Advancing clinical trials in nursing homes: A proposed roadmap to success.

An effective clinical research effort in nursing homes to address prevention and treatment of COVID-19 faced overwhelming challenges. Under the Health Care Systems Research Network-Older Americans Independence Centers AGING Initiative, a multidisciplinary Stakeholder Advisory Panel was convened to develop recommendations to improve the capability of the clinical research enterprise in US nursing homes. The Panel considered the nursing home as a setting for clinical trials, reviewed the current state of clinical trials in nursing homes, and ultimately developed recommendations for the establishment of a nursing home clinical trials research network that would be centrally supported and administered. This report summarizes the Panel's recommendations, which were developed in alignment with the following core principles: build on available research infrastructure where appropriate; leverage existing productive partnerships of researchers with groups of nursing homes and nursing home corporations; encompass both efficacy and effectiveness clinical trials; be responsive to a broad range of stakeholders including nursing home residents and their care partners; be relevant to an expansive range of clinical and health care delivery research questions; be able to pivot as necessary to changing research priorities and circumstances; create a pathway for industry-sponsored research as appropriate; invest in strategies to increase diversity in study populations and the research workforce; and foster the development of the next generation of nursing home researchers.

Residual Disability, Mortality, and Nursing Home Placement After Hip Fracture Over 2 Decades.

OBJECTIVE: To examine trends in 12-month postfracture residual disability, nursing home placement, and mortality among patients with a hip fracture between 1990 and 2011. DESIGN: Secondary analysis of 12-month outcomes from 3 cohort studies and control arms of 2 randomized controlled trials. SETTING: Original studies were conducted as part of the Baltimore Hip Studies (BHS). PARTICIPANTS: Community-dwelling patients ≥65 years of age hospitalized for surgical repair of a nonpathologic hip fracture (N=988). MAIN OUTCOME MEASURES: Twelve-month residual disability, mortality, and nursing home residency were examined in case-mix adjusted models by sex and study. Residual disability was calculated by subtracting prefracture scores of Lower Extremity Physical Activities of Daily Living from scores at 12 months postfracture. We also examined the proportion of individuals with a 12-month score higher than their prefracture score (residual disability>0). RESULTS: Only small improvements were seen in residual disability between 1990 and 2011. No significant differences were seen for men between BHS2 (enrollment 1990-1991; mean residual disability=3.1 activities; 95% confidence interval [CI], 2.16-4.10) and BHS7 (enrollment 2006-2011; mean=3.1 activities; 95% CI, 2.41-3.82). In women, residual disability significantly improved from BHS2 (mean=3.5 activities; 95% CI, 2.95-3.99) to BHS3 (enrollment 1992-1995; mean=2.7 activities; 95% CI, 2.01-3.30) with no significant improvements in later studies. After adjustment, a substantial proportion (91% of men and 79% of women) had a negative outcome (residual disability, died, or nursing home residence at 12 months) in the most recently completed study (BHS7). CONCLUSIONS: Over 2 decades, patients undergoing usual care post-hip fracture still had substantial residual disability. Additional clinical and research efforts are needed to determine how to improve hip fracture treatment, rehabilitation, and subsequent outcomes.

A comparison of outcomes between Canada and the United States in patients recovering from hip fracture repair: secondary analysis of the FOCUS trial.

OBJECTIVE: To determine if adjusted mortality, walking ability or return home differed after hip fracture surgery between Canada and the USA. DESIGN: Secondary analysis of the Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS) trial data. SETTING: Data were collected from 47 American and Canadian hospitals. PARTICIPANTS: Overall, 2016 subjects with a hip fracture (USA = 1222 (60.6%); Canada = 794 (39.4%)) were randomized to a liberal or restrictive transfusion strategy. Subjects were 50 years and older, with cardiovascular disease and/or risk factors and hemoglobin <100 g/L within 3 days post-surgery. The average age was 82 years and 1527(76%) subjects were females. INTERVENTION: Demographics, health status and health services data were collected up to 60 days post-surgery and mortality to a median of 3 years post-surgery. MAIN OUTCOMES: Mortality, inability to walk and return home. RESULTS: US subjects had higher adjusted mortality than Canadians at 30 days (odds ratio = 1.78; 95% confidence interval: 1.09-2.90), 60 days (1.53; 1.02-2.29) and up to 3 years (hazard ratio = 1.25; 1.07-1.45). There were no differences in adjusted outcomes for walking ability or return home at 30 or 60 days post-surgery. Median hospital length of stay was longer (P < 0.0001) in Canada (9 days; interquartile range: 5-18 days) than the US (3 days; 2-5 days). US subjects (52.9%) were more likely than Canadians (16.8%) to be discharged to nursing homes for rehabilitation (P < 0.001). CONCLUSIONS: Adjusted survival favored Canadians post hip fracture while walking ability and return home were not different between countries. The reason(s) for mortality differences warrant further investigation.

Predictors of mobility status one year post hip fracture among community-dwelling older adults prior to fracture: A prospective cohort study.

BACKGROUND: Orthopedists and other clinicians assess recovery potential of hip fracture patients at 2 months post-fracture for care planning. It is unclear if examining physical performance (e.g., balance, gait speed, chair stand) during this follow-up visit can identify individuals at a risk of poor functional recovery, especially mobility, beyond available information from medical records and self-report. METHODS: Data came from 162 patients with hip fracture enrolled in the Baltimore Hip Studies-7th cohort. Predictors of mobility status (ability to walk 1 block at 12 months post-fracture) were the Short Physical Performance Battery (SPPB) comprising balance, walking and chair rise tasks at 2 months; baseline medical chart information (sex, age, American Society of Anesthesiologist physical status rating, type of fracture and surgery, and comorbidities); and self-reported information about the physical function (ability to walk 10 feet and 1 block at pre-fracture and at 2 months post-fracture). Prediction models of 12-month mobility status were built using two methods: (1) logistic regression with least absolute shrinkage and selection operator (LASSO) regularization, and (2) classification and regression trees (CART). Area under ROC curves (AUROC) assessed discrimination. RESULTS: The participants had a median age of 82 years, and 49.3% (n = 80) were men. Two-month SPPB and gait speed were selected as predictors of 12-month mobility by both methods. Compared with an analytic model with medical chart and self-reported information, the model that additionally included physical performance measures had significantly better discrimination for 12-month mobility (AUROC 0.82 vs. 0.88, p = 0.004). CONCLUSION: Assessing SPPB and gait speed at 2 months after a hip fracture in addition to information from medical records and self-report significantly improves prediction of 12-month mobility. This finding has important implications in providing tailored clinical care to patients at a greater risk of being functionally dependent who would not otherwise be identified using regularly measured clinical markers.

Stakeholders' views on priorities essential for establishing a supportive environment for clinical trials in nursing homes.

BACKGROUND: The U.S. clinical research enterprise in nursing homes was unprepared to mount clinical trials in nursing homes to address urgent questions relevant to prevention and treatment during the COVID-19 pandemic. We identify priorities essential for establishing a supportive environment for future clinical trials in nursing homes. METHODS: Two cross-sectional online questionnaires were administered between January and February 2021. One was administered to nursing home providers, researchers, and policymakers; respondents rated the importance of attributes of researchers, facilities, leaders and staff for conducting clinical trials in nursing homes. Because importance may depend on trial type, respondents rated each attribute for efficacy trials (testing an intervention in ideal circumstances) and effectiveness trials (testing an intervention in "real world" circumstances). We calculated the attribute rating means and standard deviations, and used content analysis to characterize open-ended responses. The second questionnaire for resident family members and advocates included open-ended questions about nursing home research, and factors influencing willingness to participate. RESULTS: The attributes rated as most essential for conducting efficacy and effectiveness trials in nursing homes are research team attributes, that is, that researchers recognize regulatory constraints; understand and adapt to nursing home workflow; and work collaboratively with nursing home leaders to identify priorities. Resident and facility diversity emerged as essential for effectiveness trials; important dimensions included resident race, ethnicity and income, as well as nursing home urban/rural location, quality ratings, geography, staffing ratios, size, and profit status. Caregivers and resident advocates stressed the importance of communication among participants, researchers, and nursing home leadership and staff at all stages of a trial. CONCLUSION: Developing a robust U.S. clinical research enterprise capable of efficiently mounting future clinical trials in nursing homes will require a reimagining of the relationships that exist between researchers, facilities, nursing home leaders, and residents, with a research infrastructure specifically focused on supporting and fostering these connections.

Long-term sex differences in all-cause and infection-specific mortality post hip fracture.

BACKGROUND: Mortality rates among men are double that of women in the first 2 years after hip fracture and may be related to more infections. Research has only examined differences in short-term mortality after hip fracture. Thus, the objective was to determine if long-term all-cause mortality and infection-specific mortality rates are higher in men compared to women. METHODS: Data come from a prospective cohort study (Baltimore Hip Studies 7th [BHS-7]) with up to 10.2 years of follow-up (2006-2018). The participants were selected from eight acute care hospitals in the 25-hospital BHS network. Enrolled women were frequency-matched (1:1) to men on timing of admission for hip fracture that yielded an analytic sample size of 300 participants (155 women, 145 men). Associations between sex and mortality were analyzed using Cox proportional hazard models and cause-specific Cox models adjusted for age, cognition, body mass index, pre-fracture lower extremity activities of daily living limitation, depressive symptoms, and comorbidity. RESULTS: Participants had a mean age of 80 years, 48% (n = 145) were men and the median follow-up was 4.9 (interquartile range = 2.3-8.7) years. Over the follow-up period after hospital admission for hip fracture, 237 (79.0%) participants died of all causes (132 men and 105 women) and 38 (12.7%) died of infection-specific causes (25 men and 13 women). Men had significantly higher rates of all-cause mortality [hazard ratio (HR) = 2.31(95% confidence interval [CI] 2.02-2.59)] and infection-specific mortality (HR = 4.43, CI 2.07-9.51) compared to women. CONCLUSIONS: Men had a two-fold higher rate of all-cause mortality and four-fold higher rate of infection-specific mortality compared to women over a follow-up period of up to 10.2 years. Findings suggest that interventions to prevent and treat infections, tailored by sex, may be needed to narrow significant differences in long-term mortality rates between men and women after hip fracture.

Differential misclassification of cognitive impairment by sex among hip fracture patients.

BACKGROUND: Males have worse outcomes after hip fracture than female counterparts. Cognitive impairment (CI) also increases the risk of poor recovery from hip fracture; however, CI is under-recognized. Patient sex may contribute to this under-recognition through differential misclassification. The objective of this study was to measure under-recognition and differential misclassification of CI by patient sex. METHODS: A cross-sectional analysis of baseline data from an observational cohort study of community-dwelling hip fracture patients aged 65 and older (n = 339; females = 171, males = 168) recruited from eight hospitals in the greater Baltimore, MD area within 15 days of hospitalization for surgical repair with cognitive testing within 22 days of admission. Indication of Alzheimer's disease or related dementias and/or delirium as a postoperative complication in the medical record was considered evidence of documented CI. Observed CI was measured with the Modified Mini-Mental State Examination (3MS, ≤78). Source of cognitive impairment identification (SCI) was defined as: "3MS Only," "Hospital Record Only," "Both," "No CI" was compared between males and females using logistic regression. RESULTS: Males had more comorbidities and worse physical status upon admission, but otherwise had similar hospital experiences. SCI distribution was 12.7% "3MS Only" (n = 42), 11.5% "Hospital Record Only" (n = 38), 9.4% "Both" (n = 31), and "No CI" (n = 219). Males were more likely to be identified with CI using the "3MS Only" and "Both," and females were more likely to have no indication of CI. CONCLUSION: There were sex differences in the documentation of CI versus observed impairment. Males had more CI using direct testing. This may be contributing to sex differences in recovery outcomes after hip fracture. Results support the implementation of cognitive testing in hip fracture patients to reduce the impact of differential misclassification by patient sex.

Advancing Clinical Trials in Nursing Homes: A Proposed Roadmap to Success.

An effective clinical research effort in nursing homes to address prevention and treatment of COVID-19 faced overwhelming challenges. Under the Health Care Systems Research Network-Older Americans Independence Centers AGING Initiative, a multidisciplinary Stakeholder Advisory Panel was convened to develop recommendations to improve the capability of the clinical research enterprise in US nursing homes. The Panel considered the nursing home as a setting for clinical trials, reviewed the current state of clinical trials in nursing homes, and ultimately developed recommendations for the establishment of a nursing home clinical trials research network that would be centrally supported and administered. This report summarizes the Panel's recommendations, which were developed in alignment with the following core principles: build on available research infrastructure where appropriate; leverage existing productive partnerships of researchers with groups of nursing homes and nursing home corporations; encompass both efficacy and effectiveness clinical trials; be responsive to a broad range of stakeholders including nursing home residents and their care partners; be relevant to an expansive range of clinical and health care delivery research questions; be able to pivot as necessary to changing research priorities and circumstances; create a pathway for industry-sponsored research as appropriate; invest in strategies to increase diversity in study populations and the research workforce; and foster the development of the next generation of nursing home researchers.

Advancing Clinical Trials in Nursing Homes: A Proposed Roadmap to Success.

An effective clinical research effort in nursing homes to address prevention and treatment of COVID-19 faced overwhelming challenges. Under the Health Care Systems Research Network-Older Americans Independence Centers AGING Initiative, a multidisciplinary Stakeholder Advisory Panel was convened to develop recommendations to improve the capability of the clinical research enterprise in US nursing homes. The Panel considered the nursing home as a setting for clinical trials, reviewed the current state of clinical trials in nursing homes, and ultimately developed recommendations for the establishment of a nursing home clinical trials research network that would be centrally supported and administered. This report summarizes the Panel's recommendations, which were developed in alignment with the following core principles: build on available research infrastructure where appropriate; leverage existing productive partnerships of researchers with groups of nursing homes and nursing home corporations; encompass both efficacy and effectiveness clinical trials; be responsive to a broad range of stakeholders including nursing home residents and their care partners; be relevant to an expansive range of clinical and health care delivery research questions; be able to pivot as necessary to changing research priorities and circumstances; create a pathway for industry-sponsored research as appropriate; invest in strategies to increase diversity in study populations and the research workforce; and foster the development of the next generation of nursing home researchers.

Clinical risk factors for recurrent fracture after hip fracture: a prospective study.

Additional fractures after hip fracture are common, but little is known about the risk factors associated with these events. We determined the clinical risk factors associated with fracture following a low-trauma hip fracture and whether clinical risk factors for subsequent fracture were modified by zoledronic acid (ZOL). In this post hoc analysis of the HORIZON Recurrent Fracture trial, 2,127 men and women were randomized within 90 days of surgical hip fracture repair to receive intravenous ZOL 5 mg yearly or placebo. All patients received a loading dose of vitamin D and daily oral calcium and vitamin D supplements. In the multivariable model age, sex, BMI, femoral neck T score, and one or more fall risk factors were significant predictors of subsequent fracture. Race, history of prior fracture other than the index hip fracture, T score < -2.5 as a dichotomous variable, and type of index hip fracture were not associated with a different risk of subsequent fractures. Treatment with ZOL did not modify the impact of these risk factors. Well-established risk factors for fracture risk such as age, sex, BMI, and fall risk factors will also contribute to fracture risk in patients who have already suffered a hip fracture, while other prior fractures and T score < -2.5 are not predictive of subsequent fractures. Baseline risk factors in hip fracture patients were predictive of fracture in both ZOL- and placebo-treated participants, and there is no difference in the risk of subsequent fractures based on index hip fracture type.

Own the Fall: AOA Critical Issues.

ABSTRACT: Falls are the most common cause of injury to older patients, resulting in >3 million emergency room visits per year and 290,000 hip fractures annually in the United States. Orthopaedic surgeons care for the majority of these patients; however, they are rarely involved in the assessment of fall risk and providing prevention strategies. Falls also occur perioperatively (e.g., in patients with arthritis and those undergoing arthroplasty). Preoperatively, up to 40% of patients awaiting joint arthroplasty sustain a fall, and 20% to 40% have a fall postoperatively. Risk factors for falls include intrinsic factors such as age and comorbidities that are not modifiable as well as extrinsic factors, including medication reconciliation, improvement in the environment, and the management of modifiable comorbidities that can be optimized. Simple in-office fall assessment tools are available that can be adapted for the orthopaedic practice and be used to identify patients who would benefit from rehabilitation. Orthopaedic surgeons should incorporate these strategies to improve care and to reduce fall risk and associated adverse events.

Zoledronic acid and clinical fractures and mortality after hip fracture.

BACKGROUND: Mortality is increased after a hip fracture, and strategies that improve outcomes are needed. METHODS: In this randomized, double-blind, placebo-controlled trial, 1065 patients were assigned to receive yearly intravenous zoledronic acid (at a dose of 5 mg), and 1062 patients were assigned to receive placebo. The infusions were first administered within 90 days after surgical repair of a hip fracture. All patients (mean age, 74.5 years) received supplemental vitamin D and calcium. The median follow-up was 1.9 years. The primary end point was a new clinical fracture. RESULTS: The rates of any new clinical fracture were 8.6% in the zoledronic acid group and 13.9% in the placebo group, a 35% risk reduction with zoledronic acid (P=0.001); the respective rates of a new clinical vertebral fracture were 1.7% and 3.8% (P=0.02), and the respective rates of new nonvertebral fractures were 7.6% and 10.7% (P=0.03). In the safety analysis, 101 of 1054 patients in the zoledronic acid group (9.6%) and 141 of 1057 patients in the placebo group (13.3%) died, a reduction of 28% in deaths from any cause in the zoledronic acid group (P=0.01). The most frequent adverse events in patients receiving zoledronic acid were pyrexia, myalgia, and bone and musculoskeletal pain. No cases of osteonecrosis of the jaw were reported, and no adverse effects on the healing of fractures were noted. The rates of renal and cardiovascular adverse events, including atrial fibrillation and stroke, were similar in the two groups. CONCLUSIONS: An annual infusion of zoledronic acid within 90 days after repair of a low-trauma hip fracture was associated with a reduction in the rate of new clinical fractures and with improved survival. (ClinicalTrials.gov number, NCT00046254 [ClinicalTrials.gov].).

An Outreach Rehabilitation Program for Nursing Home Residents After Hip Fracture May Be Cost-Saving.

BACKGROUND: We compared the cost-effectiveness of 10 weeks of outreach rehabilitation (intervention) versus usual care (control) for ambulatory nursing home residents after hip fracture. METHODS: Enrollment occurred February 2011 through June 2015 in a Canadian metropolitan region. Seventy-seven participants were allocated in a 2:1 ratio to receive a 10-week rehabilitation program (intervention) or usual care (control) (46 intervention; 31 control). Using a payer perspective, we performed main and sensitivity analyses. Health outcome was measured by quality-adjusted life years (QALYs), using the EQ5D, completed at study entry, 3-, 6-, and 12-months. We obtained patient-specific data for outpatient visits, physician claims, and inpatient readmissions; the trial provided rehabilitation utilization/cost data. We estimated incremental cost and incremental effectiveness. RESULTS: Groups were similar at study entry; the mean age was 87.9 ± 6.6 years, 54 (71%) were female and 58 (75%) had severe cognitive impairment. EQ5D QALYs scores were nonsignificantly higher for intervention participants. Inpatient readmissions were two times higher among controls, with a cost difference of -$3,350/patient for intervention participants, offsetting the cost/intervention participant of $2,300 for the outreach rehabilitation. The adjusted incremental QALYs/patient difference was 0.024 favoring the intervention, with an incremental cost/patient of -$621 for intervention participants; these values were not statistically significant. A sensitivity analysis reinforced these findings, suggesting that the intervention was likely dominant. CONCLUSION: A 10-week outreach rehabilitation intervention for nursing home residents who sustain a hip fracture may be cost-saving, through reduced postfracture hospital readmissions. These results support further work to evaluate postfracture rehabilitation for nursing home residents.

Rehabilitation After Hip Fracture for Nursing Home Residents: A Controlled Feasibility Trial.

BACKGROUND: This study compared functional outcomes at 3 months after hip fracture surgery between nursing home residents participating in a 10-week outreach rehabilitation program and those receiving usual care. Function, health-related quality of life, and mortality were also compared over 12 months, and outreach program feasibility was assessed. METHODS: A feasibility trial was undertaken in Canadian nursing homes; of 77 participants, 46 were allocated to Outreach and 31 to Control prior to assessing function or cognition. Outreach participants received 10 weeks of rehabilitation (30 sessions), and Control participants received usual posthospital fracture care in their nursing homes. The primary outcome was the Functional Independence Measure Physical Domain (FIMphysical) score 3 months post-fracture; we also explored FIM Locomotion and Mobility. Secondary outcomes were FIM scores, EQ-5D-3L scores, and mortality over 12 months. Program feasibility was also evaluated. RESULTS: The mean age was 88.7 ± 7.0 years, 55 (71%) were female, and 58 (75%) had severe cognitive impairment with no significant group differences (p > .14). Outreach participants had significantly higher FIM Locomotion than usual care (p = .02), but no significant group differences were seen in FIMphysical or FIM Mobility score 3 months post-fracture. In adjusted analyses, Outreach participants reported significant improvements in all FIM and EQ-5D-3L scores compared with Control participants over 12 months (p < .05). Mortality did not differ by group (p = .80). Thirty (65%) Outreach participants completed the program. CONCLUSIONS: Our feasibility trial demonstrated that Outreach participants achieved better locomotion by 3 months post-fracture compared with participants receiving usual postfracture care; benefits were sustained to 12 months post-fracture. In adjusted analyses, Outreach participants also showed sustained benefits in physical function and health-related quality of life.

Research Priorities to Advance the Health and Health Care of Older Adults with Multiple Chronic Conditions.

OBJECTIVES: To prioritize research topics relevant to the care of the growing population of older adults with multiple chronic conditions (MCCs). DESIGN: Survey of experts in MCC practice, research, and policy. Topics were derived from white papers, funding announcements, or funded research projects relating to older adults with MCCs. SETTING: Survey conducted through the Health Care Systems Research Network (HCSRN) and Claude D. Pepper Older Americans Independence Centers (OAICs) Advancing Geriatrics Infrastructure and Network Growth Initiative, a joint endeavor of the HCSRN and OAICs. PARTICIPANTS: Individuals affiliated with the HCSRN or OAICs and national MCC experts, including individuals affiliated with funding agencies having MCC-related grant portfolios. MEASUREMENTS: A "top box" methodology was used, counting the number of respondents selecting the top response on a 5-point Likert scale and dividing by the total number of responses to calculate a top box percentage for each of 37 topics. RESULTS: The highest-ranked research topics relevant to the health and healthcare of older adults with MCCs were health-related quality of life in older adults with MCCs; development of assessment tools (to assess, e.g., symptom burden, quality of life, function); interactions between medications, disease processes, and health outcomes; disability; implementation of novel (and scalable) models of care; association between clusters of chronic conditions and clinical, financial, and social outcomes; role of caregivers; symptom burden; shared decision-making to enhance care planning; and tools to improve clinical decision-making. CONCLUSION: Study findings serve to inform the development of a comprehensive research agenda to address the challenges relating to the care of this "high-need, high-cost" population and the healthcare delivery systems responsible for serving it.

Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): protocol for a pragmatic, international multicentre trial.

INTRODUCTION: Hip fractures occur 1.6 million times each year worldwide, with substantial associated mortality and losses of independence. At present, anaesthesia care for hip fracture surgery varies widely within and between countries, with general anaesthesia and spinal anaesthesia representing the 2 most common approaches. Limited randomised evidence exists regarding potential short-term or long-term differences in outcomes between patients receiving spinal or general anaesthesia for hip fracture surgery. METHODS: The REGAIN trial (Regional vs General Anesthesia for Promoting Independence after Hip Fracture) is an international, multicentre, pragmatic randomised controlled trial. 1600 previously ambulatory patients aged 50 and older will be randomly allocated to receive either general or spinal anaesthesia for hip fracture surgery. The primary outcome is a composite of death or new inability to walk 10 feet or across a room at 60 days after randomisation, which will be assessed via telephone interview by staff who are blinded to treatment assignment. Secondary outcomes will be assessed by in-person assessment and medical record review for in-hospital end points (delirium; major inpatient medical complications and mortality; acute postoperative pain; patient satisfaction; length of stay) and by telephone interview for 60-day, 180-day and 365-day end points (mortality; disability-free survival; chronic pain; return to the prefracture residence; need for new assistive devices for ambulation; cognitive impairment). ETHICS AND DISSEMINATION: The REGAIN trial has been approved by the ethics boards of all participating sites. Recruitment began in February 2016 and will continue until the end of 2019. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement efforts and presentation to the public via lay media outlets. TRIAL REGISTRATION NUMBER: NCT02507505, Pre-results.

Survival and functional outcomes after hip fracture among nursing home residents.

IMPORTANCE: Little is known regarding outcomes after hip fracture among long-term nursing home residents. OBJECTIVE: To describe patterns and predictors of mortality and functional decline in activities of daily living (ADLs) among nursing home residents after hip fracture. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of 60,111 Medicare beneficiaries residing in nursing homes who were hospitalized with hip fractures between July 1, 2005, and June 30, 2009. MAIN OUTCOMES AND MEASURES: Data sources included Medicare claims and the Nursing Home Minimum Data Set. Main outcomes included death from any cause at 180 days after fracture and a composite outcome of death or new total dependence in locomotion at the latest available assessment within 180 days. Additional analyses described within-residents changes in function in 7 ADLs before and after fracture. RESULTS: Of 60,111 patients, 21,766 (36.2%) died by 180 days after fracture; among patients not totally dependent in locomotion at baseline, 53.5% died or developed new total dependence within 180 days. Within individual patients, function declined substantially after fracture across all ADL domains assessed. In adjusted analyses, the greatest decreases in survival after fracture occurred with age older than 90 years (vs ≤75 years: hazard ratio [HR], 2.17; 95% CI, 2.09-2.26 [P < .001]), nonoperative fracture management (vs internal fixation: HR for death, 2.08; 95% CI, 2.01-2.15 [P < .001]), and advanced comorbidity (Charlson score of ≥5 vs 0: HR, 1.66; 95% CI, 1.58-1.73 [P < .001]). The combined risk of death or new total dependence in locomotion within 180 days was greatest among patients with very severe cognitive impairment (vs intact cognition: relative risk [RR], 1.66; 95% CI, 1.56-1.77 [P < .001]), patients receiving nonoperative management (vs internal fixation: RR, 1.48; 95% CI, 1.45-1.51 [P < .001]), and patients older than 90 years (vs ≤75 years: RR, 1.42; 95% CI, 1.37-1.46 [P < .001]). CONCLUSIONS AND RELEVANCE: Survival and functional outcomes are poor after hip fracture among nursing home residents, particularly for patients receiving nonoperative management, the oldest old, and patients with multiple comorbidities and advanced cognitive impairment. Care planning should incorporate appropriate prognostic information related to outcomes in this population.