Defining Safety in the Nursing Home Setting: Implications for Future Research

JAMDA 17 (2016) 473e481

JAMDA journal homepage: www.jamda.com

Special Article

Defining Safety in the Nursing Home Setting: Implications for Future Research Sandra F. Simmons PhD a, b, c, *, John F. Schnelle PhD a, b, c, Nila A. Sathe MA, MLIS d, e, Jason M. Slagle PhD f, David G. Stevenson PhD d, Maria E. Carlo MD, MPH c, g, Melissa L. McPheeters PhD, MPH d, e a

Division of Geriatrics, Department of Medicine, Vanderbilt University, Nashville, TN Center for Quality Aging, Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University, Nashville, TN Geriatric Research, Education and Clinical Center (GRECC), VA Tennessee Valley Healthcare System, Nashville, TN d Department of Health Policy, Vanderbilt University Medical Center, Nashville, TN e Vanderbilt Evidence-based Practice Center, Institute for Medicine and Public Health, Vanderbilt University Medical Center, Nashville, TN f Department of Anesthesiology, Center for Research and Innovation in Systems Safety (CRISS) Vanderbilt University Medical Center, Nashville, TN g Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University, Nashville, TN b c

a b s t r a c t Keywords: Nursing home long-term care post-acute care patient safety measurement

Currently, the Agency for Healthcare Research and Quality (AHRQ) Common Format for nursing homes (NHs) accommodates voluntary reporting for 4 adverse events: falls with injury, pressure ulcers, medication errors, and infections. In 2015, AHRQ funded a technical brief to describe the state of the science related to safety in the NH setting to inform a research agenda. Thirty-six recent systematic reviews evaluated NH safety-related interventions to address these 4 adverse events and reported mostly mixed evidence about effective approaches to ameliorate them. Furthermore, these 4 events are likely inadequate to capture safety issues that are unique to the NH setting and encompass other domains related to residents’ quality of care and quality of life. Future research needs include expanding our definition of safety in the NH setting, which differs considerably from that of hospitals, to include contributing factors to adverse events as well as more resident-centered care measures. Second, future research should reflect more rigorous implementation science to include objective measures of care processes related to adverse events, intervention fidelity, and staffing resources for intervention implementation to inform broader uptake of efficacious interventions. Weaknesses in implementation contribute to the current inconclusive and mixed evidence base as well as remaining questions about what outcomes are even achievable in the NH setting, given the complexity of most resident populations. Also related to implementation, future research should determine the effects of specific staffing models on care processes related to safety outcomes. Last, future efforts should explore the potential for safety issues in other care settings for older adults, most notably dementia care within assisted living. Ó 2016 AMDA e The Society for Post-Acute and Long-Term Care Medicine.

As in other health care settings, adverse events and resident safety issues may occur frequently in nursing homes (NHs). In 2014, The authors declare no conflicts of interest. This project was funded by the Agency for Healthcare Research and Quality (AHRQ contract number: HHSA290201500003I), US Department of Health and Human Services. We appreciate the input of our AHRQ Task Order Officer and AHRQ leadership and full review team throughout the project. The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by AHRQ or the US Department of Health and Human Services. * Address correspondence to Sandra F. Simmons, PhD, Vanderbilt University, School of Medicine, Center for Quality Aging, Division of Geriatrics, VA Medical Center, Geriatric Research Education & Clinical Center (GRECC), 2525 West End Avenue, Ste. 350, Nashville, TN 37203. E-mail address: [email protected] (S.F. Simmons). http://dx.doi.org/10.1016/j.jamda.2016.03.005 1525-8610/Ó 2016 AMDA e The Society for Post-Acute and Long-Term Care Medicine.

nationwide state surveys identified an average of 7.96 deficiencies in care per NH facility. Most commonly these were failures in infection control, environmental safety, food sanitation, quality of care, and unnecessary medication use. Although deficiencies do not necessarily represent safety lapses or adverse events, the average number of deficiencies per facility suggests the potential for harm to occur. Indeed, more than 20% of facilities had a deficiency denoted as actual harm or jeopardy. An estimated mean of 1.5 falls per NH bed per year occur in long-term care facilities, with 4% resulting in fracture and 11% in serious injuries such as lacerations and head trauma.1,2 Specific to short-stay skilled nursing facility (SNF) residents, 1 in 5 older adults admitted to an SNF after hospitalization experiences adverse events, and as many as 60% of these events may be preventable.3 As noted in

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the 2014 Office of the Inspector General report, Adverse Events in Skilled Nursing Facilities: National Incidence Among Medicare Beneficiaries, of the 10% of residents harmed by adverse events, half were readmitted to the hospital for treatment, resulting in $2.8 billion in Medicare spending.3 More than 90% of NHs nationwide have dually certified Medicare and Medicaid beds.4 Thus, the overwhelming majority of facilities provide care for both short-stay, who typically receive skilled nursing care, and long-stay residents. Although residents who receive skilled nursing care are much more likely to return home after rehabilitation, they are also susceptible to adverse events and other safety issues. One recent study reported that 33% of short-stay residents discharged home suffered an adverse medication-related event within 45 days of SNF discharge, and only 28% of this group remained living at home 90 days after SNF discharge.5,6 In addition, 10% experienced a hospital readmission within 30 days of SNF discharge.7 Based on these findings, new quality indicators are currently being developed by the Centers for Medicare and Medicaid Services (CMS) and others for short-stay residents discharged home related to hospital readmission rates, with the rationale that this measure reflects the quality of the SNF discharge process. Other new CMS quality indicators will measure rates of readmission to the hospital or emergency room from an SNF within 30 days due to evidence that many of these health care utilization events may be preventable. Based in part on these reports and recent CMS policy initiatives, which suggest that important safety issues need to be addressed in both short- and long-stay NH care environments, the Agency for Healthcare Research and Quality (AHRQ) commissioned the Vanderbilt University Evidence-based Practice Center in 2015 to develop a technical brief on patient safety in NHs to include both short- and long-stay resident populations. Formally, AHRQ defines safety as “a type of process or structure that reduces the probability of an adverse event,”8 with an adverse event defined as harm to a resident as a result of medical care or in a health care setting.3 This definition is fairly nonspecific, and in conjunction with variability in the literature, suggests that safety can be conceptualized narrowly in terms of specific adverse events, or more broadly to include a number of measures reflective of care quality. There is currently no standard acceptance in the clinical or research arenas about which approach is most appropriate for NHs. However, due to the purview established by AHRQ and the scope of a technical brief, we focused the overview of literature on a core set of NH safety measures currently in beta-testing mode within the AHRQ Patient Safety Organization Program Common Format.9 These core safety measures included falls with injury, pressure ulcers, medication errors, and infections. As this Common Format for NHs is in betatesting, it is not currently required but provides a framework in which one might conceptualize safety in this setting. We discuss the strengths and weaknesses of this approach in the technical brief.10 Our methods involved multiple steps, including the identification of relevant literature and future research needs. First, we summarized existing systematic reviews in the 4 foci of the Common Format (ie, falls with injury, pressure ulcers, medication errors, and infections) and identified gaps in the existing research science based on these reviews. Second, we made recommendations for future research related to ways in which a definition based on the current Common Format might be more appropriately expanded to encompass safety issues relevant to both short- and long-stay NH residents. Of note, there is overlap of the Common Format and the CMS quality monitoring system for NHs in that prevalence of falls, pressure ulcers, and a subset of infections are already routinely monitored in this national system (www.medicare.gov/nursinghomecompare). In addition, both falls and pressure ulcers represent 2 of the most common NH litigation complaints.11 However, additional quality metrics are also required by CMS for routine monitoring and public-reporting

but are not specified in the Common Format. These include incontinence, functional decline, antipsychotic medication use, and unintentional weight loss. Each of these clinical outcomes has the potential to lead to 1 or more adverse events defined within the Common Format and also meet the criteria within the broad AHRQ definition of safety. Therefore, we discuss the potential that the Common Format set of adverse events may be too narrow to adequately define safety in the NH setting and suggest that inclusion of additional domains may be more appropriate, and amenable to intervention. Congruent with this perspective, the National Quality Forum recently endorsed unintentional weight loss as a safety indicator for long-term care residents.12 Methods The goal of the larger AHRQ-funded technical brief10 on which this article is based was twofold: (1) to develop a research agenda on safety in the NH setting using the current literature as a starting point; and (2) to consider whether an existing paradigm for safety research, developed primarily in the hospital setting, would be appropriate to the NH setting. To accomplish these goals, we identified systematic reviews in each of the 4 safety areas defined within the Common Format to estimate the size of the literature, types of interventions evaluated, and study designs (as a crude measure of quality). We also gathered input from 7 key informants in the field and identified where there appeared to be gaps that might serve to inform a future research agenda. Because of the breadth of literature, we focused only on systematic reviews rather than primary studies. We report a general overview of the types of studies included in each review and the review’s area of focus. To supplement this information, we also conducted searches to determine the numbers of new studies that could potentially add to existing reviews. We searched the published literature (MEDLINE and the Cumulative Index of Nursing and Allied Health Literature [CINAHL]) from 2005 to 2015 for systematic reviews and studies that specifically evaluated interventions related to the 4 key safety areas identified by the current AHRQ Common Format. We also updated the searches used in the systematic reviews from the end search date forward to identify newly published literature. The literature search is described in more detail in the technical brief.10 Two investigators independently screened systematic reviews against predetermined inclusion criteria to identify reviews or studies of interventions addressing the 4 safety areas. Discrepancies between investigators were resolved via discussion or review by a senior investigator. We used the Risk of Bias in Systematic Reviews (ROBIS) tool13 to assess the overall risk of bias of each systematic review. The ROBIS tool is designed to evaluate the rigor of the design and conduct of a systematic review and assesses a review’s relevance, potential for bias in the study eligibility criteria, identification and selection of studies, data collection and study appraisal, and synthesis and findings. Results Summary of Available Systematic Reviews We identified 36 systematic reviews addressing interventions relevant to the 4 adverse events identified in the Common Format (ie, falls, pressure ulcers, medication errors, and infections). The reviews meeting our inclusion criteria may have addressed multiple outcomes including, but not necessarily limited to, the targeted adverse events of interest. Some reviews also broadly targeted older adults and may include only a small number of studies conducted in NHs. We included these reviews to provide a comprehensive representation of the literature potentially relevant to older adults.

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We rated 19 of the 36 identified reviews as having low risk of bias using the ROBIS tool. We summarize information reported in the reviews with low risk of bias in the following sections. Where possible, however, we delineate the number of NH-specific studies and NH participants within these studies evaluated in each systematic review. Conclusions related to intervention components and effectiveness are summarized as reported within the systematic reviews and not based on our own review of each individual study. Reviews across the 4 safety areas commented on the generally poor quality of the studies included in each, noting deficiencies such as high attrition, inadequate randomization methods, lack of blinding, small sample sizes, heterogeneous and poorly described interventions, limited follow-up, incomplete outcome reporting, and notably limited assessment of adverse effects. Interventions related to falls A wide range of interventions may be associated with falls prevention, including interventions to improve toileting assistance, delirium prevention, appropriate medication use, and physical restraint use. Thus, the reviews included here, which focus specifically on interventions to prevent falls, represent only a subset of potential studies on this topic. Table 1 shows the intervention components addressed in 14 systematic reviews.14e27 Among these 14 identified reviews, 8 were considered to have low risk of bias based on our ROBIS assessment.14,17,19,22e26 Three low risk of bias reviews assessed multiple interventions or multimodal approaches.14,17,24 One 2015 review included 13 randomized controlled trials (RCTs), all conducted in the NH setting (22,915 total participants).14 Interventions evaluated in the review included staff training, educational materials, health informatics tools for appropriate medication use, vitamin D supplementation, exercise programs, environmental modifications, and management of urinary incontinence. Outcomes included number of falls, number of fallers, and number of recurrent fallers. The review reported reductions in the numbers of falls and recurrent fallers associated with multicomponent interventions but no significant effects of single interventions or interventions not customized to fall risk. A 2012 Cochrane review included 60 RCTs, also with a diverse set of interventions implemented in NHs or hospitals.17 This review also examined number of falls and fallers, as well as fractures, complications and economic outcomes. Forty-three of the 60 studies included in this review were conducted in the NH setting (30,373 total

Table 1 Components of Intervention Studies Related to Falls Intervention Component

Estimated No. of Studies Including Component*

Exercise Hip protectors/protective aids Staff training/educational materials Vitamin D or calcium or fluoride supplementation or sunlight exposure Fall risk/safety risk assessment Environmental modification, including physical alerts Guidelines/treatment recommendations Medication review Multidisciplinary falls prevention team/coordinator Optometry Health informatics tools Sensory stimulation Restraint reduction Podiatry Incontinence care Audit and feedback Transition coordinator

22 20 19 13

*Studies could include more than 1 component.

12 7 6 6 4 2 2 2 2 1 1 1 1

475

participants). The review reported a reduction in falls associated with vitamin D supplementation and inconsistent evidence for the benefits associated with exercise programs in the NH. A 2010 review included 20 studies (24,943 participants), all conducted in the NH and evaluating multiple interventions including vitamin D supplementation, sunlight exposure, alendronate, exercise, and hip protectors.24 This review reported significant reductions in hip fracture risk associated with vitamin D supplementation and conflicting evidence for hip protectors. Staff education, risk assessment, sunlight exposure, and alendronate were not associated with significant fracture reductions; however, exercise was associated with a reduction in falls. Other reviews specifically examined a single category of intervention such as hip protectors,22,23,25 exercise,26 or environmental modification.19 Among the reviews assessing hip protectors, a 2014 Cochrane review included 19 studies, 14 of which were set in NHs (11,808 participants), and reported moderate-quality evidence for a small reduction in hip fracture risk and little effect on falls associated with hip protectors.25 Another 2007 review including only NH studies (4 studies; 1922 participants) reported a decrease in risk of fracture with hip protectors.22 In contrast, one 2005 review including 3 RCTs set in the NH (1188 participants), reported limited evidence for a reduction in hip fracture risk among residents using hip protectors, with mixed findings of benefit across studies and wide confidence intervals in analyses. The most common outcomes evaluated in these systematic reviews were the number and rate of fractures and the number and frequency of falls. Interventions evaluated in studies typically included multiple components, reflecting the multiple risk factors that contribute to falls. Across all systematic reviews, vitamin D supplementation and exercise appeared to have the strongest evidence for falls prevention, whereas evidence was mixed for protective aids. Reviews typically did not report positive effects of other approaches, such as staff education, environmental modification, and risk assessment. Interventions related to pressure ulcers We identified 8 systematic reviews addressing pressure ulcer prevention or treatment.28e35 Table 2 summarizes the intervention components addressed in studies across all 8 systematic reviews. We considered 3 of these 8 reviews to have low risk of bias.28,33,34 One 2014 Cochrane review with a low risk of bias focused on repositioning to prevent pressure ulcers and included 3 RCTs, 2 set in NHs (N participants not reported).28 The review found no strong evidence for the benefit of a 30-degree tilt compared with 90
and limited evidence for a specific effect of repositioning frequency. Importantly, however, the review notes that repositioning is a key component of pressure ulcer prevention and that “the lack of robust evaluations of repositioning frequency and position for pressure ulcer prevention mean that great uncertainty remains but it does not mean these interventions are ineffective since all comparisons are grossly underpowered.” Two other low risk of bias reviews, both published in 2013, were conducted by AHRQ evidence-based practice centers and addressed multiple interventions for pressure ulcer prevention34 and treatment.33 The prevention-focused review included roughly 20 comparative studies in the NH setting (N participants not reported) and reported moderate-quality evidence for a lower risk of pressure ulcers with advanced static support mattresses or overlays compared with standard mattresses in high-risk NH populations. The review noted limited evidence to support the use of other types of support surfaces (eg, low air loss mattresses) and insufficient evidence for interventions such as repositioning and cleansers in preventing pressure ulcers. The treatment-focused review included approximately 45 randomized or observational studies in NHs (N participants not reported) and noted moderate evidence for the effect of

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Table 2 Components of Intervention Studies Related to Pressure Ulcer Prevention and Treatment Intervention Component

Estimated No. of Studies Including Component*

Support surfaces (eg, overlays, specialized mattresses/beds) Wound dressings/topical wound treatments Repositioning Nutritional supplementation Risk assessment/documentation Staff education/training Guidelines/protocols External consultants Wheelchair cushions/pads/protective cushions Biologic agents/growth factors Skin champion Skin examinations Lotions/creams Incontinence management Multidisciplinary teams Laser Information technology Resident/family education Ambulation Hyperbaric oxygen Massage Forced air warming therapy Chemical debridement Vibration Dermal replacement Ultrasound

26 30 12 11 9 7 7 6 7 4 4 4 3 3 3 2 2 2 1 1 1 1 1 1 1 1

*Studies could include more than 1 component.

air-fluidized beds, nutritional supplements, radiant heat dressings, and electrical stimulation on wound improvement compared with placebo or other interventions. The review found limited evidence for the effects of alternating pressure mattresses, hydrocolloid dressings, light therapy, and platelet-derived growth factor on improved wound healing. Overall, these low risk of bias reviews reported moderate evidence for the treatment of pressure ulcers with specialized support surfaces and limited evidence for prevention interventions. Medication errors and adverse drug events We identified 11 systematic reviews related to medication errors and/or adverse drug events,36e45 7 of which we rated as low risk of bias.36,38,39,42,44e46 Table 3 summarizes the intervention components evaluated in all 11 systematic reviews. Four of the reviews with low risk of bias addressed multiple interventions, typically including medication review. One 2014 Cochrane review on polypharmacy

Table 3 Components of Intervention Studies Related to Medication Errors and Adverse Drug Events Intervention Component

Estimated No. of Studies Including Component*

Clinician/pharmacist education Pharmacist review of medications Information technology (CPOE, CDS) Academic detailing Multidisciplinary case conferences Interdisciplinary care (including clinical pharmacist) Clinician/multidisciplinary medication review or medication reconciliation Guidelines Transition coordination/documentation

19 13 7 5 4 3 4 3 3

CDS, clinical decision support; CPOE, computerized physician order entry. *Studies could include more than 1 component.

included 3 studies conducted in the NH setting (8320 participants).36 Most studies in the review evaluated multicomponent interventions (eg, education and medication review) intended to promote appropriate medication use, and the review noted some positive effects on appropriate prescribing but limited evidence overall. Another 2014 Cochrane review identified 2 trials (3636 participants) that focused on nonpharmacologic delirium prevention approaches in long-term care settings. Of the 2 studies, one was a small hydration-based intervention that found no effect, and the other was a large cluster-RCT of a computer system to identify medications that could trigger delirium and included pharmacist medication review. This study reported a large reduction in delirium based on NH staffereported assessments.45 A 2013 Cochrane review of interventions to optimize prescribing in NHs included 8 RCTs (7653 participants) that primarily addressed medication reviews and multidisciplinary case conferences.38 The review noted no evidence for an effect of any intervention on adverse drug events, mortality, or hospital admissions and some evidence for improved identification of medication-related problems. Some studies also reported improvements in appropriate prescribing. A 2011 review evaluated interventions to reduce potentially inappropriate use of medications in the NH and included 20 RCTs (approximately 5817 participants). Interventions included medication review, staff education, resident activity programs, and geriatric assessment and care teams.39 The review reported low-quality evidence for modest positive effects of education and pharmacist medication review on reducing inappropriate drug use and insufficient evidence for the remaining interventions addressed. Three reviews had more specific foci: one addressed medication review specifically, another evaluated interventions to improve antibiotic prescribing in long-term care settings, and a third assessed medication-related interventions during care transitions. One 2014 review evaluated 12 studies (10,861 participants) of pharmacist or multidisciplinary team medication reviews in NH residents to reduce mortality and hospitalization and reported no effects on these outcomes.44 A 2013 review included 4 RCTs (11,271 participants) addressing interventions to reduce inappropriate antibiotic use in NHs or improve adherence to prescribing guidelines.42 Interventions included the provision of guidelines, physician and/or nurse education, and feedback on prescribing patterns. The review reported limited evidence for improved guideline adherence associated with these interventions but little effect on the appropriate use of antibiotics. Finally, a 2012 review targeted studies evaluating medication reconciliation during transfers to and from long-term care settings and included 7 studies, 5 of which had an NH component (N participants not reported).46 The review reported some improvements in identifying medication discrepancies and some reductions in medication errors but noted weak evidence overall. Across the various types of interventions addressed (Table 3), the reviews identified generally weak evidence to support the effects of interventions on optimizing NH prescribing or improving related outcomes, such as mortality, hospitalizations, falls, delirium prevention, and other health outcomes. Medication review was associated with some positive outcomes, but reviews uniformly commented on significant limitations in the evidence base that precluded firm conclusions. Infections, including health careeassociated infection, urinary tract infection, and antibiotic stewardship We identified 3 systematic reviews related to infection prevention in the NH setting addressing interventions including oral care and staff education (Table 4).47e49 We rated only 1 of these 3 reviews as low risk of bias.47 This Cochrane review addressed methods to prevent the transmission of methicillin-resistant Staphylococcus aureus (MRSA) in NHs and included one cluster randomized trial of 32 sites

S.F. Simmons et al. / JAMDA 17 (2016) 473e481 Table 4 Components of Intervention Studies Related to Infection Prevention Intervention Component

Estimated No. of Studies Including Component*

Professional oral care (dental hygienist, nurse, or dentist) Oral cleaning tools/rinses and self-delivered oral care Staff education and training Vitamin/mineral or herbal supplements Antibiotic treatment Audit and feedback Guidelines Pneumococcal vaccine UV light Isolation or contact precautions Chlorhexidine bathing Swallowing and posture intervention Catheter drainage bag instillation (peroxide, vinegar)

7 7 4 3 2 1 1 1 1 1 1 1 1

*Studies could include more than 1 component.

(16 matched pairs; 1125 participants). The intervention included providing baseline data and infection control education to the staff as well as infection control audits and was not associated with a significant change in the rate of infections.47 It should be noted that more research has been conducted in the hospital setting related to infection prevention relative to the NH setting.50e58 However, little research has evaluated the extent to which efficacious hospital-based interventions to prevent infections can be generalized to the NH setting. Primary studies published since the publication of the included systematic reviews Since the publication of the most recent systematic reviews, we identified an estimated 90 comparative studies evaluating NH safetyerelated interventions in these 4 domains (Table 5). A reasonable number of RCTs in each of these areas suggests a growing evidence base of potentially high-quality studies that should be reviewed indepth to determine the most current evidence relevant to safety in these 4 domains. Implications of Findings for a Safety Research Agenda in the NH Setting Available systematic reviews report a number of interventions to address NH adverse events. The conclusions of these reviews are inconsistent. As such, available reviews did not provide strong evidence of clearly effective approaches for addressing pressure ulcers, falls, or infections in NH residents. Nor were there examples of evidence developed in the hospital setting and successfully disseminated to NH settings. In terms of medication errors, although more

Table 5 Estimated Numbers of New Intervention Studies Related to Nursing Home Safety Safety DomaineAdverse Event

RCT

Prospective or Pre-Post Studies With Comparison Groups

Falls Pressure ulcers Infections, including healthcare-associated infections, urinary tract infections, and antibiotic stewardship Medication errors and adverse drug events, including inappropriate medication use and polypharmacy

33 22 11

5 7 0

7

5

477

appropriate prescribing decisions have been shown to result from various consultative and educational interventions, there is little evidence that such interventions have a significant impact on the rate of medication errors specifically in the NH setting. One of the challenges in the NH care environment is that multiple contributing factors lay the groundwork for potential adverse events and often are (and should be) the actual target of interventions. An intervention directed toward incontinence, for example, may not only affect the frequency of urinary accidents but may also be associated with falls prevention. The complexity of evaluating a wide range of interventions with multiple potential outcomes means that key information about the resource requirements to implement the intervention are often not reported in published studies. The lack of specific information related to the staffing and management resources required to implement complex interventions directed toward multiple risk factors among NH residents represents a major barrier to replicating successful interventions for broader uptake. The key outcome of the larger technical brief was the identification by our research team and key informants of a list of research foci that we believe would represent a significant contribution to the field of safety research in the NH setting. The full technical brief10 outlines several future directions for research, some of which we briefly describe next. Recommendation for future research related to safety in the NH setting 1. Evaluate the definition of safety in the NH setting. One of the key findings from the technical brief process was that, although limiting our reviews to the 4 measures already identified in the AHRQ Common Format as safety issues provided focus to the effort, it is unlikely that this limited set of adverse events is adequate to fully capture the safety issues in the NH setting for both short- and long-stay residents. In part, this is likely because these 4 adverse events reflect safety issues initially identified and studied in the context of hospital-based (acute) care; thus, they may not adequately reflect the range of safety issues in the NH setting, where residents live for longer periods of time with a greater number of physical dependencies. The complexity of the NH population is reflected in research studies demonstrating that multiple factors contribute to pressure ulcers, falls, infections, and medication errors that may also lead to events that cause injury and/or adverse events outside of the 4 safety domains that were the focus of this article.17,59e69 Moreover, these conditions and associated adverse events also may be improved with interventions, which suggest that they meet the AHRQ safety definition of a “process or structure that prevents adverse events.” Thus, these domains, which are outside the Common Format, may themselves provide amenable targets for intervention. Potential domains that meet these criteria include unintentional weight loss, dehydration; functional activities of daily living (ADL) decline, fecal and urinary incontinence, including constipation; depressive symptoms; moderate to severe pain; influenza vaccine, pneumococcal vaccine; physical restraints, catheter use, antipsychotic medication use, and polypharmacy.17,36,39,70e73 One primary conclusion of the technical brief was that more work needs to be done to assess the degree to which these contributing factors should, themselves, be defined as safety outcomes. Of note, it may be impossible to mitigate or avoid some factors that contribute to adverse outcomes in the NH setting, particularly for some segments of the population, such as severe cognitive impairment associated with ADL decline. Furthermore, dementia, which is common in NHs, is a risk factor for many types of adverse events, but is typically not considered a safety issue on its own. It also should be mentioned that there are currently significant efforts under way to reduce hospital readmissions and emergency

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room visits for different segments of the NH population (eg, SNF, residents discharged from SNF, long-stay residents) based on evidence that at least some readmissions are preventable and, hence, may reflect safety issues in the NH setting. Consequently, CMS will soon publicly report NH quality measures related to hospital readmissions, which will likely facilitate further quality improvement efforts in this area. Thus, these measures should be incorporated into a broader definition of NH safety for provider and consumer organizations as well as research agencies, such as AHRQ. 2. Encourage rigorous implementation research specific to NH safety. Many studies in this field, to date, have not included standardized, independent measures of safety outcomes beyond those self-reported by NH staff. In addition, objective measures related to the specific care processes thought to be related to those safety outcomes are also lacking in most studies, as are details about the staffing resources (number, time, training, equipment) necessary to consistently implement the intervention. There is also a dearth of data related to the information systems, and regulatory and payment characteristics that may affect day-to-day implementation and maintenance of interventions. Because these components are so often lacking in the literature, it is difficult to determine the extent to which mixed results in prior systematic reviews for various outcomes are attributable to a lack of an intervention effect, lack of intervention fidelity, lack of resources to support the consistent implementation of the intervention, or some combination of all of these factors. It is noteworthy that many of these same implementation challenges were discussed in a recent AHRQsponsored report on nonpharmacological interventions for behavioral disturbance in long-term care settings.74 These weaknesses in implementation contribute to the current inconclusive and mixed evidence base and remaining questions about staffing resource requirements necessary to improve both clinical and safety outcomes as well as what outcomes are even achievable in the NH setting. These are interrelated, important issues that should be addressed in future studies. 3. Develop consensus related to achievable outcomes in the NH setting. Specific outcome performance standards (eg, absolute rather than relative performance) for acceptable quality of care and safety in NHs are currently absent, and this likely impedes the uptake of interventions with demonstrated effectiveness. Limited “natural history” evidence informs expected levels of different safety outcomes absent intervention, given that some degree of decline and associated clinical events will likely occur in this vulnerable and complex population. It is possible that NHs could more confidently adopt evidence-based care practices with more realistic targets for achievable outcomes. One way to identify performance standards is to actively develop consensus among experts in the field. Another approach is to encourage the application of rigorous implementation science to help identify what is achievable under controlled conditions, and, in this context, describe fully the resources and circumstances necessary to achieve those outcomes. Finally, implementation research also could provide important clinical information about the resident characteristics that may modify the effectiveness of an intervention (ie, how do we identify which residents will benefit the most from a given intervention?). Specific research questions that should be addressed in future studies include the following:  What are the maximum achievable outcomes (eg, fall or pressure ulcer incidence rate reduction) when specific care processes thought to be related to those outcomes are implemented with high fidelity?

 What are the resources required to consistently implement the intervention to all residents in need within a given facility (eg, number of staff, training, and equipment)?  What resident characteristics modify intervention effectiveness such that clinically meaningful criteria can be used to target interventions, especially in the context of limited staffing resources? 4. Rigorously study the role of staffing to achieve safe NH environments. In contrast to hospitals, NHs rely heavily on nonlicensed personnel (eg, nurse aides) who are responsible for most laborintensive and nonclinical ADL care (eg, helping residents get in/ out of bed, dressing, bathing, feeding, toileting, oral care, walking assistance) delivered to residents daily over a prolonged period of time. Also in contrast to hospitals, NHs rely more on licensed practical nurses or licensed vocational nurses as opposed to registered nurses, which may have implications for specific adverse events such as medication errors as well as overall clinical management. A mixed body of research has explicitly explored the association of staffing levels and quality-of-care issues that may contribute to safety, with most studies reporting positive associations (ie, higher staffing associated with better care quality), although systematic and narrative reviews have identified substantial variation in the study methods and measurement of staffing interventions, which contributes to mixed results.75e79 Staffing data have long been submitted by NHs as part of the federal regulatory process. The largest and most standardized database that currently includes this information is perhaps the 5-star NH rating system, which catalogs staffing (overall and by type), survey deficiency, and quality outcome data for all NHs in the United States on a routine basis using a standardized reporting format (www. medicare.gov/nursinghomecompare). Data from these facility selfreports suggest positive associations between total staffing (ie, licensed nurses plus nurse aides), survey deficiencies, 30-day hospital readmissions from an SNF, and successful community discharge from an SNF.80e82 However, the mechanism (ie, specific care processes) through which staffing may be affecting care quality in these 5-star reports is unclear. Other research has demonstrated that lower staffing levels are significantly related to omissions in care in both the hospital and NH care settings.82e87 Care omissions are typically defined as staff assistance with ADLs, which is expected to occur daily or multiple times per day but that is not adequately provided, either in terms of frequency and/or timeliness of care delivery. Many aspects of daily ADL care for NH residents are relevant to the risk factors for pressure ulcers, falls, and upper respiratory infection (eg, incontinence care, repositioning, mobility assistance, oral care). If daily care in these areas does not occur in a consistent, timely manner due to low overall staffing levels or other factors, it is unlikely that any safety intervention targeted toward these adverse outcomes will be effective. Future studies should be conducted to determine the effects of specific staffing models on objective measures of care processes thought to be related to safety outcomes, including care omissions. Concurrently, effectiveness studies should report details about staffing that can be used to assess this potential modifier of effectiveness.88e90 An increased focus on implementation in the evaluation of NH interventions could provide a basis for understanding the role of staffing models and would, in fact, provide more nuanced information about the type(s) of staffing that affect outcomes. Many NHs nationwide currently report total staffing levels that are consistent with expert consensus recommendations (www.medicare.gov/nursinghomecompare). However, staffing levels and types of staff still vary significantly among facilities, with inconsistent evidence to suggest that a particular model is optimal for improving quality and safety.75,91 A potential reason for the current variability in staffing levels is the absence of reliable and empirically

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established models that describe an optimal level and mix of staffing resources based on resident care needs. Research questions that should be addressed in future studies include the following:  What are the staff-time requirements and type(s) of staff required to consistently implement interventions known to prevent adverse events?  Given staff-time requirements and staffing skill mix, are there specific staffing models that are more efficient and effective than others in practice for preventing adverse events?  How can labor resource data be converted into an information system useful for planning the number and skill mix of staff necessary to prevent adverse events in a given facility based on resident care needs? 5. Data accuracy for adverse event and safety reporting. It is important to note that NHs currently report pressure ulcer and fall prevalence data, as well as some data related to infections, on a quarterly basis to CMS which, in turn, uses this information to publicly rate NHs using a 5-star quality system. There can be both financial and public relations implications of these ratings, which may create an inherent incentive for biased reporting of these data by NHs. To date, we are unaware of systematic internal auditing programs used by NHs to ensure accurate reporting of these safety outcomes. Outside of the federal and state inspection process and recent targeted chart review protocols used in Office of the Inspector General studies,3 most research to date has relied solely on self-reported information from NH facilities. Because discrepancies have been noted between self-reported and externally collected data in NHs, validation research as well as direct observation studies would be informative.3,84,92,93 In particular, due to questions that have arisen about the accuracy of self-reported staffing information that is part of the current 5-star reporting systems, staffing data submitted to CMS will soon be based on NH payroll data in lieu of facility self-report. As an example of changes in practice that may improve the accuracy of available data, CMS has now instructed survey staff to increase their audits during the survey process.94,95 Research questions to address in future studies include the following:  What auditing approaches are most effective for verifying the accuracy of adverse event reporting in NHs?  Does the effectiveness of such auditing differ based on the frequency of the audits?  What are the most accurate information sources to identify safety issues in the NH? 6. Safety issues in other care settings: Assisted-living facilities and dementia care within assisted-living facilities. The technical brief was focused on NHs, to include SNFs, but there was interest on the part of both AHRQ and our key informants to identify other longterm care settings serving older adults in which there may be similar safety concerns. Historically, individuals with multiple ADLs and cognitive impairments who required long-term care were typically served in an NH care environment. However, residential care in assisted living facilities (ALFs) now represents not only the fastest growing segment of older adult congregate living, but ALFs also house increasing numbers of individuals with multiple ADLs and cognitive impairments.96,97 Some state-level regulations govern ALF care, but these regulations vary by state and are generally much less restrictive than those for NHs. In particular, the significant growth in dementia care services within ALFs makes this segment of the ALF population similar to those with dementia in NHs in terms of their daily care needs.97,98 This suggests that safety issues, at least for those with dementia in the ALF care setting, may

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be comparable to safety issues for those with dementia in the NH setting. One of the biggest challenges in assessing resident safety in ALFs is the lack of standardized quality or safety data. Thus, the extent of care quality and/or safety problems in this care setting is largely unknown, with only a few studies examining ALF care quality.97e100 Future research in this area is warranted for multiple reasons. First, the number of ALFs is growing, with an estimated 36,000 facilities serving more than 1 million older adults nationwide.96 A recent nationwide survey of 31,100 ALFs revealed dementia as one of the most prevalent chronic conditions.97 At least partially due to the prevalence of dementia, 74% of ALF residents require caregiver assistance with 1 or more ADLs, such as bathing (72%), dressing (52%), and toileting (36%).97 Moreover, a longitudinal study showed that ALF residents and long-stay NH residents both experienced significant and comparable decline in their ability to independently perform ADLs.99 Functional decline is a quality indicator for both short- and long-stay NH residents, and evidence suggests that optimal care can prevent decline.90 Thus, safety issues related to functional decline may be similar in both the NH and ALF care settings. It is also likely that measures related to person-centered care and quality of life are equally applicable to both care settings. One Key Informant, who represented the ALF industry, shared the opinion that resident care needs are increasing in this population and current ALF staffing, both in terms of number and skill set, may be inadequate to meet future needs. Some of the safety concerns raised by key informants included medication errors, at least partially due to the skill set of the staff responsible for medication management in ALFs (eg, use of medication aides as opposed to licensed nurses), falls, and accurate assessments of clinical conditions (eg, delirium, dehydration, depression) in the absence of licensed nurses with this skill set to support routine assessment and timely treatment. A recent national report of staffing data in ALFs showed that total staffing (licensed nurses and nurse aides) averaged 2.79 hours per resident per day among facilities that did not primarily serve those with dementia and 3.62 hours per resident per day among facilities that did primarily serve those with dementia.101 Last, unlike NHs, there is currently no national or standardized system for reporting adverse events or safety issues in the ALF setting. Conclusions Current discourse about safety and adverse events in NHs is largely based on the study of patient safety in the hospital. The 4 areas currently identified by the AHRQ Common Format for measuring safety in NHs (falls with injury, pressure ulcers, medication errors, and infections) are taken directly from hospital-based concerns. As described here, these 4 areas alone are likely inadequate to capture the breadth of safety concerns in the NH setting for both short- and longstay resident populations. NHs differ from hospitals in many ways, including resident functional status and the complexity of their daily care needs as well as the type of staff providing care. A large and growing body of literature related to NH safety exists. In a number of areas that have existing systematic reviews, enough recent studies are available that new systematic reviews may be warranted. In terms of primary research, we have presented recommendations for future research to improve our knowledge of safety issues, and how to address them, in the NH setting. These recommendations should be considered by the research community and funding agencies as they set priorities for future research on this important topic. References 1. Rubenstein LZ, Josephson KR, Robbins AS. Falls in the nursing home. Ann Intern Med 1994;121:442e451.

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