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

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, 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

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 .

Keywords: Delirium; Delirium superimposed on dementia; Long-term care; Modifiable risk factors; Multicomponent intervention; Nursing.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Timeline of Research Activities per Trial LTC Facility
Fig. 2
Fig. 2
Delirium Risk Screening Tool and Decision Tree
Fig. 3
Fig. 3
PREPARED Cluster Randomized Trial Sample Size Estimation
Fig. 4
Fig. 4
PREPARED Trial SPIRIT Diagram

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