Clinical trial NCT03718156: The Prevention Program for Alzheimer's Related Delirium (PREPARED) Trial
Official title: The Prevention Program for Alzheimer's Related Delirium (PREPARED) Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Delirium
Dementia
Keywords: delirium
dementia
long-term care
cluster randomized trial
nursing
geriatrics
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 800
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The PREPARED Trial is a 4-year cluster randomized intervention study. A cluster design was adopted in order to prevent contamination across the intervention and control arms by nursing staff who may provide replacement hours of employment at different units/floors within their long-term care facilities (LTCFs). Participating LTCFs (clusters) will be assigned to either the PREPARED Trial intervention or the control (usual care) arm of the study using a covariate constrained randomization procedure. In addition, given the need to assess each resident weekly for a follow-up period of 18 weeks and logistical limitations (large geographical coverage, 40-50 LTCFs included, and limited work force), the investigators will employ a sequential approach whereby sets of clusters (LTCFs) will be randomized into the two study arms in consecutive 'waves' of follow-up lasting 18 weeks each. It is estimated that 4 waves of trial follow-up, comprised of 10-12 clusters each, will be completed.
Primary purpose: PREVENTION

Brief 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.

Detailed description: Overall Goal: To reduce the incidence, severity, duration, and frequency of delirium episodes in cognitively impaired long-term care (LTC) residents at high risk for delirium.

Background: Delirium is a significant cause of morbidity and mortality among older people admitted to both acute and LTC settings. Prevention, founded on a thorough understanding of associated risk factors, is the best approach for dealing with delirium. Several successful multicomponent interventions have been developed to reduce delirium incidence in the acute care setting (30%-73% reduction) by intervening on identified modifiable risk factors. Little work, however, has focused on using this approach to reduce delirium incidence in LTC. As such, co-investigators within the study team employed an integrated knowledge translation strategy to develop a LTC multicomponent delirium prevention program (PREPARED Trial intervention). The feasibility and acceptability of this program has been demonstrated using a participatory approach in two Quebec LTC facilities (LTCFs), and the program has received recognition by the scientific community. Given its large expected impact and high knowledge translation potential, a thorough and well-designed large-scale evaluation is urgently needed in order to demonstrate the effectiveness of the multicomponent delirium prevention program in preventing delirium among high-risk LTC residents.

Primary Objective: To assess efficacy of the PREPARED Trial intervention in reducing delirium incidence, and delirium episode severity, duration, and frequency among cognitively impaired, high-risk LTC residents.

Secondary Objectives: To compare the effect of the PREPARED Trial intervention to that of usual care on the incidence of falls among cognitively impaired LTC residents, to estimate the association between medication use and delirium incidence in LTCFs, to estimate if there is an effect modification by motor subtype of delirium or by dementia subtype, and to measure the prevalence of delirium in participating institutions.

Tertiary Objectives: To compare the effect of the PREPARED Trial intervention on other health outcomes, including: changes in functional autonomy or social engagement, the number of transfers to acute care, consultations with healthcare providers, and mortality rates.

Methods: This 4-year cluster randomized study will involve nursing staff and residents in 40-50 public and semi-private LTC facilities in Quebec, Canada. Institutions within all 5 of the Montreal island Integrated University Health and Social Services networks (CIUSSS) and one private provincial network are currently participating. Approximately 900 LTC residents will be enrolled in the study and followed for 18 weeks only if they are at high risk of delirium and are delirium-free at baseline. The PREPARED Trial intervention is a program consisting of four components: a decision tree, an instruction manual, a training package and a toolkit. Primary study outcomes such as delirium incidence (measured by the Confusion Assessment Method), delirium severity (measured by the Delirium Index), and level of adherence to the PREPARED Trial protocol will be assessed weekly. Functional autonomy levels will be assessed at the beginning and end of follow-up, while information pertaining to modifiable delirium risk factors, medical consultations, and institutional transfers will be collected for the duration of the follow-up period. For primary analysis, hazard ratios will be modeled using Cox regression to compare the effect of the PREPARED Trial intervention to that of usual care on the time to first delirium episode. Clustering effects will be taken into account using frailty models, an extension of Cox regression for the addition of random effects.

Expected Outcomes and Significance: 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. In addition to reducing delirium in this frail population, deliverables include validation of this prevention program, as well as the transferring of its components (including bilingual video training modules for LTC staff) to relevant knowledge users across Canada.

Eligibility criteria: Inclusion Criteria:

* has dementia and/or cognitive impairment (as determined by discussions with the nursing staff and chart abstraction);
* a minimum length of stay in the LTC institution of at least two weeks prior to the start of the baseline assessments;
* at high risk of delirium, as indicated by a score of 3 or higher on a validated 5-item delirium risk screening tool;
* delirium-free at baseline, as assessed by the Confusion Assessment Method (CAM), the Delirium Index (DI) and a brief chart review over a screening period of two consecutive weeks.

Exclusion Criteria:

* unable to communicate verbally in English or French (as determined by either the nursing staff or two consecutive 0-score administrations of the composite cognitive interview at screening);
* has a history of specific psychiatric conditions (bipolar disorder, depression with signs of psychosis, and psychotic disorders) or intellectual disability;
* is receiving comfort/end-of-life care.

Primary outcomes:
measure: Incidence of delirium
timeFrame: over the 18 week follow-up period
measure: Delirium severity
timeFrame: over the 18 week follow-up period
measure: Delirium episode duration
timeFrame: over the 18 week follow-up period
measure: Number of delirium episodes
timeFrame: over the 18 week follow-up period
Secondary outcomes:
measure: Delirium motoric subtype
timeFrame: over the 18 week follow-up period
measure: Number of falls
timeFrame: over the 18 week follow-up period
measure: Time to first fall
timeFrame: over the 18 week follow-up period
measure: Change in functional autonomy
timeFrame: over the study period (18 weeks)
measure: Change in cognitive functioning
timeFrame: over the study period (18 weeks)
measure: Change in level of social engagement
timeFrame: over the study period (18 weeks)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Association des établissements privés conventionnés
city: Montréal
country: Canada
facility: Integrated University Health and Social Services Centre for East Montreal
city: Montréal
country: Canada
facility: Integrated University Health and Social Services Centre for North Montreal
city: Montréal
country: Canada
facility: Integrated University Health and Social Services Centre for South-Central Montreal
city: Montréal
country: Canada
facility: Integrated University Health and Social Services Centre for West Montreal
city: Montréal
country: Canada
facility: Integrated University Health and Social Services Centre for West-Central Montreal
Study officials:
affiliation: McGill University
name: Machelle Wilchesky, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Philippe Voyer, Inf. PhD
role: STUDY_CHAIR
affiliation: Université de Montréal
name: Nathalie Champoux, MD, MSc
role: STUDY_CHAIR
affiliation: McGill University
name: Antonio Ciampi, PhD
role: STUDY_CHAIR
affiliation: Université de Montréal
name: Ovidiu Lungu, PhD
role: STUDY_CHAIR
affiliation: McGill University
name: Jane McCusker, MD, PhD
role: STUDY_CHAIR
affiliation: Lady Davis Institute for Medical Research
name: Johanne Monette, MD, MSc
role: STUDY_CHAIR
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: T.T. Minh Vu, MD, FRCPC
role: STUDY_CHAIR
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