@article {11, title = {Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial.}, journal = {Implement Sci}, volume = {10}, year = {2015}, month = {2015 Jun 04}, pages = {82}, abstract = {

BACKGROUND: The majority of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs are regularly prescribed as first-line treatment of neuropsychiatric symptoms in persons with dementia, although guidelines clearly prioritise non-pharmacological interventions. Frequently, antipsychotic drugs are prescribed for inappropriate reasons and for too long without regular reviewing. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. The aim of the study is to investigate whether a person-centred care approach, successfully evaluated in nursing homes in the United Kingdom, can be implemented in German nursing homes and, in comparison with a control group, can result in a clinically relevant reduction of the proportion of residents with antipsychotic prescriptions.

METHODS/DESIGN: The study is a cluster-randomised controlled trial comparing an intervention group (two-day initial training on person-centred care and ongoing training and support programme) with a control group. Both study groups will receive, as optimised usual care, a medication review by an experienced psychiatrist/geriatrician providing feedback to the prescribing physician. Overall, 36 nursing homes in East, North, and West Germany will be randomised. The primary outcome is the proportion of residents receiving at least one antipsychotic prescription (long-term medication) after 12~months of follow-up. Secondary outcomes are residents{\textquoteright} quality of life, agitated behaviour, as well as safety parameters like falls and fall-related medical attention. A health economic evaluation and a process evaluation will be performed alongside the study.

DISCUSSION: To improve care, a reduction of the current high prescription rate of antipsychotics in nursing homes by the intervention programme is expected.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT02295462.

}, keywords = {Accidental Falls, Antipsychotic Agents, Costs and Cost Analysis, Dementia, Drug Utilization, Germany, Homes for the Aged, Humans, Inservice Training, Mental Disorders, Nursing Homes, Patient-Centered Care, Psychomotor Agitation, Quality of Life, Research Design}, issn = {1748-5908}, doi = {10.1186/s13012-015-0268-3}, author = {Richter, Christin and Berg, Almuth and Fleischer, Steffen and K{\"o}pke, Sascha and Balzer, Katrin and Fick, Eva-Maria and S{\"o}nnichsen, Andreas and L{\"o}scher, Susanne and Vollmar, Horst Christian and Haastert, Burkhard and Icks, Andrea and Dintsios, Charalabos-Markos and Mann, Eva and Wolf, Ursula and Meyer, Gabriele} } @article {13, title = {Compliance with trial registration in five core journals of clinical geriatrics: a survey of original publications on randomised controlled trials from 2008 to 2012.}, journal = {Age Ageing}, volume = {43}, year = {2014}, month = {2014 Nov}, pages = {872-6}, abstract = {

OBJECTIVE: to assess the proportion of registered randomised controlled trials in five core clinical geriatric journals and to analyse whether registered study outcomes correspond with published outcomes.

DESIGN: survey of original papers published 2008 to 2012.

METHODS: two independent reviewers retrieved the sample through search in the web-based archives of Age and Ageing, the Journal of the American Geriatric Society, the American Journal of Geriatric Psychiatry, the Journal of the American Medical Directors Association and International Psychogeriatrics. Data extraction was performed by two independent reviewers using a pre-tested 13-item checklist. Registration status was checked and information provided in registers compared with information presented in the original publication. A third reviewer was consulted if no consensus could be reached.

RESULTS: the sample comprised 220 original publications on randomised controlled trials. A total of 140 (63.6\%) were registered. Registration was in accordance with the ICMJE requirements in 54 out of 140 registered trials (38.6\%). Less than one-third of registered papers (n = 40) reported on all study outcomes listed in the study register. In 74 out of the 80 non-registered trials, the missing registration was not declared in the publication. There was no consistent upward trend towards higher registration compliance throughout journals and years.

CONCLUSION: our survey shows that prospective trial registration and compliance between outcomes declared in the registry and reported in the publication is poor. Concerted action of authors, editors and peer-reviewers is overdue aimed to irreversibly implement the imperative of registration of randomised controlled trials and complete outcome reporting.

}, keywords = {Geriatrics, Guideline Adherence, Guidelines as Topic, Humans, Periodicals as Topic, Publication Bias, Randomized Controlled Trials as Topic, Registries, Research Design}, issn = {1468-2834}, doi = {10.1093/ageing/afu086}, author = {Mann, Eva and Nguyen, Natalie and Fleischer, Steffen and Meyer, Gabriele} }