The Prevention Program for Alzheimer's Related Delirium (PREPARED) Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 800
- 试验地点
- 6
- 主要终点
- Incidence of delirium
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: PREPARED Trial Intervention (Other)
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.
结局指标
主要结局
Incidence of delirium
时间窗: over the 18 week follow-up period
Confusion Assessment Method (CAM) scores
Delirium severity
时间窗: over the 18 week follow-up period
Delirium Index scores (0-21)
Delirium episode duration
时间窗: 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
时间窗: over the 18 week follow-up period
count of delirium episodes
次要结局
- 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))
- Change in level of social engagement(over the study period (18 weeks))
研究者
Machelle Wilchesky
Assistant Professor
McGill University