Prevalence of Unrecognized Cognitive Impairment in Federally Qualified Health Centers.

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.

Mobile Critical Care Recovery Program for Survivors of Acute Respiratory Failure: A Randomized Clinical Trial.

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.

Relationship between health-related quality of life, depression, and anxiety in older primary care patients and their family members.

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.

Association between Change in the peripheral biomarkers of inflammation, astrocyte activation, and neuroprotection at one week of critical illness and hospital mortality in patients with delirium: A prospective cohort study.

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.

Technology caregiver intervention for Alzheimer's disease (I-CARE): Feasibility and preliminary efficacy of Brain CareNotes.

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.

Social Determinants of Health in Community-Dwelling Dementia Patients Aged 65 and Over: Analysis of the 2019 National Health Interview Survey.

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.

Association of Antipsychotic-Related Weight Gain With Treatment Adherence and Switching Using Electronic Medical Records Data.

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.

CMS Practice Assessment Tool validity for alternative payment models.

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.

The impact of antipsychotic adherence on acute care utilization.

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.

Delirium severity does not differ between medical and surgical intensive care units after adjusting for medication use.

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.

Development of Written Materials for Participants in an Alzheimer's Disease and Related Dementias Screening Trial.

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.

Deprescribing anticholinergics in primary care older adults: Experience from two models and impact on a continuous measure of exposure.

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.

Dynamic Delirium Severity Trajectories and Their Association With 2-Year Healthcare Utilization and Mortality Outcomes.

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.

Multicomponent behavioral intervention to reduce exposure to anticholinergics in primary care older adults.

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.

Reducing anticholinergic medication exposure among older adults using consumer technology: Protocol for a randomized clinical trial.

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.

Technology intervention to support caregiving for Alzheimer's disease (I-CARE): study protocol for a randomized controlled pilot trial.

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.

Delirium Severity Trajectories and Outcomes in ICU Patients. Defining a Dynamic Symptom Phenotype.

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.

Examining the benefits and harms of Alzheimer's disease screening for family members of older adults: study protocol for a randomized controlled trial.

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.