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.

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.

Biomarkers of Delirium Duration and Delirium Severity in the ICU.

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-100ß 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-100ß 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-100ß 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-100ß 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.

Targeting Functional Decline in Alzheimer Disease: A Randomized Trial.

BACKGROUND: Alzheimer disease results in progressive functional decline, leading to loss of independence. OBJECTIVE: To determine whether collaborative care plus 2 years of home-based occupational therapy delays functional decline. DESIGN: Randomized, controlled clinical trial. (ClinicalTrials.gov: NCT01314950). SETTING: Urban public health system. PATIENTS: 180 community-dwelling participants with Alzheimer disease and their informal caregivers. INTERVENTION: All participants received collaborative care for dementia. Patients in the intervention group also received in-home occupational therapy delivered in 24 sessions over 2 years. MEASUREMENTS: The primary outcome measure was the Alzheimer's Disease Cooperative Study Group Activities of Daily Living Scale (ADCS ADL); performance-based measures included the Short Physical Performance Battery (SPPB) and Short Portable Sarcopenia Measure (SPSM). RESULTS: At baseline, clinical characteristics did not differ significantly between groups; the mean Mini-Mental State Examination score for both groups was 19 (SD, 7). The intervention group received a median of 18 home visits from the study occupational therapists. In both groups, ADCS ADL scores declined over 24 months. At the primary end point of 24 months, ADCS ADL scores did not differ between groups (mean difference, 2.34 [95% CI, -5.27 to 9.96]). We also could not definitively demonstrate between-group differences in mean SPPB or SPSM values. LIMITATION: The results of this trial are indeterminate and do not rule out potential clinically important effects of the intervention. CONCLUSION: The authors could not definitively demonstrate whether the addition of 2 years of in-home occupational therapy to a collaborative care management model slowed the rate of functional decline among persons with Alzheimer disease. This trial underscores the burden undertaken by caregivers as they provide care for family members with Alzheimer disease and the difficulty in slowing functional decline. PRIMARY FUNDING SOURCE: National Institute on Aging.

The Confusion Assessment Method for the ICU-7 Delirium Severity Scale: A Novel Delirium Severity Instrument for Use in the ICU.

OBJECTIVES: Delirium severity is independently associated with longer hospital stays, nursing home placement, and death in patients outside the ICU. Delirium severity in the ICU is not routinely measured because the available instruments are difficult to complete in critically ill patients. We designed our study to assess the reliability and validity of a new ICU delirium severity tool, the Confusion Assessment Method for the ICU-7 delirium severity scale. DESIGN: Observational cohort study. SETTING: Medical, surgical, and progressive ICUs of three academic hospitals. PATIENTS: Five hundred eighteen adult (≥ 18 yr) patients. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Patients received the Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, and Delirium Rating Scale-Revised-98 assessments. A 7-point scale (0-7) was derived from responses to the Confusion Assessment Method for the ICU and Richmond Agitation-Sedation Scale items. Confusion Assessment Method for the ICU-7 showed high internal consistency (Cronbach's α = 0.85) and good correlation with Delirium Rating Scale-Revised-98 scores (correlation coefficient = 0.64). Known-groups validity was supported by the separation of mechanically ventilated and nonventilated assessments. Median Confusion Assessment Method for the ICU-7 scores demonstrated good predictive validity with higher odds (odds ratio = 1.47; 95% CI = 1.30-1.66) of in-hospital mortality and lower odds (odds ratio = 0.8; 95% CI = 0.72-0.9) of being discharged home after adjusting for age, race, gender, severity of illness, and chronic comorbidities. Higher Confusion Assessment Method for the ICU-7 scores were also associated with increased length of ICU stay (p = 0.001). CONCLUSIONS: Our results suggest that Confusion Assessment Method for the ICU-7 is a valid and reliable delirium severity measure among ICU patients. Further research comparing it to other delirium severity measures, its use in delirium efficacy trials, and real-life implementation is needed to determine its role in research and clinical practice.

Relationship Between African-American Race and Delirium in the ICU.

OBJECTIVES: Delirium is a highly prevalent syndrome of acute brain dysfunction among critically ill patients that has been linked to multiple risk factors, such as age, preexisting cognitive impairment, and use of sedatives; but to date, the relationship between race and delirium is unclear. We conducted this study to identify whether African-American race is a risk factor for developing ICU delirium. DESIGN: A prospective cohort study. SETTING: Medical and surgical ICUs of a university-affiliated, safety net hospital in Indianapolis, IN. PATIENTS: A total of 2,087 consecutive admissions with 1,008 African Americans admitted to the ICU services from May 2009 to August 2012. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Incident delirium was defined as first positive Confusion Assessment Method for the ICU result after an initial negative Confusion Assessment Method for the ICU; and prevalent delirium was defined as positive Confusion Assessment Method for the ICU on first Confusion Assessment Method for the ICU assessment. The overall incident delirium rate in African Americans was 8.7% compared with 10.4% in Caucasians (p = 0.26). The prevalent delirium rate was 14% in both African Americans and Caucasians (p = 0.95). Significant age and race interactions were detected for incident delirium (p = 0.02) but not for prevalent delirium (p = 0.3). The hazard ratio for incident delirium for African Americans in the 18-49 years age group compared with Caucasians of similar age was 0.4 (0.1-0.9). The hazard and odds ratios for incident and prevalent delirium in other groups were not different. CONCLUSIONS: African-American race does not confer any additional risk for developing incident or prevalent delirium in the ICU. Instead, younger African Americans tend to have lower rates of incident delirium compared with Caucasians of similar age.

Report on milestones for care and support under the U.S. National Plan to Address Alzheimer's Disease.

INTRODUCTION: Under the U.S. national Alzheimer's plan, the National Institutes of Health identified milestones required to meet the plan's biomedical research goal (Goal 1). However, similar milestones have not been created for the goals on care (Goal 2) and support (Goal 3). METHODS: The Alzheimer's Association convened a workgroup with expertise in clinical care, long-term services and supports, dementia care and support research, and public policy. The workgroup reviewed the literature on Alzheimer's care and support; reviewed how other countries are addressing the issue; and identified public policies needed over the next 10 years to achieve a more ideal care and support system. RESULTS: The workgroup developed and recommended 73 milestones for Goal 2 and 56 milestones for Goal 3. DISCUSSION: To advance the implementation of the U.S. national Alzheimer's plan, the U.S. government should adopt these recommended milestones, or develop similar milestones, to be incorporated into the national plan.

The confusion assessment method for the intensive care unit in patients with cirrhosis.

In the intensive care unit (ICU), delirium is routinely measured with the widely-used, validated Confusion Assessment Method for the ICU (CAM-ICU), but CAM-ICU has not been studied in patients with cirrhosis. We studied a group of patients with cirrhosis to determine the relationship between delirium measured by CAM-ICU and clinical outcomes. Consecutive patients with cirrhosis admitted to the ICU from 2009 to 2012 were included in a retrospective cohort study. Patients were screened twice daily for coma and delirium during their ICU stay using the Richmond Agitation Sedation Scale (RASS) and CAM-ICU. The association between delirium/coma and mortality was determined using multiple logistic regression. RASS and CAM-ICU were also compared to a retrospective assessment of hepatic encephalopathy (HE). Of 91 patients with cirrhosis, 26 (28.6 %) developed delirium/coma. RASS/CAM-ICU had fair agreement with the HE assessment (κ 0.38). Patients with delirium/coma had numerically greater mortality in-hospital (23.1 vs. 7.7 %, p = 0.07) and at 90 days (30.8 vs. 18.5 %, p = 0.26), and they also had longer hospital length of stay (median 19.5 vs. 6 days, p < 0.001). Delirium/coma was associated with increased inpatient mortality, independent of disease severity (unadjusted OR 3.6; 95 % CI, 0.99-13.1; MELD-adjusted OR 5.4; 95 % CI, 1.3-23.8; acute physiology score-adjusted OR 2.2; 95 % CI, 0.53-8.9). Delirium/coma was also associated with longer length of stay after adjusting for disease severity. In critically ill patients with cirrhosis, delirium/coma as measured by the RASS and CAM-ICU is associated with increased mortality and hospital length of stay. For these patients, these measures provide valuable information and may be useful tools for clinical care. RASS and CAM-ICU need to be compared to HE-specific measures in future studies.

Effectiveness of implementing a wake up and breathe program on sedation and delirium in the ICU.

OBJECTIVES: Mechanically ventilated critically ill patients receive significant amounts of sedatives and analgesics that increase their risk of developing coma and delirium. We evaluated the impact of a "Wake-up and Breathe Protocol" at our local ICU on sedation and delirium. DESIGN: A pre/post implementation study design. SETTING: A 22-bed mixed surgical and medical ICU. PATIENTS: Seven hundred two consecutive mechanically ventilated ICU patients from June 2010 to January 2013. INTERVENTIONS: Implementation of daily paired spontaneous awakening trials (daily sedation vacation plus spontaneous breathing trials) as a quality improvement project. MEASUREMENTS AND MAIN RESULTS: After implementation of our program, there was an increase in the mean Richmond Agitation Sedation Scale scores on weekdays of 0.88 (p < 0.0001) and an increase in the mean Richmond Agitation Sedation Scale scores on weekends of 1.21 (p < 0.0001). After adjusting for age, race, gender, severity of illness, primary diagnosis, and ICU, the incidence and prevalence of delirium did not change post implementation of the protocol (incidence: 23% pre vs 19.6% post; p = 0.40; prevalence: 66.7% pre vs 55.3% post; p = 0.06). The combined prevalence of delirium/coma decreased from 90.8% pre protocol implementation to 85% postimplementation (odds ratio, 0.505; 95% CI, 0.299-0.853; p = 0.01). CONCLUSIONS: Implementing a "Wake Up and Breathe Program" resulted in reduced sedation among critically ill mechanically ventilated patients but did not change the incidence or prevalence of delirium.

Acceptance of and attitudes towards Alzheimer's disease screening in elderly German adults.

BACKGROUND: Considering the discussion on implementing routine dementia screening in Germany, the objective of the current study was to validate the German version of the Perceptions Regarding Investigational Screening for Memory in Primary Care (PRISM-PC) questionnaire and to determine the acceptance of Alzheimer's disease screening in elderly German adults. METHODS: The German version of the PRISM-PC was administered to a subsample of participants who attended the Berlin Aging Study II (n = 506). The questionnaire was validated by exploratory as well as confirmatory factor analysis. RESULTS: Regarding acceptance of Alzheimer's disease screening (Section B) a single factor structure fitted best. In terms of attitudes regarding Alzheimer's disease (Section D), a hierarchical factor structure was modeled with the higher-order factor "Harms" covering the domains "Family Burden," "Dependence," "Emotional Suffering," "Stigma," and "Medical Care" on the one hand and the domain "Future Planning" on the other hand. Internal consistency of the different scales reached from α = 0.67 to α = 0.94. Overall, 71.2% of the participants indicated that they wanted to be screened for Alzheimer's disease on a regular basis. CONCLUSIONS: This study suggests that acceptance can reliably be assessed with the section "Acceptance of Alzheimer's disease screenings" of the German PRISM-PC questionnaire. Furthermore, the majority of elderly German adults would like to be screened for Alzheimer's disease regularly, which might be an effective starting point in order to implement routine dementia screenings. As the sample is a convenience sample of (relatively) healthy older adults, generalizability of these results is limited.

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.

Comorbidity profile and healthcare utilization in elderly patients with serious mental illnesses.

OBJECTIVES: Patients with serious mental illness are living longer. Yet, there remain few studies that focus on healthcare utilization and its relationship with comorbidities in these elderly mentally ill patients. DESIGN: Comparative study. Information on demographics, comorbidities, and healthcare utilization was taken from an electronic medical record system. SETTING: Wishard Health Services senior care and community mental health clinics. PARTICIPANTS: Patients age 65 years and older-255 patients with serious mental illness (schizophrenia, major recurrent depression, and bipolar illness) attending a mental health clinic and a representative sample of 533 nondemented patients without serious mental illness attending primary care clinics. RESULTS: Patients having serious mental illness had significantly higher rates of medical emergency department visits (p = 0.0027) and significantly longer lengths of medical hospitalizations (p <0.0001) than did the primary care control group. The frequency of medical comorbidities such as diabetes, coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, thyroid disease, and cancer was not significantly different between the groups. Hypertension was lower in the mentally ill group (p <0.0001). Reported falls (p <0.0001), diagnoses of substance abuse (p = 0.02), and alcoholism (p = 0.0016) were higher in the seriously mentally ill. The differences in healthcare utilization between the groups remained significant after adjusting for comorbidity levels, lifestyle factors, and attending primary care. CONCLUSIONS: Our findings of higher rates of emergency care, longer hospitalizations, and increased frequency of falls, substance abuse, and alcoholism suggest that seriously mentally ill older adults remain a vulnerable population requiring an integrated model of healthcare.

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.

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.

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.

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.

Enhancing care for hospitalized older adults with cognitive impairment: a randomized controlled trial.

BACKGROUND: Approximately 40% of hospitalized older adults have cognitive impairment (CI) and are more prone to hospital-acquired complications. The Institute of Medicine suggests using health information technology to improve the overall safety and quality of the health care system. OBJECTIVE: Evaluate the efficacy of a clinical decision support system (CDSS) to improve the quality of care for hospitalized older adults with CI. DESIGN: A randomized controlled clinical trial. SETTING: A public hospital in Indianapolis. POPULATION: A total of 998 hospitalized older adults were screened for CI, and 424 patients (225 intervention, 199 control) with CI were enrolled in the trial with a mean age of 74.8, 59% African Americans, and 68% female. INTERVENTION: A CDSS alerts the physicians of the presence of CI, recommends early referral into a geriatric consult, and suggests discontinuation of the use of Foley catheterization, physical restraints, and anticholinergic drugs. MEASUREMENTS: Orders of a geriatric consult and discontinuation orders of Foley catheterization, physical restraints, or anticholinergic drugs. RESULTS: Using intent-to-treat analyses, there were no differences between the intervention and the control groups in geriatric consult orders (56% vs 49%, P = 0.21); discontinuation orders for Foley catheterization (61.7% vs 64.6%, P = 0.86); physical restraints (4.8% vs 0%, P = 0.86), or anticholinergic drugs (48.9% vs 31.2%, P = 0.11). CONCLUSION: A simple screening program for CI followed by a CDSS did not change physician prescribing behaviors or improve the process of care for hospitalized older adults with CI.

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.