@article{SanchezThomasDeekenetal.2019, author = {S{\´a}nchez, Alba and Thomas, Christine and Deeken, Friederike and Wagner, S{\"o}ren and Kl{\"o}ppel, Stefan and Kentischer, Felix and von Arnim, Chrstine A. F. and Denkinger, Michael and Conzelmann, Lars O. and Biermann-Stallwitz, Janine and Joos, Stefanie and Sturm, Heidrun and Metz, Brigitte and Auer, Ramona and Skrobik, Yoanna and Eschweiler, Gerhard W. and Rapp, Michael Armin}, title = {Patient safety, cost-effectiveness, and quality of life}, series = {Trials}, volume = {20}, journal = {Trials}, number = {71}, publisher = {BioMed Central}, address = {London}, issn = {1468-6694}, doi = {10.1186/s13063-018-3148-8}, pages = {15}, year = {2019}, abstract = {Background Postoperative delirium is a common disorder in older adults that is associated with higher morbidity and mortality, prolonged cognitive impairment, development of dementia, higher institutionalization rates, and rising healthcare costs. The probability of delirium after surgery increases with patients' age, with pre-existing cognitive impairment, and with comorbidities, and its diagnosis and treatment is dependent on the knowledge of diagnostic criteria, risk factors, and treatment options of the medical staff. In this study, we will investigate whether a cross-sectoral and multimodal intervention for preventing delirium can reduce the prevalence of delirium and postoperative cognitive decline (POCD) in patients older than 70 years undergoing elective surgery. Additionally, we will analyze whether the intervention is cost-effective. Methods The study will be conducted at five medical centers (with two or three surgical departments each) in the southwest of Germany. The study employs a stepped-wedge design with cluster randomization of the medical centers. Measurements are performed at six consecutive points: preadmission, preoperative, and postoperative with daily delirium screening up to day 7 and POCD evaluations at 2, 6, and 12 months after surgery. Recruitment goals are to enroll 1500 patients older than 70 years undergoing elective operative procedures (cardiac, thoracic, vascular, proximal big joints and spine, genitourinary, gastrointestinal, and general elective surgery procedures. Discussion Results of the trial should form the basis of future standards for preventing delirium and POCD in surgical wards. Key aims are the improvement of patient safety and quality of life, as well as the reduction of the long-term risk of conversion to dementia. Furthermore, from an economic perspective, we expect benefits and decreased costs for hospitals, patients, and healthcare insurances. Trial registration German Clinical Trials Register, DRKS00013311. Registered on 10 November 2017.}, language = {en} } @article{TreuschMajicPageetal.2015, author = {Treusch, Yvonne and Majic, Tomislav and Page, Julie and Gutzmann, Hans and Heinz, Andreas and Rapp, Michael Armin}, title = {Apathy in nursing home residents with dementia: Results from a cluster-randomized controlled trial}, series = {European psychiatry : the journal of the Association of European Psychiatrists}, volume = {30}, journal = {European psychiatry : the journal of the Association of European Psychiatrists}, number = {2}, publisher = {Elsevier}, address = {Paris}, issn = {0924-9338}, doi = {10.1016/j.eurpsy.2014.02.004}, pages = {7}, year = {2015}, abstract = {Purpose: Here we evaluate an interdisciplinary occupational and sport therapy intervention for dementia patients suffering from apathy. Subjects and methods: A prospective, controlled, rater-blinded, clinical trial with two follow-ups was conducted as part of a larger cluster-randomized trial in 18 nursing homes in Berlin. n = 117 dementia patients with apathy, defined as a score of 40 or more on the apathy evaluation scale (AES) or presence of apathy on the Neuropsychiatric Inventory (NPI), were randomly assigned to intervention or control group. The intervention included 10 months of brief activities, provided once a week. The primary outcome measure was the total score on the AES scale measured directly after the intervention period and again after 12 months. Results: We found significant group differences with respect to apathy during the 10 month intervention period (F-2,F-82 = 7.79, P < 0.01), which reflected an increase in apathy in the control group, but not in the intervention group. Within one year after the intervention was ceased, the treatment group worsened and no longer differed significantly from the control group (P = 0.55). Conclusions: Our intervention was effective for the therapy of apathy in dementia, when applied, but not one year after cessation of therapy. (C) 2014 Elsevier Masson SAS. All rights reserved.}, language = {en} } @article{RappMellMajicetal.2013, author = {Rapp, Michael Armin and Mell, Thomas and Majic, Tomislav and Treusch, Yvonne and Nordheim, Johanna and Niemann-Mirmehdi, Mechthild and Gutzmann, Hans and Heinz, Andreas}, title = {Agitation in Nursing Home Residents With Dementia (VIDEANT Trial) - Effects of a Cluster-Randomized, Controlled, Guideline Implementation Trial}, series = {Journal of the American Medical Directors Association}, volume = {14}, journal = {Journal of the American Medical Directors Association}, number = {9}, publisher = {Elsevier}, address = {New York}, issn = {1525-8610}, doi = {10.1016/j.jamda.2013.05.017}, pages = {690 -- 695}, year = {2013}, abstract = {Objective: To test the effect of a complex guideline-based intervention on agitation and psychotropic prescriptions. Design, Setting, Participants: Cluster randomized controlled trial (VIDEANT) with blinded assessment of outcome in 18 nursing homes in Berlin, Germany, comprising 304 dementia patients. Intervention: Training, support, and activity therapy intervention, delivered at the level of each nursing home, focusing on the management of agitation in dementia. Control group nursing homes received treatment as usual. Measurements: Levels of agitated and disruptive behavior (Cohen-Mansfield agitation inventory [CMAI]) as the primary outcome. Number of neuroleptics, antidepressants, and cholinesterase inhibitors (ChEIs) prescribed in defined daily dosages (DDDs). Results: Of 326 patients screened, 304 (93.3\%) were eligible and cluster-randomized to 9 intervention (n = 163) and 9 control (n = 141) nursing homes. Data were collected from 287 (94.4\%) patients at 10 months. At 10 months, compared with controls, nursing home residents with dementia in the intervention group exhibited significantly less agitation as measured with the CMAI (adjusted mean difference, 6.24; 95\% CI 2.03-14.14; P = .009; Cohen's d = 0.43), received fewer neuroleptics (P < .05), more ChEIs (P < .05), and more antidepressants (P < .05). Conclusion: Complex guideline-based interventions are effective in reducing agitated and disruptive behavior in nursing home residents with dementia. At the same time, increased prescription of ChEIs and antidepressants together with decreased neuroleptic prescription suggests an effect toward guideline-based pharmacotherapy.}, language = {en} }