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Sophia Wang,1–3 Jared W Meeker,4 Anthony J Perkins,5 Sujuan Gao,5 Sikandar H Khan,4,6 Ninotchka L Sigua,4,7 Shalini Manchanda,4,7 Malaz A Boustani,2,3,6,8 Babar A Khan3,4,6,8 1Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN 46202 USA; 2Center for Health Innovation and Implementation Science, Clinical and Translational Science Institute, Indianapolis, IN, USA; 3Sandra Eskenazi Center for Brain Care Innovation, Eskenazi Hospital, Indianapolis, IN, USA; 4Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; 5Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA; 6IU Center of Aging Research, Regenstrief Institute, Indianapolis, IN, USA; 7Indiana University Health Sleep Disorders Center, Indiana University School of Medicine, Indianapolis, IN, USA; 8Division of Geriatrics and General Internal Medicine, Department of Internal Medicine, Indiana University School of Medicine, Indianapolis, IN, USA Background: Sleep disturbances in critically ill patients are associated with poorer long-term clinical outcomes and quality of life. Studies are needed to better characterize associations and risk factors for persistent sleep disturbances after intensive care unit (ICU) discharge. Psychiatric disorders are frequently associated with sleep disturbances, but the role of psychiatric symptoms in sleep disturbances in ICU survivors has not been well-studied. Objective: To examine the association between psychiatric symptoms and sleep disturbances in ICU survivors. Methods: 112 adult ICU survivors seen from July 2011 to August 2016 in the Critical Care Recovery Center, an ICU survivor clinic at the Eskenazi Hospital in Indianapolis, IN, USA, were assessed for sleep disturbances (insomnia, hypersomnia, difficulty with sleep onset, difficulty with sleep maintenance, and excessive daytime sleepiness) and psychiatric symptoms (trauma-related symptoms and moderate to severe depressive symptoms) 3 months after ICU discharge. A multivariate logistic regression model was performed to examine the association between psychiatric symptoms and sleep disturbances. Analyses were controlled for age, hypertension, history of depression, and respiratory failure. Results: ICU survivors with both trauma-related and depression symptoms (OR 16.66, 95% CI 2.89–96.00) and trauma-related symptoms alone (OR 4.59, 95% CI 1.11–18.88) had a higher likelihood of sleep disturbances. Depression symptoms alone were no longer significantly associated with sleep disturbances when analysis was controlled for trauma-related symptoms. Conclusion: Trauma-related symptoms and trauma-related plus moderate to severe depressive symptoms were associated with a higher likelihood of sleep disturbances. Future studies are needed to determine whether psychiatric symptoms are associated with objective changes on polysomnography and actigraphy and whether adequate treatment of psychiatric symptoms can improve sleep disturbances. Keywords: sleep disturbance, post-traumatic stress disorder, depression, ICU survivor, psychiatric disorders, post-intensive care syndrome

Nicole R Fowler,1–4 Anthony J Perkins,4 Sujuan Gao,5 Greg A Sachs,1–3 Austin K Uebelhor,2,3 Malaz A Boustani1–4 1Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; 2Indiana University Center for Aging Research, Indianapolis, IN, USA; 3Regenstrief Institute, Inc., Indianapolis, IN, USA; 4Center for Health Innovation and Implementation Science, Indiana Clinical and Translational Science Institute, Indianapolis, IN, USA; 5Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA Introduction: Screening all older adults for Alzheimer’s disease and related dementias (ADRD) in primary care may not be acceptable or feasible. The goal of this study was to identify factors that could optimize screening in primary care and enhance its feasibility.Methods: This is a cross-sectional study in rural, suburban, and urban primary care practices in Indiana. A total of 1,723 patients ≥65 years of age were screened for ADRD using the Memory Impairment Screen. Logistic regression was used to identify patient-specific factors associated with screening positive for ADRD.Results: The positive screening rate was 4.9%. Rates varied significantly across the three study sites. The rural site had the lowest rate (2.8%), which was significantly lower than the rates at the suburban (5.6%) and urban (6.6%) sites (P

Michael A LaMantia,1–4 Anthony J Perkins,5,6 Sujuan Gao,2,7 Mary G Austrom,8,9 Cathy A Alder,10 Dustin D French,11,12 Debra K Litzelman,2,3,13 Ann H Cottingham,3 Malaz A Boustani1–3,5 1Indiana University Center for Aging Research, 2Regenstrief Institute, Inc., 3Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, 4Department of Medicine, University of Vermont College of Medicine, Burlington, VT, 5Indiana University Center for Health Innovation and Implementation Science, 6Indiana Clinical and Translational Sciences Institute, 7Department of Biostatistics, Indiana University School of Medicine, 8Department of Psychiatry, Indiana University School of Medicine, 9Indiana University Alzheimer’s Disease Center, 10Eskenazi Health, Indianapolis, IN, 11Department of Ophthalmology, Feinberg School of Medicine, Northwestern University, 12Veterans Affairs Health Services Research and Development Service, Chicago, IL, 13Indiana University Center for Health Services and Outcomes Research, Indianapolis, IN, USA Objective: To evaluate the effect of the Aging Brain Care (ABC) Medical Home program’s depression module on patients’ depression severity measurement over time.Design: Retrospective chart review.Setting: Public hospital system.Participants: Patients enrolled in the ABC Medical Home program between October 1, 2012 and March 31, 2014.Methods: The response of 773 enrolled patients who had multiple patient health questionnaire-9 (PHQ-9) scores recorded in the ABC Medical Home program’s depression care protocol was evaluated. Repeatedly measured PHQ-9 change scores were the dependent variables in the mixed effects models, and demographic and comorbid medical conditions were tested as potential independent variables while including random effects for time and intercept.Results: Among those patients with baseline PHQ-9 scores >10, there was a significant decrease in PHQ-9 scores over time (P50% decline from baseline) on the PHQ-9 at 6 months. Conclusion: These analyses demonstrate evidence for the sustained effectiveness of the ABC Medical Home program at inducing depression remission outcomes while employing clinical staff who required less formal training than earlier clinical trials. Keywords: geriatrics, care coordination, Medicare

Noll L Campbell,1–4 Todd C Skaar,5 Anthony J Perkins,2 Sujuan Gao,2,3,6 Lang Li,7 Babar A Khan,2,3,5 Malaz A Boustani2,3,81College of Pharmacy, Purdue University, West Lafayette, 2Indiana University Center for Aging Research, 3Regenstrief Institute, 4Department of Pharmacy, Eskenazi Health Services, 5Division of Clinical Pharmacology, Department of Medicine, 6Department of Biostatistics, 7Department of Medical and Molecular Genetics, Indiana University School of Medicine, 8Center for Innovation and Implementation Science, Indiana University, Indianapolis, IN, USAObjective: To determine the frequency of pharmacogenomic variants and concurrent medications that may alter the efficacy and tolerability of acetylcholinesterase inhibitors (AChEIs).Materials and methods: A multisite cross-sectional study was carried out across four memory care practices in the greater Indianapolis area. Participants were adults aged 65 years and older with a diagnosis of probable or possible Alzheimer’s disease (AD) (n=105). Blood samples and self-reported medication data were collected. Since two of the three AChEIs are metabolized by cytochrome P450 (CYP)-2D6, we determined the frequency of functional genetic variants in the CYP2D6 gene and calculated their predicted CYP2D6-activity scores. Concurrent medication data were collected from self-reported medication surveys, and their predicted effect on the pharmacokinetics of AChEIs was determined based on their known effects on CYP2D6 and CYP3A4/5 enzyme activities.Results: Among the 105 subjects enrolled, 72% were female and 36% were African American. Subjects had a mean age of 79.6 years. The population used a mean of eight medications per day (prescription and nonprescription). The CYP2D6 activity score frequencies were 0 (3.8%), 0.5 (4.8%), 1.0 (36.2%), 1.5–2.0 (51.4%), and >2.0 (3.8%). Nineteen subjects (18.1%) used a medication considered a strong or moderate inhibitor of CYP2D6, and eight subjects (7.6%) used a medication considered a strong or moderate inhibitor of CYP3A4/5. In total, 28.6% of the study population was predicted to have reduced activity of the CYP2D6 or CYP3A4/5 enzymes due to either genetic variants or concomitant medications.Conclusion: Both pharmacogenetic variants and concurrent drug therapies that are predicted to alter the pharmacokinetics of AChEIs should be evaluated in older adults with AD. Pharmacogenetic and drug-interaction data may help personalize AD therapy and increase adherence by improving tolerability.Keywords: dementia, acetylcholinesterase inhibitor, pharmacogenomics

Patrick O Monahan,1 Catherine A Alder,2–4 Babar A Khan,1–3 Timothy Stump,1 Malaz A Boustani1–4 1Indiana University School of Medicine, Indianapolis, IN, USA; 2Indiana University Center for Aging Research, Indianapolis, IN, USA; 3Regenstrief Institute Inc., Indianapolis, IN, USA; 4Eskenazi Health, Indianapolis, IN, USA Background: Primary care providers need an inexpensive, simple, user-friendly, easily standardized, sensitive to change, and widely available multidomain instrument to measure the cognitive, functional, and psychological symptoms of patients suffering from multiple chronic conditions. We previously validated the Caregiver Report Version of the Healthy Aging Brain Care Monitor (HABC Monitor) for measuring and monitoring the severity of symptoms through caregiver reports. The purpose of this study was to assess the reliability and validity of the Patient Self-Report Version of the HABC Monitor (Self-Report HABC Monitor).Design: Cross-sectional study.Setting: Primary care clinics affiliated with a safety net urban health care system in Indianapolis, Indiana, USA.Subjects: A total of 291 subjects aged ≥65 years with a mean age of 72.7 (standard deviation 6.2) years, 76% female, and 56% African Americans.Analysis: Psychometric validity and reliability of the Self-Report HABC Monitor.Results: Among 291 patients analyzed, the Self-Report HABC Monitor demonstrated excellent fit for the confirmatory factor analysis model (root mean square error of approximation =0.030, comparative fit index =0.974, weighted root mean square residual =0.837) and good internal consistency (0.78–0.92). Adequate convergent–divergent validity (differences between the Telephone Interview for Cognitive Status test-based cognitive function impairment versus nonimpairment groups) was demonstrated only when patients were removed from analysis if they had both cognitive function test impairment and suspiciously perfect self-report HABC Monitor cognitive floor scores of 0.Conclusion: The Self-Report HABC Monitor demonstrates good reliability and validity as a clinically practical multidimensional tool for measuring symptoms. The tool can be used along with its caregiver version to provide useful feedback (via monitoring of symptoms) for modifying care plans. Determining the validity of HABC Monitor scores from patients who self-report a perfect cognitive score of 0 requires cognitive function test results (eg, Telephone Interview for Cognitive Status or Mini Mental State Examination) or Caregiver Report HABC Monitor scores or further clinical examination to rule out the possibility that the patient is denying or unaware of their cognitive symptoms. Keywords: symptoms, monitor, validation, cognitive, psychological, functional

Babar A Khan,1–3 Mark O Farber,1 Noll Campbell,2–5 Anthony Perkins,2,3 Nagendra K Prasad,6 Siu L Hui,1–3 Douglas K Miller,1–3 Enrique Calvo-Ayala,1 John D Buckley,1 Ruxandra Ionescu,1 Anantha Shekhar,1 E Wesley Ely,7,8 Malaz A Boustani1–3 1Indiana University School of Medicine, 2Indiana University Center for Aging Research, 3Regenstrief Institute, Inc., 4Wishard Health Services, Indianapolis, 5Department of Pharmacy Practice, Purdue University College of Pharmacy, West Lafayette, 6Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN, 7Vanderbilt University School of Medicine, 8VA Tennessee Valley Geriatric Research Education Clinical Center (GRECC), Nashville, TN, USA Background: Currently, there are no valid and reliable biomarkers to identify delirious patients predisposed to longer delirium duration. We investigated the hypothesis that elevated S100 calcium binding protein B (S100β) levels will be associated with longer delirium duration in critically ill patients. Methods: A prospective observational cohort study was performed in the medical, surgical, and progressive intensive care units (ICUs) of a tertiary care, university affiliated, and urban hospital. Sixty-three delirious patients were selected for the analysis, with two samples of S100β collected on days 1 and 8 of enrollment. The main outcome measure was delirium duration. Using the cutoff of

Malaz A Boustani,1–3 Amie Frame,1,2 Stephanie Munger,1,2 Patrick Healey,4 Jessie Westlund,5 Martin Farlow,6,7 Ann Hake,8 Mary Guerriero Austrom,6,9 Polly Shepard,10 Corby Bubp,10 Jose Azar,3 Arif Nazir,3 Nadia Adams,11 Noll L Campbell,1,2,12,13 Azita Chehresa,5 Paul Dexter2,31Indiana University Center for Aging Research, 2Regenstrief Institute, Inc, 3Department of Medicine, Indiana University School of Medicine (IUSM), 4St Vincent Health Network, 5Community Health Network, 6Indiana Alzheimer Disease Center, IUSM, 7Department of Neurology, IUSM, 8Eli Lilly and Company, 9Department of Psychiatry, IUSM, 10The Memory Clinic of Indianapolis, 11Indiana University Health, Indianapolis, IN, USA; 12Department of Pharmacy Practice, Purdue University College of Pharmacy, West Lafayette, IN, USA; 13Department of Pharmacy, Wishard Health Services, Indianapolis, IN, USABackground: The US Institute of Medicine has recommended an integrated, locally sensitive collaboration among the various members of the community, health care systems, and research organizations to improve dementia care and dementia research.Methods: Using complex adaptive system theory and reflective adaptive process, we developed a professional network called the “Indianapolis Discovery Network for Dementia” (IDND). The IDND facilitates effective and sustainable interactions among a local and diverse group of dementia researchers, clinical providers, and community advocates interested in improving care for dementia patients in Indianapolis, Indiana.Results: The IDND was established in February 2006 and now includes more than 250 members from more than 30 local (central Indiana) organizations representing 20 disciplines. The network uses two types of communication to connect its members. The first is a 2-hour face-to-face bimonthly meeting open to all members. The second is a web-based resource center (http://www.indydiscoverynetwork.org). To date, the network has: (1) accomplished the development of a network website with an annual average of 12,711 hits per day; (2) produced clinical tools such as the Healthy Aging Brain Care Monitor and the Anticholinergic Cognitive Burden Scale; (3) translated and implemented the collaborative dementia care model into two local health care systems; (4) created web-based tracking software, the Enhanced Medical Record for Aging Brain Care (eMR-ABC), to support care coordination for patients with dementia; (5) received more than USD$24 million in funding for members for dementia-related research studies; and (6) adopted a new group-based problem-solving process called the “IDND consultancy round.”Conclusion: A local interdisciplinary “think-tank” network focused on dementia that promotes collaboration in research projects, educational initiatives, and quality improvement efforts that meet the local research, clinical, and community needs relevant to dementia care has been built.Keywords: cognitive impairment, community research, translational research, complex adaptive system

Patrick O Monahan,1 Malaz A Boustani,1–3,6 Catherine Alder,2,3,6 James E Galvin,7 Anthony J Perkins,2,3 Patrick Healey,4 Azita Chehresa,5 Polly Shepard,8 Corby Bubp,8 Amie Frame,2,3 Chris Callahan1–3,61Indiana University School of Medicine, 2Indiana University Center for Aging Research, 3Regenstrief Institute Inc, 4St Vincent’s Health Network, 5Community Health Network, 6Wishard Health Services, Eskenazi Health, Indianapolis IN, 7Alzheimer Disease Center, Departments of Neurology and Psychiatry, New York University School of Medicine, New York, NY, 8Memory Clinic of Indianapolis, Indianapolis, IN, USABackground: Dementia care providers need a clinical assessment tool similar to the blood pressure cuff (sphygmomanometer) used by clinicians and patients for managing hypertension. A “blood pressure cuff” for dementia would be an inexpensive, simple, user-friendly, easily standardized, sensitive to change, and widely available multidomain instrument for providers and informal caregivers to measure severity of dementia symptoms. The purpose of this study was to assess the reliability and validity of the Healthy Aging Brain Care Monitor (HABC-Monitor) for measuring and monitoring the severity of dementia symptoms through caregiver reports.Methods: The first prototype of the HABC-Monitor was developed in collaboration with the Indianapolis Discovery Network for Dementia, which includes 200 members representing 20 disciplines from 20 local organizations, and an expert panel of 22 experts in dementia care and research. The HABC-Monitor has three patient symptom domains (cognitive, functional, behavioral/psychological) and a caregiver quality of life domain. Patients (n = 171) and their informal caregivers (n = 171) were consecutively approached and consented during, or by phone shortly following, a patient’s routine visit to their memory care provider.Results: The HABC-Monitor demonstrated good internal consistency (0.73–0.92); construct validity indicated by correlations with the caregiver-reported Neuropsychiatric Inventory (NPI) total score and NPI caregiver distress score; sensitivity to three-month change compared with NPI “reliable change” groups; and known-groups validity, indicated by significant separation of Mini-Mental Status Examination severity groups and clinical diagnostic groups. Although not designed as a screening study, there was evidence for good operating characteristics, according to area under the receiver-operator curve with respect to gold standard clinical diagnoses, relative to Mini-Mental Status Examination or NPI.Conclusion: The HABC-Monitor demonstrates good reliability and validity as a clinically practical multidimensional tool for monitoring symptoms of dementia through the informal caregiver.Keywords: dementia, symptoms, monitor, validation, cognitive impairment, memory care

BACKGROUND: Cognitive impairment challenges the ability to adhere to the complex medication regimens needed to treat multiple medical problems in older adults. OBJECTIVE: Our aim was to conduct a systematic evidence-based review to identify barriers to medication adherence in cognitively impaired older adults and interventions aimed at improving medication adherence. METHODS: A search of MEDLINE, EMBASE, PsycINFO, GoogleDocs, and CINAHL for articles published between 1966 and February 29, 2012 was performed. Studies included older adults with a diagnosis of cognitive impairment of any degree (mild cognitive impairment or mild, moderate, or severe dementia). To identify barriers to adherence, we reviewed observational studies. To identify relevant interventions, we reviewed clinical trials targeting medication adherence in cognitively impaired older adults. We excluded studies lacking a measure of medication adherence or lacking an assessment of cognitive function, case reports or series, reviews, and those focusing on psychiatric disorders or infectious diseases. Population demographics, baseline cognitive function, medication adherence methods, barriers to adherence, and prospective intervention methodologies were extracted. RESULTS: The initial search identified 594 articles. Ten studies met inclusion criteria for barriers to adherence and three met inclusion criteria for interventional studies. Unique barriers to adherence included understanding new directions, living alone, scheduling medication administration into the daily routine, using potentially inappropriate medications, and uncooperative patients. Two studies evaluated reminder systems and showed no benefit in a small group of participants. One study improved adherence through telephone and televideo reminders at each dosing interval. The results of the review are limited by reviewing only published articles, missing barriers or interventions due to lack of subgroup analysis, study selection and extraction completed by 1 reviewer, and articles with at least an abstract published in English. CONCLUSIONS: The few studies identified limit the assessment of barriers to medication adherence in the cognitively impaired population. Successful interventions suggest that frequent human communication as reminder systems are more likely to improve adherence than nonhuman reminders. [ABSTRACT FROM AUTHOR]

Context: Most older adults with dementia will be cared for by primary care physicians, but the primary care practice environment presents important challenges to providing quality care.Objective: To test the effectiveness of a collaborative care model to improve the quality of care for patients with Alzheimer disease.Design, Setting, and Patients: Controlled clinical trial of 153 older adults with Alzheimer disease and their caregivers who were randomized by physician to receive collaborative care management (n = 84) or augmented usual care (n = 69) at primary care practices within 2 US university-affiliated health care systems from January 2002 through August 2004. Eligible patients (identified via screening or medical record) met diagnostic criteria for Alzheimer disease and had a self-identified caregiver.Intervention: Intervention patients received 1 year of care management by an interdisciplinary team led by an advanced practice nurse working with the patient's family caregiver and integrated within primary care. The team used standard protocols to initiate treatment and identify, monitor, and treat behavioral and psychological symptoms of dementia, stressing nonpharmacological management.Main Outcome Measures: Neuropsychiatric Inventory (NPI) administered at baseline and at 6, 12, and 18 months. Secondary outcomes included the Cornell Scale for Depression in Dementia (CSDD), cognition, activities of daily living, resource use, and caregiver's depression severity.Results: Initiated by caregivers' reports, 89% of intervention patients triggered at least 1 protocol for behavioral and psychological symptoms of dementia with a mean of 4 per patient from a total of 8 possible protocols. Intervention patients were more likely to receive cholinesterase inhibitors (79.8% vs 55.1%; P = .002) and antidepressants (45.2% vs 27.5%; P = .03). Intervention patients had significantly fewer behavioral and psychological symptoms of dementia as measured by the total NPI score at 12 months (mean difference, -5.6; P = .01) and at 18 months (mean difference, -5.4; P = .01). Intervention caregivers also reported significant improvements in distress as measured by the caregiver NPI at 12 months; at 18 months, caregivers showed improvement in depression as measured by the Patient Health Questionnaire-9. No group differences were found on the CSDD, cognition, activities of daily living, or on rates of hospitalization, nursing home placement, or death.Conclusions: Collaborative care for the treatment of Alzheimer disease resulted in significant improvement in the quality of care and in behavioral and psychological symptoms of dementia among primary care patients and their caregivers. These improvements were achieved without significantly increasing the use of antipsychotics or sedative-hypnotics.Trial Registration: clinicaltrials.gov Identifier: NCT00246896. [ABSTRACT FROM AUTHOR]

Abstract Background Drug pharmacokinetics parameters, drug interaction parameters, and pharmacogenetics data have been unevenly collected in different databases and published extensively in the literature. Without appropriate pharmacokinetics ontology and a well annotated pharmacokinetics corpus, it will be difficult to develop text mining tools for pharmacokinetics data collection from the literature and pharmacokinetics data integration from multiple databases. Description A comprehensive pharmacokinetics ontology was constructed. It can annotate all aspects of in vitro pharmacokinetics experiments and in vivo pharmacokinetics studies. It covers all drug metabolism and transportation enzymes. Using our pharmacokinetics ontology, a PK-corpus was constructed to present four classes of pharmacokinetics abstracts: in vivo pharmacokinetics studies, in vivo pharmacogenetic studies, in vivo drug interaction studies, and in vitro drug interaction studies. A novel hierarchical three level annotation scheme was proposed and implemented to tag key terms, drug interaction sentences, and drug interaction pairs. The utility of the pharmacokinetics ontology was demonstrated by annotating three pharmacokinetics studies; and the utility of the PK-corpus was demonstrated by a drug interaction extraction text mining analysis. Conclusions The pharmacokinetics ontology annotates both in vitro pharmacokinetics experiments and in vivo pharmacokinetics studies. The PK-corpus is a highly valuable resource for the text mining of pharmacokinetics parameters and drug interactions.

Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared to subjects treated in the control group. Outcomes The primary outcome is the Alzheimer’s Disease Cooperative Studies Group Activities of Daily Living Scale; secondary outcome measures are two performance-based measures including the Short Physical Performance Battery and Short Portable Sarcopenia Measure. Outcome assessments for both the caregiver-reported scale and subjects’ physical performance scales are completed in the subject’s home. Randomization Eligible patient-care giver dyads will be stratified by clinic type and block randomized with a computer developed randomization scheme using a 1:1 allocation ratio. Blinding Single blinded. Research assistants completing the outcome assessments were blinded to the subjects’ treatment group. Trial status Ongoing ClinicalTrial.Gov identifier NCT01314950; date of completed registration 10 March 2011; date first patient randomized 9 March 2011

Abstract Background Delirium prevalence in the intensive care unit (ICU) is high. Numerous psychotropic agents are used to manage delirium in the ICU with limited data regarding their efficacy or harms. Methods/Design This is a randomized controlled trial of 428 patients aged 18 and older suffering from delirium and admitted to the ICU of Wishard Memorial Hospital in Indianapolis. Subjects assigned to the intervention group will receive a multicomponent pharmacological management protocol for delirium (PMD) and those assigned to the control group will receive no change in their usual ICU care. The primary outcomes of the trial are (1) delirium severity as measured by the Delirium Rating Scale revised-98 (DRS-R-98) and (2) delirium duration as determined by the Confusion Assessment Method for the ICU (CAM-ICU). The PMD protocol targets the three neurotransmitter systems thought to be compromised in delirious patients: dopamine, acetylcholine, and gamma-aminobutyric acid. The PMD protocol will target the reduction of anticholinergic medications and benzodiazepines, and introduce a low-dose of haloperidol at 0.5-1 mg for 7 days. The protocol will be delivered by a combination of computer (artificial intelligence) and pharmacist (human intelligence) decision support system to increase adherence to the PMD protocol. Discussion The proposed study will evaluate the content and the delivery process of a multicomponent pharmacological management program for delirium in the ICU. Trial Registration ClinicalTrials.gov: NCT00842608

Abstract Background Delirium is a state of confusion characterized by an acute and fluctuating decline in cognitive functioning. Delirium is common and deadly in older adults with dementia, and is often referred to as delirium superimposed on dementia, or DSD. Interventions that treat DSD are not well-developed because the mechanisms involved in its etiology are not completely understood. We have developed a theory-based intervention for DSD that is derived from the literature on cognitive reserve and based on our prior interdisciplinary work on delirium, recreational activities, and cognitive stimulation in people with dementia. Our preliminary work indicate that use of simple, cognitively stimulating activities may help resolve delirium by helping to focus inattention, the primary neuropsychological deficit in delirium. Our primary aim in this trial is to test the efficacy of Recreational Stimulation for Elders as a Vehicle to resolve DSD (RESERVE- DSD). Methods/Design This randomized repeated measures clinical trial will involve participants being recruited and enrolled at the time of admission to post acute care. We will randomize 256 subjects to intervention (RESERVE-DSD) or control (usual care). Intervention subjects will receive 30-minute sessions of tailored cognitively stimulating recreational activities for up to 30 days. We hypothesize that subjects who receive RESERVE-DSD will have: decreased severity and duration of delirium; greater gains in attention, orientation, memory, abstract thinking, and executive functioning; and greater gains in physical function compared to subjects with DSD who receive usual care. We will also evaluate potential moderators of intervention efficacy (lifetime of complex mental activities and APOE status). Our secondary aim is to describe the costs associated with RESERVE-DSD. Discussion Our theory-based intervention, which uses simple, inexpensive recreational activities for delivering cognitive stimulation, is innovative because, to our knowledge it has not been tested as a treatment for DSD. This novel intervention for DSD builds on our prior delirium, recreational activity and cognitive stimulation research, and draws support from cognitive reserve theory. Trial registration ClinicalTrials.gov identifier: NCT01267682

Importance: There is a need for early and equitable detection of cognitive impairment among older adults., Objective: To examine the prevalence of unrecognized cognitive impairment among older adults receiving primary care from federally qualified health centers (FQHCs)., Design, Setting, and Participants: This cross-sectional study was conducted at 5 FQHCs providing primary care in Indianapolis, Indiana, between 2021 and 2023. Participants were adults aged 65 years and older, without a diagnosis of mild cognitive impairment (MCI), dementia, or severe mental illness. Data analysis was performed from September 2023 to April 2024., Main Outcomes and Measures: The primary outcome was a diagnosis of dementia or MCI, as determined by an interdisciplinary clinical team using data from structured patient and study partner interviews, medical record reviews, and a detailed cognitive assessment, including neuropsychological testing. Differences between participants determined to have normal cognition, MCI, and dementia were assessed statistically using analysis of variance for continuous variables, χ2 or Fisher exact tests for categorical variables, or Fisher exact test alone when expected cell counts were 5 or less., Results: A total of 844 eligible individuals were consecutively approached, 294 consented to participate, and 204 completed the study (mean [SD] age, 70.0 [5.1] years; 127 women [62.3%]). One hundred eight participants (52.9%) were African American, 5 (2.5%) were Hispanic, 199 (97.5%) were not Hispanic, and 90 (44.1%) were White. The mean (SD) duration of education was 13.1 (2.6) years, and the mean (SD) Area Deprivation Index score was 78.3 (19.9), indicating a high level of neighborhood disadvantage. In total, 127 patients (62.3%) met the diagnostic criteria for MCI, 25 (12.3%) had dementia, and 52 (25.5%) had no cognitive impairment. Compared with non-Hispanic White individuals and after adjusting for age, sex, and education level, African American individuals were more than twice as likely to have MCI or dementia (odds ratio, 2.73; 95% CI, 1.38-5.53; P = .02)., Conclusions and Relevance: This cross-sectional study found that unrecognized cognitive impairment is ubiquitous among older adults from underrepresented, minoritized racial and ethnic groups and those who are socially vulnerable receiving primary care from FQHCs. To overcome the disparity in early detection of cognitive impairment, timely, equitable, scalable, and sustainable detection approaches need to be developed.

Objectives: Patient-family member dyads experience transitions through illness as an interdependent team. This study measures the association of depression, anxiety, and health-related quality of life (HRQOL) of older adult primary care patient-family member dyads., Methods: Baseline data from 1,808 patient-family member dyads enrolled in a trial testing early detection of Alzheimer's disease and related dementias in primary care. Actor-Partner Independence Model was used to analyze dyadic relationships between patients' and family members' depression (PHQ-9), anxiety (GAD-7), and HRQOL (SF-36 Physical Component Summary score and Mental Component Summary score)., Results: Family member mean (SD) age is 64.2 (13) years; 32.2% male; 84.6% White; and 64.8% being the patient's spouse/partner. Patient mean (SD) age is 73.7 (5.7) years; 47% male; and 85.1% White. For HRQOL, there were significant actor effects for patient and family member depression alone and depression and anxiety together on their own HRQOL ( p  < 0.001). There were significant partner effects where family member depression combined with anxiety was associated with the patient's physical component summary score of the SF-36 ( p  = 0.010), and where the family member's anxiety alone was associated with the patient's mental component summary score of the SF-36 ( p  = 0.031)., Conclusion: Results from this study reveal that many dyads experience covarying health status (e.g. depression, anxiety) even prior to entering a caregiving situation.

Importance: Over 50% of Acute Respiratory Failure (ARF) survivors experience cognitive, physical, and psychological impairments that negatively impact their quality of life (QOL)., Objective: To evaluate the efficacy of a post-intensive care unit (ICU) program, the Mobile Critical Care Recovery Program (m-CCRP) consisting of a nurse care coordinator supported by an interdisciplinary team, in improving the QOL of ARF survivors., Design, Setting, and Participants: This randomized clinical trial with concealed outcome assessments among ARF survivors was conducted from March 1, 2017, to April 30, 2022, with a 12-month follow-up. Patients were admitted to the ICU services of 4 Indiana hospitals (1 community, 1 county, 2 academic), affiliated with the Indiana University School of Medicine., Intervention: A 12-month nurse-led collaborative care intervention (m-CCRP) supported by an interdisciplinary group of clinicians (2 intensivists, 1 geriatrician, 1 ICU nurse, and 1 neuropsychologist) was compared with a telephone-based control. The intervention comprised longitudinal symptom monitoring coupled with nurse-delivered care protocols targeting cognition, physical function, personal care, mobility, sleep disturbances, pain, depression, anxiety, agitation or aggression, delusions or hallucinations, stress and physical health, legal and financial needs, and medication adherence., Main Outcomes and Measures: The primary outcome was QOL as measured by the 36-item Medical Outcomes Study Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary (MCS), with scores on each component ranging from 0-100, and higher scores indicating better health status., Results: In an intention-to-treat analysis among 466 ARF survivors (mean [SD] age, 56.1 [14.4] years; 250 [53.6%] female; 233 assigned to each group), the m-CCRP intervention for 12 months did not significantly improve the QOL compared with the control group (estimated difference in change from baseline between m-CCRP and control group: 1.61 [95% CI, -1.06 to 4.29] for SF-36 PCS; -2.50 [95% CI, -5.29 to 0.30] for SF-36 MCS. Compared with the control group, the rates of hospitalization were higher in the m-CCRP group (117 [50.2%] vs 95 [40.8%]; P = .04), whereas the 12-month mortality rates were not statistically significantly lower (24 [10.3%] vs 38 [16.3%]; P = .05)., Conclusions and Relevance: Findings from this randomized clinical trial indicated that a nurse-led 12-month comprehensive interdisciplinary care intervention did not significantly improve the QOL of ARF survivors after ICU hospitalization. These results suggest that further research is needed to identify specific patient groups who could benefit from tailored post-ICU interventions., Trial Registration: ClinicalTrials.gov Identifier: NCT03053245.

Background: The primary aim of the current pilot study was to examine enrollment rate, data completion, usability, acceptance and use of a mobile telehealth application, Brain CareNotes. A secondary aim was to estimate the application's effect in reducing caregiver burden and behavioral and psychological symptoms related to dementia (BPSD)., Methods: Patient-caregiver dyads (n = 53) were recruited and randomized to intervention and control groups. Assessment of usability, acceptance, BPSD symptoms, and caregiver burden were collected at baseline, 3- and 6-month follow-up., Results: The enrollment rate was acceptable despite pandemic related challenges (53/60 target recruitment sample). Among randomized individuals, there was a retention rate of 85% and data completion was attained for 81.5% of those allocated to usual care and 88.5% of those allocated to Brain CareNotes. Mean caregiver-reported app usability at 6 months was 72.5 (IQR 70.0-90.0) on the System Usability Scale-considered "Good to Excellent"-and user acceptance was reasonable as indicated by 85%-90% of caregivers reporting they would intend to use the app to some degree in the next 6 months, if able. Regarding intervention effect, although differences in outcome measures between the groups were not statistically significant, compared to baseline, we found a reduction of caregiver burden (NPI-Caregiver Distress) of 1.0 at 3 months and 0.7 at 6 months for those in the intervention group. BPSD (NPI Total Score) was also reduced from baseline by 4.0 at 3 months and by 0.5 at 6 months., Conclusions: Brain CareNotes is a highly scalable, usable and acceptable mobile caregiver intervention. Future studies should focus on testing Brain CareNotes on a larger sample size to examine efficacy of reducing caregiver burden and BPSD., (© 2023 The Authors. Journal of the American Geriatrics Society published by Wiley Periodicals LLC on behalf of The American Geriatrics Society.)

Objective: In critically ill adults with delirium, biomarkers of systemic inflammation, astrocyte activation, neuroprotection, and systemic inflammation measured at one week of critical illness may be associated with mortality., Design: Prospective observational study., Setting: Intensive care unit (ICU)., Patients: 178 ICU patients with delirium, alive and remaining in ICU at one week., Interventions: None., Measurements and Main Results: Blood samples collected for a pair of previously published, negative, clinical trials were utilized. Samples were collected at study enrollment/ICU admission (Day 1 sample) and one week later (Day 8 sample), and analyzed for interleukins (IL)-6, 8, 10, Insulin-like Growth Factor (IGF), S100 Binding Protein (S100B), Tumor Necrosis Factor Alpha (TNF-A) and C-Reactive Protein (CRP). Delirium, delirium severity, and coma were assessed twice daily using Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), CAM-ICU-7, and Richmond Agitation-Sedation Scale (RASS), respectively. Mortality was assessed until discharge using the electronic medical record. Logistic regression models adjusting for age, sex, severity of illness, comorbidities, sepsis, and randomization status, were used to assess the relationship among biomarkers and mortality. Higher IL-10 quartiles at day 8 were associated with increased odds of hospital mortality (IL-10: OR 2.00 95%CI: 1.1-3.65, p = 0.023). There was a significant interaction between day 1 and day 8 biomarker quartiles only for IL-6. Patients with IL-6 values in the first three quartiles on admission to the ICU that transitioned to higher IL-6 quartiles at day 8 had increased probability of hospital mortality., Conclusion: In this hypothesis-generating study, higher IL-6 and IL-10 quartiles at one week, and increase in IL-6 from day 1 to day 8 were associated with increased hospital mortality. Studies with larger sample sizes are needed to confirm the mechanisms for these observations., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Khan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Alzheimer's Disease and related dementias affect 3.4 million community-dwelling adults in the United States. Given the burden of disease, a greater understanding of modifiable risk factors is crucial for targeted public health strategies. Social determinants of health (SDOH) are modifiable risk factors categorized in five domains: economic status, education, healthcare access, environment, and community context. Although individual SDOH have been linked to dementia, limited research exists on the interaction of SDOH with dementia across multiple domains. The aim of this study was to evaluate the association between SDOH across all five domains and dementia among community-dwelling adults in the United States. A cross-sectional study was performed on community-dwelling adults aged ≥65 years from the 2019 National Health Interview Survey (NHIS). Respondents ( N  = 9,277), of whom 303 (4%) self-reported positive dementia diagnosis, were predominantly female (55%), white (76%), and non-Hispanic (91%). Residing in a non-metropolitan area, having a usual place for healthcare, and receiving annual eye or dental exams were negatively associated with dementia. Minority compared to white status was not significantly associated with dementia, suggesting underdiagnosis of dementia within minority groups in the NHIS. We present the first comprehensive national view of SDOH among community-dwelling dementia patients in the United States., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2023.)

Objective: To leverage electronic health record (EHR) data to explore the relationship between weight gain and antipsychotic adherence among patients with schizophrenia and bipolar disorder (BD)., Methods: EHR data were used to identify individuals with at least 60 days of continuous antipsychotic use between 2005 and 2019. Patients were diagnosed with schizophrenia, schizoaffective disorder, BD, or neither diagnosis (psychiatric controls). We examined the association of weight gain in the first 90 days with the proportion of days covered (PDC) with an antipsychotic and with the frequency of medication switching or stopping., Results: We identified 590 adults with schizophrenia or schizoaffective disorder, 819 adults with BD, and 642 psychiatric controls. In the first 90 days, the percentages of patients with a PDC ≥ 0.80 were 76.8% (schizophrenia), 77.1% (BD), and 70.7% (controls). Logistic regression models revealed that weight gain of ≥ 7% trended toward being significantly associated with greater adherence in the first 90 days (odds ratio = 1.29, P  = .077) and was significantly associated with an increased likelihood of a medication switch in the first 180 days (odds ratio = 1.60, P  = .003)., Discussion: Patients whose weight increased by 7% or more in the first 90 days were more adherent but were also more likely to switch medications during the first 180 days., (© Copyright 2023 Physicians Postgraduate Press, Inc.)

Objectives: To study the predictive validity of the CMS Practice Assessment Tool (PAT) among 632 primary care practices., Study Design: Retrospective observational study., Methods: The study included primary care physician practices recruited by the Great Lakes Practice Transformation Network (GLPTN), 1 of 29 CMS-awarded networks, and used data from 2015 to 2019. At enrollment, trained quality improvement advisers scored each of the PAT's 27 milestones by its degree of implementation based on interviews with staff, review of documents, direct observation of practice activity, and professional judgment. The GLPTN also tracked each practice's status regarding alternative payment model (APM) enrollment. Exploratory factor analysis (EFA) was used to identify summary scores; mixed-effects logistic regression was used to assess the relationship between derived scores with APM participation., Results: EFA revealed that the PAT's 27 milestones could be summed into 1 overall score and 5 secondary scores. By the end of the 4-year project, 38% of practices were enrolled in an APM. A baseline overall score and 3 secondary scores were associated with increased odds of joining an APM (overall score: odds ratio [OR], 1.06; 95% CI, 0.99-1.12; P = .061; data-driven care quality score: OR, 1.11; 95% CI, 1.00-1.22; P = .040; efficient care delivery score: OR, 1.08; 95% CI, 1.03-1.13; P = .003; collaborative engagement score: OR, 0.88; 95% CI, 0.80-0.96; P = .005)., Conclusions: These results demonstrate that the PAT has adequate predictive validity for APM participation.

Background: Non-adherence to psychotropic medications is common in schizophrenia and bipolar disorders (BDs) leading to adverse outcomes. We examined patterns of antipsychotic use in schizophrenia and BD and their impact on subsequent acute care utilization., Methods: We used electronic health record (EHR) data of 577 individuals with schizophrenia, 795 with BD, and 618 using antipsychotics without a diagnosis of either illness at two large health systems. We structured three antipsychotics exposure variables: the proportion of days covered (PDC) to measure adherence; medication switch as a new antipsychotic prescription that was different than the initial antipsychotic; and medication stoppage as the lack of an antipsychotic order or fill data in the EHR after the date when the previous supply would have been depleted. Outcome measures included the frequency of inpatient and emergency department (ED) visits up to 12 months after treatment initiation., Results: Approximately half of the study population were adherent to their antipsychotic medication (a PDC ≥ 0.80): 53.6% of those with schizophrenia, 52.4% of those with BD, and 50.3% of those without either diagnosis. Among schizophrenia patients, 22.5% switched medications and 15.1% stopped therapy. Switching and stopping occurred in 15.8% and 15.1% of BD patients and 7.4% and 20.1% of those without either diagnosis, respectively. Across the three cohorts, non-adherence, switching, and stopping therapy were all associated with increased acute care utilization, even after adjusting for baseline demographics, health insurance, past acute care utilization, and comorbidity., Conclusion: Non-continuous antipsychotic use is common and associated with high acute care utilization., (© 2023. The Author(s).)

Background: Deprescribing interventions delivered through the electronic medical record have not significantly reduced the use of high-risk anticholinergics in prior trials. Pharmacists have been identified as ideal practitioners to conduct deprescribing; however, little experience beyond collaborative consult models has been published., Objective: To evaluate the impact of two pilot pharmacist-based advanced practice models nested within primary care., Methods: Pilot studies of a collaborative clinic-based pharmacist deprescribing intervention and a telephone-based pharmacist deprescribing intervention were conducted. Patients receiving the clinic-based pharmacy model were aged 55 years and older and referred for deprescribing at a specialty clinic. Patients receiving the telephone-based pharmacy model were aged 65 years and older and called by a clinical pharmacist for deprescribing without referral. Deprescribing was defined as a discontinuation or dose reduction reported either in clinical records or through self-reporting., Results: The 18 patients receiving clinic-based deprescribing had a mean age of 68 years and 78% were female. Among 24 medications deemed eligible for deprescribing, 23 (96%) were deprescribed. The clinic-based deprescribing model resulted in a 93% reduction in median annualized total standardized dose (TSD), 56% lowered their annualized exposure below a cognitive risk threshold, and 4 (17%) of medications were represcribed within 6 months. The 24 patients receiving telephone-based deprescribing had a mean age of 73 years and 92% were female. Among 24 medications deemed eligible for deprescribing, 12 (50%) were deprescribed. There was no change in the median annualized TSD, the annualized TSD was lowered below a cognitive risk threshold in 46%, and no medications were represcribed within 6 months. Few withdrawal symptoms or adverse events were reported in both groups., Conclusions: Pharmacist-based deprescribing successfully reduced exposure to high-risk anticholinergics in primary care older adults, yet further work is needed to understand the impact on clinical outcomes., Competing Interests: The authors declare no conflicts of interest., (© 2022 The Authors. JACCP: Journal of the American College of Clinical Pharmacy published by Wiley Periodicals LLC on behalf of Pharmacotherapy Publications, Inc.)

Severe delirium is associated with an increased risk of mortality, institutionalization, and length of stay. Few studies have examined differences in delirium severity between different populations of critically ill patients. The objective of the study was to compare delirium severity and the presence of the four core features between adults in the surgical intensive care unit (SICU) and medical intensive care unit (MICU) while controlling for variables known to be associated with delirium. This is a secondary analysis of two parallel randomized multi-center trials conducted from March 2009 to January 2015 at 3 Indianapolis hospitals. A total of 474 adults with delirium were included in the analysis. Subjects were randomized in a 1:1 ratio in random blocks of 4 by a computer program. Patients were randomized to either haloperidol prescribing or de-prescribing regimen vs usual care. Delirium severity was assessed daily or twice-daily using the CAM-ICU-7 beginning after 24 h of ICU admission and until discharge from the hospital, death, or 30 days after enrollment. Secondary outcomes included hospital length of stay, hospital and 30-day mortality, and delirium-related adverse events. These outcomes were compared between SICU and MICU settings for this secondary analysis. Out of 474 patients, 237 were randomized to intervention. At study enrollment, the overall cohort had a mean age of 59 (SD 16) years old, was 54% female, 44% African-American, and 81% were mechanically ventilated upon enrollment. MICU participants were significantly older and severely ill with a higher premorbid cognitive and physical dysfunction burden. In univariate analysis, SICU participants had significantly higher mean total CAM-ICU-7 scores, corresponding to delirium severity, (4.15 (2.20) vs 3.60 (2.32), p = 0.02), and a lower mean RASS score (- 1.79 (1.28) vs - 1.53 (1.27), p < 0.001) compared to MICU participants. Following adjustment for benzodiazepines and opioids, delirium severity did not significantly differ between groups. The presence of Feature 3, altered level of consciousness, was significantly associated with the SICU participants, identifying as Black, premorbid functional impairment, benzodiazepines, opioids, and dexmedetomidine. In this secondary analysis examining differences in delirium severity between MICU and SICU participants, we did not identify a difference between participant populations following adjustment for administered benzodiazepines and opioids. We did identify that an altered level of consciousness, core feature 3 of delirium, was associated with SICU setting, identifying as Black, activities of daily living, benzodiazepines and opioid medications. These results suggest that sedation practice patterns play a bigger role in delirium severity than the underlying physiologic insult, and expression of core features of delirium may vary based on individual factors.Trial registration CT#: NCT00842608., (© 2022. The Author(s).)

Given that participants' experiences in clinical trials include a variety of communication touchpoints with clinical trial staff, these communications should be designed in a way that enhances the participant experience by paying attention to the self-determination theoretical concepts of competence, autonomy, and relatedness. In this feature, we argue that clinical trial teams need to consider the importance of how they design their written participant communication materials, and we explain in detail the process our multidisciplinary team took to design written materials for the patient and family caregiver participants in our Alzheimer's disease and related dementias (ADRD) screening trial. This article concludes with suggested guidance and steps for other clinical trial teams., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2022.)

Delirium severity has been associated with a higher risk of mortality and an increasing morbidity burden. Recently defined delirium severity trajectories were predictive of 30-day mortality in a critically ill patient population. No studies to date have examined associations between delirium severity trajectories and 2-year mortality and healthcare utilization outcomes., Objectives: To examine the associations between recently defined delirium severity trajectories and 2-year healthcare utilization outcomes of emergency department visits, rehospitalizations, and mortality., Design Setting and Participants: This is a secondary analysis using data from the randomized controlled clinical trial Pharmacological Management of Delirium in the Intensive Care Unit and Deprescribing in the Pharmacologic Management of Delirium trial conducted from 2009 to 2015. Patients who were greater than or equal to 18 years old, were in the ICU for greater than or equal to 24 hours, and had a positive delirium assessment (Confusion Assessment Method for the ICU) were included in the original trial. Participants were included in the secondary analysis if 2-year healthcare utilization and mortality data were available ( n = 431)., Main Outcomes and Measures: Healthcare utilization data within 2 years of the initial discharge date were pulled from the Indiana Network for Patient Care. Data over a 2-year period on emergency department visits (days to first emergency department visit, number of emergency department visits), inpatient hospitalizations (days to first hospitalizations, number of hospitalizations), and mortality (time to death) were extracted. Univariate relationships, Cox proportional hazard models, and competing risk modeling were used to examine statistical relationships in SAS v9.4., Results: The overall sample ( n = 431) had a mean age of 60 (sd, 16), 56% were females, and 49% African-Americans. No significant associations were identified between delirium severity trajectories and time to event for emergency department visit, mortality, or rehospitalization within 2 years of the index hospital discharge., Conclusions and Relevance: This secondary analysis did not identify a significant relationship between delirium severity trajectories and healthcare utilization or mortality within 2 years of hospital discharge., Competing Interests: Drs. Lindroth was supported by T32: National Heart, Lung, and Blood Institute (NHLBI) 5T32HL091816-07. Drs. Gao and Khan are supported by NHLBI R01HL131730 and NIA R01AG055391. Dr. Boustani was supported by National Institute on Aging (NIA) R01AG034205. The remaining authors have disclosed that they do not have any conflicts of interest., (Copyright © 2021 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine.)

Objective: To test the impact of a multicomponent behavioral intervention to reduce the use of high-risk anticholinergic medications in primary care older adults., Design: Cluster-randomized controlled trial., Setting and Participants: Ten primary care clinics within Eskenazi Health in Indianapolis., Intervention: The multicomponent intervention included provider- and patient-focused components. The provider-focused component was computerized decision support alerting of the presence of a high-risk anticholinergic and offering dose- and indication-specific alternatives. The patient-focused component was a story-based video providing education and modeling an interaction with a healthcare provider resulting in a medication change. Alerts within the medical record triggered staff to play the video for a patient. Our design intended for parallel, independent priming of both providers and patients immediately before an outpatient face-to-face interaction., Measurement: Medication orders were extracted from the electronic medical record system to evaluate the prescribing behavior and population prevalence of anticholinergic users. The intervention was introduced April 1, 2019, through March 31, 2020, and a preintervention observational period of April 1, 2018, through March 31, 2019, facilitated difference in difference comparisons., Results: A total of 552 older adults had visits at primary care sites during the study period, with mean age of 72.1 (SD 6.4) years and 45.3% African American. Of the 259 provider-focused alerts, only three (1.2%) led to a medication change. Of the 276 staff alerts, 4.7% were confirmed to activate the patient-focused intervention. The intervention resulted in no significant differences in either the number of discontinue orders for anticholinergics (intervention: two additional orders; control: five fewer orders, p = 0.7334) or proportion of the population using anticholinergics following the intervention (preintervention: 6.2% and postintervention: 5.1%, p = 0.6326)., Conclusion: This multicomponent intervention did not reduce the use of high-risk anticholinergics in older adults receiving primary care. Improving nudges or a policy-focused component may be necessary to reduce use of high-risk medications., (© 2021 The American Geriatrics Society.)

Introduction: A growing body of scientific evidence points to the potentially harmful cognitive effects of anticholinergic medications among older adults. Most interventions designed to promote deprescribing of anticholinergics have directly targeted healthcare professionals and have had mixed results. Consumer-facing technologies may provide a unique benefit by empowering patients and can complement existing healthcare professional-centric efforts., Methods: We initiated a randomized clinical trial to evaluate the effectiveness of a patient-facing mobile application (Brain Safe app) compared to an attention control medication list app in reducing anticholinergic exposure among community-dwelling older adults. Study participants are adults aged 60 years and above, currently using at least one prescribed strong anticholinergic, and receiving primary care. The trial plans to enroll a total of 700 participants, randomly allocated in 1:1 proportion to the two study arms. Participants will have the Brain Safe app (intervention arm) or attention control medication list app (control arm) loaded onto a smartphone (study provided or personal device). All participants will be followed for 12 months and will have data collected at baseline, at 6 months, and 12 months by blinded outcome assessors. The primary outcome of the study is anticholinergic exposure measured as total standard daily dose (TSDD) computed from medication prescription electronic records. Secondary outcomes of the study are cognitive function and health-related quality of life., Discussion: A consumer-facing intervention to promote deprescribing of potentially high-risk medications can be part of a multi-pronged approach to reduce inappropriate medication use among older adult patients. Delivering a deprescribing intervention via a mobile app is a novel approach and may hold great promise to accelerate deployment of medication safety initiatives across diverse patient populations., Clinical Trial Registration: Registered at ClinicalTrials.gov on October 10, 2019. Identifier number: NCT04121858., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Informal caregivers of patients with Alzheimer's disease and related dementias (ADRD) manage a complex spectrum of patient behavioral and psychological symptoms of dementia (BPSD). Mobile health information technologies have quickly become sources for modern social support and chronic disease management. These technologies can improve our understanding of how to care for patients with ADRD and their informal caregivers. A mobile telehealth intervention could help reduce caregiver burden and BPSD., Methods: This is a pilot randomized controlled trial of 60 dyads of patients living with ADRD and their caregivers, to test the feasibility and estimate the potential effect of the Brain CareNotes (BCN) mobile telehealth system. Participants will be recruited from two health systems. Participants will be randomly assigned to either the BCN intervention arm or usual care comparator. Data will be collected at baseline, 3- and 6-month follow-up. The primary objectives of this trial are to assess feasibility outcomes: (a) recruitment rate, (b) data completion, (c) BCN usability, (d) BCN acceptance, and (e) BCN use and assessed either on an ongoing basis or at 3- and 6-month post-intervention. A secondary objective was to estimate the intervention's effects on caregiver burden and patient BPSD outcomes at 3 and 6 months, assessed by the Neuropsychiatric Inventory., Discussion: The study will assess the intervention feasibility and potential effect size of the BCN telehealth system as a potentially scalable and lower-cost solution for addressing the ADRD public health crisis., Trial Registration: Clinical Trials. NCT03119259 . Registered on April 18, 2017.

Rationale: Delirium severity and duration are independently associated with higher mortality and morbidity. No studies to date have described a delirium trajectory by integrating both severity and duration. Objectives: The primary aim was to develop delirium trajectories by integrating symptom severity and duration. The secondary aim was to investigate the association among trajectory membership, clinical characteristics, and 30-day mortality. Methods: A secondary analysis of the PMD (Pharmacologic Management of Delirium) randomized control trial (ClinicalTrials.gov Identifier: NCT00842608; N  = 531) was conducted. The presence of delirium and symptom severity were measured at least daily for 7 days using the Confusion Assessment Method for the intensive care unit (CAM-ICU) and CAM-ICU-7 (on a scale of 0-7, with 7 being the most severe). Delirium trajectories were defined using an innovative, data-driven statistical method (group-based trajectory modeling [GBTM]) and SAS v9.4. Results: A total of 531 delirious participants (mean age 60 yr [standard deviation = 16], 55% female, and 46% African American) were analyzed. Five distinct delirium trajectories were described (CAM-ICU-7: mean [standard deviation]); mild-brief (CAM-ICU-7: 0.5 [0.5]), severe-rapid recovers (CAM-ICU-7: 2.1 [1.0]), mild-accelerating (CAM-ICU-7: 2.2 [0.9]), severe-slow recovers (CAM-ICU-7: 3.9 [0.9]), and severe-nonrecovers (CAM-ICU-7: 5.9 [1.0]). Baseline cognition and race were associated with trajectory membership. Trajectory membership independently predicted 30-day mortality while controlling for age, sex, race, cognition, illness severity, and comorbidities. Conclusions: This secondary analysis described five distinct delirium trajectories based on delirium symptom severity and duration using group-based trajectory modeling. Trajectory membership predicted 30-day mortality.

As the prevalence of persons with dementia increases, a larger, trained, and skilled healthcare workforce is needed. Attention has been given to models of person-centered care as a standard for dementia care. One promising role to deliver person-centered care is the care coordinator assistant. An inquiry about care coordinator assistant's job satisfaction is reasonable to consider for retention and quality improvement purposes. We evaluated care coordinator assistants' job satisfaction quantitatively and qualitatively. This study was part of a Centers for Medicare & Medicaid Services Health Care Innovation Award to the Indiana University School of Medicine. Sixteen care coordinator assistants, predominately female, African American or Caucasian, college graduates with a mean age of 43.1 years participated. Care coordinator assistants wrote quarterly case reports to share stories, lessons learned, and/or the impact of their job and completed the revised Job Satisfaction Inventory and Job in General scales during the second year of the Centers for Medicare & Medicaid Services award. For the Job Descriptive Index subscales promotion, supervision, and coworkers and Job in General, care coordinator assistants scored similar to normative means. Care coordinator assistants reported significantly higher satisfaction on the work subscale and significantly lower satisfaction on the pay subscale compared to normative data. Care coordinator assistants completed 119 quarterly case reports. Job satisfaction and teamwork were recurring themes in case reports, referenced in 47.1% and 60.5% of case reports, respectively. To address the demands of increasing dementia diagnoses, care coordinator assistants can constitute a compassionate, competent, and satisfied workforce. Training care coordinator assistants to work together in a team to address the needs of persons with dementia and caregivers provides a viable model of workforce development necessary to meet the growing demands of this population.

Background/objective: The benefits and harms of screening of Alzheimer disease and related dementias (ADRDs) are unknown. This study addressed the question of whether the benefits outweigh the harms of screening for ADRDs among older adults in primary care., Design, Setting, and Participants: Single-blinded, two-arm, randomized controlled trial (October 2012-September 2016) in urban, suburban, and rural primary care settings in Indiana. A total of 4005 primary care patients (aged ≥65 years) were randomized to ADRD screening (n = 2008) or control (n = 1997)., Intervention: Patients were screened using the Memory Impairment Screen or the Mini-Cog and referred for a voluntary follow-up diagnostic assessment if they screened positive on either or both screening tests., Measurements: Primary measures were health-related quality of life (HRQOL; Health Utilities Index) at 12 months, depressive symptoms (Patient Health Questionnaire-9), and anxiety symptoms (Generalized Anxiety Disorder seven-item scale) at 1 month., Results: The mean age was 74.2 years (SD = 6.9 years); 2257 (66%) were female and 2301 (67%) were white. At 12 months, we were unable to detect differences in HRQOL between the groups (effect size = 0.009 [95% confidence interval {CI} = -0.063 to 0.080]; P = .81). At 1 month, differences in mean depressive symptoms (mean difference = -0.23 [90% CI = -0.42 to -0.039]) and anxiety symptoms (mean difference = -0.087 [90% CI = -0.246 to 0.072]) were within prespecified equivalency range. Scores for depressive and anxiety symptoms were similar between the groups at all time points. No differences in healthcare utilization, advance care planning, and ADRD recognition by physicians were detected at 12 months., Conclusion: We were unable to detect a difference in HRQOL for screening for ADRD among older adults. We found no harm from screening measured by symptoms of depression or anxiety. Missing data, low rates of dementia detection, and high rate of refusal for follow-up diagnostic assessments after a positive screen may explain these findings. J Am Geriatr Soc 68:535-543, 2020., (© 2019 The American Geriatrics Society.)

Objectives: Both delirium duration and delirium severity are associated with adverse patient outcomes. Serum biomarkers associated with delirium duration and delirium severity in ICU patients have not been reliably identified. We conducted our study to identify peripheral biomarkers representing systemic inflammation, impaired neuroprotection, and astrocyte activation associated with delirium duration, delirium severity, and in-hospital mortality., Design: Observational study., Setting: Three Indianapolis hospitals., Patients: Three-hundred twenty-one critically ill delirious patients., Interventions: None., Measurements and Main Results: We analyzed the associations between biomarkers collected at delirium onset and delirium-/coma-free days assessed through Richmond Agitation-Sedation Scale/Confusion Assessment Method for the ICU, delirium severity assessed through Confusion Assessment Method for the ICU-7, and in-hospital mortality. After adjusting for age, gender, Acute Physiology and Chronic Health Evaluation II score, Charlson comorbidity score, sepsis diagnosis and study intervention group, interleukin-6, -8, and -10, tumor necrosis factor-α, C-reactive protein, and S-100β levels in quartile 4 were negatively associated with delirium-/coma-free days by 1 week and 30 days post enrollment. Insulin-like growth factor-1 levels in quartile 4 were not associated with delirium-/coma-free days at both time points. Interleukin-6, -8, and -10, tumor necrosis factor-α, C-reactive protein, and S-100β levels in quartile 4 were also associated with delirium severity by 1 week. At hospital discharge, interleukin-6, -8, and -10 retained the association but tumor necrosis factor-α, C-reactive protein, and S-100β lost their associations with delirium severity. Insulin-like growth factor-1 levels in quartile 4 were not associated with delirium severity at both time points. Interleukin-8 and S-100β levels in quartile 4 were also associated with higher in-hospital mortality. Interleukin-6 and -10, tumor necrosis factor-α, and insulin-like growth factor-1 were not found to be associated with in-hospital mortality., Conclusions: Biomarkers of systemic inflammation and those for astrocyte and glial activation were associated with longer delirium duration, higher delirium severity, and in-hospital mortality. Utility of these biomarkers early in delirium onset to identify patients at a higher risk of severe and prolonged delirium, and delirium related complications during hospitalization needs to be explored in future studies.

Background: Multiple national expert panels have identified early detection of Alzheimer's disease and related dementias (ADRD) as a national priority. However, the United States Preventive Services Task Force (USPSTF) does not currently support screening for ADRD in primary care given that the risks and benefits are unknown. The USPSTF stresses the need for research examining the impact of ADRD screening on family caregiver outcomes., Methods: The Caregiver Outcomes of Alzheimer's Disease Screening (COADS) is a randomized controlled trial that will examine the potential benefits or harms of ADRD screening on family caregivers. It will also compare the effectiveness of two strategies for diagnostic evaluation and management after ADRD screening. COADS will enroll 1800 dyads who will be randomized into three groups (n = 600/group): the 'Screening Only' group will receive ADRD screening at baseline and disclosure of the screening results, with positive-screen participants receiving a list of local resources for diagnostic follow-up; the 'Screening Plus' group will receive ADRD screening at baseline coupled with disclosure of the screening results, with positive-screen participants referred to a dementia collaborative care program for diagnostic evaluation and potential care; and the control group will receive no screening. The COADS trial will measure the quality of life of the family member (the primary outcome) and family member mood, anxiety, preparedness and self-efficacy (the secondary outcomes) at baseline and at 6, 12, 18 and 24 months. Additionally, the trial will examine the congruence of depressive and anxiety symptoms between older adults and family members at 6, 12, 18 and 24 months and compare the effectiveness of two strategies for diagnostic evaluation and management after ADRD screening between the two groups randomized to screening (Screening Only versus Screening Plus)., Discussion: We hypothesize that caregivers in the screening arms will express higher levels of health-related quality of life, lower depressive and anxiety symptoms, and better preparation for caregiving with higher self-efficacy at 24 months. Results from this study will directly inform the National Plan to Address Alzheimer's Disease, the USPSTF and other organizations regarding ADRD screening and early detection policies., Trial Registration: ClinicalTrials.gov, NCT03300180. Registered on 3 October.

Our aim is to develop a machine learning (ML) model that can predict dementia in a general patient population from multiple health care institutions one year and three years prior to the onset of the disease without any additional monitoring or screening. The purpose of the model is to automate the cost-effective, non-invasive, digital pre-screening of patients at risk for dementia. Towards this purpose, routine care data, which is widely available through Electronic Medical Record (EMR) systems is used as a data source. These data embody a rich knowledge and make related medical applications easy to deploy at scale in a cost-effective manner. Specifically, the model is trained by using structured and unstructured data from three EMR data sets: diagnosis, prescriptions, and medical notes. Each of these three data sets is used to construct an individual model along with a combined model which is derived by using all three data sets. Human-interpretable data processing and ML techniques are selected in order to facilitate adoption of the proposed model by health care providers from multiple institutions. The results show that the combined model is generalizable across multiple institutions and is able to predict dementia within one year of its onset with an accuracy of nearly 80% despite the fact that it was trained using routine care data. Moreover, the analysis of the models identified important predictors for dementia. Some of these predictors (e.g., age and hypertensive disorders) are already confirmed by the literature while others, especially the ones derived from the unstructured medical notes, require further clinical analysis., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Mobile health technology can improve medication safety for older adults, for instance, by educating patients about the risks associated with anticholinergic medication use., Objective: This study's objective was to test the usability and feasibility of Brain Buddy, a consumer-facing mobile health technology designed to inform and empower older adults to consider the risks and benefits of anticholinergics., Methods: Twenty-three primary care patients aged ≥60 years and using anticholinergic medications participated in summative, task-based usability testing of Brain Buddy. Self-report usability was assessed by the System Usability Scale and performance-based usability data were collected for each task through observation. A subset of 17 participants contributed data on feasibility, assessed by self-reported attitudes (feeling informed) and behaviors (speaking to a physician), with confirmation following a physician visit., Results: Overall usability was acceptable or better, with 100% of participants completing each Brain Buddy task and a mean System Usability Scale score of 78.8, corresponding to "Good" to "Excellent" usability. Observed usability issues included higher rates of errors, hesitations, and need for assistance on three tasks, particularly those requiring data entry. Among participants contributing to feasibility data, 100% felt better informed after using Brain Buddy and 94% planned to speak to their physician about their anticholinergic related risk. On follow-up, 82% reported having spoken to their physician, a rate independently confirmed by physicians., Conclusion: Consumer-facing technology can be a low-cost, scalable intervention to improve older adults' medication safety, by informing and empowering patients. User-centered design and evaluation with demographically heterogeneous clinical samples uncovers correctable usability issues and confirms the value of interventions targeting consumers as agents in shared decision making and behavior change., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Antipsychotics are prescribed to treat various symptoms in older adults, however, their safety in this context has not been fully evaluated. The objective was to evaluate mortality risks associated with off-label use of antipsychotics among older adults with no preexisting mental illness or dementia relative to those with diagnosis of dementia., Methods: Data (2007-2015) were derived from Department of Veterans Affairs registries for 730,226 patients (≥65 years) with no baseline serious mental illness, dementia). We estimated the cumulative incidence of antipsychotics prescription and 10-year all-cause mortality. The extended Cox models were used to estimate Hazard Ratios (HRs) associated with antipsychotics prescription, adjusted for time-varying covariates, dementia diagnosis, comorbidity index score, and age at time of first exposure to antipsychotics., Results: The study included 98% males, 13% African Americans, and 81% Caucasian. Patients with dementia and antipsychotics had the highest risk of mortality (78.0%), followed by (73.0%) for patients with dementia alone and compared with patients without dementia or antipsychotics exposure who had the lowest mortality risk (42.0%). Exposure to typical antipsychotics was associated with (HR: 2.1, confidence interval [CI] 2.0-2.2) compared with atypical antipsychotics (HR: 1.5, CI 1.4-1.5, p = <.0001)., Conclusion: In a large cohort of older adults, antipsychotics were associated with an increased risk of all-cause mortality. While significant increase in mortality was attributable to the diagnosis of dementia, the addition of antipsychotics resulted in added mortality risk among all patients. Antipsychotic medications should be used cautiously in all older adults, not only those with dementia., (Published by Oxford University Press on behalf of The Gerontological Society of America 2019.)

Background/objective: Delirium in the intensive care units (ICUs) is prevalent, with both delirium duration and delirium severity associated with adverse outcomes. We designed a pragmatic trial to test the efficacy of a pharmacological management of delirium (PMD) bundle in improving delirium/coma-free days and reducing delirium severity among ICU patients., Design: A randomized pragmatic clinical trial., Setting: Medical, surgical, and progressive ICUs of three tertiary care hospitals., Participants: A total of 351 critically ill patients., Intervention: A multicomponent PMD bundle consisting of reducing the exposure to 20 definite anticholinergic medications and benzodiazepines and prescribing low-dose haloperidol., Measurements: The primary outcomes were delirium/coma-free days, measured through the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the ICU (CAM-ICU), and delirium severity, measured through Delirium Rating Scale-Revised-98 and the CAM-ICU-7. Secondary outcomes were in-hospital and posthospital discharge 30-day mortality, ICU and hospital lengths of stay, and delirium-related hospital complications., Results: We randomized 351 critically ill delirious patients (mean age = 59.3 years [SD = 16.9 years]; 52% female, 42% African Americans) to receive the PMD bundle or usual care. There were no significant differences in median delirium/coma-free days at day 8 (PMD vs usual care = 4 [interquartile range {IQR} = 2-7] days vs 5 [IQR = 1-7] days; P = .888) or at day 30 (PMD vs usual care = 26 [IQR 19-29] days vs 26 [IQR, 14-29] days; P = .991). There were no significant differences for decrease in delirium severity at day 8, but at hospital discharge, the intervention group showed a greater reduction in delirium severity (mean decrease in CAM-ICU-7 score for PMD vs usual care = 3.2 [SD = 3.3] vs 2.5 [SD = 3.2]; P = .046). No differences were observed between groups for ICU and hospital lengths of stay, mortality, and delirium-related hospital complications. Similar results were observed when analyses were limited to patients 65 years or older and 75 years or older., Conclusion and Relevance: Implementing the PMD bundle in the ICU did not reduce delirium duration or severity among critically ill patients., Trial Registration: clinicaltrials.gov Identifier: NCT00842608. J Am Geriatr Soc 67:1057-1065, 2019., (© 2019 The American Geriatrics Society.)

Objective: Benzodiazepines and anticholinergics are risk factors for delirium in the intensive care unit (ICU). We tested the impact of a deprescribing intervention on short-term delirium outcomes., Design: Multisite randomized clinical trial., Setting: ICUs of three large hospitals., Participants: Two hundred adults aged 18 years or older and admitted to an ICU with delirium, according to the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the ICU (CAM-ICU). Participants had a contraindication to haloperidol (seizure disorder or prolonged QT interval) or preference against haloperidol as a treatment for delirium, and were excluded for serious mental illness, stroke, pregnancy, or alcohol withdrawal. Participants were randomized to a deprescribing intervention or usual care. The intervention included electronic alerts combined with pharmacist support to deprescribe anticholinergics and benzodiazepines., Measurements: Primary outcomes were delirium duration measured by the CAM-ICU and severity measured by the Delirium Rating Scale Revised-98 (DRS-R-98) and the CAM-ICU-7; secondary outcomes included adverse events and mortality., Results: Participants had a mean age of 61.8 (SD = 14.3) years, 59% were female, and 52% were African American, with no significant differences in baseline characteristics between groups. No differences between groups were identified in the number exposed to anticholinergics (P = .219) or benzodiazepines (P = .566), the median total anticholinergic score (P = .282), or the median total benzodiazepine dose in lorazepam equivalents (P = .501). Neither median delirium/coma-free days (P = .361) nor median change in delirium severity scores (P = .582 for DRS-R-98; P = .333 for CAM-ICU-7) were different between groups. No differences in adverse events or mortality were identified., Conclusions: When added to state-of-the-art clinical services, this deprescribing intervention had no impact on medication use in ICU participants. Given the age of the population, results of clinical outcomes may not be easily extrapolated to older adults. Nonetheless, improved approaches for deprescribing or preventing anticholinergics and benzodiazepines should be developed to determine the impact on delirium outcomes. J Am Geriatr Soc 67:695-702, 2019., (© 2019 The American Geriatrics Society.)

Background: Older adults purchase and use over-the-counter (OTC) medications with potentially significant adverse effects. Some OTC medications, such as those with anticholinergic effects, are relatively contraindicated for use by older adults due to evidence of impaired cognition and other adverse effects., Objective: To inform the design of future OTC medication safety interventions for older adults, this study investigated consumers' decision making and behavior related to OTC medication purchasing and use, with a focus on OTC anticholinergic medications., Methods: The study had a cross-sectional design with multiple methods. A total of 84 adults participated in qualitative research interviews (n = 24), in-store shopper observations (n = 39), and laboratory-based simulated OTC shopping tasks (n = 21). Simulated shopping participants also rank-ordered eight factors on their importance for OTC decision making., Results: Findings revealed that many participants had concerns about medication adverse effects, generally, but were not aware of age-related risk associated with the use of anticholinergic medications. Analyses produced a map of the workflow of OTC-related behavior and decision making as well as related barriers such as difficulty locating medications or comparing them to an alternative. Participants reported effectiveness, adverse effects or health risks, and price as most important to their OTC medication purchase and use decisions. A persona analysis identified two types of consumers: the habit follower, who frequently purchased OTC medications and considered them safe; and the deliberator, who was more likely to weigh their options and consider alternatives to OTC medications., Conclusion: A conceptual model of OTC medication purchase and use is presented. Drawing on study findings and behavioral theories, the model depicts dual processes for OTC medication decision making - habit-based and deliberation-based - as well as the antecedents and consequences of decision making. This model suggests several design directions for consumer-oriented interventions to promote OTC medication safety., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives: To assess the efficacy of haloperidol in reducing postoperative delirium in individuals undergoing thoracic surgery., Design: Randomized double-blind placebo-controlled trial., Setting: Surgical intensive care unit (ICU) of tertiary care center., Participants: Individuals undergoing thoracic surgery (N=135)., Intervention: Low-dose intravenous haloperidol (0.5 mg three times daily for a total of 11 doses) administered postoperatively., Measurements: The primary outcome was delirium incidence during hospitalization. Secondary outcomes were time to delirium, delirium duration, delirium severity, and ICU and hospital length of stay. Delirium was assessed using the Confusion Assessment Method for the ICU and delirium severity using the Delirium Rating Scale-Revised., Results: Sixty-eight participants were randomized to receive haloperidol and 67 placebo. No significant differences were observed between those receiving haloperidol and those receiving placebo in incident delirium (n=15 (22.1%) vs n=19 (28.4%); p = .43), time to delirium (p = .43), delirium duration (median 1 day, interquartile range (IQR) 1-2 days vs median 1 day, IQR 1-2 days; p = .71), delirium severity, ICU length of stay (median 2.2 days, IQR 1-3.3 days vs median 2.3 days, IQR 1-4 days; p = .29), or hospital length of stay (median 10 days, IQR 8-11.5 days vs median 10 days, IQR 8-12 days; p = .41). In the esophagectomy subgroup (n = 84), the haloperidol group was less likely to experience incident delirium (n=10 (23.8%) vs n=17 (40.5%); p = .16). There were no differences in time to delirium (p = .14), delirium duration (median 1 day, IQR 1-2 days vs median 1 day, IQR 1-2 days; p = .71), delirium severity, or hospital length of stay (median 11 days, IQR 10-12 days vs median days 11, IQR 10-15 days; p = .26). ICU length of stay was significantly shorter in the haloperidol group (median 2.8 days, IQR 1.1-3.8 days vs median 3.1 days, IQR 2.1-5.1 days; p = .03). Safety events were comparable between the groups., Conclusion: Low-dose postoperative haloperidol did not reduce delirium in individuals undergoing thoracic surgery but may be efficacious in those undergoing esophagectomy. J Am Geriatr Soc 66:2289-2297, 2018., (© 2018, Copyright the Authors Journal compilation © 2018, The American Geriatrics Society.)

Objectives: To examine the effect of the Medicare Annual Wellness Visit (AWV) on the detection of cognitive impairment and on follow-up cognitive care for older adults., Design: Retrospective matched-cohort study., Setting: United States., Participants: A 5% random sample of fee-for-service Medicare beneficiaries continuously enrolled for 12 months before and after an index ambulatory visit occurring from 2011 to 2013 with no claims evidence of cognitive impairment before index., Measurements: Outcomes include 12-month post-index visit claims-based measurements of cognitive impairment, including new Alzheimer's disease and related dementia (ADRD) diagnoses; medications for ADRD; and cognitive care-related diagnostic examination such as neurobehavioral testing, brain imaging, and blood tests for thyroid-stimulating hormone (TSH), serum B12, folate, and syphilis. We also measured changes in burden of anticholinergic medication., Results: There were no clinically relevant differences between the AWV and control groups in the rates of incident ADRD diagnoses (6.16% vs 6.86%, p<.001) and initiation of ADRD medications (1.00% vs 1.08%, p=.15), although there were differences favoring the AWV group in rates of TSH (39.80% vs 28.36%, p<.001), B12 (9.41% vs 6.97%, p<.001), folate (4.76% vs 3.72%, p<.001), and neurobehavioral (0.75% vs 0.55%, p<.001) testing., Conclusions: Although the AWV is correlated with an increase in some measures of cognitive care, such as laboratory testing for reversible causes of cognitive impairment, it does not appear to substantially increase recognition of undetected ADRD., (© 2018, Copyright the Authors Journal compilation © 2018, The American Geriatrics Society.)

Study Objective: To determine the influence of anticholinergic medications on transitions in cognitive diagnosis of older adults in primary care., Design: This observational cohort study was conducted over a mean follow-up of 3.2 years. Anticholinergic exposure was defined by pharmacy dispensing and claims records. Cognitive diagnosis was performed by an expert panel at baseline and annually up to 4 years., Data Source: Medication exposure and other clinical data were extracted from the Indiana Network for Patient Care (INPC). The cognitive diagnosis was derived from a cognitive screening and diagnosis study., Participants: A total of 350 adults 65 years and older without dementia and receiving primary care in a safety net health care system., Measurement and Main Results: Cognitive diagnosis followed a two-phase screening and consensus-based neuropsychiatric examination to determine a baseline diagnosis as normal cognition, mild cognitive impairment (MCI), or dementia, with a follow-up neuropsychiatric examination and consensus-based diagnosis repeated annually. The Anticholinergic Cognitive Burden scale was used to identify anticholinergics dispensed up to 10 years before enrollment and annually throughout the study. A total standard daily dose of anticholinergics was calculated by using pharmacy dispensing data from the INPC. Among 350 participants, a total of 978 diagnostic assessments were completed over a mean follow-up of 3.2 years. Compared with stable cognition, increasing use of strong anticholinergics calculated by total standard daily dose increased the odds of transition from normal cognition to MCI (odds ratio [OR] 1.15, 95% confidence interval [CI] 1.01-1.31, p = 0.0342). Compared with stable MCI, strong anticholinergics did not influence the reversion of MCI to normal cognition (OR 0.95, 95% CI 0.86-1.05, p = 0.3266)., Conclusion: De-prescribing interventions in older adults with normal cognition should test anticholinergics as potentially modifiable risk factors for cognitive impairment., (© 2018 Pharmacotherapy Publications, Inc.)

The workforce available to care for older adults has not kept pace with the need. In response to workforce limitations and the growing complexity of healthcare, scientists have tested new models of care that redesign clinical practice. This article describes why new models of care in aging, dementia, and mental health diffuse inadequately into the healthcare systems and communities where they might benefit older adults. We review a general framework for the diffusion of innovations and highlight the importance of other features of innovations that deter or facilitate diffusion. Although scientists often focus on generating evidence-based innovations, end-users apply their own criteria to determine an innovation's value. In 1962, Rogers suggested six features of an innovation that facilitate or deter diffusion suggested: relative advantage, compatibility with the existing environment, ease or difficulty of implementation, trial-ability or ability to "test drive", adaptability, and observed effectiveness. We describe examples of models of care in aging, dementia and mental health that enjoy a modicum of diffusion into practice and place the features of these models in the context of deterrents and facilitators for diffusion. Developers of models of care in aging, dementia, and mental health typically fail to incorporate the complexities of health systems, the barriers to diffusion, and the role of emotion into design considerations of new models. We describe agile implementation as a strategy to facilitate the speed and scale of diffusion in the setting of complex adaptive systems, social networks, and dynamic macroenvironments., (© 2018, Copyright the Authors Journal compilation © 2018, The American Geriatrics Society.)