit design factors and compare spatial and environmental factors of units with higher- versus lower-than-expected fall rates. METHODS We will first conduct walk-through interviews with facility personnel in 10 medical/surgical units at 3 VHA medical centers to identify environmental fall risk factors. Data will be used to finalize an environmental assessment survey for nurse managers and facilities managers. We will then use fall data from the VA Inpatient Evaluation Center and patient data from additional sources to identify 50 medical/surgical nursing units with higher- and lower-than-expected fall rates. We will measure spatial factors by analyzing computer-aided design files of unit floorplans and environmental factors from the environmental assessment survey. Statistical tests will be performed to identify design factors that distinguish high and low outliers. RESULTS The VA Health Services Research and Development Service approved funding for the study. The research protocol was approved by institutional review boards and VA research committees at both sites. Data collection started in February 2018. Results of the data analysis are expected by February 2022. Data collection and analysis was completed for aim 1 with a manuscript of results in progress. For aim 2, the medical/surgical units were categorized into higher- and lower-than-expected fall categories, the environmental assessment surveys were distributed to facility managers and nurse managers. Data to measure spatial characteristics are being compiled. CONCLUSIONS To our knowledge, this study is the first to objectively identify spatial risks for falls in hospitals within in a large multihospital system. Findings can contribute to evidence-based design guidelines for hospitals such as those of the Facility Guidelines Institute and the Department of Veterans Affairs. The metrics for characterizing spatial features are quantitative indices that could be incorporated in larger scale contextual studies examining contributors to falls, which to date often exclude physical environmental factors at the unit level. Space syntax measures could be used as physical environmental factors in future research examining a range of contextual factors—social, personal, organizational, and environmental—that contribute to patient falls. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24974

Hospital falls remain an intractable problem worldwide and patient education is one approach to falls mitigation. Although educating patients can help their understanding of risks and empower them with prevention strategies, patient experiences of hospital falls education are poorly understood. This study aimed to understand the perspectives and preferences of hospitalized patients about falls prevention education. Three focus groups were conducted in Australian hospitals. A phenomenological approach was used to explore patient perspectives and data were analyzed thematically. The focus groups revealed that most people did not realize their own risk of falling whilst an inpatient. Experiences of falls prevention education were inconsistent and sometimes linked to beliefs that falls were not relevant to them because they were being cared for in hospital. Other barriers to falls mitigation included poor patient knowledge about hospital falls risk and inconsistencies in the delivery of falls prevention education. A strong theme was that individualized, consistent education, and small interactive groups were helpful.

Background/Objectives Recognition and documentation of delirium is a challenge in the hospital. Education programs lack standardized screening tools. The presence of dementia or depression contribute to poor recognition of delirium. Many front-line healthcare workers attribute delirium to dementia, often misidentifying or delaying a correct diagnosis and in turn, treatment. Unrecognized and untreated delirium is costly. Non-pharmacologic interventions improve patient outcomes and decrease costs. Without delirium education, nurses are vulnerable to injury and low job satisfaction when caring for delirious patients. We describe an education program improving recognition and attitudes towards patients experiencing delirium. Design An education program about screening, documenting, and treating delirium. Setting A large Veterans Health System Hospital. Participants Healthcare professionals(n = 389) participated in the education program. 355 Nurses and patient-care assistants took the pre and post-test, and 43 returned the post program follow-up survey. A delirium education program with three steps; 1) self-directed online module; 2) dementia simulation experience; and 3) a multi-station delirium skills fair. Pre and post-tests were conducted after step 2, as well as a four-month follow-up survey. Measurements Changes in attitude toward patients with cognitive impairment and their abilities. Self-assessment of attitudes toward patients with delirium. Results Statistically significant differences in pre and post-testing suggested increased understanding of the experience and abilities of people experiencing cognitive impairment . The four-month follow-up survey showed a continued understanding of the importance of recognizing, documenting, and treating delirium. Conclusion Nursing Education about delirium that includes instruction on a standardized screening tool, documentation, and non-pharmacologic interventions improved knowledge and recognition of delirium and may have changed attitudes surrounding delirium in the hospital.

Background The majority of stroke survivors return to their homes and need assistance from family caregivers to perform activities of daily living. These increased demands coupled with the lack of preparedness for their new roles lead to a high risk for caregivers developing depressive symptoms and other negative outcomes. Follow-up home support and problem-solving interventions with caregivers are crucial for maintaining stroke survivors in their homes. Problem-solving interventions are effective but are underused in practice because they require large amounts of staff time to implement and are difficult for caregivers logistically. Objective The aim of this study is to test a problem-solving intervention for stroke caregivers that can be delivered over the telephone during the patient’s transitional care period (time when the stroke survivor is discharged to home) followed by 8 asynchronous online sessions. Methods The design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 240 caregivers from eight Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a modified problem-solving intervention that uses telephone and web-based support and training with interactive modules, fact sheets, and tools on the previously developed and nationally available Resources and Education for Stroke Caregivers’ Understanding and Empowerment Caregiver website. In the usual care group, no changes are made in the information, discharge planning, or care the patients who have had a stroke normally receive, and caregivers have access to existing VA resources (eg, caregiver support line, self-help materials). The primary outcome is a change in caregiver depressive symptoms at 11 and 19 weeks after baseline data collection. Secondary outcomes include changes in stroke caregivers’ burden, knowledge, positive aspects of caregiving, self-efficacy, perceived stress, health-related quality of life, and satisfaction with care and changes in stroke survivors’ functional abilities and health care use. The team will also determine the budgetary impact, facilitators, barriers, and best practices for implementing the intervention. Throughout all phases of the study, we will collaborate with members of an advisory panel. Results Study enrollment began in June 2015 and is ongoing. The first results are expected to be submitted for publication in 2021. Conclusions This is the first known study to test a transitional care and messaging center intervention combined with technology to decrease caregiver depressive symptoms and to improve the recovery of stroke survivors. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post stroke. Trial Registration ClinicalTrials.gov NCT01600131; https://www.clinicaltrials.gov/ct2/show/NCT01600131 International Registered Report Identifier (IRRID) DERR1-10.2196/21799

BACKGROUND The majority of stroke survivors return to their homes and need assistance from family caregivers to perform activities of daily living. These increased demands coupled with the lack of preparedness for their new roles lead to a high risk for caregivers developing depressive symptoms and other negative outcomes. Follow-up home support and problem-solving interventions with caregivers are crucial for maintaining stroke survivors in their homes. Problem-solving interventions are effective but are underused in practice because they require large amounts of staff time to implement and are difficult for caregivers logistically. OBJECTIVE The aim of this study is to test a problem-solving intervention for stroke caregivers that can be delivered over the telephone during the patient’s transitional care period (time when the stroke survivor is discharged to home) followed by 8 asynchronous online sessions. METHODS The design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 240 caregivers from eight Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a modified problem-solving intervention that uses telephone and web-based support and training with interactive modules, fact sheets, and tools on the previously developed and nationally available Resources and Education for Stroke Caregivers’ Understanding and Empowerment Caregiver website. In the usual care group, no changes are made in the information, discharge planning, or care the patients who have had a stroke normally receive, and caregivers have access to existing VA resources (eg, caregiver support line, self-help materials). The primary outcome is a change in caregiver depressive symptoms at 11 and 19 weeks after baseline data collection. Secondary outcomes include changes in stroke caregivers’ burden, knowledge, positive aspects of caregiving, self-efficacy, perceived stress, health-related quality of life, and satisfaction with care and changes in stroke survivors’ functional abilities and health care use. The team will also determine the budgetary impact, facilitators, barriers, and best practices for implementing the intervention. Throughout all phases of the study, we will collaborate with members of an advisory panel. RESULTS Study enrollment began in June 2015 and is ongoing. The first results are expected to be submitted for publication in 2021. CONCLUSIONS This is the first known study to test a transitional care and messaging center intervention combined with technology to decrease caregiver depressive symptoms and to improve the recovery of stroke survivors. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post stroke. CLINICALTRIAL ClinicalTrials.gov NCT01600131; https://www.clinicaltrials.gov/ct2/show/NCT01600131 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/21799

BackgroundHospital falls remain common and approximately 30% of falls in hospital result in injury. The aims of the study were the following: (i) to identify the association between fall interventions present at the time of the injurious fall and injurious faller characteristics and (ii) to identify the association between fall preventive interventions present at the time of the injurious fall and the injurious fall circumstances.MethodsSecondary data analysis of deidentified case series of injurious falls across 24 acute medical/surgical units in the United States. Variables of interest were falls prevention interventions (physical therapy, bed alarm, physical restraint, room change, or a sitter) in place at the time of fall. Data were analyzed using logistic regression and hazard ratios.ResultsThere were 1,033 patients with an injurious fall, occurrence peaked between Day 1 and Day 4, with 46.8% of injurious falls having occurred by Day 3 of admission. Injurious fallers with a recorded mental state change 24 hours prior to the fall were more likely to have a bed alarm provided (adjusted odds ratio [OR] 2.56, 95% confidence interval [CI] 1.61, 4.08) and receive a physical restraint as fall prevention interventions (adjusted OR 6.36, 95% CI 4.35, 9.30). Injurious fallers restrained fell later (stay Day 6) than those without a restraint (stay Day 4) (p = .007) and had significantly longer lengths of stay (13 days vs 9 days).ConclusionsOn medical/surgical units, injurious falls occur early following admission suggesting interventions should be commenced immediately. Injurious fallers who had a physical restraint as an intervention had longer lengths of stay.

Bed and chair alarms are widely used in hospitals, despite lack of effectiveness and unintended negative consequences. In this cross-sectional, observational study, we examined alarm prevalence and contributions of patient- and unit-level factors to alarm use on 59 acute care nursing units in 57 U.S. hospitals participating in the National Database of Nursing Quality Indicators®. Nursing unit staff reported data on patient-level fall risk and fall prevention measures for 1,489 patients. Patient-level propensity scores for alarm use were estimated using logistic regression. Expected alarm use on each unit, defined as the mean patient propensity-for-alarm score, was compared to the observed rate of alarm use. Over one-third of patients assessed had an alarm in the “on” position. Patient characteristics associated with higher odds of alarm use included recent fall, need for ambulation assistance, poor mobility judgment, and altered mental status. Observed rates of unit alarm use ranged from 0%-100% (median 33%, 10(th) percentile 5%, 90(th) percentile 67%). Expected alarm use varied less (median 31%, 10(th) percentile 27%, 90(th) percentile 45%). Only 29% of variability in observed alarm use was accounted for by expected alarm use. Unit assignment was a stronger predictor of alarm use than patient-level fall risk variables. Alarm use is common, varies widely across hospitals, and cannot be fully explained by patient fall risk factors; alarm use is driven largely by unit practices. Alarms are used too frequently and too indiscriminately, and guidance is needed for optimizing alarm use to reduce noise and encourage mobility in appropriate patients.

Objectives To examine the association between central nervous system (CNS) medication dosage burden and risk of serious falls, including hip fractures, in individuals with a history of a recent fall. Design Nested case–control study. Setting Veterans Health Administration (VHA) Community Living Centers (CLCs). Participants CLC residents aged 65 and older with a history of a fall or hip fracture in the year before a CLC admission between July 1, 2005, and June 30, 2009. Each case (n = 316) was matched to four controls (n = 1264) on age, sex, and length of stay. Measurements Outcomes were serious falls identified using International Classification of Diseases, Ninth Revision (ACD‐9) or Current Procedural Terminology (CPT) E codes, diagnosis codes, or procedure codes associated with a VHA emergency department visit or hospitalization during the CLC stay. Bar code medication administration data were used to calculate CNS standardized daily doses (SDDs) for opioid and benzodiazepine receptor agonists, some antidepressants, antiepileptics, and antipsychotics received in the 6 days before the outcome date by dividing residents' actual CNS daily doses by the minimum effective geriatric daily doses and adding the results. Multivariable conditional logistic regression models were used to evaluate the association between total CNS medication dosage burden, categorized as 0, 1 to 2, and 3 or more SDDs, and the outcome of recurrent serious falls. Results More cases (44.3%) than controls (35.8%) received 3.0 or more CNS SDDs (p = .02). Risk of serious falls was greater in residents with 3.0 or more SDDs than in those with 0 (adjusted odds ratio (aOR)=1.49, 95% confidence interval (CI)=1.03–2.14). Those with 1.0 to 2.9 SDDs had a risk similar to that of those with 0 SDDs (aOR=1.03, 95%CI=0.72–1.48). Conclusion Nursing home residents with a history of a fall or hip fracture receiving 3.0 or more CNS SDDs were more likely to have a recurrent serious fall than those taking no CNS medications. Interventions targeting this vulnerable population may help reduce serious falls. J Am Geriatr Soc 67:74–80, 2019.

Background older adults are known to have increased falls rates and functional decline following hospital discharge, with substantial economic healthcare costs. This systematic review aimed to synthesise the evidence for effective falls prevention interventions in older adults recently discharged from hospital. Methods literature searches of six databases of quantitative studies conducted from 1990 to June 2017, reporting falls outcomes of falls prevention interventions for community-dwelling older adults discharged from hospital were included. Study quality was assessed using a standardised JBI critical appraisal tool (MAStARI) and data pooled using Rev-Man Review Manager® Results sixteen studies (total sample size N = 3,290, from eight countries, mean age 77) comprising 12 interventions met inclusion criteria. We found home hazard modification interventions delivered to those with a previous falls history (1 study), was effective in reducing the number of falls (RR 0.63, 95%CI 0.43, 0.93, Low GRADE evidence). Home exercise interventions (3 studies) significantly increased the proportion of fallers (OR 1.74, 95%CI 1.17, 2.60, Moderate GRADE evidence), and did not significantly reduce falls rate (RR 1.27, 95%CI 0.99, 1.62, Very Low GRADE evidence) or falls injury rate (RR 1.16, 95%CI, 0.83,1.63, Low GRADE evidence). Nutritional supplementation for malnourished older adults (1 study) significantly reduced the proportion of fallers (HR 0.41, 95% CI 0.19, 0.86, Low GRADE evidence). Conclusion the recommended falls prevention interventions for older adults recently discharged from hospital are to provide home hazard minimisation particularly if they have a recent previous falls history and consider nutritional supplementation if they are malnourished.

Background Patient falls are the most common adverse events reported in hospitals. Although it is well understood that the physical hospital environment contributes to nearly 40% of severe or fatal hospital falls, there are significant gaps in the knowledge about the relationship between inpatient unit design and fall rates. The few studies that have examined unit design have been conducted in a single hospital (non-Veterans Health Administration [VHA]) or a small number of inpatient units, limiting generalizability. The goal of this study is to identify unit design factors contributing to inpatient falls in the VHA. Objective The first aim of the study is to investigate frontline and management perceptions of and experiences with veteran falls as they pertain to inpatient environmental factors. An iterative rapid assessment process will be used to analyze the data. Interview findings will directly inform the development of an environmental assessment survey to be conducted as part of aim 2 and to contribute to interpretation of aim 2. The second aim of this study is to quantify unit design factors and compare spatial and environmental factors of units with higher- versus lower-than-expected fall rates. Methods We will first conduct walk-through interviews with facility personnel in 10 medical/surgical units at 3 VHA medical centers to identify environmental fall risk factors. Data will be used to finalize an environmental assessment survey for nurse managers and facilities managers. We will then use fall data from the VA Inpatient Evaluation Center and patient data from additional sources to identify 50 medical/surgical nursing units with higher- and lower-than-expected fall rates. We will measure spatial factors by analyzing computer-aided design files of unit floorplans and environmental factors from the environmental assessment survey. Statistical tests will be performed to identify design factors that distinguish high and low outliers. Results The VA Health Services Research and Development Service approved funding for the study. The research protocol was approved by institutional review boards and VA research committees at both sites. Data collection started in February 2018. Results of the data analysis are expected by February 2022. Data collection and analysis was completed for aim 1 with a manuscript of results in progress. For aim 2, the medical/surgical units were categorized into higher- and lower-than-expected fall categories, the environmental assessment surveys were distributed to facility managers and nurse managers. Data to measure spatial characteristics are being compiled. Conclusions To our knowledge, this study is the first to objectively identify spatial risks for falls in hospitals within in a large multihospital system. Findings can contribute to evidence-based design guidelines for hospitals such as those of the Facility Guidelines Institute and the Department of Veterans Affairs. The metrics for characterizing spatial features are quantitative indices that could be incorporated in larger scale contextual studies examining contributors to falls, which to date often exclude physical environmental factors at the unit level. Space syntax measures could be used as physical environmental factors in future research examining a range of contextual factors—social, personal, organizational, and environmental—that contribute to patient falls. International Registered Report Identifier (IRRID) DERR1-10.2196/24974

The objective of this review is to synthesize the best available evidence on the effectiveness of falls prevention interventions provided just prior or immediately after discharge from hospital on falls rates and falls injuries among older adults living in the community in the first 6 months after discharge from hospital.

SummaryWhat is known and objective There are few studies examining both drug–drug and drug–disease interactions in older adults. Therefore, the objective of this study was to describe the prevalence of potential drug–drug and drug–disease interactions and associated factors in community-dwelling older adults. Methods This cross-sectional study included 3055 adults aged 70–79 without mobility limitations at their baseline visit in the Health Aging and Body Composition Study conducted in the communities of Pittsburgh PA and Memphis TN, USA. The outcome factors were potential drug–drug and drug–disease interactions as per the application of explicit criteria drawn from a number of sources to self-reported prescription and non-prescription medication use. Results Over one-third of participants had at least one type of interaction. Approximately one quarter (25·1%) had evidence of had one or more drug–drug interactions. Nearly 10·7% of the participants had a drug–drug interaction that involved a non-prescription medication. % The most common drug–drug interaction was non-steroidal anti-inflammatory drugs (NSAIDs) affecting antihypertensives. Additionally, 16·0% had a potential drug–disease interaction with 3·7% participants having one involving non-prescription medications. The most common drug–disease interaction was aspirin/NSAID use in those with history of peptic ulcer disease without gastroprotection. Over one-third (34·0%) had at least one type of drug interaction. Each prescription medication increased the odds of having at least one type of drug interaction by 35–40% [drug–drug interaction adjusted odds ratio (AOR) = 1·35, 95% confidence interval (CI) = 1·27–1·42; drug–disease interaction AOR = 1·30; CI = 1·21–1·40; and both AOR = 1·45; CI = 1·34–1·57]. A prior hospitalization increased the odds of having at least one type of drug interaction by 49–84% compared with those not hospitalized (drug–drug interaction AOR = 1·49, 95% CI = 1·11–2·01; drug–disease interaction AOR = 1·69, CI = 1·15–2·49; and both AOR = 1·84, CI = 1·20–2·84). What is new and conclusion Drug interactions are common among community-dwelling older adults and are associated with the number of medications and hospitalization in the previous year. Longitudinal studies are needed to evaluate the impact of drug interactions on health-related outcomes.

Background The Centers for Medicare & Medicaid Services (CMS) implemented the Hospital-Acquired Conditions (HACs) Initiative in October 2008; the CMS no longer reimbursed hospitals for fall injury. The effects of this payment change on fall and fall injury rates are not well described, nor its effect on physical restraint use. Objective The aim of this study was to examine the effects of the 2008 HACs Initiative on the rates of falls, injurious falls, and physical restraint use. Design/setting This was a nine-year retrospective cohort study (July 2006-December 2015) involving 2,862 adult medical, medical-surgical, and surgical nursing units from 734 hospitals. Measurements Annual rates of change in falls, injurious falls, and physical restraint use during the two years before the payment rule went into effect were compared with one-, four-, and seven-year rates of annual change after implementation, adjusting for unit- and facility-level covariates. Stratified analyses were conducted according to bed size and teaching status. Results Compared with prior to the payment change, there was stable acceleration in the one-, four-, and seven-year annual rates of decline in falls as follows: -2.1% (-3.3%, -0.9%), -2.2% (-3.2%, -1.1%), and -2.2% (-3.4%, -1.0%) respectively. For injurious falls, there was an increasing acceleration in the annual declines, achieving statistical significance only at seven years post CMS change as follows: -3.2% (-5.5%, -1.0%). Physical restraint use prevalence decreased from 1.6% to 0.6%. Changes in the rates of falls, injurious falls, and restraint use varied according to hospital bed size and teaching status. Conclusions and relevance Since the HACs Initiative, there was at best a modest decline in the rates of falls and injurious falls observed primarily in larger, major teaching hospitals. An increase in restraint use was not observed. Falls remain a difficult patient safety problem for hospitals, and further research is required to develop cost-effective, generalizable strategies for their prevention.

OBJECTIVES Concern about falling is common among older hypertension patients and could impact decisions to intensify blood pressure therapy. Our aim was to determine whether intensive therapy targeting a systolic blood pressure (SBP) of 120 mm Hg is associated with greater changes in concern about falling when compared with standard therapy targeting an SBP of 140 mm Hg. DESIGN Subsample analysis of participants randomized to either intensive or standard therapy in the Systolic Blood Pressure Intervention Trial (SPRINT). SETTING Approximately 100 outpatient sites. PARTICIPANTS A total of 2313 enrollees in SPRINT; participants were all age 50 or older (mean = 69 y) and diagnosed with hypertension. MEASUREMENTS Concern about falling was described by the shortened version of the Falls Efficacy Scale International as measured at baseline, 6 months, 1 year, and annually thereafter. RESULTS Concern about falling showed a small but significant increase over time among all hypertension patients. No differences were noted, however, among those randomized to intensive vs standard therapy (P = .95). Among participants younger than 75 years, no increase in concern about falling over time was noted, but among participants aged 75 years and older, the mean falls self-efficacy score increased by .3 points per year (P

Shared medical appointments provided rural diabetic veterans and their primary care providers with a program that decreased wait times, improved glycemic control, and minimized cost.

Background Older adults recently discharged from the hospital are known to be at risk of functional decline and falls. This study evaluated the effect of a tailored education program provided in the hospital on older adult engagement in fall prevention strategies within 6 months after hospital discharge. Methods A process evaluation of a randomized controlled trial that aimed to improve older adult fall prevention behaviors after hospital discharge. Participants (n = 390) were aged 60 years and older with good cognitive function (greater than 7 of 10 Abbreviated Mental Test Score), discharged home from three hospital rehabilitation wards in Perth, Australia. The primary outcomes were engagement in fall prevention strategies, including assistance with daily activities, home modifications, and exercise. Data were analyzed using generalized linear modeling. Results There were 76.4% (n = 292) of participants who completed the final interview (n = 149 intervention, n = 143 control). There were no significant differences between groups in engagement in fall prevention strategies, including receiving instrumental activity of daily living (IADL) assistance (adjusted odds ratio [AOR] = 1.3 [95% confidence interval {CI} = 0.7-2.1]; P = .3), completion of home modifications (AOR = 1.2 [95% CI = 0.7-1.9]; P = .4), and exercise (AOR = 1.3 [95% CI = 0.7-2.2]; P = .3). There was a high proportion of unmet ADL needs within both groups, and levels of participant dependency remained higher at 6 months compared to baseline levels at admission. The proportion of all participants who engaged in exercise following hospital discharge increased by 30%; however, the mean duration of exercise reduced from 3 hours per week at baseline to 1 hour per week at 6-month follow-up (SD = 1.12 hours per week). Conclusion Tailored education did not increase older adult engagement in fall prevention strategies after hospital discharge compared to usual care. Further research is required to evaluate older adults' capacity to change their behaviors once they return home from hospital, which may enable a safer recovery of their independence. J Am Geriatr Soc 67:2274-2281, 2019.

BackgroundGait speed decline, an early marker of functional impairment, is a sensitive predictor of adverse health outcomes in older adults. The effect of potentially inappropriate medications, including drug-disease and drug-drug interactions, on gait speed decline is not well known.ObjectiveThe aim of this study was to determine if drug interactions impair functional status as measured by gait speed.MethodsThe sample included 2402 older adults with medication and gait speed data from the Health, Aging and Body Composition study. The independent variable was the frequency of drug-disease and/or drug-drug interactions at baseline and 3 additional years. The main outcome was a clinically meaningful gait speed decline of ≥0.1m/s the year following drug interaction assessment. Adjusted odds ratios and 95% confidence intervals (CIs) were calculated using multivariate generalized estimating equations for both the overall sample and a sample stratified by gait speed at time of drug interaction assessment.ResultsThe prevalence of drug-disease and drug-drug interactions ranged from 7.6 to 9.3 and 10.5 to 12.3%, respectively, with few participants (3.8-5.7%) having multiple drug interactions. At least 22% of participants had a gait speed decline of ≥0.1m/s annually. Drug interactions were not significantly associated with gait speed decline overall or in the stratified sample of fast walkers. There was some evidence, however, that drug interactions increased the risk of gait speed decline among those participants with slower gait speeds, though p values did not reach statistical significance (adjusted odds ratio 1.22; 95% CIs 0.96-1.56; p=0.11). Moreover, a marginally significant dose-response relationship was seen with multiple drug interactions and gait speed decline (adjusted odds ratio 1.40; 95% CIs 0.95-2.04; p=0.08).ConclusionsDrug interactions may increase the likelihood of gait speed decline among older adults with evidence of preexisting debility. Future studies should focus on frail elders with less physiological reserve who may be more susceptible to the harms associated with potentially inappropriate medications.

Background Older people are at high risk of falls after hospital discharge. The study aimed to evaluate the effect of providing individualized falls prevention education in addition to usual care on falls rates in older people after hospital discharge compared to providing a social intervention in addition to usual care. Methods A randomized clinical trial at three hospitals in Western Australia: participants followed for 6 months after discharge. Baseline and outcomes measured by assessors masked to group allocation. Participants: aged 60 years and over, admitted for rehabilitation. Eligibility included: cognitively able to undertake education (Abbreviated mental test score >7/10). Intervention: tailored education comprising patient video and workbook, structured discussion and goal setting led by trained therapist. Main outcomes: falls in the 6 months after discharge; proportion of participants sustaining one or more falls. Results There were 382 (194 intervention; 188 control) participants (mean age 77.7 [SD 8.7] years). There were 378 falls (fall rate per 1,000 patient-days, 5.9 intervention; 5.9 control) reported by 164 (42.9%) participants in the 6 months following hospital discharge; 188 (49.7%) of these falls were injurious. There were no significant differences in falls rates between intervention and control groups: (adjusted IRR, 1.09; 95% CI [0.78 to 1.52]) or the proportion of participants who fell once or more (adjusted OR, 1.37; 95% CI [0.90 to 2.07]). Conclusions Providing individualized falls prevention education prior to discharge did not reduce falls at home after discharge. Further research is warranted to investigate how to reduce falls during this high-risk transition period.

OBJECTIVES: To examine the association between central nervous system (CNS) medication dosage burden and risk of serious falls, including hip fractures, in individuals with a history of a recent fall. DESIGN: Nested case–control study. SETTING: Veterans Health Administration (VHA) Community Living Centers (CLCs). PARTICIPANTS: CLC residents aged 65 and older with a history of a fall or hip fracture in the year before a CLC admission between July 1, 2005, and June 30, 2009. Each case (n = 316) was matched to four controls (n = 1264) on age, sex, and length of stay. MEASUREMENTS: Outcomes were serious falls identified using International Classification of Diseases, Ninth Revision (ACD-9) or Current Procedural Terminology (CPT) E codes, diagnosis codes, or procedure codes associated with a VHA emergency department visit or hospitalization during the CLC stay. Bar code medication administration data were used to calculate CNS standardized daily doses (SDDs) for opioid and benzodiazepine receptor agonists, some antidepressants, antiepileptics, and antipsychotics received in the 6 days before the outcome date by dividing residents’ actual CNS daily doses by the minimum effective geriatric daily doses and adding the results. Multivariable conditional logistic regression models were used to evaluate the association between total CNS medication dosage burden, categorized as 0, 1 to 2, and 3 or more SDDs, and the outcome of recurrent serious falls. RESULTS: More cases (44.3%) than controls (35.8%) received 3.0 or more CNS SDDs (p = .02). Risk of serious falls was greater in residents with 3.0 or more SDDs than in those with 0 (adjusted odds ratio (aOR)=1.49, 95% confidence interval (CI)=1.03–2.14). Those with 1.0 to 2.9 SDDs had a risk similar to that of those with 0 SDDs (aOR=1.03, 95%CI=0.72–1.48). CONCLUSION: Nursing home residents with a history of a fall or hip fracture receiving 3.0 or more CNS SDDs were more likely to have a recurrent serious fall than those taking no CNS medications. Interventions targeting this vulnerable population may help reduce serious falls.

BACKGROUND: SPRINT found that treatment of systolic hypertension to a goal of

BACKGROUND: Up to 50% of patient falls in hospital result in injury. This study was conducted to determine whether injurious falls were associated with increased hospital length of stay (LOS), discharge to a place other than home, and in-hospital mortality. METHODS: A secondary data analysis from a prospective case-control study was conducted in 24 medical-surgical units in four hospitals in the United States. Patients who fell and sustained an injury were matched with at least one control patient who was on the same unit, at the same time, for a similar number of days on the unit at the time of the fall. Data were collected by viewing patients’ electronic health records, as well as the hospitals’ incident reporting systems. Logistic regression and Cox regression analyses were conducted. RESULTS: The 1,033 patients (mean age, 63.7 years; 510 males (49.4%)] who sustained an injurious fall were matched with 1,206 controls [mean age 61.6 years; 486 males (40.3%). Fallers were significantly more likely than controls to stay longer than 10 days in hospital (Odds Ratio [OR] 1.59, 95% confidence interval [CI] 1.46–1.74) and to be discharged to a place other than home ([OR 1.52, 95% CI 1.21–1.91). CONCLUSIONS: Compared to controls, hospital patients who sustained an injurious fall had longer LOS and were more likely discharged to a place other than home. These associations remained when controlling for patient-level confounders, suggesting that the fall altered trajectory was sustained towards these outcomes. Injurious falls were not significantly associated with increased risk of mortality. Falls are the most frequent adverse event reported in hospitals in the United Kingdom, and nearly one million patients fall in hospitals in the United States each year.(1, 2) Fall rates vary widely—ranging from 3.4 to more than 11 falls/1,000 patient days, partly on the basis of ward (unit) and hospital population studied.(3–6) Injurious fall rates in acute care settings range from 0.9 to 1.6 injurious falls/1,000 patient days, meaning that 26% to 60% of all in-hospital falls cause physical injury to patients.(7, 8) A large study that compared the prevalence of injurious falls in hospitals before and after the implementation in 2008 of the Centers for Medicare and Medicaid Services (CMS) nonpayment for injurious falls as a “never event,”(9) found that these injurious falls did not decrease over time.(10)

Background There is no gold standard to assess potential anticholinergic burden of medications.

Background: Although it is generally accepted that anticholinergic use may lead to a fall, results from studies assessing the association between anticholinergic use and falls are mixed. In addition, direct evidence of an association between use of anticholinergic medications and recurrent falls among community-dwelling elders is not available. Objective: To assess the association between anticholinergic use across multiple anticholinergic subclasses, including over-the-counter medications, and recurrent falls. Methods: This was a longitudinal analysis of 2948 participants, with data collected via interview at year 1 from the Health, Aging and Body Composition study and followed through year 7 (1997-2004). Self-reported use of anticholinergic medication was identified at years 1, 2, 3, 5, and 6 as defined by the list from the 2015 American Geriatrics Society Beers Criteria. Dosage and duration were also examined. The main outcome was recurrent falls (≥2) in an ensuing 12-month period from each medication data collection. Results: Using multivariable generalized estimating equation models, controlling for demographic, health status/behaviors, and access-to-care factors, a 34% increase in likelihood of recurrent falls in anticholinergic users (adjusted odds ratio = 1.34; 95% CI = 0.93-1.93) was observed, but the results were not statistically significant; similar results were found with higher doses and longer duration of use. Conclusion: Increased point estimates suggest an association of anticholinergic use with recurrent falls, but the associations did not reach statistical significance. Future studies are needed for more definitive evidence and to examine other measures of anticholinergic burden and associations with more intermediate adverse effects such as cognitive function.

Background and ObjectivesIn October 2008, the Centers for Medicare & Medicaid Services (CMS) stopped reimbursing hospitals for costs related to patient falls. This study aimed to examine whether the CMS no-pay policy influenced four fall prevention practices: bed alarms, sitters, room changes, and physical restraints.Research Design and MethodsUsing electronic medical record data collected from four hospitals between 2005 and 2010, this secondary observational analysis examined the associations between the CMS no-pay policy and nursing interventions and medical orders related to fall prevention. Multivariable generalized linear mixed models with logit link function and accommodation for matching was used to assess the associations between the CMS no-pay policy and nursing interventions and medical orders.ResultsAfter the CMS policy change, nurses were more likely to perform one or more fall-related interventions (adjusted odds ratio (aOR): 1.667; 95% confidence interval (CI): 1.097–2.534). Of the four prevention practices, the use of bed alarms (aOR: 2.343; 95% CI: 1.409–3.897) increased significantly after the CMS policy change.Discussion and ImplicationsThe CMS no-pay policy increased utilization of fall prevention strategies despite little evidence that these measures prevent falls.

U.S. blacks have a higher risk of death than whites. This varies by cause of death; stroke, kidney disease and some cancers are higher in blacks. We evaluated cause-specific mortality risk factors in Health ABC to determine whether specific risk factors are more important for these causes of death in blacks than whites. Potential risk factors included: demographics, smoking, body mass index, chronic disease, physical function, and cognition. Among N=3075 participants ages 70–79 (41.7% black), average follow-up was 11.9 years. Underlying cause of death was adjudicated by committee and categorized as: cardiovascular disease, stroke, cancer, dementia, pulmonary, infection, kidney, and other cause. Median survival (95% confidence interval) among black men, white men, black women, and white women was 10.6 (10.0, 11.5), 12.8 (12.4, 13.4), 13.4 (12.6, 14.6), and 15.3 (14.8, 16.2) years, respectively. Adjusting for age and sex, blacks had higher risks of dying from: any cause (hazard ratio=1.32 (1.21, 1.44)), kidney disease (HR=2.10 (1.17, 3.78)), cancer (HR=1.35 (1.13, 1.62)), and stroke (HR=1.32 (0.97, 1.75)). Higher all-cause mortality risk among blacks was attenuated by further adjustment for gait speed (black race adjusted HR=1.06 (0.95, 1.17)) or digit symbol substitution test (black race adjusted HR=1.01 (0.91, 1.12)), but minimally by prevalent diseases (black race adjusted HR=1.25 (1.13, 1.38)). Gait speed also attenuated higher risk of kidney and stroke deaths among blacks, but not cancer deaths. Factors contributing to poorer physical and cognitive function in similarly aged community-dwelling ambulatory black men and women could be targets to reduce disparity and excess mortality.

Introduction Older adults frequently fall after discharge from hospital. Older people may have low self-perceived risk of falls and poor knowledge about falls prevention. The primary aim of the study is to evaluate the effect of providing tailored falls prevention education in addition to usual care on falls rates in older people after discharge from hospital compared to providing a social intervention in addition to usual care. Methods and analyses The ‘Back to My Best’ study is a multisite, single blind, parallel-group randomised controlled trial with blinded outcome assessment and intention-to-treat analysis, adhering to CONSORT guidelines. Patients (n=390) (aged 60 years or older; score more than 7/10 on the Abbreviated Mental Test Score; discharged to community settings) from aged care rehabilitation wards in three hospitals will be recruited and randomly assigned to one of two groups. Participants allocated to the control group shall receive usual care plus a social visit. Participants allocated to the experimental group shall receive usual care and a falls prevention programme incorporating a video, workbook and individualised follow-up from an expert health professional to foster capability and motivation to engage in falls prevention strategies. The primary outcome is falls rates in the first 6 months after discharge, analysed using negative binomial regression with adjustment for participant9s length of observation in the study. Secondary outcomes are injurious falls rates, the proportion of people who become fallers, functional status and health-related quality of life. Healthcare resource use will be captured from four sources for 6 months after discharge. The study is powered to detect a 30% relative reduction in the rate of falls (negative binomial incidence ratio 0.70) for a control rate of 0.80 falls per person over 6 months. Ethics and dissemination Results will be presented in peer-reviewed journals and at conferences worldwide. This study is approved by hospital and university Human Research Ethics Committees. Trial registration number ACTRN12615000784516.

Medical and health policy decision makers require improved design and analysis methods for comparative effectiveness research (CER) trials. In CER trials, there may be limited information to guide initial design choices. In general settings, adaptive designs (ADs) have effectively overcome limits on initial information. However, CER trials have fundamental differences from standard clinical trials including population heterogeneity and a vaguer concept of a "minimum clinically meaningful difference".To explore the use of a particular form of ADs for comparing treatments within the CER trial context.We review the current state of clinical CER, identify areas of CER as particularly strong candidates for application of novel ADs, and illustrate potential usefulness of the designs and methods for two group comparisons.ADs can stabilize power. The designs ensure adequate power for true effects are at least at clinically significant preplanned effect size, or when variability is larger than expected. The designs allow for sample size savings when the true effect is larger or when variability is smaller than planned.ADs in CER have great potential to allow trials to successfully and efficiently make important comparisons.

Article-at-a-Glance Background Many hospitals classify inpatient falls as assisted (if a staff member is present to ease the patient's descent or break the fall) or unassisted for quality measurement purposes. Unassisted falls are more likely to result in injury, but there is limited research quantifying this effect or linking the assisted/unassisted classification to processes of care. A study was conducted to link the assisted/unassisted fall classification to both processes and outcomes of care, thereby demonstrating its suitability for use in quality measurement. This was only the second known published study to quantify the increased risk of injury associated with falling unassisted (versus assisted), and the first to estimate the effects of falling unassisted (versus assisted) on the likelihood of specific levels of injury. Methods A cross-sectional analysis of falls from all available 2011 data for 6,539 adult medical, surgical, and medical-surgical units in 1,464 general hospitals participating in the National Database of Nursing Quality Indicators® (NDNQI®) was performed. Results Participating units reported 166,883 falls (3.44 falls per 1,000 patient-days). Excluding repeat falls, 85.5% of falls were unassisted. Assisted and unassisted falls were associated with different processes and outcomes: Fallers for whom a fall prevention protocol was not in place were more likely to fall unassisted than those for whom one was in place (adjusted odds ratio [aOR], 1.39 [95% confidence interval (CI), 1.32, 1.46]), and unassisted falls were more likely to result in injury (aOR, 1.59 [95% CI, 1.52, 1.67]). Conclusions The assisted/unassisted fall classification is associated with care processes and patient outcomes, making it suitable for quality measurement. Unassisted falls are more likely than assisted falls to result in injury and should be considered a target for future prevention efforts.

OBJECTIVES: To compare falls and fall-related injuries that a fall evaluator or hospital incident report identified with injuries identified according to discharge International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for the same set of inpatient episodes of care. DESIGN: Prospective, descriptive study. SETTING: Sixteen adult general medical and surgical units in a major urban teaching hospital. PARTICIPANTS: All adults who sustained a fall with injury during a 5-year period (380 falls with injury). MEASUREMENTS: Falls that a fall evaluator or hospital incident report identified were classified according to their injury severity. Discharge abstracts provided diagnosis codes (ICD-9-CM) for the discharge, including fall-related injury codes. RESULTS: Three hundred forty-three inpatient falls with injury (90.2%) resulted in temporary harm to the individual; the remaining 37 falls (9.8%) resulted in more-serious harm. Sixteen of the 37 falls with injury extending hospitalization or resulting in death were identified using Centers for Medicare and Medicaid Services (CMS)-targeted injury code ranges combined with present-on-admission indicators. Of the 21 falls with injury that were not identified, nine (42.9%) lacked documentation of any injury, and seven (33.3%) identified other injuries outside the CMS-targeted injury code ranges. CONCLUSION: The CMS-targeted ICD-9-CM codes used to identify fall-related injuries in claims data do not always detect the most-serious falls. Language: en

Background Older blacks are less likely to receive guideline-recommended antilipemic therapy and achieve lipid control than older whites because, in part, of out-of-pocket costs. We sought to determine whether racial differences in antilipemic use and lipid control narrowed after Medicare Part D's implementation. Methods This before-after study included 1,091 black and white adults 70 years or older with coronary heart disease and/or diabetes mellitus from the Health Aging and Body Composition Study. Primary outcomes were antilipemic use and low-density lipoprotein cholesterol control. Key independent variables were race, time (pre–Part D vs post–Part D), and their interaction. Results Before Part D, fewer blacks than whites reported taking an antilipemic (32.70% vs 49.35%), and this difference was sustained after Part D (blacks 48.30% vs whites 64.57%). Multivariable generalized estimating equations confirmed no post–Part D change in racial differences in antilipemic use (adjusted ratio of the odds ratio 1.07, 95% CI 0.79-1.45). Compared with whites, more blacks had poor lipid control both before Part D (24.30% vs 12.36%, respectively) and after Part D (24.46% vs 13.72%, respectively), with no post–Part D change in racial differences in lipid control (adjusted ratio of the odds ratio 0.82, 95% CI 0.51-1.33). Conclusion Although antilipemic use increased after Medicare Part D for both races, this policy change was associated with a change neither in lipid control for either racial group nor in the racial differences in antilipemic use or lipid control.

Importance The appropriate treatment target for systolic blood pressure (SBP) in older patients with hypertension remains uncertain. Objective To evaluate the effects of intensive ( Design, Setting, and Participants A multicenter, randomized clinical trial of patients aged 75 years or older who participated in the Systolic Blood Pressure Intervention Trial (SPRINT). Recruitment began on October 20, 2010, and follow-up ended on August 20, 2015. Interventions Participants were randomized to an SBP target of less than 120 mm Hg (intensive treatment group, n = 1317) or an SBP target of less than 140 mm Hg (standard treatment group, n = 1319). Main Outcomes and Measures The primary cardiovascular disease outcome was a composite of nonfatal myocardial infarction, acute coronary syndrome not resulting in a myocardial infarction, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes. All-cause mortality was a secondary outcome. Results Among 2636 participants (mean age, 79.9 years; 37.9% women), 2510 (95.2%) provided complete follow-up data. At a median follow-up of 3.14 years, there was a significantly lower rate of the primary composite outcome (102 events in the intensive treatment group vs 148 events in the standard treatment group; hazard ratio [HR], 0.66 [95% CI, 0.51-0.85]) and all-cause mortality (73 deaths vs 107 deaths, respectively; HR, 0.67 [95% CI, 0.49-0.91]). The overall rate of serious adverse events was not different between treatment groups (48.4% in the intensive treatment group vs 48.3% in the standard treatment group; HR, 0.99 [95% CI, 0.89-1.11]). Absolute rates of hypotension were 2.4% in the intensive treatment group vs 1.4% in the standard treatment group (HR, 1.71 [95% CI, 0.97-3.09]), 3.0% vs 2.4%, respectively, for syncope (HR, 1.23 [95% CI, 0.76-2.00]), 4.0% vs 2.7% for electrolyte abnormalities (HR, 1.51 [95% CI, 0.99-2.33]), 5.5% vs 4.0% for acute kidney injury (HR, 1.41 [95% CI, 0.98-2.04]), and 4.9% vs 5.5% for injurious falls (HR, 0.91 [95% CI, 0.65-1.29]). Conclusions and Relevance Among ambulatory adults aged 75 years or older, treating to an SBP target of less than 120 mm Hg compared with an SBP target of less than 140 mm Hg resulted in significantly lower rates of fatal and nonfatal major cardiovascular events and death from any cause. Trial Registration clinicaltrials.gov Identifier:NCT01206062

Background: Few studies have compared the risk of recurrent falls across various antidepressant agents—using detailed dosage and duration data—among community-dwelling older adults, including those who have a history of a fall/fracture. Objective: To examine the association of antidepressant use with recurrent falls, including among those with a history of falls/fractures, in community-dwelling elders. Methods: This was a longitudinal analysis of 2948 participants with data collected via interview at year 1 from the Health, Aging and Body Composition study and followed through year 7 (1997-2004). Any antidepressant medication use was self-reported at years 1, 2, 3, 5, and 6 and further categorized as (1) selective serotonin reuptake inhibitors (SSRIs), (2) tricyclic antidepressants, and (3) others. Dosage and duration were examined. The outcome was recurrent falls (≥2) in the ensuing 12-month period following each medication data collection. Results: Using multivariable generalized estimating equations models, we observed a 48% greater likelihood of recurrent falls in antidepressant users compared with nonusers (adjusted odds ratio [AOR] = 1.48; 95% CI = 1.12-1.96). Increased likelihood was also found among those taking SSRIs (AOR = 1.62; 95% CI = 1.15-2.28), with short duration of use (AOR = 1.47; 95% CI = 1.04-2.00), and taking moderate dosages (AOR = 1.59; 95% CI = 1.15-2.18), all compared with no antidepressant use. Stratified analysis revealed an increased likelihood among users with a baseline history of falls/fractures compared with nonusers (AOR = 1.83; 95% CI = 1.28-2.63). Conclusion: Antidepressant use overall, SSRI use, short duration of use, and moderate dosage were associated with recurrent falls. Those with a history of falls/fractures also had an increased likelihood of recurrent falls.

Background Although it is plausible that nurse staffing is associated with use of physical restraints in hospitals, this has not been well established. This may be due to limitations in previous cross-sectional analyses lacking adequate control for unmeasured differences in patient-level variables among nursing units. Objective To conduct a longitudinal study, with units serving as their own control, examining whether nurse staffing relative to a unit’s long-term average is associated with restraint use. Design We analyzed 17 quarters of longitudinal data using mixed logistic regression, modeling quarterly odds of unit restraint use as a function of quarterly staffing relative to the unit’s average staffing across study quarters. Subjects 3101 medical, surgical, and medical-surgical units in US hospitals participating in the National Database of Nursing Quality Indicators during 2006–2010. Units had to report at least one quarter with restraint use and one quarter without. Main Measures We studied two nurse staffing variables: staffing level (total nursing hours per patient day) and nursing skill mix (proportion of nursing hours provided by RNs). Outcomes were any use of restraint, regardless of reason, and use of restraint for fall prevention. Key Results Nursing skill mix was inversely correlated with restraint use for fall prevention and for any reason. Compared to average quarters, odds of fall prevention restraint and of any restraint were respectively 16 % (95 % CI: 3–29 %) and 18 % (95 % CI: 8–29 %) higher for quarters with very low skill mix. Conclusions In this longitudinal study there was a strong negative correlation between nursing skill mix and physical restraint use. Ensuring that skill mix is consistently adequate should reduce use of restraint.

Objectives: To evaluate whether the use of angiotensin-converting enzyme (ACE) inhibitors and statins is associated with a lower risk of incident mobility limitation in older community dwelling adults. Design: Longitudinal cohort study. Setting: Health, Aging and Body Composition (Health ABC) study. Participants: Three thousand fifty-five participants who were well functioning at baseline (no mobility limitations). Measurements: Summated standardized daily doses (low, medium, high) and duration of ACE inhibitor and statin use were computed. Mobility limitation (two consecutive self-reports of having any difficulty walking one-quarter of a mile or climbing 10 steps without resting) was assessed every 6 months after baseline. Multivariable Cox proportional hazards analyses were conducted, adjusting for demographics, health status, and health behaviors. Results: At baseline, 15.2% used ACE inhibitors and 12.9% used statins; use of both was greater than 25% by Year 6. Over 6.5 years of follow-up, 49.8% had developed mobility limitation. In separate multivariable models, neither ACE inhibitor (multivariate hazard ratio (HR) = 0.95, 95% confidence interval (CI) = 0.82�1.09) nor statin use (multivariate HR = 1.02, 95% CI = 0.87�1.17) was associated with lower risk of mobility limitation. Similar findings were seen in analyses examining dose�response and duration�response relationships and a sensitivity analysis restricted to those with hypertension. Conclusion: ACE inhibitors and statins widely prescribed to treat hypertension and hypercholesterolemia, respectively, do not lower risk of mobility limitation, an important indicator of quality of life.

OBJECTIVES: To evaluate whether use of certain medications with potential urological effects is associated with development of incident urinary incontinence in community-resident older women. DESIGN: Longitudinal cohort study. SETTING: Pittsburgh, PA, and Memphis, TN. PARTICIPANTS: Nine hundred fifty-nine healthy black and white women aged 65 and older enrolled in the Health, Aging and Body Composition Study without baseline (Year 1) self-reported urinary incontinence. MEASUREMENTS: Use of alpha blockers, anticholinergics, central nervous system medications (opioids, benzodiazepines, antidepressants, antipsychotics), diuretics (thiazide, loop, potassium sparing), and estrogen (all dosage forms) was determined during Year 3 interviews. Self-reported incident (≥weekly) incontinence in during the previous 12 months was assessed at Year 4 interviews. RESULTS: Overall, 20.5% of these women reported incident incontinence at Year 4 (3 years from baseline). The most common medication used with potential urological activity was a thiazide diuretic (24.3%), followed by estrogen (22.2%); alpha blockers were the least commonly used (2.3%). Multivariable logistic regression analyses revealed that current users of alpha blockers (adjusted odds ratio (AOR)=4.98, 95% confidence interval (CI)=1.96–12.64) and estrogen (AOR=1.60, 95% CI=1.08–2.36) had a greater risk of urinary incontinence than nonusers. There was no greater risk (P>.05) of urinary incontinence with the current use of anticholinergics, central nervous system medications, or diuretics. No statistically significant race-by–medication use interactions were found (all P>.05). CONCLUSION: These results corroborate earlier reports that, in elderly women, use of alpha blockers or estrogens is associated with risk of self-reported incident urinary incontinence.

Objectives—To determine if sensory and motor nerve function was associated cross-sectionally with quadriceps strength or ankle dorsiflexion strength in an older community-based population. Design, Setting, Participants—Health, Aging, and Body Composition Study participants (N=2059; 50% men; 37% black, aged 73-82 years) in 2000-2001.

This article describes medical students' evaluation of a geriatric clerkship in postacute rehabilitative care settings. This was a cross-sectional study of fourth-year medical students who completed a mandatory 2-week rotation at a postacute care facility. Students were provided with three instructional methods: Web-based interactive learning modules; small-group sessions with geriatric faculty; and Geriatric Interdisciplinary Care Summary (GICS), a grid that students used to formulate comprehensive interdisciplinary care plans for their own patients. After the rotation, students evaluated the overall clerkship, patient care activities, and usefulness of the three instructional methods using a 5-point Likert scale (1=poor to 5=excellent) and listed their area of future specialty. Of 156 students who completed the rotation, 117 (75%) completed the evaluation. Thirty (26%) chose specialties providing chronic disease management such as family, internal medicine, and psychiatry; 34 (29%) chose specialties providing primarily procedural services such as surgery, radiology, anesthesiology, pathology, and radiation oncology. Students rated the usefulness of the GICS as good to very good (mean+/-standard deviation 3.3+/-1.0). Similarly, they rated overall clerkship as good to excellent (3.8+/-1.0). Analysis of variance revealed no significant group difference in any of the responses from students with the overall clerkship (F(112, 4)=1.7, P=.20). Students rated the geriatric clerkship favorably and found the multimodal instruction to be useful. Even for students whose career choice was not primary care, geriatrics was a good model for interdisciplinary care training and could serve as a model for other disciplines.

Purpose To evaluate whether CNS medication use in older adults was associated with a higher risk of future incident mobility limitation. Methods This 5-year longitudinal cohort study included 3055 participants from the health, aging and body composition (Health ABC) study who were well-functioning at baseline. CNS medication use (benzodiazepine and opioid receptor agonists, antipsychotics, and antidepressants) was determined yearly (except year 4) during in-home or in-clinic interviews. Summated standardized daily doses (low, medium, and high) and duration of CNS drug use were computed. Incident mobility limitation was operationalized as two consecutive self-reports of having any difficulty walking 1/4 mile or climbing 10 steps without resting every 6 months after baseline. Multivariable Cox proportional hazard analyses were conducted adjusting for demographics, health behaviors, health status, and common indications for CNS medications. Results Each year at least 13.9% of participants used a CNS medication. By year 6, overall 49% had developed incident mobility limitation. In multivariable models, CNS medication users compared to never users showed a higher risk for incident mobility limitation (adjusted hazard ratio (Adj. HR) 1.28; 95% confidence interval (CI) 1.12–1.47). Similar findings of increased risk were seen in analyses examining dose– and duration–response relationships. Conclusions CNS medication use is independently associated with an increased risk of future incident mobility limitation in community dwelling elderly. Further studies are needed to determine the impact of reducing CNS medication exposure on mobility problems. Copyright © 2009 John Wiley & Sons, Ltd.