The Prevention Program for Alzheimer's Related Delirium (PREPARED) Trial

Summary

By the year 2038, over a million Canadians are expected to have Alzheimer's disease, a type of dementia. Dementia increases the risk of nursing home placement among the elderly more than fivefold. Given the exceptionally vulnerable nature of this patient population, there is a pressing need to ensure that the clinical care they receive is evidence-based, tailored specifically for them, and meeting the high standards of quality that would be expected in any other health-care setting. Delirium is a sudden and severe change in brain function that can cause a person to appear confused or disoriented, have memory loss, and have difficulties maintaining focus. It is an urgent care issue facing elderly patients residing in nursing homes, or long-term care (LTC) facilities. Delirium is a significant cause of illness and mortality, affecting between 10%-89% of LTC patients, but little research has focused on delirium prevention in the LTC setting. This study will assess the effectiveness of a LTC multicomponent delirium prevention program (PREPARED Trial intervention). The PREPARED Trial intervention is an intervention provided to nursing staff working in LTC facilities that consists of four components: a decision tree, an instruction manual, a training package, and a toolkit. The feasibility and acceptability of the PREPARED Trial intervention has already been successfully demonstrated; however, a thorough and well-designed large scale study is needed in order to confirm its ability to reduce delirium among LTC residents. In this study, approximately 40-50 LTC facilities will be randomized to either receive the PREPARED Trial intervention or to receive usual care. At the end of the 4-year study period, the investigators will be able to demonstrate the degree to which the PREPARED Trial intervention reduces: 1) the number of new cases of delirium; 2) delirium severity; and 3) the duration of delirium episodes. This study will provide the blueprint of a program that can be transferable to LTC facilities across Canada.

Conditions

• Delirium
• Dementia

Interventions

OTHER

PREPARED Trial Intervention

Nursing staff members will be trained to adjust the therapeutic nursing plans (TNP) for residents enrolled in the study, as follows: 1) by providing optimal stimulation (surveying the use of eyeglasses and hearing aids, the room lighting and space organization; orienting the resident to time and space; and stimulating the resident using familiar objects, photos, and life histories); and 2) by assessing the presence of 4 modifiable delirium risk factors (antipsychotic use, sensory impairment, restraint use, and dehydration) and taking specific actions once a given risk factor is identified. For instance, if physical restraints are used, the TNP will require that they are to be removed during care when a caregiver is present (nail care, feeding, and wound care).

Sponsors & Collaborators

• McGill University

  lead OTHER

Principal Investigators

• Machelle Wilchesky, PhD · McGill University

• Philippe Voyer, Inf. PhD · Laval University

• Nathalie Champoux, MD, MSc · Université de Montréal

• Antonio Ciampi, PhD · McGill University

• Ovidiu Lungu, PhD · Université de Montréal

• Jane McCusker, MD, PhD · McGill University

• Johanne Monette, MD, MSc · Lady Davis Institute for Medical Research

• T.T. Minh Vu, MD, FRCPC · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-23

Primary Completion

2025-06-30

Completion

2026-06-30

Countries

• Canada

Study Locations