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

NCT03718156 | Suspended

• 1 other identifier: PT 71435
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 6

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.

Conditions

Delirium; Dementia

Keywords

delirium; dementia; long-term care; cluster randomized trial; nursing; geriatrics

Outcome Measures

Primary Outcomes (4)

• Incidence of delirium

  Confusion Assessment Method (CAM) scores

  over the 18 week follow-up period

• Delirium severity

  Delirium Index scores (0-21)

  over the 18 week follow-up period

• Delirium episode duration

  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

  count of delirium episodes

  over the 18 week follow-up period

Secondary Outcomes (6)

• Delirium motoric subtype

  over the 18 week follow-up period

• Number of falls

  over the 18 week follow-up period

• Time to first fall

  over the 18 week follow-up period

• Change in functional autonomy

  over the study period (18 weeks)

• Change in cognitive functioning

  over the study period (18 weeks)

Study Arms (2)

PREPARED Trial Intervention

EXPERIMENTAL

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

Care as Usual

NO INTERVENTION

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.

Interventions

PREPARED Trial Intervention OTHER

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).

PREPARED Trial Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University: lead

Study Sites (6)

Association des établissements privés conventionnés

Montreal, Canada

Location

Integrated University Health and Social Services Centre for East Montreal

Montreal, Canada

Location

Integrated University Health and Social Services Centre for North Montreal

Montreal, Canada

Location

Integrated University Health and Social Services Centre for South-Central Montreal

Montreal, Canada

Location

Integrated University Health and Social Services Centre for West Montreal

Montreal, Canada

Location

Integrated University Health and Social Services Centre for West-Central Montreal

Montreal, Canada

Location

Related Publications (23)

• Elie M, Rousseau F, Cole M, Primeau F, McCusker J, Bellavance F. Prevalence and detection of delirium in elderly emergency department patients. CMAJ. 2000 Oct 17;163(8):977-81.

  PMID: 11068569 BACKGROUND

• Fick DM, Agostini JV, Inouye SK. Delirium superimposed on dementia: a systematic review. J Am Geriatr Soc. 2002 Oct;50(10):1723-32. doi: 10.1046/j.1532-5415.2002.50468.x.

  PMID: 12366629 BACKGROUND

• Lemiengre J, Nelis T, Joosten E, Braes T, Foreman M, Gastmans C, Milisen K. Detection of delirium by bedside nurses using the confusion assessment method. J Am Geriatr Soc. 2006 Apr;54(4):685-9. doi: 10.1111/j.1532-5415.2006.00667.x.

  PMID: 16686883 BACKGROUND

• Voyer P, Richard S, Doucet L, Carmichael PH. Detecting delirium and subsyndromal delirium using different diagnostic criteria among demented long-term care residents. J Am Med Dir Assoc. 2009 Mar;10(3):181-8. doi: 10.1016/j.jamda.2008.09.006. Epub 2009 Jan 8.

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• McCusker J, Cole MG, Voyer P, Monette J, Champoux N, Ciampi A, Vu M, Belzile E. Prevalence and incidence of delirium in long-term care. Int J Geriatr Psychiatry. 2011 Nov;26(11):1152-61. doi: 10.1002/gps.2654. Epub 2011 Jan 27.

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• Cole MG. Persistent delirium in older hospital patients. Curr Opin Psychiatry. 2010 May;23(3):250-4. doi: 10.1097/YCO.0b013e32833861f6.

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• Cole MG, McCusker J. Treatment of delirium in older medical inpatients: a challenge for geriatric specialists. J Am Geriatr Soc. 2002 Dec;50(12):2101-3. doi: 10.1046/j.1532-5415.2002.50634.x. No abstract available.

  PMID: 12473034 BACKGROUND

• Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.

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• Reston JT, Schoelles KM. In-facility delirium prevention programs as a patient safety strategy: a systematic review. Ann Intern Med. 2013 Mar 5;158(5 Pt 2):375-80. doi: 10.7326/0003-4819-158-5-201303051-00003.

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• Vidan MT, Sanchez E, Alonso M, Montero B, Ortiz J, Serra JA. An intervention integrated into daily clinical practice reduces the incidence of delirium during hospitalization in elderly patients. J Am Geriatr Soc. 2009 Nov;57(11):2029-36. doi: 10.1111/j.1532-5415.2009.02485.x. Epub 2009 Sep 15.

  PMID: 19754498 BACKGROUND

• Hshieh TT, Yue J, Oh E, Puelle M, Dowal S, Travison T, Inouye SK. Effectiveness of multicomponent nonpharmacological delirium interventions: a meta-analysis. JAMA Intern Med. 2015 Apr;175(4):512-20. doi: 10.1001/jamainternmed.2014.7779.

  PMID: 25643002 BACKGROUND

• Martinez F, Tobar C, Hill N. Preventing delirium: should non-pharmacological, multicomponent interventions be used? A systematic review and meta-analysis of the literature. Age Ageing. 2015 Mar;44(2):196-204. doi: 10.1093/ageing/afu173. Epub 2014 Nov 25.

  PMID: 25424450 BACKGROUND

• Gentric A, Le Deun P, Estivin S. [Prevention of delirium in an acute geriatric care unit]. Rev Med Interne. 2007 Sep;28(9):589-93. doi: 10.1016/j.revmed.2007.04.004. Epub 2007 May 15. French.

  PMID: 17512095 BACKGROUND

• Pisani MA, Murphy TE, Van Ness PH, Araujo KL, Inouye SK. Characteristics associated with delirium in older patients in a medical intensive care unit. Arch Intern Med. 2007 Aug 13-27;167(15):1629-34. doi: 10.1001/archinte.167.15.1629.

  PMID: 17698685 BACKGROUND

• Voyer P, McCusker J, Cole MG, Monette J, Champoux N, Vu M, Ciampi A, Sanche S, Richard S, de Raad M. Feasibility and acceptability of a delirium prevention program for cognitively impaired long term care residents: a participatory approach. J Am Med Dir Assoc. 2014 Jan;15(1):77.e1-9. doi: 10.1016/j.jamda.2013.08.013. Epub 2013 Oct 2.

  PMID: 24094898 BACKGROUND

• Rockwood K. Making delirium prevention acceptable in nursing homes. J Am Med Dir Assoc. 2014 Jan;15(1):6-7. doi: 10.1016/j.jamda.2013.09.002. Epub 2013 Oct 8. No abstract available.

  PMID: 24113630 BACKGROUND

• Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

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• Wei LA, Fearing MA, Sternberg EJ, Inouye SK. The Confusion Assessment Method: a systematic review of current usage. J Am Geriatr Soc. 2008 May;56(5):823-30. doi: 10.1111/j.1532-5415.2008.01674.x. Epub 2008 Apr 1.

  PMID: 18384586 BACKGROUND

• McCusker J, Cole MG, Dendukuri N, Belzile E. The delirium index, a measure of the severity of delirium: new findings on reliability, validity, and responsiveness. J Am Geriatr Soc. 2004 Oct;52(10):1744-9. doi: 10.1111/j.1532-5415.2004.52471.x.

  PMID: 15450055 BACKGROUND

• Allison PD (1995) Survival analysis using SAS: A practical guide. Cary, NC: SAS Institute. Inc.

  BACKGROUND

• Klein J. ea (2003) Survival Analysis (2nd ed.). New York: Springer.

  BACKGROUND

• Therneau TM, Grambsch PM (2000) Modeling survival data: extending the Cox model: Springer Science & Business Media.

  BACKGROUND

• Wilchesky M, Ballard SA, Voyer P, McCusker J, Lungu O, Champoux N, Vu TTM, Cole MG, Monette J, Ciampi A, Belzile E, Carmichael PH, McConnell T. The PREvention Program for Alzheimer's RElated Delirium (PREPARED) cluster randomized trial: a study protocol. BMC Geriatr. 2021 Nov 16;21(1):645. doi: 10.1186/s12877-021-02558-3.

  PMID: 34784897 DERIVED

MeSH Terms

Conditions

Delirium; Dementia

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases

Study Officials

• Machelle Wilchesky, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

• 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)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: October 24, 2018
• Study Start: June 23, 2018
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2026
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

CA (6)