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

Hosie, A; Phillips, J; Lam, L; Kochovska, S; Noble, B; Brassil, M; Kurrle, SE; Cumming, A; Caplan, GA; Chye, R; Le, B; Ely, EW; Lawlor, PG; Bush, SH; Davis, JM; Lovell, M; Brown, L; Fazekas, B; Cheah, SL; Edwards, L; Agar, M

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

Hosie, A

Phillips, J

Lam, L

Kochovska, S

Noble, B Brassil, M Kurrle, SE Cumming, A Caplan, GA Chye, R Le, B

Ely, EW Lawlor, PG Bush, SH

Davis, JM Lovell, M

Brown, L

Fazekas, B Cheah, SL

Edwards, L Agar, M

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Publication Type:: Journal Article
Citation:: BMJ Open, 2019, 9 (1)
Issue Date:: 2019-01-01

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Field	Value	Language
dc.contributor.author	Hosie, A https://orcid.org/0000-0003-1674-2124	en_US
dc.contributor.author	Phillips, J https://orcid.org/0000-0002-3691-8230	en_US
dc.contributor.author	Lam, L https://orcid.org/0000-0001-6183-6854	en_US
dc.contributor.author	Kochovska, S https://orcid.org/0000-0002-3531-0389	en_US
dc.contributor.author	Noble, B	en_US
dc.contributor.author	Brassil, M	en_US
dc.contributor.author	Kurrle, SE	en_US
dc.contributor.author	Cumming, A	en_US
dc.contributor.author	Caplan, GA	en_US
dc.contributor.author	Chye, R	en_US
dc.contributor.author	Le, B https://orcid.org/0000-0002-0830-4864	en_US
dc.contributor.author	Ely, EW	en_US
dc.contributor.author	Lawlor, PG	en_US
dc.contributor.author	Bush, SH https://orcid.org/0000-0001-8907-1283	en_US
dc.contributor.author	Davis, JM	en_US
dc.contributor.author	Lovell, M https://orcid.org/0000-0002-1407-2748	en_US
dc.contributor.author	Brown, L https://orcid.org/0000-0003-4892-5822	en_US
dc.contributor.author	Fazekas, B	en_US
dc.contributor.author	Cheah, SL https://orcid.org/0000-0003-4734-5770	en_US
dc.contributor.author	Edwards, L	en_US
dc.contributor.author	Agar, M https://orcid.org/0000-0002-6756-6119	en_US
dc.date.issued	2019-01-01	en_US
dc.identifier.citation	BMJ Open, 2019, 9 (1)	en_US
dc.identifier.uri	http://hdl.handle.net/10453/130366
dc.description.abstract	© 2019 Author(s) (or their employer(s)). 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.	en_US
dc.relation.ispartof	BMJ Open	en_US
dc.relation.isbasedon	10.1136/bmjopen-2018-026177	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Neoplasms	en_US
dc.subject.mesh	Delirium	en_US
dc.subject.mesh	Palliative Care	en_US
dc.subject.mesh	Incidence	en_US
dc.subject.mesh	Risk Factors	en_US
dc.subject.mesh	Time Factors	en_US
dc.subject.mesh	Inpatients	en_US
dc.subject.mesh	Australia	en_US
dc.subject.mesh	Multicenter Studies as Topic	en_US
dc.subject.mesh	Randomized Controlled Trials as Topic	en_US
dc.subject.mesh	Clinical Trials, Phase II as Topic	en_US
dc.title	Multicomponent non-pharmacological intervention to prevent delirium for hospitalised people with advanced cancer: Study protocol for a phase II cluster randomised controlled trial	en_US
dc.type	Journal Article
utslib.citation.volume	1	en_US
utslib.citation.volume	9	en_US
utslib.for	1103 Clinical Sciences	en_US
utslib.for	1117 Public Health and Health Services	en_US
utslib.for	1199 Other Medical and Health Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/DVC (Research)
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
pubs.organisational-group	/University of Technology Sydney/Strength - CHSP - Health Services and Practice
pubs.organisational-group	/University of Technology Sydney/Strength - CHT - Health Technologies
utslib.copyright.status	open_access
pubs.issue	1	en_US
pubs.publication-status	Published	en_US
pubs.volume	9	en_US

Abstract:

© 2019 Author(s) (or their employer(s)). 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.

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http://hdl.handle.net/10453/130366