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Multicomponent interventions have been shown to reduce delirium incidence in the acute care setting (30\u201373%) by acting on modifiable risk factors. Little work, however, has focused on using this approach to reduce delirium incidence in LTCFs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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\u201350 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\u2013600 LTC residents aged 65 and older with dementia and\/or cognitive impairment will be enrolled in the study and followed for 18\u2009weeks. 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03718156\">NCT03718156<\/jats:ext-link>,<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s12877-021-02558-3","type":"journal-article","created":{"date-parts":[[2021,11,16]],"date-time":"2021-11-16T10:02:55Z","timestamp":1637056975000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["The PREvention Program for Alzheimer\u2019s RElated Delirium (PREPARED) cluster randomized trial: a study protocol"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4138-009X","authenticated-orcid":false,"given":"Machelle","family":"Wilchesky","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie A.","family":"Ballard","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philippe","family":"Voyer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane","family":"McCusker","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ovidiu","family":"Lungu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nathalie","family":"Champoux","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T. 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The study will involve the recruitment of nursing staff and LTC residents. Nursing staff will be approached at a quiet moment during their work shift and will be asked to sign an informed consent after they have agreed to participate following the presentation of the study objectives and procedures.Resident consent procedures will depend on resident capacity to consent, and will follow a protocol implemented by members of our research team in one of the precursor delirium studies conducted in this LTC population with dementia []. As in that study, competence to consent will be based on legal mandates or, in cases where no mandate is available, the clinical impressions of the primary nurse. As per Article 21 of the Civil Code of Qu\u00e9bec and Article 3.9 of the TriCouncil Policy Statement (TCPS) (2014), authorized third party individuals (i.e. legal guardians or responsible family members) will be asked to provide consent on behalf of residents who are unable to provide informed consent themselves. In cases where the primary nurse has indicated incapacity to consent in the absence of legal documentation and a participant acquires or regains decision-making capacity during the course of the trial (as perceived by the primary nurse and reported to the research staff), the research staff will promptly seek the consent of the individual as a condition of continuing participation as per Article 3.8 of the TCPS (2014).In order to protect the confidentiality of LTC residents and their families, the research team will not have access to resident or proxy contact information initially. Instead, a list of potential study subjects will be identified based on general eligibility screening criteria by the RN or LPN responsible for direct care. The RN or LPN will then approach all residents who are eligible to participate (or their proxies) to briefly discuss the study and obtain permission to speak with the research team about their potential participation (either in person or by post). Only residents (or proxies) who have agreed to speak with the research team will then be asked to provide consent. All participant consent will be sought prior to group allocation (the CCR procedure) and resident randomization.All important protocol modifications will be communicated to the Comit\u00e9 central d\u2019\u00e9thique de la recherche du ministre de la Sant\u00e9 et des Services Sociaux du Qu\u00e9bec as per their published guidelines and procedures.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"645"}}