The PREvention Program for Alzheimer’s RElated Delirium (PREPARED) cluster randomized trial: a study protocol

Abstract Background Delirium is a significant cause of morbidity and mortality among older people admitted to both acute and long-term care facilities (LTCFs). Multicomponent interventions have been shown to reduce delirium incidence in the acute care setting (30–73%) by acting on modifiable risk fa...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Machelle Wilchesky, Stephanie A. Ballard, Philippe Voyer, Jane McCusker, Ovidiu Lungu, Nathalie Champoux, T. T. Minh Vu, Martin G. Cole, Johanne Monette, Antonio Ciampi, Eric Belzile, Pierre-Hugues Carmichael, Ted McConnell
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Delirium Delirium superimposed on dementia Modifiable risk factors Multicomponent intervention Nursing Long-term care Geriatrics RC952-954.6
Acceso en línea:	https://doaj.org/article/0901d07d4b2a47dca80487adbb0b613b
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:0901d07d4b2a47dca80487adbb0b613b
record_format	dspace
spelling	oai:doaj.org-article:0901d07d4b2a47dca80487adbb0b613b2021-11-21T12:07:20ZThe PREvention Program for Alzheimer’s RElated Delirium (PREPARED) cluster randomized trial: a study protocol10.1186/s12877-021-02558-31471-2318https://doaj.org/article/0901d07d4b2a47dca80487adbb0b613b2021-11-01T00:00:00Zhttps://doi.org/10.1186/s12877-021-02558-3https://doaj.org/toc/1471-2318Abstract Background Delirium is a significant cause of morbidity and mortality among older people admitted to both acute and long-term care facilities (LTCFs). Multicomponent interventions have been shown to reduce delirium incidence in the acute care setting (30–73%) by acting on modifiable risk factors. Little work, however, has focused on using this approach to reduce delirium incidence in LTCFs. Methods The objective is to assess the effectiveness of the multicomponent PREPARED Trial intervention in reducing the following primary outcomes: incidence, severity, duration, and frequency of delirium episodes in cognitively impaired residents. This 4-year, parallel-design, cluster randomized study will involve nursing staff and residents in 45–50 LTCFs in Montreal, Canada. Participating public and private LTCFs (clusters) that provide 24-h nursing care will be assigned to either the PREPARED Trial intervention or the control (usual care) arm of the study using a covariate constrained randomization procedure. Approximately 400–600 LTC residents aged 65 and older with dementia and/or cognitive impairment will be enrolled in the study and followed for 18 weeks. Residents must be at risk of delirium, delirium-free at baseline and have resided at the facility for at least 2 weeks. Residents who are unable to communicate verbally, have a history of specific psychiatric conditions, or are receiving end-of-life care will be excluded. The PREPARED Trial intervention consists of four main components: a decision tree, an instruction manual, a training package, and a toolkit. Primary study outcomes will be assessed weekly. Functional autonomy and cognitive levels will be assessed at the beginning and end of follow-up, while information pertaining to modifiable delirium risk factors, medical consultations, and facility transfers will be collected retrospectively for the duration of the follow-up period. Primary outcomes will be reported at the level of intervention assignment. All researchers analyzing the data will be blinded to group allocation. Discussion This large-scale intervention study will contribute significantly to the development of evidence-based clinical guidelines for delirium prevention in this frail elderly population, as it will be the first to evaluate the efficacy of a multicomponent delirium prevention program translated into LTC clinical practice on a large scale. Trial registration NCT03718156 , ClinicalTrials.gov .Machelle WilcheskyStephanie A. BallardPhilippe VoyerJane McCuskerOvidiu LunguNathalie ChampouxT. T. Minh VuMartin G. ColeJohanne MonetteAntonio CiampiEric BelzilePierre-Hugues CarmichaelTed McConnellBMCarticleDeliriumDelirium superimposed on dementiaModifiable risk factorsMulticomponent interventionNursingLong-term careGeriatricsRC952-954.6ENBMC Geriatrics, Vol 21, Iss 1, Pp 1-13 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Delirium Delirium superimposed on dementia Modifiable risk factors Multicomponent intervention Nursing Long-term care Geriatrics RC952-954.6
spellingShingle	Delirium Delirium superimposed on dementia Modifiable risk factors Multicomponent intervention Nursing Long-term care Geriatrics RC952-954.6 Machelle Wilchesky Stephanie A. Ballard Philippe Voyer Jane McCusker Ovidiu Lungu Nathalie Champoux T. T. Minh Vu Martin G. Cole Johanne Monette Antonio Ciampi Eric Belzile Pierre-Hugues Carmichael Ted McConnell The PREvention Program for Alzheimer’s RElated Delirium (PREPARED) cluster randomized trial: a study protocol
description	Abstract Background Delirium is a significant cause of morbidity and mortality among older people admitted to both acute and long-term care facilities (LTCFs). Multicomponent interventions have been shown to reduce delirium incidence in the acute care setting (30–73%) by acting on modifiable risk factors. Little work, however, has focused on using this approach to reduce delirium incidence in LTCFs. Methods The objective is to assess the effectiveness of the multicomponent PREPARED Trial intervention in reducing the following primary outcomes: incidence, severity, duration, and frequency of delirium episodes in cognitively impaired residents. This 4-year, parallel-design, cluster randomized study will involve nursing staff and residents in 45–50 LTCFs in Montreal, Canada. Participating public and private LTCFs (clusters) that provide 24-h nursing care will be assigned to either the PREPARED Trial intervention or the control (usual care) arm of the study using a covariate constrained randomization procedure. Approximately 400–600 LTC residents aged 65 and older with dementia and/or cognitive impairment will be enrolled in the study and followed for 18 weeks. Residents must be at risk of delirium, delirium-free at baseline and have resided at the facility for at least 2 weeks. Residents who are unable to communicate verbally, have a history of specific psychiatric conditions, or are receiving end-of-life care will be excluded. The PREPARED Trial intervention consists of four main components: a decision tree, an instruction manual, a training package, and a toolkit. Primary study outcomes will be assessed weekly. Functional autonomy and cognitive levels will be assessed at the beginning and end of follow-up, while information pertaining to modifiable delirium risk factors, medical consultations, and facility transfers will be collected retrospectively for the duration of the follow-up period. Primary outcomes will be reported at the level of intervention assignment. All researchers analyzing the data will be blinded to group allocation. Discussion This large-scale intervention study will contribute significantly to the development of evidence-based clinical guidelines for delirium prevention in this frail elderly population, as it will be the first to evaluate the efficacy of a multicomponent delirium prevention program translated into LTC clinical practice on a large scale. Trial registration NCT03718156 , ClinicalTrials.gov .
format	article
author	Machelle Wilchesky Stephanie A. Ballard Philippe Voyer Jane McCusker Ovidiu Lungu Nathalie Champoux T. T. Minh Vu Martin G. Cole Johanne Monette Antonio Ciampi Eric Belzile Pierre-Hugues Carmichael Ted McConnell
author_facet	Machelle Wilchesky Stephanie A. Ballard Philippe Voyer Jane McCusker Ovidiu Lungu Nathalie Champoux T. T. Minh Vu Martin G. Cole Johanne Monette Antonio Ciampi Eric Belzile Pierre-Hugues Carmichael Ted McConnell
author_sort	Machelle Wilchesky
title	The PREvention Program for Alzheimer’s RElated Delirium (PREPARED) cluster randomized trial: a study protocol
title_short	The PREvention Program for Alzheimer’s RElated Delirium (PREPARED) cluster randomized trial: a study protocol
title_full	The PREvention Program for Alzheimer’s RElated Delirium (PREPARED) cluster randomized trial: a study protocol
title_fullStr	The PREvention Program for Alzheimer’s RElated Delirium (PREPARED) cluster randomized trial: a study protocol
title_full_unstemmed	The PREvention Program for Alzheimer’s RElated Delirium (PREPARED) cluster randomized trial: a study protocol
title_sort	prevention program for alzheimer’s related delirium (prepared) cluster randomized trial: a study protocol
publisher	BMC
publishDate	2021
url	https://doaj.org/article/0901d07d4b2a47dca80487adbb0b613b
work_keys_str_mv	AT machellewilchesky thepreventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT stephanieaballard thepreventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT philippevoyer thepreventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT janemccusker thepreventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT ovidiulungu thepreventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT nathaliechampoux thepreventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT ttminhvu thepreventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT martingcole thepreventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT johannemonette thepreventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT antoniociampi thepreventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT ericbelzile thepreventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT pierrehuguescarmichael thepreventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT tedmcconnell thepreventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT machellewilchesky preventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT stephanieaballard preventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT philippevoyer preventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT janemccusker preventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT ovidiulungu preventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT nathaliechampoux preventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT ttminhvu preventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT martingcole preventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT johannemonette preventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT antoniociampi preventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT ericbelzile preventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT pierrehuguescarmichael preventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol AT tedmcconnell preventionprogramforalzheimersrelateddeliriumpreparedclusterrandomizedtrialastudyprotocol
_version_	1718419166771281920

The PREvention Program for Alzheimer’s RElated Delirium (PREPARED) cluster randomized trial: a study protocol

Ejemplares similares