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      Implementing advance care planning in nursing homes – study protocol of a cluster-randomized clinical trial

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          Abstract

          Background

          Close to half of all deaths in Norway occur in nursing homes, which signals a need for good communication on end-of-life care. Advance care planning (ACP) is one means to that end, but in Norwegian nursing homes, ACP is not common. This paper describes the protocol of a project evaluating an ACP-intervention in Norwegian nursing homes. The aims of this research project were to promote the possibility for conversations about the end of life with patients and relatives; promote patient autonomy; create a better foundation for important decisions in the case of medical emergencies and at the end of life; and gain experiences in order to find out what characterizes good ACP and good implementation strategies.

          Methods/design

          This study was a mixed method study including a cluster-randomized clinical trial. Eight nursing home wards or “clusters” were pair-matched, and one ward from each pair was randomly selected for a 12-month intervention. The intervention consisted of implementing an ACP-guideline. Implementation strategies were training and supervision of project teams and staff in using the guideline, written information to patients and next of kin, and information meetings with nursing home staff. The project was evaluated using both quantitative and qualitative data, and both outcome and process evaluation. Quantitative data included patient chart reviews of ACP, diagnoses, patient preferences for decision-making and treatment, values and wishes that are more general, documented life-prolonging treatment and hospitalizations, and concordance between patient wishes and treatment. The primary outcome was documented ACP. Qualitative data included observations of conversations, interviews with patients, next of kin and health care personnel, logs from project coordinators and conversations, and transcripts from meetings with project teams in the intervention group.

          Discussion

          This project attempted to increase the quality and use of ACP in Norwegian nursing homes (NH). A mixed methods approach, inclusion of patients with dementia, attempts to involve, as many patients as possible, and a sustainable implementation plan adapted to real life in nursing homes were strengths of the project.

          Electronic supplementary material

          The online version of this article (10.1186/s12877-018-0869-1) contains supplementary material, which is available to authorized users.

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          Most cited references30

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          Defining Advance Care Planning for Adults: A Consensus Definition From a Multidisciplinary Delphi Panel.

          Despite increasing interest in advance care planning (ACP) and previous ACP descriptions, a consensus definition does not yet exist to guide clinical, research, and policy initiatives.
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            The prevalence of psychiatric symptoms and behavioural disturbances and the use of psychotropic drugs in Norwegian nursing homes.

            Psychiatric and behavioural symptoms in dementia are associated with a range of negative outcomes, including institutional placement and the widespread use of psychotropic drugs in spite of limited evidence for their efficacy. To determine the prevalence of psychiatric and behavioural symptoms and the pattern of psychotropic drug prescription in patients with various degrees of dementia. A sample of 1,163 non-selected nursing home patients were assessed by means of the Neuropsychiatric Inventory, the Clinical Dementia Rating scale and Lawton's activities of daily living scale. In addition, information was collected from the patients' records. Dementia was found in 81% of the patients and 72% of them had clinically significant psychiatric and behavioural symptoms. The frequencies of symptoms increased with the severity of the dementia. Psychotropic medication was being prescribed to 75% of patients with dementia. There was a significant relationship between the type of drug and the symptom for which it had been dispensed. Psychiatric and behavioural symptoms are frequent in nursing homes and the rate increases with the progression of the dementia. Systematic programmes are needed for disseminating skills and providing guidance regarding the evaluation and treatment of these symptoms in nursing homes.
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              Methodological bias in cluster randomised trials

              Background Cluster randomised trials can be susceptible to a range of methodological problems. These problems are not commonly recognised by many researchers. In this paper we discuss the issues that can lead to bias in cluster trials. Methods We used a sample of cluster randomised trials from a recent review and from a systematic review of hip protectors. We compared the mean age of participants between intervention groups in a sample of 'good' cluster trials with a sample of potentially biased trials. We also compared the effect sizes, in a funnel plot, between hip protector trials that used individual randomisation compared with those that used cluster randomisation. Results There is a tendency for cluster trials, with evidence methodological biases, to also show an age imbalance between treatment groups. In a funnel plot we show that all cluster trials show a large positive effect of hip protectors whilst individually randomised trials show a range of positive and negative effects, suggesting that cluster trials may be producing a biased estimate of effect. Conclusion Methodological biases in the design and execution of cluster randomised trials is frequent. Some of these biases associated with the use of cluster designs can be avoided through careful attention to the design of cluster trials. Firstly, if possible, individual allocation should be used. Secondly, if cluster allocation is required, then ideally participants should be identified before random allocation of the clusters. Third, if prior identification is not possible, then an independent recruiter should be used to recruit participants.
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                Author and article information

                Contributors
                t.j.l.savareid@medisin.uio.no
                lillian.lillemoen@medisin.uio.no
                lisbeth.thoresen@medisin.uio.no
                reidun.forde@medisin.uio.no
                elisabeth.gjerberg@medisin.uio.no
                reidar.pedersen@medisin.uio.no
                Journal
                BMC Geriatr
                BMC Geriatr
                BMC Geriatrics
                BioMed Central (London )
                1471-2318
                13 August 2018
                13 August 2018
                2018
                : 18
                : 180
                Affiliations
                [1 ]ISNI 0000 0004 1936 8921, GRID grid.5510.1, Centre for Medical Ethics, , University of Oslo, ; Kirkeveien 166 Frederik Holsts hus, 0450 Oslo, Norway
                [2 ]ISNI 0000 0004 1936 8921, GRID grid.5510.1, Department of Health Sciences, , University of Oslo, ; Forskningsveien 3A Harald Schjelderups hus, 0373 Oslo, Norway
                Author information
                http://orcid.org/0000-0001-9062-7787
                Article
                869
                10.1186/s12877-018-0869-1
                6090595
                30103692
                0c2c2fc3-af32-4c2d-bda2-95811182ad13
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 4 October 2017
                : 31 July 2018
                Funding
                Funded by: The Research Council of Norway
                Award ID: Project number: 222088
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Geriatric medicine
                advance care planning,autonomy,nursing home,dementia,decision-making capacity assessment,complex intervention,train the trainer,mixed-methods

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