Wilchesky, Machelle http://orcid.org/0000-0003-4138-009X
Ballard, Stephanie A.
Voyer, Philippe
McCusker, Jane
Lungu, Ovidiu
Champoux, Nathalie
Vu, T. T. Minh
Cole, Martin G.
Monette, Johanne
Ciampi, Antonio
Belzile, Eric
Carmichael, Pierre-Hugues
McConnell, Ted
Funding for this research was provided by:
canadian institutes of health research (PJT-148937)
Article History
Received: 28 July 2021
Accepted: 15 October 2021
First Online: 16 November 2021
Declarations
:
: The Comité central d’éthique de la recherche du ministre de la Santé et des Services Sociaux du Québec provided ethical oversight and approved the study (ethics certificate number: CCER 17–18-04). 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 [CitationRef removed]. 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 Québec 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 Comité central d’éthique de la recherche du ministre de la Santé et des Services Sociaux du Québec as per their published guidelines and procedures.
: Not applicable.
: The authors declare that they have no competing interests.