Community Participation Transition After Stroke (COMPASS) Randomized Controlled Trial: Effect on Adverse Health Events.

OBJECTIVE: To compare adverse health events in intervention versus control group participants in the Community Participation Transition After Stroke trial to reduce barriers to independent living for community-dwelling stroke survivors. DESIGN: Randomized controlled trial. SETTING: Inpatient rehabilitation (IR) to home and community transition. PARTICIPANTS: Stroke survivors aged ≥50 years being discharged from IR who had been independent in activities of daily living prestroke (N=183). INTERVENTIONS: Participants randomized to intervention group (n=85) received home modifications and self-management training from an occupational therapist over 4 visits in the home. Participants randomized to control group (n=98) received the same number of visits consisting of stroke education. MAIN OUTCOME MEASURES: Death, skilled nursing facility (SNF) admission, 30-day rehospitalization, and fall rates after discharge from IR. RESULTS: Time-to-event analysis revealed that the intervention reduced SNF admission (cumulative survival, 87.8%; 95% confidence interval [CI], 78.6%-96.6%) and death (cumulative survival, 100%) compared with the control group (SNF cumulative survival, 78.9%; 95% CI, 70.4%-87.4%; P=.039; death cumulative survival, 87.3%; 95% CI, 79.9%-94.7%; P=.001). Thirty-day rehospitalization also appeared to be lower among intervention participants (cumulative survival, 95.1%; 95% CI, 90.5%-99.8%) than among control participants (cumulative survival, 86.3%; 95% CI, 79.4%-93.2%; P=.050) but was not statistically significant. Fall rates did not significantly differ between the intervention group (5.6 falls per 1000 participant-days; 95% CI, 4.7-6.5) and the control group (7.2 falls per 1000 participant-days; 95% CI, 6.2-8.3; incidence rate ratio, 0.78; 95% CI, 0.46-1.33; P=.361). CONCLUSIONS: A home-based occupational therapist-led intervention that helps stroke survivors transition to home by reducing barriers in the home and improving self-management could decrease the risk of mortality and SNF admission after discharge from rehabilitation.

Examining the impact of a health report card on follow through with fall risk recommendations: an observational study.

BACKGROUND: Increasing older adults' awareness of their personal fall risk factors may increase their engagement in fall prevention. The purpose of this study was to explore the impact of and participant satisfaction with a comprehensive occupational therapy fall risk screening and recommendations for evidence-based fall prevention strategies based on personalized fall risk results for community-dwelling older adults. METHODS: Cognitively normal participants (Clinical Dementia Rating = 0) were recruited from an ongoing longitudinal study of memory and aging. Participants completed 2 annual in-home visits, fall risk questionnaires, and 12 months of fall monitoring between visits. Participants received a health report card with their fall risks and tailored recommendations in 6 domains. Participants completed follow-up questions at their next annual in-home visit about the fall risk recommendations and their satisfaction with receiving their fall risk results. RESULTS: Two hundred five participants completed 2 annual visits and 12 months of fall monitoring. Of the 6 domains of recommendations provided, participants were most likely to follow through with getting an annual eye exam and reviewing their medications with their doctor or pharmacist. Older adults who fell were significantly more likely to receive recommendations for finding fall prevention classes (p = 0.01) and having a doctor or pharmacist review their medications (p = 0.004). The majority of participants were satisfied receiving their fall risk results (92%) and believed it to be beneficial (90%), though few participants shared their results with their doctor (20%). CONCLUSIONS: An occupational therapy fall risk screening and tailored recommendations were not sufficient to encourage follow through with fall risk recommendations. Older adults may benefit from additional support and encouragement to reduce their fall risk. Additional research is needed to examine awareness of fall risks and follow through with fall risk recommendations among community-dwelling older adults.

Psychometric Evaluation of the Perceived Research Burden Assessment (PeRBA) in Longitudinal Studies of Alzheimer Disease Using Rasch Analysis.

INTRODUCTION: The Perceived Research Burden Assessment (PeRBA) was developed to measure participant perceptions of burden in research studies. This study aimed to examine the psychometric properties of this assessment using Rasch analysis in participants in the longitudinal studies of the Alzheimer disease (AD) and their family members. METHODS: PeRBA was administered to 443 participants in studies of AD and 212 family members across 4 Alzheimer Disease Research Centers. We used Rasch analysis to examine PeRBA's psychometric properties, and data-model fit both at item and scale levels. RESULTS: PeRBA demonstrated good reliability and item and person fit for participants and family members. A few items did not fit the model for participants or family members. Areas of content redundancy were found in items assessing similar amounts of perceived research burden. Areas of content gaps were also found, with no items assessing certain levels of perceived research burden. CONCLUSION: Analysis results support the good overall psychometric properties of PeRBA among research participants in studies of AD and their family members. Recommendations have been provided to improve the assessment, including rewording items and adding items that could account for a broader range of perceived research burden.

Environmental interventions for preventing falls in older people living in the community.

BACKGROUND: Falls and fall-related injuries are common. A third of community-dwelling people aged over 65 years fall each year. Falls can have serious consequences including restricting activity or institutionalisation. This review updates the previous evidence for environmental interventions in fall prevention. OBJECTIVES: To assess the effects (benefits and harms) of environmental interventions (such as fall-hazard reduction, assistive technology, home modifications, and education) for preventing falls in older people living in the community. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, other databases, trial registers, and reference lists of systematic reviews to January 2021. We contacted researchers in the field to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials evaluating the effects of environmental interventions (such as reduction of fall hazards in the home, assistive devices) on falls in community-residing people aged 60 years and over.   DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Our primary outcome was rate of falls. MAIN RESULTS: We included 22 studies from 10 countries involving 8463 community-residing older people. Participants were on average 78 years old, and 65% were women. For fall outcomes, five studies had high risk of bias and most studies had unclear risk of bias for one or more risk of bias domains. For other outcomes (e.g. fractures), most studies were at high risk of detection bias. We downgraded the certainty of the evidence for high risk of bias, imprecision, and/or inconsistency.  Home fall-hazard reduction (14 studies, 5830 participants) These interventions aim to reduce falls by assessing fall hazards and making environmental safety adaptations (e.g. non-slip strips on steps) or behavioural strategies (e.g. avoiding clutter).  Home fall-hazard interventions probably reduce the overall rate of falls by 26% (rate ratio (RaR) 0.74, 95% confidence interval (CI) 0.61 to 0.91; 12 studies, 5293 participants; moderate-certainty evidence); based on a control group risk of 1319 falls per 1000 people a year, this is 343 (95% CI 118 to 514) fewer falls. However, these interventions were more effective in people who are selected for higher risk of falling, with a reduction of 38% (RaR 0.62, 95% CI 0.56 to 0.70; 9 studies, 1513 participants; 702 (95% CI 554 to 812) fewer falls based on a control risk of 1847 falls per 1000 people; high-certainty evidence). We found no evidence of a reduction in rate of falls when people were not selected for fall risk (RaR 1.05, 95% CI 0.96 to 1.16; 6 studies, 3780 participants; high-certainty evidence). Findings were similar for the number of people experiencing one or more falls. These interventions probably reduce the overall risk by 11% (risk ratio (RR) 0.89, 95% CI 0.82 to 0.97; 12 studies, 5253 participants; moderate-certainty evidence); based on a risk of 519 per 1000 people per year, this is 57 (95% CI 15 to 93) fewer fallers. However, for people at higher risk of falling, we found a 26% decrease in risk (RR 0.74, 95% CI 0.65 to 0.85; 9 studies, 1473 participants), but no decrease for unselected populations (RR 0.99, 95% CI 0.92 to 1.07; 6 studies, 3780 participants) (high-certainty evidence). These interventions probably make little or no important difference to health-related quality of life (HRQoL) (standardised mean difference 0.09, 95% CI -0.10 to 0.27; 5 studies, 1848 participants; moderate-certainty evidence). They may make little or no difference to the risk of fall-related fractures (RR 1.00, 95% 0.98 to 1.02; 2 studies, 1668 participants), fall-related hospitalisations (RR 0.96, 95% CI 0.87 to 1.06; 3 studies, 325 participants), or in the rate of falls requiring medical attention (RaR 0.91, 95% CI 0.58 to 1.43; 3 studies, 946 participants) (low-certainty evidence). The evidence for number of fallers requiring medical attention was unclear (2 studies, 216 participants; very low-certainty evidence). Two studies reported no adverse events. Assistive technology Vision improvement interventions may make little or no difference to the rate of falls (RaR 1.12, 95% CI 0.84 to 1.50; 3 studies, 1489 participants) or people experiencing one or more falls (RR 1.09, 95% CI 0.79 to 1.50) (low-certainty evidence). We are unsure of the evidence for fall-related fractures (2 studies, 976 participants) and falls requiring medical attention (1 study, 276 participants) because the certainty of the evidence is very low. There may be little or no difference in HRQoL (mean difference 0.40, 95% CI -1.12 to 1.92) or adverse events (falls while switching glasses; RR 1.00, 95% CI 0.98 to 1.02) (1 study, 597 participants; low-certainty evidence). Results for other assistive technology - footwear and foot devices, and self-care and assistive devices (5 studies, 651 participants) - were not pooled due to the diversity of interventions and contexts.  Education  We are uncertain whether an education intervention to reduce home fall hazards reduces the rate of falls or the number of people experiencing one or more falls (1 study; very low-certainty evidence). These interventions may make little or no difference to the risk of fall-related fractures (RR 1.02, 95% CI 0.96 to 1.08; 1 study, 110 participants; low-certainty evidence).  Home modifications We found no trials of home modifications that measured falls as an outcome for task enablement and functional independence. AUTHORS' CONCLUSIONS: We found high-certainty evidence that home fall-hazard interventions are effective in reducing the rate of falls and the number of fallers when targeted to people at higher risk of falling, such as having had a fall in the past year and recently hospitalised or needing support with daily activities. There was evidence of no effect when interventions were targeted to people not selected for risk of falling. Further research is needed to examine the impact of intervention components, the effect of awareness raising, and participant-interventionist engagement on decision-making and adherence.  Vision improvement interventions may or may not impact the rate of falls. Further research is needed to answer clinical questions such as whether people should be given advice or take additional precautions when changing eye prescriptions, or whether the intervention is more effective when targeting people at higher risk of falls. There was insufficient evidence to determine whether education interventions impact falls.

Evaluation of race as a predictor of fear of falling in Black older adults.

OBJECTIVE: Determine whether race predicts fear of falling (FOF) in older adults with a history of previous fall(s) while controlling for mobility performance, activity of daily living (ADL) independence, age, gender, and education. METHODS: We examined predictors of FOF among community-dwelling older adults using data from two longitudinal randomized controlled trials that implemented fall prevention programs for community-dwelling older adults. RESULTS: Two hundred fifty-nine participants were included in the analysis; 145 reported low FOF, while 59 reported high FOF. After controlling for mobility performance, ADL independence, and sociodemographic factors, Black older adults were more likely to report FOF (OR = 2.17) compared to White older adults. Overall, older adults with lower mobility performance/functioning scores were more likely to have FOF (OR = 0.08). CONCLUSIONS: Older adults (aged ≥65 years) who are at higher risk, based on a prior history of fall(s), are more susceptible to developing FOF, as evidenced by the older adults within this study, due to limited mobility performance and functioning. CLINICAL IMPLICATIONS: Black older adults may be at greater risk of FOF than their White counterparts based on previous fall history and level of functional mobility. Incorporating measures of objective performance-based function along with measures of psychological factors are viable methods to identify and address FOF within Black older adult populations.

Efficacy, feasibility, and acceptability of in-home stroke education for stroke survivors.

Barriers to learning after a stroke may prevent stroke survivors from acquiring helpful information regarding stroke prevention and preparedness. The objective of this study was to evaluate the efficacy, feasibility, and acceptability of a novel in-home stroke education program for survivors in the acute phase following a stroke. Study participants completed four in-home education sessions about stroke prevention and preparedness following their discharge home from inpatient rehabilitation. Sessions were designed to be completed within an 8-week period. Sessions were presented with evidence-based teaching methods and could be tailored to individual needs. Participants completed short quizzes before and after each education session to measure knowledge attainment. Forty-nine participants were included in this study. On average, the program was completed in 10 weeks, or 69.5 days (SD 29.6), and visits lasted 66.26 minutes; 81.5% of participants completed Visit 1, 77.5% completed Visit 2, and 73.5% completed Visits 3 and 4. Statistically significant changes from pretest-to-posttest scores were found for all races and genders and for ages 50-79. There was no significant change in pretest-to-posttest scores for participants over age 80 (n = 3). Results show that delivering a stroke education program can be accomplished, on an expanded timeline. The program was effective in increasing stroke knowledge for participants recently discharged from inpatient rehabilitation following a stroke.

Perceptions of Research Burden and Retention Among Participants in ADRC Cohorts.

OBJECTIVES: Alzheimer disease (AD) and related dementias clinical research is associated with significant participant burden. The Perceived Research Burden Assessment (PeRBA) measures participants' perceptions of logistical, psychological, and physical burdens. The purpose of this study was to assess PeRBA's psychometric properties, perceptual sources, and behavioral consequences with participants in a multisite study of participant retention in longitudinal cohort studies of Alzheimer disease and related dementias. DESIGN: Multicenter mixed methods. SETTING: In-person or phone. PARTICIPANTS: A total of 443 participants at 4 NIA-funded Alzheimer Disease Research Centers (ADRCs) were randomly selected and invited to participate if they were 45 years of age or more, enrolled in longitudinal studies, and had a Clinical Dementia Rating Scale global score ≤1. MEASUREMENTS: Participants completed a 20-minute survey including the 21-item PeRBA about their research participation. RESULTS: PeRBA demonstrated high-internal consistency and convergent validity. PeRBA scores correlated with expected perceptual factors. Higher PeRBA scores were associated with lower attendance and higher dropout rates. CONCLUSIONS: PeRBA can be used by researchers to identify participants who may feel overburdened and tailor approaches and strategies to support participants in longitudinal AD studies, maximizing participation, and reducing dropout. Making efforts to increase participants' understanding of study procedures, and building and maintaining trust throughout the study, can contribute to reducing perceived burden and potentially increasing retention in longitudinal AD studies.

World guidelines for falls prevention and management for older adults: a global initiative.

BACKGROUND: falls and fall-related injuries are common in older adults, have negative effects on functional independence and quality of life and are associated with increased morbidity, mortality and health related costs. Current guidelines are inconsistent, with no up-to-date, globally applicable ones present. OBJECTIVES: to create a set of evidence- and expert consensus-based falls prevention and management recommendations applicable to older adults for use by healthcare and other professionals that consider: (i) a person-centred approach that includes the perspectives of older adults with lived experience, caregivers and other stakeholders; (ii) gaps in previous guidelines; (iii) recent developments in e-health and (iv) implementation across locations with limited access to resources such as low- and middle-income countries. METHODS: a steering committee and a worldwide multidisciplinary group of experts and stakeholders, including older adults, were assembled. Geriatrics and gerontological societies were represented. Using a modified Delphi process, recommendations from 11 topic-specific working groups (WGs), 10 ad-hoc WGs and a WG dealing with the perspectives of older adults were reviewed and refined. The final recommendations were determined by voting. RECOMMENDATIONS: all older adults should be advised on falls prevention and physical activity. Opportunistic case finding for falls risk is recommended for community-dwelling older adults. Those considered at high risk should be offered a comprehensive multifactorial falls risk assessment with a view to co-design and implement personalised multidomain interventions. Other recommendations cover details of assessment and intervention components and combinations, and recommendations for specific settings and populations. CONCLUSIONS: the core set of recommendations provided will require flexible implementation strategies that consider both local context and resources.

Primary Care of Adult Patients After Stroke: A Scientific Statement From the American Heart Association/American Stroke Association.

Primary care teams provide the majority of poststroke care. When optimally configured, these teams provide patient-centered care to prevent recurrent stroke, maximize function, prevent late complications, and optimize quality of life. Patient-centered primary care after stroke begins with establishing the foundation for poststroke management while engaging caregivers and family members in support of the patient. Screening for complications (eg, depression, cognitive impairment, and fall risk) and unmet needs is both a short-term and long-term component of poststroke care. Patients with ongoing functional impairments may benefit from referral to appropriate services. Ongoing care consists of managing risk factors such as high blood pressure, atrial fibrillation, diabetes, carotid stenosis, and dyslipidemia. Recommendations to reduce risk of recurrent stroke also include lifestyle modifications such as healthy diet and exercise. At the system level, primary care practices can use quality improvement strategies and available resources to enhance the delivery of evidence-based care and optimize outcomes.

Effect of electroencephalogram-guided anaesthesia administration on 1-yr mortality: follow-up of a randomised clinical trial.

BACKGROUND: Intraoperative EEG suppression duration has been associated with postoperative delirium and mortality. In a clinical trial testing anaesthesia titration to avoid EEG suppression, the intervention did not decrease the incidence of postoperative delirium, but was associated with reduced 30-day mortality. The present study evaluated whether the EEG-guided anaesthesia intervention was also associated with reduced 1-yr mortality. METHODS: This manuscript reports 1 yr follow-up of subjects from a single-centre RCT, including a post hoc secondary outcome (1-yr mortality) in addition to pre-specified secondary outcomes. The trial included subjects aged 60 yr or older undergoing surgery with general anaesthesia between January 2015 and May 2018. Patients were randomised to receive EEG-guided anaesthesia or usual care. The previously reported primary outcome was postoperative delirium. The outcome of the current study was all-cause 1-yr mortality. RESULTS: Of the 1232 subjects enrolled, 614 subjects were randomised to EEG-guided anaesthesia and 618 subjects to usual care. One-year mortality was 57/591 (9.6%) in the guided group and 62/601 (10.3%) in the usual-care group. No significant difference in mortality was observed (adjusted absolute risk difference, -0.7%; 99.5% confidence interval, -5.8% to 4.3%; P=0.68). CONCLUSIONS: An EEG-guided anaesthesia intervention aiming to decrease duration of EEG suppression during surgery did not significantly decrease 1-yr mortality. These findings, in the context of other studies, do not provide supportive evidence for EEG-guided anaesthesia to prevent intermediate term postoperative death. CLINICAL TRIAL REGISTRATION: NCT02241655.

Translating a Functional Exercise Program for Fall Prevention Among Diverse Older Adults in Urban Medically Underserved Areas: A Mixed Methods Study.

The Lifestyle-integrated Functional Exercise Program (LiFE) is proven to have high adherence rates and can significantly reduce falls, but it has not yet been implemented for diverse older adults residing in urban medically underserved (MU) areas. An exploratory sequential mixed methods study was conducted to adapt LiFE and test the adapted program's preliminary feasibility. Focus groups with MU older adults and service providers were conducted to identify modifications. The new adapted program, Diverse Older Adults Doing LiFE (DO LiFE), was then evaluated with older adults. Thematic analysis revealed health literacy and lack of racial representation as barriers to implementing LIFE in this population. The pilot study showed that DO LiFE was feasible with good retention (89%) and high adherence (81.27%) rates. DO LiFE demonstrated preliminary feasibility for diverse MU older adults. Researchers should proceed to larger studies for translating DO LiFE from research to the community.

Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden.

IMPORTANCE: Informal caregivers often receive limited training and support, especially in providing assistance with toileting, a physically and emotionally demanding activity of daily living. This increases caregivers' risk for physical injury and burnout and jeopardizes older adults' ability to age in place. OBJECTIVE: To assess the feasibility, acceptability, and preliminary efficacy of a toileting intervention using an automated bidet to reduce the amount of physical assistance required from caregivers. DESIGN: Randomized wait-list control feasibility study. SETTING: Caregiver's home. PARTICIPANTS: Ten informal caregivers. INTERVENTION: An occupational therapy intervention to educate and train caregiving dyads to use an automated bidet system. Outcomes and Measures: Feasibility was measured in terms of recruitment and retention, bidet installation, ability to operate the bidet, acceptability (a process evaluation), preliminary efficacy (physical barriers and impact on caregiver outcomes of performance, satisfaction, and self-efficacy), and adverse events. RESULTS: All bidets were installed successfully. All caregivers reported that the intervention made toileting easier and increased their confidence. Physical barriers decreased for the treatment group. The bidet had a large effect on self-efficacy for the treatment group. CONCLUSIONS AND RELEVANCE: The results suggest that the automated bidet intervention is feasible and acceptable and can have a positive impact on caregiver outcomes when assisting with toileting. What This Article Adds: A toileting intervention using an automated bidet is feasible and acceptable for caregivers of older adults and can reduce the amount of physical assistance required from caregivers.

Preoperative Cognitive Abnormality, Intraoperative Electroencephalogram Suppression, and Postoperative Delirium: A Mediation Analysis.

BACKGROUND: Postoperative delirium is a common complication that hinders recovery after surgery. Intraoperative electroencephalogram suppression has been linked to postoperative delirium, but it is unknown if this relationship is causal or if electroencephalogram suppression is merely a marker of underlying cognitive abnormalities. The hypothesis of this study was that intraoperative electroencephalogram suppression mediates a nonzero portion of the effect between preoperative abnormal cognition and postoperative delirium. METHODS: This is a prespecified secondary analysis of the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) randomized trial, which enrolled patients age 60 yr or older undergoing surgery with general anesthesia at a single academic medical center between January 2015 and May 2018. Patients were randomized to electroencephalogram-guided anesthesia or usual care. Preoperative abnormal cognition was defined as a composite of previous delirium, Short Blessed Test cognitive score greater than 4 points, or Eight Item Interview to Differentiate Aging and Dementia score greater than 1 point. Duration of intraoperative electroencephalogram suppression was defined as number of minutes with suppression ratio greater than 1%. Postoperative delirium was detected via Confusion Assessment Method or chart review on postoperative days 1 to 5. RESULTS: Among 1,113 patients, 430 patients showed evidence of preoperative abnormal cognition. These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001). Of this 17.2% total effect size (99.5% CI, 9.3 to 25.1%), an absolute 2.4% (99.5% CI, 0.6 to 4.8%) was an indirect effect mediated by electroencephalogram suppression, while an absolute 14.8% (99.5% CI, 7.2 to 22.5%) was a direct effect of preoperative abnormal cognition. Randomization to electroencephalogram-guided anesthesia did not change the mediated effect size (P = 0.078 for moderation). CONCLUSIONS: A small portion of the total effect of preoperative abnormal cognition on postoperative delirium was mediated by electroencephalogram suppression. Study precision was too low to determine if the intervention changed the mediated effect.

Perspective on the "African American participation in Alzheimer disease research: Effective strategies" workshop, 2018.

The Washington University School of Medicine Knight Alzheimer Disease Research Center's "African American Participation in Alzheimer Disease Research: Effective Strategies" Workshop convened to address a major limitation of the ongoing scientific progress regarding Alzheimer's disease and related dementias (ADRD): participants in most ADRD research programs overwhelmingly have been limited to non-Hispanic white persons, thus precluding knowledge as to how ADRD may be represented in non-white individuals. Factors that may contribute to successful recruitment and retention of African Americans into ADRD research were discussed and organized into actionable next steps as described within this report.

A scoping review of fall hazards in the homes of older adults and development of a framework for assessment and intervention.

INTRODUCTION: Comprehensive evaluation and intervention provided by occupational therapists is effective in reducing the presence of fall hazards in the homes of older adults. The purpose of this study was to document known environmental hazards and to update a previous content analysis. A secondary goal reviewed a framework for evaluation and practice. METHODS: A comprehensive scoping review of published academic articles was performed from 1996 to 2019 to answer: What environmental hazards have been associated with falls in the homes of community-dwelling older adults? Data was extracted in a standardised critical appraisal worksheet and content analysis was conducted. A review of a conceptual framework for assessment and intervention was conducted by international experts (n = 6) in face-to-face interviews. RESULTS: Fourteen studies met the inclusion criteria for the scoping study. The studies reported 17 in-home environmental hazards: throw rugs/carpets, clutter, cords/wires, poorly placed light switches, items placed too low, items placed too high, no grab bars, toilet seats too low, uneven floor surfaces, slippery/wet surfaces, snowy/icy surfaces, backless/unsupportive shoes, unsteady stairs, inadequate lighting, inadequate heating/cooling, step stools without railings, and pets. CONCLUSION: A comprehensive list of specific fall hazards in and around the homes of older adults and a guiding framework offers occupational therapists an evidence-based foundation for fall prevention efforts.

Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial.

Importance: Intraoperative electroencephalogram (EEG) waveform suppression, often suggesting excessive general anesthesia, has been associated with postoperative delirium. Objective: To assess whether EEG-guided anesthetic administration decreases the incidence of postoperative delirium. Design, Setting, and Participants: Randomized clinical trial of 1232 adults aged 60 years and older undergoing major surgery and receiving general anesthesia at Barnes-Jewish Hospital in St Louis. Recruitment was from January 2015 to May 2018, with follow-up until July 2018. Interventions: Patients were randomized 1:1 (stratified by cardiac vs noncardiac surgery and positive vs negative recent fall history) to receive EEG-guided anesthetic administration (n = 614) or usual anesthetic care (n = 618). Main Outcomes and Measures: The primary outcome was incident delirium during postoperative days 1 through 5. Intraoperative measures included anesthetic concentration, EEG suppression, and hypotension. Adverse events included undesirable intraoperative movement, intraoperative awareness with recall, postoperative nausea and vomiting, medical complications, and death. Results: Of the 1232 randomized patients (median age, 69 years [range, 60 to 95]; 563 women [45.7%]), 1213 (98.5%) were assessed for the primary outcome. Delirium during postoperative days 1 to 5 occurred in 157 of 604 patients (26.0%) in the guided group and 140 of 609 patients (23.0%) in the usual care group (difference, 3.0% [95% CI, -2.0% to 8.0%]; P = .22). Median end-tidal volatile anesthetic concentration was significantly lower in the guided group than the usual care group (0.69 vs 0.80 minimum alveolar concentration; difference, -0.11 [95% CI, -0.13 to -0.10), and median cumulative time with EEG suppression was significantly less (7 vs 13 minutes; difference, -6.0 [95% CI, -9.9 to -2.1]). There was no significant difference between groups in the median cumulative time with mean arterial pressure below 60 mm Hg (7 vs 7 minutes; difference, 0.0 [95% CI, -1.7 to 1.7]). Undesirable movement occurred in 137 patients (22.3%) in the guided and 95 (15.4%) in the usual care group. No patients reported intraoperative awareness. Postoperative nausea and vomiting was reported in 48 patients (7.8%) in the guided and 55 patients (8.9%) in the usual care group. Serious adverse events were reported in 124 patients (20.2%) in the guided and 130 (21.0%) in the usual care group. Within 30 days of surgery, 4 patients (0.65%) in the guided group and 19 (3.07%) in the usual care group died. Conclusions and Relevance: Among older adults undergoing major surgery, EEG-guided anesthetic administration, compared with usual care, did not decrease the incidence of postoperative delirium. This finding does not support the use of EEG-guided anesthetic administration for this indication. Trial Registration: ClinicalTrials.gov Identifier: NCT02241655.

Scoring, Clinical Utility, and Psychometric Properties of the In-Home Medication Management Performance Evaluation (HOME-Rx).

IMPORTANCE: Forty percent to 75% of community-dwelling older adults are not able to adhere to their medication routine. A medication management assessment can correctly identify the reasons for nonadherence and the barriers contributing to it. OBJECTIVE: To further develop the HOME-Rx, an in-home medication management assessment, by modifying scoring metrics, improving clinical utility, and establishing psychometric properties. DESIGN: In Phase 1, the scoring metrics were modified, and the clinical procedures were evaluated. In Phase 2, the psychometric properties were established. SETTING: The homes of older adults. PARTICIPANTS: Older adults who took three or more medications, managed their own medications, and lived in their own home were eligible. Older adults with cognitive impairment were ineligible. OUTCOMES AND MEASURES: We assessed concurrent validity with the Performance Assessment for Self-Care Skills (PASS) and Medication Management Instrument for Deficiencies in the Elderly (MedMaIDE) and established interrater reliability. RESULTS: The PASS was positively correlated with the HOME-Rx Performance and Safety subscales; the MedMaIDE was negatively correlated with the HOME-Rx Performance subscale and positively correlated with the Barriers subscale. Interrater reliability was excellent (ICCs = .87-1.00). CONCLUSIONS AND RELEVANCE: All relationships were as predicted: The HOME-Rx is a valid and reliable performance-based assessment that provides clinicians and researchers with a measure of older adults' actual medication management ability in the home using their medications. The results can potentially be used to guide treatment planning and improve medication management. WHAT THIS ARTICLE ADDS: Occupational therapy practitioners can use the HOME-Rx to adequately determine performance problems, safety concerns, and environmental barriers and potentially to guide treatment planning and improve medication management for older adults.

Cognitive Improvement in Older Adults in the Year After Hip Fracture: Implications for Brain Resilience in Advanced Aging.

OBJECTIVE: We examined cognitive function in nondemented, nondelirious older adults 1 year post hip fracture. DESIGN: Prospective observational study. SETTING AND PARTICIPANTS: Three hundred eighty-six hip fracture patients aged 60 years and older with no history of cognitive impairment, such as clinical dementia or persistent delirium, recruited from eight area hospitals 2-3 days after hip surgery (week 0), and 101 older adults with no recent acute medical events for control comparison. METHODS: Cognitive function was examined with the Repeatable Battery for the Assessment of Neuropsychological Status and the Short Blessed Test (SBT) at weeks 0 (SBT only), 4, and 52 using a repeated measures mixed model analysis. Baseline predictor variables included demographics, personality, genetic factors, and depressive symptom level. RESULTS: Hip fracture participants had lower cognitive scores than healthy comparisons. Cognitive scores improved in the hip fracture group relative to healthy comparison participants from week 4-52. The only significant predictor of cognitive improvement after hip fracture was education: individuals with college education showed cognitive improvement by week 52, while those with high school or less did not. CONCLUSION: Nondemented, nondelirious older adults suffering hip fracture have poorer cognitive function immediately after the fracture but then exhibit cognitive improvement over the ensuing year, especially among those with high education. This demonstrates brain resilience in older adults even in the context of advanced age, medical illness, and frailty.

Achieving Milestones as a Prerequisite for Proceeding With a Clinical Trial.

BACKGROUND: Although the National Institutes of Health (NIH) invests $30 billion in research annually, many funded studies fail to generate results that can inform practice. The National Institutes of Health introduced a phased funding mechanism as one potential solution. Study-specific milestones are established for an initial pilot phase. We assess the utility of this phased approach through the ongoing Electroencephalography (EEG) Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) pragmatic clinical trial. The hypothesis of the trial is that EEG guidance of general anesthesia, through prevention of EEG suppression, can decrease postoperative delirium and its downstream negative sequelae. METHODS: In collaboration with study stakeholders, we identified critical milestones for the ENGAGES study, with themes common to many clinical trials. These themes include: regulatory tasks; enrollment targets; feasibility and impact of study intervention; primary outcome incidence; measurement reliability of primary outcome; and follow-up. Progress in achieving the milestones was assessed at regular intervals during the pilot phase by ENGAGES investigators, a National Institute on Aging program officer, and a nonpartisan research organization (Westat). RESULTS: Regulatory tasks, including institutional review board approval, infrastructure establishment, and trial registration, were completed on schedule. A total of 117 patients were randomized, exceeding the target by 51. The EEG-guided protocol was successfully implemented, and a relevant effect on anesthetic practice was demonstrated (decrease in median age-adjusted minimum alveolar anesthetic concentration from 0.93 to 0.78 [P < .001] and increase in median proportion of zero EEG suppression time from 87% to 94% [P < .01]). Nearly all patients (115 of 117, 98.3%) were assessed for delirium using the Confusion Assessment Method, and the delirium incidence was similar (28.1%; 95% CI, 20%-37%) to the estimate (25%) used for the sample size calculation. Good interrater reliability of delirium assessment was demonstrated (κ = 0.94 [95% CI, 0.86-1]). Finally, 1-month follow-up vital status data were obtained for 96.9% of patients, with 85.7% of patients completing at least 1 survey. CONCLUSIONS: With the ENGAGES trial, we demonstrated that key milestones can be identified and progressively assessed during a pilot phase. Success in attaining appropriate milestones hypothetically predicts meaningful completion of a study, and can provide justification for proceeding beyond a pilot phase. The impact of this phased approach on return on investment and scientific yield requires additional study.

Feasibility Trial of Tailored Home Modifications: Process Outcomes.

OBJECTIVE: The aim of this study was to conduct a process evaluation to examine the implementation of a randomized controlled trial of home modifications designed to reduce the risk of falls and improve daily activity performance among community-dwelling older adults. METHOD: A process evaluation was conducted alongside a blinded, randomized sham-controlled trial (n = 92). Participants were followed for 1 yr after intervention. The process evaluation was framed using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. RESULTS: The treatment group improved daily activity performance over 12 mo compared with the sham control group (F = 4.13; p = .024). The intervention elements and dose were delivered with greater than 90% accuracy. Participants reported a 91% adherence rate at 12 mo. CONCLUSION: The complex intervention of home modifications examined in this study is acceptable to older adults, is feasible, and can be delivered with high fidelity for frail, community-dwelling older adults.