The Prevention Program for Alzheimer's Related Delirium (PREPARED) Trial
NCT ID: NCT03718156
Last Updated: 2022-07-15
Study Results
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Basic Information
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SUSPENDED
NA
800 participants
INTERVENTIONAL
2018-06-23
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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).
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.
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
65 Years
ALL
No
Sponsors
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McGill University
OTHER
Responsible Party
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Machelle Wilchesky
Assistant Professor
Principal Investigators
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Machelle Wilchesky, PhD
Role: PRINCIPAL_INVESTIGATOR
McGill University
Philippe Voyer, Inf. PhD
Role: STUDY_CHAIR
Laval University
Nathalie Champoux, MD, MSc
Role: STUDY_CHAIR
Université de Montréal
Antonio Ciampi, PhD
Role: STUDY_CHAIR
McGill University
Ovidiu Lungu, PhD
Role: STUDY_CHAIR
Université de Montréal
Jane McCusker, MD, PhD
Role: STUDY_CHAIR
McGill University
Johanne Monette, MD, MSc
Role: STUDY_CHAIR
Lady Davis Institute for Medical Research
T.T. Minh Vu, MD, FRCPC
Role: STUDY_CHAIR
Centre hospitalier de l'Université de Montréal (CHUM)
Locations
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Association des établissements privés conventionnés
Montreal, , Canada
Integrated University Health and Social Services Centre for East Montreal
Montreal, , Canada
Integrated University Health and Social Services Centre for North Montreal
Montreal, , Canada
Integrated University Health and Social Services Centre for South-Central Montreal
Montreal, , Canada
Integrated University Health and Social Services Centre for West Montreal
Montreal, , Canada
Integrated University Health and Social Services Centre for West-Central Montreal
Montreal, , Canada
Countries
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References
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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.
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.
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.
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.
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.
Cole MG. Persistent delirium in older hospital patients. Curr Opin Psychiatry. 2010 May;23(3):250-4. doi: 10.1097/YCO.0b013e32833861f6.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PT 71435
Identifier Type: -
Identifier Source: org_study_id
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