DeliriumPREPAREDNCT03718156
The Prevention Program for Alzheimer's Related Delirium (PREPARED) Trial
A study testing PREPARED Trial Intervention in people with Delirium and Dementia, run by McGill University at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- PREPARED Trial Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 6 sitesCanada
- Study dates
- 23 Jun 2018to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Association des établissements privés conventionnés
Montreal
Integrated University Health and Social Services Centre for East Montreal
Montreal
Integrated University Health and Social Services Centre for North Montreal
Montreal
Integrated University Health and Social Services Centre for South-Central Montreal
Montreal
Integrated University Health and Social Services Centre for West Montreal
Montreal
Integrated University Health and Social Services Centre for West-Central Montreal
Montreal
About this study
Official title: 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.
Read the 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.
- Being tested
- PREPARED Trial Intervention
- Keywords
- delirium, dementia, long-term care, cluster randomized trial, nursing, geriatrics
- Medical subject headings
- Delirium, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREPARED Trial InterventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium
Confusion Assessment Method (CAM) scores
Measured: over the 18 week follow-up period
Delirium severity
Delirium Index scores (0-21)
Measured: 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
Measured: over the 18 week follow-up period
Number of delirium episodes
count of delirium episodes
Measured: over the 18 week follow-up period
Secondary outcomes (6)
Delirium motoric subtype
Delirium Motor Subtype Scale scores
Measured: over the 18 week follow-up period
Number of falls
count of falls and fall-related injuries, as documented in medical charts
Measured: over the 18 week follow-up period
Time to first fall
days to first reported fall
Measured: over the 18 week follow-up period
Change in functional autonomy
Barthel Index (Shah version) scores
Measured: over the study period (18 weeks)
Change in cognitive functioning
Hierarchic Dementia Scale scores
Measured: over the study period (18 weeks)
Change in level of social engagement
Revised Index of Social Engagement in Long-Term Care Facilities scores
Measured: over the study period (18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start23 Jun 2018
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: COVID-19 prevented us from continuing this study which involves active participation from long-term care front-line staff. More funding is being sought to continue our trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Machelle Wilchesky, McGill University
- Investigators
- Machelle Wilchesky, PhD, Principal investigator, McGill UniversityPhilippe Voyer, Inf. PhD, Study chair, Laval UniversityNathalie Champoux, MD, MSc, Study chair, Université de MontréalAntonio Ciampi, PhD, Study chair, McGill UniversityOvidiu Lungu, PhD, Study chair, Université de MontréalJane McCusker, MD, PhD, Study chair, McGill UniversityJohanne Monette, MD, MSc, Study chair, Lady Davis Institute for Medical ResearchT.T. Minh Vu, MD, FRCPC, Study chair, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718156
- Sponsor's protocol ID
- PT 71435
- Acronym
- PREPARED
- Status last verified
- Jul 2022
- First submitted
- 20 Aug 2018
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11068569Fick 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.
PubMed 12366629Lemiengre 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.
PubMed 16686883Voyer 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.
PubMed 19233058McCusker 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.
PubMed 21274904Cole MG. Persistent delirium in older hospital patients. Curr Opin Psychiatry. 2010 May;23(3):250-4. doi: 10.1097/YCO.0b013e32833861f6.
PubMed 20224406Cole 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.
PubMed 12473034Inouye 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.
PubMed 10053175Reston 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.
PubMed 23460093Vidan 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.
PubMed 19754498Hshieh 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.
PubMed 25643002Martinez 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.
PubMed 25424450Gentric 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.
PubMed 17512095Pisani 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.
PubMed 17698685Voyer 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.
PubMed 24094898
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevention Program for Alzheimer's Related Delirium (PREPARED) Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT03718156
- Acronym / sponsor ID
- PREPARED / PT 71435
- Keywords
- delirium, dementia, long-term care, cluster randomized trial, nursing, geriatrics
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19 prevented us from continuing this study which involves active participation from long-term care front-line staff. More funding is being sought to continue our trial
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 23 Jun 2018 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PREPARED Trial Intervention | Experimental | Other: PREPARED Trial InterventionParticipating 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREPARED Trial InterventionNursing 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). | Other | PREPARED Trial Intervention |
Primary outcome
Incidence of delirium
Time frame: over the 18 week follow-up period
Confusion Assessment Method (CAM) scores
Delirium severity
Time frame: over the 18 week follow-up period
Delirium Index scores (0-21)
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
Number of delirium episodes
Time frame: over the 18 week follow-up period
count of delirium episodes
6 secondary outcomes
Delirium motoric subtype
Time frame: over the 18 week follow-up period
Number of falls
Time frame: over the 18 week follow-up period
Time to first fall
Time frame: over the 18 week follow-up period
Change in functional autonomy
Time frame: over the study period (18 weeks)
Change in cognitive functioning
Time frame: over the study period (18 weeks)
Change in level of social engagement
Time frame: over the study period (18 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Background: PubMed 11068569Elie 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.
- Background: PubMed 12366629Fick 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.
- Background: PubMed 16686883Lemiengre 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.
- Background: PubMed 19233058Voyer 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.
- Background: PubMed 21274904McCusker 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.
- Background: PubMed 20224406Cole MG. Persistent delirium in older hospital patients. Curr Opin Psychiatry. 2010 May;23(3):250-4. doi: 10.1097/YCO.0b013e32833861f6.
- Background: PubMed 12473034Cole 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.
- Background: PubMed 10053175Inouye 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.
- Background: PubMed 23460093Reston 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.
- Background: PubMed 19754498Vidan 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.
- Background: PubMed 25643002Hshieh 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.
- Background: PubMed 25424450Martinez 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Machelle Wilchesky, PhD principal investigator
McGill University
Philippe Voyer, Inf. PhD study chair
Laval University
Nathalie Champoux, MD, MSc study chair
Université de Montréal
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREPARED Trial Intervention in people with Delirium and Dementia, run by McGill University at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium (time frame: over the 18 week follow-up period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03718156, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.