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

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ClinicalTrials.gov Identifier: NCT03718156
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Machelle Wilchesky, McGill University

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.

Condition or disease Intervention/treatment Phase
Delirium Dementia Other: PREPARED Trial Intervention Not Applicable

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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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Masking Description: Long-term care facilities (LTCFs) cannot be blinded, as trial arm allocation will be obvious (those in the intervention group will undergo delirium prevention protocol training before their respective follow-up periods, and those in the control group will not). Similarly, research assistants (RAs) tasked with conducting resident assessments cannot be blinded to group allocation, as they will be constantly exposed to the everyday workings of participating LTCFs. However, RAs will be blinded to resident cognitive scores. All researchers analyzing the data will be blinded to group allocation, as LTCF names will be anonymized and randomization statuses will be concealed prior to data analysis.
Primary Purpose: Prevention
Official Title: The Prevention Program for Alzheimer's Related Delirium (PREPARED) Cluster Randomized Trial
Actual Study Start Date : June 23, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium Dementia

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.



Primary Outcome Measures :
  1. Incidence of delirium [ Time Frame: over the 18 week follow-up period ]
    Confusion Assessment Method (CAM) scores

  2. Delirium severity [ Time Frame: over the 18 week follow-up period ]
    Delirium Index scores (0-21)

  3. 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

  4. Number of delirium episodes [ Time Frame: over the 18 week follow-up period ]
    count of delirium episodes


Secondary Outcome Measures :
  1. Delirium motoric subtype [ Time Frame: over the 18 week follow-up period ]
    Delirium Motor Subtype Scale scores

  2. Number of falls [ Time Frame: over the 18 week follow-up period ]
    count of falls and fall-related injuries, as documented in medical charts

  3. Time to first fall [ Time Frame: over the 18 week follow-up period ]
    days to first reported fall

  4. Change in functional autonomy [ Time Frame: over the study period (18 weeks) ]
    Barthel Index (Shah version) scores

  5. Change in cognitive functioning [ Time Frame: over the study period (18 weeks) ]
    Hierarchic Dementia Scale scores

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718156


Contacts
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Contact: Machelle Wilchesky, PhD 514-483-2121 ext 2346 Machelle.Wilchesky@mcgill.ca
Contact: Stephanie Ballard, MSc 514-483-2121 ext 2386 stephanie.ballard@mail.mcgill.ca

Locations
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Canada
Association des établissements privés conventionnés Recruiting
Montréal, Canada
Contact: Machelle Wilchesky, PhD         
Integrated University Health and Social Services Centre for East Montreal Not yet recruiting
Montréal, Canada
Contact: Machelle Wilchesky, PhD         
Integrated University Health and Social Services Centre for North Montreal Not yet recruiting
Montréal, Canada
Contact: Machelle Wilchesky, PhD         
Integrated University Health and Social Services Centre for South-Central Montreal Recruiting
Montréal, Canada
Contact: Machelle Wilchesky, PhD         
Integrated University Health and Social Services Centre for West Montreal Recruiting
Montréal, Canada
Contact: Machelle Wilchesky, PhD         
Integrated University Health and Social Services Centre for West-Central Montreal Not yet recruiting
Montréal, Canada
Contact: Machelle Wilchesky, PhD         
Sponsors and Collaborators
McGill University
Investigators
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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'Université de Montréal (CHUM)

Publications:
Allison PD (1995) Survival analysis using SAS: A practical guide. Cary, NC: SAS Institute. Inc.
Klein J. ea (2003) Survival Analysis (2nd ed.). New York: Springer.
Therneau TM, Grambsch PM (2000) Modeling survival data: extending the Cox model: Springer Science & Business Media.

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Responsible Party: Machelle Wilchesky, Assistant Professor, McGill University
ClinicalTrials.gov Identifier: NCT03718156     History of Changes
Other Study ID Numbers: PT 71435
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Machelle Wilchesky, McGill University:
delirium
dementia
long-term care
cluster randomized trial
nursing
geriatrics

Additional relevant MeSH terms:
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Dementia
Delirium
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms