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ABSTRACTObjectivesThis study examined the effectiveness of an integrated care pathway (ICP), including a medication algorithm, to treat agitation associated with dementia. DesignAnalyses of data (both prospective and retrospective) collected during routine clinical care. SettingGeriatric Psychiatry Inpatient Unit. ParticipantsPatients with agitation associated with dementia (n = 28) who were treated as part of the implementation of the ICP and those who received treatment-as-usual (TAU) (n = 28) on the same inpatient unit before the implementation of the ICP. Two control groups of patients without dementia treated on the same unit contemporaneously to the TAU (n = 17) and ICP groups (n = 36) were included to account for any secular trends. InterventionICP. MeasurementsCohen Mansfield Agitation Inventory (CMAI), Neuropsychiatric Inventory Questionnaire (NPIQ), and assessment of motor symptoms were completed during the ICP implementation. Chart review was used to obtain length of inpatient stay and rates of psychotropic polypharmacy. ResultsPatients in the ICP group experienced a reduction in their scores on the CMAI and NPIQ and no changes in motor symptoms. Compared to the TAU group, the ICP group had a higher chance of an earlier discharge from hospital, a lower rate of psychotropic polypharmacy, and a lower chance of having a fall during hospital stay. In contrast, these outcomes did not differ between the two control groups. ConclusionsThese preliminary results suggest that an ICP can be used effectively to treat agitation associated with dementia in inpatients. A larger randomized study is needed to confirm these results.

Background The Cohen-Mansfield Agitation Inventory-Short Form (CMAI-SF) is a 14-item scale for assessing agitation and aggression, derived from the original 29-item CMAI, and completed by a proxy. Because the CMAI-SF has not yet been validated in German language, the aim of this study is to explore its construct validity. Methods Baseline data from a cluster-randomized trial to evaluate a non-pharmacological complex intervention for people living with dementia (PlwD) and mild cognitive impairment (MCI) were analyzed. The study sample consisted of 97 shared-housing arrangements (SHAs) in Germany, comprising N  = 341 residents with mild to severe dementia and MCI. Trained nursing staff collected data by proxy-rating the CMAI-SF, Neuropsychiatric Inventory-Nursing Home Version (NPI-NH), and QUALIDEM. They also conducted the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). Results In an exploratory factor analysis, three factors emerged: “aggressive behavior”, “verbally agitated behavior”, and “physically non-aggressive behavior”. The CMAI-SF total score showed good internal consistency (α = .85), and the factors themselves showed adequate internal consistency (α = .75/.76/.73). The CMAI-SF showed convergent validity with the NPI-NH agitation item ( r  = .66) and the NPI-NH “agitation & restless behavior” factor ( r  = .82). Discriminant validity was confirmed by a low ( r  = .28) correlation with the NPI-NH apathy item. Quality of life decreased significantly with agitation, as the CMAI-SF showed a moderate negative correlation with the QUALIDEM total score ( r  = -.35). Conclusions The 14-item CMAI-SF is a time-efficient, reliable, and valid assessment instrument. Three factors emerged that were similar to those already found in nursing home samples for the original CMAI and the CMAI-SF and in day care samples for the CMAI-SF. The findings provide preliminary evidence that the CMAI-SF can be used instead of the CMAI to reduce time, costs, and burden in future trials. Trial registration The DemWG study from which data were used to draft this manuscript was prospectively registered on 16 July 2019 at ISRCTN registry (ISRCTN89825211).

INTRODUCTION iWHELD is a digital person‐centered care program for people with dementia in nursing homes adapted for remote delivery during the COVID‐19 pandemic. METHODS A 16‐week two‐arm cluster‐randomized controlled trial in 149 UK nursing homes compared iWHELD with treatment as usual (TAU). Primary outcome was the overall quality of life with secondary outcomes of agitation and psychotropic use. RESULTS iWHELD conferred benefit to quality of life on the primary (F = 4.3, p = 0.04) and secondary measures of quality of life (F = 6.45, p = 0.01) and reduced psychotropic medication use (χ2 = 4.08, p = 0.04) with no worsening of agitation. Benefit was seen in participants who contracted COVID‐19, those with agitation at baseline, and those taking psychotropic medications. DISCUSSION iWHELD confers benefits to quality of life and key measures of well‐being, can be delivered during the challenging conditions of a pandemic, and should be considered for use alongside any emerging pharmacological treatment for neuropsychiatric symptoms. Highlights iWHELD is the only remote, digital delivery nursing home training programme for dementia care iWHELD improved quality of life in people with dementia and reduced antipsychotic use without worsening of agitation Residents who contracted Covid‐19 during the study also experienced benefits from iWHELD iWHELD offers a valuable, pandemic‐safe tool for improving dementia care

To compare citalopram and risperidone for the treatment of psychotic symptoms and agitation associated with dementia, with a priori hypotheses that risperidone would be more efficacious for psychosis and citalopram for agitation. A 12-week randomized, controlled trial in nondepressed patients with dementia hospitalized because of behavioral symptoms (N = 103) was conducted at the University of Pittsburgh Medical Center. Participants were consecutively recruited on an inpatient unit if they had at least one moderate to severe target symptom (aggression, agitation, hostility, suspiciousness, hallucinations, or delusions). Once they improved sufficiently, they were discharged to nursing homes, personal care homes, or residential homes for continued treatment. Planned pre-post and mixed model analyses of the main outcome measures of Neurobehavioral Rating Scale and Side Effect Rating Scale at baseline and at weekly/biweekly intervals were conducted. Completion rates did not differ for citalopram and risperidone (overall completion rate: 44%). Agitation symptoms (aggression, agitation, or hostility) and psychotic symptoms (suspiciousness, hallucinations, or delusions) decreased in both treatment groups but the improvement did not differ significantly between the two groups. There was a significant increase in side effect burden with risperidone but not with citalopram such that the two groups differed significantly. No statistical difference was found in the efficacy of citalopram and risperidone for the treatment of either agitation or psychotic symptoms in patients with dementia. These findings need to be replicated before citalopram or other serotonergic antidepressants can be recommended as alternatives to antipsychotics for the treatment of agitation or psychotic symptoms associated with dementia.

To assess the efficacy and safety of aripiprazole for psychosis associated with Alzheimer dementia (AD). In this double-blind, multicenter study, 487 institutionalized patients with psychosis associated with AD were randomized to placebo or aripiprazole, 2, 5 or 10 mg/day. Primary efficacy assessment was the mean change from baseline to week 10 on the Neuropsychiatric Inventory–Nursing Home (NPI-NH) version Psychosis Subscale score. Secondary measures included NPI-NH Total, Clinical Global Impression–Severity of Illness (CGI-S), Brief Psychiatric Rating Scale (BPRS) Core and Total, and the Cohen–Mansfield Agitation Inventory (CMAI) scores. Aripiprazole 10 mg/day showed significantly greater improvements (mean change [2 × SD]) than placebo on the NPI-NH Psychosis Subscale (−6.87 [8.6] versus −5.13 [10.0]; F = 6.29, df = 1, 422, p = 0.013 by analysis of covariance [ANCOVA]); CGI-S (−0.72 [1.8] versus −0.46 [1.6]; F = 4.68, df = 1, 419, p = 0.031 [ANCOVA]); BPRS Total (−7.12 [18.4] versus −4.17 [21.6]; F = 4.72, df = 1, 399, p = 0.030 [ANCOVA]); BPRS Core (−3.07 [6.9] versus −1.74 [7.8]; F = 7.30, df = 1, 407, p = 0.007 [ANCOVA]); CMAI (−10.96 [22.6] versus −6.64 [28.6]; F = 5.23, df = 1, 410, p = 0.023 [ANCOVA]), and NPI-NH Psychosis response rate (65 versus 50%; χ2 = 5.52, df = 1, p = 0.019 [CMH]). Aripiprazole 5 mg/day showed significant improvements versus placebo on BPRS and CMAI scores. Aripiprazole 2 mg/day was not efficacious. Cerebrovascular adverse events were reported: aripiprazole 2 mg/day, N = 1; 5 mg/day, N = 2; 10 mg/day, N = 4; placebo, N = 0. No deaths in any group (aripiprazole 2 mg/day, 3%; 5 mg/day, 2%; 10 mg/day, 7%; placebo, 3%) were considered to be treatment-related. Aripiprazole 10 mg/day was efficacious and safe for psychosis associated with AD, significantly improving psychotic symptoms, agitation, and clinical global impression. However, clinicians should be aware of the safety considerations of atypical antipsychotic uses in this population.

Background The rapid control of patients presenting to the emergency department (ED) with psychomotor agitation and violent behavior is paramount for the safety of patients and ED staff. The use of intramuscular (IM) ketamine in the pre-hospital and ED settings has demonstrated promising preliminary results to provide rapid and safe behavioral control. A prospective, randomized controlled trial is required to measure the potential superiority of IM ketamine compared to current standard care (IM benzodiazepines plus antipsychotics). Methods This will be a parallel, prospective, randomized, controlled trial of 5 mg/kg IM ketamine compared to a combination of 5 mg IM midazolam and 5 mg IM haloperidol. The study will enroll approximately 184 patients, randomized equally to two study arms. There will be one study visit during which study medication will be administered and assessments will be completed. A follow-up safety visit will occur on day 3. The primary objective of this study is to compare IM ketamine to a combination of IM midazolam and haloperidol with regards to the time required for adequate behavioral control, in minutes, in patients presenting to the ED with psychomotor agitation and violent behavior, as measured by the Richmond Agitation-Sedation Scale (RASS). Discussion We present a novel study to determine whether ketamine is a rapid and safe option, compared to a combination of midazolam and haloperidol for the sedation of patients presenting to the ED with psychomotor agitation and violent behavior. To our knowledge, this study is the first randomized controlled trial to compare ketamine to current standard care for this indication. We have attempted to address numerous logistical issues with the design of this study including a waiver of consent, ensuring adequate blinding of outcome assessors, patient enrolment, and data monitoring. Trial registration Clinicaltrials.gov, NCT03375671 . Registered on 18 December 2017.

The aim of this study is to compare the Empirical Behavioral Rating Scale (E-BEHAVE-AD), Neurobehavioral Rating Scale (NBRS), and Neuropsychiatric Interview (NPI) in detecting behavioral disturbance and psychotic symptoms in dementia and characterizing changes in response to treatment. Eighty-seven subjects in the randomized controlled trial “Continuation Pharmacotherapy for Agitation of Dementia” were included in this analysis. We compared the detection in, and changes of, both agitation and psychosis, using these three instruments. A receiver operating characteristic analysis was performed to compare the performance of the three instruments in detecting global improvement. The instruments were equally likely to detect agitation. The NBRS was most likely to detect psychosis. Although the NPI best detected improvement in agitation, the instruments were equal for detecting improvement in psychosis. In the receiver operating characteristic analysis for overall clinical improvement in response to treatment, there were no differences in the areas under the correlated curves for the three instruments, but they demonstrated different sensitivity and specificity at different cutoff points for target symptom reduction. The E-BEHAVE-AD performed best at a cut point of 30% target symptom reduction and the NBRS and NPI both performed best at 50%. The E-BEHAVE-AD, NBRS, and NPI were more similar than different in characterizing symptoms but differed in detecting response to treatment. Differences in sensitivity and specificity may lead clinicians to prefer a specific instrument, depending on their goal and the expected magnitude of response to any specific intervention.

Background Nearly all persons with dementia will experience neuropsychiatric symptoms (NPS) during the course of their disease. Clinicians and researchers emphasize the need for an evidence-informed standardized approach to managing NPS that integrates pharmacological and nonpharmacological treatments for real-world implementation. The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) represents such an approach and is a multicomponent intervention based on the theoretical framework of cognitive behavioural therapy. Methods/design The trial is a 3-month cluster randomized trial conducted in 30 nursing homes including 168 participants with dementia and a high level of agitation. Each nursing home defined as a cluster will be randomized to receive either the TIME intervention (the intervention group) or a brief education-only intervention regarding dementia and NPS (the control group). TIME is a manual-based, multicomponent programme that includes a rigorous assessment, one or more case conferences and the treatment and evaluation of NPS. Patient-level measurements are taken at baseline (prior to randomization) and 8 and 12 weeks later. The primary outcome measure is the change in agitation, as defined by the Neuropsychiatric Inventory-Nursing Home Version, at 8 weeks from baseline. Secondary outcome measures include change in agitation at 12 weeks from baseline, and change from baseline at 8 and 12 weeks in other NPS, quality of life, and the use of psychotropic and analgesic medications. Mixed methods will be used to follow, measure and explore the implementation process and the effect of the intervention at the individual staff level and the organization level. Combining measurements of clinical effectiveness and implementation outcomes define this trial as an effectiveness-implementation hybrid trial. Discussion Measuring the implementation and effect of complex interventions aimed at reducing NPS in nursing homes is challenging. In this study protocol, we describe a multicomponent program, TIME, and discuss how an effectiveness-implementation cluster randomized hybrid trial can meet these challenges. Trial registration ClinicalTrials.gov identifier NCT02655003 . Registered 6 January 2016.

The objectives of this study were to evaluate the efficacy, safety, and tolerability of quetiapine for treating psychosis in patients with probable/possible Alzheimer disease and assess its impact on other psychopathology and social and daily functioning. The authors conducted a multicenter, double-blind, placebo-controlled, randomized trial of flexibly dosed quetiapine and haloperidol. Primary outcomes were change in total Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impressions–Severity of Illness (CGI-S) scores at week 10. Secondary outcomes included BPRS factors, Neuropsychiatric Inventory (NPI), Multidimensional Observation Scale for Elderly Subjects (MOSES), and Physical Self-Maintenance Scale (PSMS). Two hundred eighty-four participants (mean age: 83.2 years) were randomized; 63.4% completed; and mean Mini-Mental State Examination score was 12.8. Median of the mean daily dose was 96.9 mg for quetiapine and 1.9 mg for haloperidol. No differential benefit was seen on any psychosis measure. BPRS agitation factor scores improved with quetiapine versus placebo and not quetiapine versus haloperidol. BPRS anergia scores worsened with haloperidol versus quetiapine but not quetiapine versus placebo. No NPI factors showed change, including the agitation factor. MOSES Withdrawal Subscale and PSMS total scores worsened with haloperidol versus quetiapine. Somnolence occurred in 25.3%, 36.2%, and 4.1% of the quetiapine, haloperidol, and placebo groups, respectively; parkinsonism was most prevalent in the haloperidol group; other safety and tolerability measures differed little among groups. All treatment groups showed improvement in measures of psychosis without significant differences between them when planned comparisons were performed. Participants treated with quetiapine or haloperidol showed inconsistent evidence of improvement in agitation. Tolerability was better with quetiapine compared with haloperidol.

Background To determine whether continuous intravenous infusion of dexmedetomidine (DEX) can affect the incidence of Emergence Agitation (EA) after general anesthesia in infant undergoing cleft palate repair surgery. Methods Forty infants underwent cleft palate repair surgery under general anesthesia were randomly divided into the DEX (D) group and Placebo (P) groups. Patients in group D received continuous intravenous infusion of DEX 0.8 μg · kg-1 · min-1 after the induction. Patients in group P were administered with continuous intravenous infusion of the equivalent volume of normal saline. Both groups were induced with fentanyl 0.005 mg/Kg, propofol 2 mg/Kg and cisatracurium 0.2 mg/Kg. Anaesthesia was maintained with continuous intravenous infusion of propofol (2 mg/Kg · h), remifentanil (0.1 μg/Kg · h), and inhalation of 1 to 3 % sevoflurane. Result The heart rate (HR) in group P was significant higher than that in group D at the time of operation ( P  < 0.05), postoperative 15 min, 30 min and the time of extubation ( P  < 0.01). The mean arterial pressure (MAP) in group P was higher comparing with MAP in group D at the time of extubation ( P  < 0.05). The spontaneous eye opening times and spontaneous arm or leg motion times were longer in group D ( P  < 0.05). The mean agitation scores of patients in group D were significantly lower than that in group P ( P  < 0.01). However, the incidence of EA in group P and group D was 90 % and 15 % ( P  <0.05). Conclusion The continuous intravenous infusion of DEX after induction could significantly reduce the occurrence of EA. Trial registration The Chinese Clinical Trial Register ChiCTR-TRC-13003865