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    Multicomponent non-pharmacological intervention to prevent delirium for hospitalised people with advanced cancer: study protocol for a phase II cluster randomised controlled trial

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    Author
    Hosie, A; Phillips, J; Lam, L; Kochovska, S; Noble, B; Brassil, M; Kurrle, SE; Cumming, A; Caplan, GA; Chye, R; ...
    Date
    2019-06-01
    Source Title
    BMJ Open
    Publisher
    BMJ PUBLISHING GROUP
    University of Melbourne Author/s
    Le, Brian
    Affiliation
    Medicine and Radiology
    Metadata
    Show full item record
    Document Type
    Journal Article
    Citations
    Hosie, A., Phillips, J., Lam, L., Kochovska, S., Noble, B., Brassil, M., Kurrle, S. E., Cumming, A., Caplan, G. A., Chye, R., Le, B., Ely, E. W., Lawlor, P. G., Bush, S. H., Davis, J. M., Lovell, M., Brown, L., Fazekas, B., Cheah, S. L. ,... Agar, M. (2019). Multicomponent non-pharmacological intervention to prevent delirium for hospitalised people with advanced cancer: study protocol for a phase II cluster randomised controlled trial. BMJ OPEN, 9 (1), https://doi.org/10.1136/bmjopen-2018-026177.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/253802
    DOI
    10.1136/bmjopen-2018-026177
    Abstract
    INTRODUCTION: Delirium is a significant medical complication for hospitalised patients. Up to one-third of delirium episodes are preventable in older inpatients through non-pharmacological strategies that support essential human needs, such as physical and cognitive activity, sleep, hydration, vision and hearing. We hypothesised that a multicomponent intervention similarly may decrease delirium incidence, and/or its duration and severity, in inpatients with advanced cancer. Prior to a phase III trial, we aimed to determine if a multicomponent non-pharmacological delirium prevention intervention is feasible and acceptable for this specific inpatient group. METHODS AND ANALYSIS: The study is a phase II cluster randomised wait-listed controlled trial involving inpatients with advanced cancer at four Australian palliative care inpatient units. Intervention sites will introduce delirium screening, diagnostic assessment and a multicomponent delirium prevention intervention with six domains of care: preserving natural sleep; maintaining optimal vision and hearing; optimising hydration; promoting communication, orientation and cognition; optimising mobility; and promoting family partnership. Interdisciplinary teams will tailor intervention delivery to each site and to patient need. Control sites will first introduce only delirium screening and diagnosis, later implementing the intervention, modified according to initial results. The primary outcome is adherence to the intervention during the first seven days of admission, measured for 40 consecutively admitted eligible patients. Secondary outcomes relate to fidelity and feasibility, acceptability and sustainability of the study intervention, processes and measures in this patient population, using quantitative and qualitative measures. Delirium incidence and severity will be measured to inform power calculations for a future phase III trial. ETHICS AND DISSEMINATION: Ethical approval was obtained for all four sites. Trial results, qualitative substudy findings and implementation of the intervention will be submitted for publication in peer-reviewed journals, and reported at conferences, to study sites and key peak bodies. TRIAL REGISTRATION NUMBER: ACTRN12617001070325; Pre-results.

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