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

July 13, 2022 updated by: Machelle Wilchesky, McGill University

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montréal, Canada
        • Association des établissements privés conventionnés
      • Montréal, Canada
        • Integrated University Health and Social Services Centre for East Montreal
      • Montréal, Canada
        • Integrated University Health and Social Services Centre for North Montreal
      • Montréal, Canada
        • Integrated University Health and Social Services Centre for South-Central Montreal
      • Montréal, Canada
        • Integrated University Health and Social Services Centre for West Montreal
      • Montréal, Canada
        • Integrated University Health and Social Services Centre for West-Central Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PREPARED Trial Intervention
Participating nursing staff will be trained to apply the PREPARED Trial interventions, and will apply this knowledge to modify the therapeutic nursing plans of residents under their care who are enrolled in the study, accordingly.
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).
No Intervention: Care as Usual
Participating nursing staff will only be provided with general information about delirium, but will not be trained or instructed to modify the therapeutic nursing plans that are in place for residents enrolled in the study. However, at the end of the follow-up period, nursing staff in the control arm will be provided with the PREPARED Trial intervention training program (including bedside coaching), which they can then use after the study has ended at their facility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of delirium
Time Frame: over the 18 week follow-up period
Confusion Assessment Method (CAM) scores
over the 18 week follow-up period
Delirium severity
Time Frame: over the 18 week follow-up period
Delirium Index scores (0-21)
over the 18 week follow-up period
Delirium episode duration
Time Frame: over the 18 week follow-up period
the total number of days that a given resident experiences active episode(s) of delirium
over the 18 week follow-up period
Number of delirium episodes
Time Frame: over the 18 week follow-up period
count of delirium episodes
over the 18 week follow-up period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delirium motoric subtype
Time Frame: over the 18 week follow-up period
Delirium Motor Subtype Scale scores
over the 18 week follow-up period
Number of falls
Time Frame: over the 18 week follow-up period
count of falls and fall-related injuries, as documented in medical charts
over the 18 week follow-up period
Time to first fall
Time Frame: over the 18 week follow-up period
days to first reported fall
over the 18 week follow-up period
Change in functional autonomy
Time Frame: over the study period (18 weeks)
Barthel Index (Shah version) scores
over the study period (18 weeks)
Change in cognitive functioning
Time Frame: over the study period (18 weeks)
Hierarchic Dementia Scale scores
over the study period (18 weeks)
Change in level of social engagement
Time Frame: over the study period (18 weeks)
Revised Index of Social Engagement in Long-Term Care Facilities scores
over the study period (18 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Investigators

  • Principal Investigator: Machelle Wilchesky, PhD, McGIll University
  • Study Chair: Philippe Voyer, Inf. PhD, Laval University
  • Study Chair: Nathalie Champoux, MD, MSc, Université de Montréal
  • Study Chair: Antonio Ciampi, PhD, McGIll University
  • Study Chair: Ovidiu Lungu, PhD, Université de Montréal
  • Study Chair: Jane McCusker, MD, PhD, McGIll University
  • Study Chair: Johanne Monette, MD, MSc, Lady Davis Institute for Medical Research
  • Study Chair: T.T. Minh Vu, MD, FRCPC, Centre Hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2018

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

August 20, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Actual)

July 15, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT 71435

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Delirium

Clinical Trials on PREPARED Trial Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe