Initial and long-term evaluation of patients with Alzheimer’s after hospitalization in cognitive and behavioural units: the EVITAL study design

Alzheimer’s disease and related disorders (ADRD) are characterized by cognitive impairment associated with behavioral and psychological symptoms of dementia (BPSD) [1]. The BPSD are common in ADRD and often associated with one another [2]-[4]. They may occur at all stages of the disease and worsen with cognitive decline.

Besides apathy and depression, which are frequent during the early/middle stages of the disease (40 to 60% of patients), other BPSD such as agitation (30%), irritability (30%), delusions (10 to 20%), aberrant motor behavior (15 to 30%) and hallucinations (6 to 10%) [5],[6] can be very upsetting for both the patient and the caregiver.

BPSD have significant consequences for both the patient and the family as they may lead to difficulties in activities of daily living (ADL) [3] and interfere with patients’ quality of life (QoL) [7]. Moreover, they are associated with faster cognitive impairment [8]. They increase the risk of hospitalization as well as developing other complications of dementia. Furthermore, they can lead to an increase in caregivers’ health problems and a decrease in their QoL [7]. Studies have shown that the severity of BPSD was connected with the burden and psychological state of caregivers [9]-[11]. All these consequences result in increased health expenditures [12]. Finally, they can precipitate nursing home placement regardless of cognitive impairment [13],[14].

Identification of BPSD is important to optimize ADRD patient management. Current treatment strategies consist in non-drug therapies and subsequently pharmacological treatments, including specific treatment for Alzheimer’s disease. A previous study showed that the management of BPSD can reduce the rate of home nursing placement as well as caregivers’ burden and increase a QoL [15]. The unpredictable occurrence of these symptoms and difficulty to stabilize them may lead to crises. The French Alzheimer Plan 2008-2012 has provided specific hospital units called cognitive and behavioral units (CBUs). These units are intended for patients with ADRD and productive behavior disorders. While risk factors for BPSD have been identified in several studies, few studies have focused on the evolution of these symptoms. To our knowledge, only two studies focused on BPSD evolution in patients admitted to CBUs. The first one assessed short-term BPSD evolution from CBU admission to discharge [16]. The second showed a favorable effect of hospitalization in the CBU on BPSD at hospital discharge and 15 days after discharge [17]. Beyond the assessment of the short-term BPSD evolution during hospitalization in CBUs, it would be important to identify factors that are linked to the long-term evolution of BPSD, as well as patients’ and caregivers’ QoL. The EVITAL study was designed to assess these questions. The purpose of this paper is to provide the methodology of the EVITAL study.

The EVITAL project aims to better understand the factors associated with the evolution of BPSD in the year following patient hospitalization in CBUs. It should help us better identify the factors affecting patient’s and caregiver’s QoL. Moreover, it could bring out factors that modulate the risk of unplanned hospital readmission. Finally, it should contribute to a better understanding of the natural history of BPSD.

The originality of this project is based on three criteria: the choice of the study population, duration of follow-up and inclusion of patients from different CBUs. Our study focuses on patients with ADRD and productive BPSD requiring hospitalization in a specific unit. To our knowledge, only two previous studies assessed the evolution of BPSD during hospitalization in CBUs. The results of these studies were encouraging, showing a decrease in BPSD after patient management in CBUs. However, both studies were limited as they only assessed the evolution of the BPSD from patient admission to discharge [16] and 15 days after discharge [17], respectively. These studies did not give us information on the long-term outcome of the patients after CBU management. The present study is the first to follow patients for one year, with assessments performed 3, 6 and 12 months after their CBU discharge.

Moreover, these studies were conducted in only one CBU whereas the present study includes patients from different CBUs. The multicenter design may allow us to include patients with various profiles, regardless of each unit specific organization.

BPSD are also known to have a negative impact on both patients’ and caregivers’ quality of life [7], which is an important point to consider. Moreover, caregivers play a major role in helping patients stay at home, which is one of the CBU objectives. It was showed that successful patient management with a specific pharmacological or non- drug therapy can have a positive impact on both patients’ and caregivers’ QoL, which are intrinsically connected to each other [24]. It will be interesting to observe the evolution of their QoL as well as caregivers’ burden after CBU management.

The assessment of patients admitted to CBUs will help better describe and value the work done by the CBU healthcare team. Moreover, the results of this study could be helpful for other CBU teams to develop effective management strategies in the CBU, and to better identify patients at high risk of increasing BPSD. The database designed in the present research could also be proposed to other CBUs to help them better describe their activity with standardized data.

The EVITAL study may have several limitations. Some patients who were living at home before their admission in the CBU may move to a new place of residence, e.g. in an institution, after discharge. Some scales, such as the mini-Zarit, will be therefore used only for patients living at home. Furthermore, the NPI will be assessed by two different persons. However, the inter-rater reliability of the NPI has been established [19] and the number of patients involved should be limited, as one of the main objectives of CBU management is to facilitate the return to their initial place of residence after discharge.

In spite of these limitations, the management of patients with Alzheimer’s disease or related diseases is currently a major challenge. Therefore, it seems important to better identify the factors associated with BPSD reduction and patients’ and caregivers’ QoL in order to improve patient management in the CBU and after hospitalization discharge. The EVITAL project will help better understand these topics.

IR conceived the idea for the study, helped to draft the manuscript, and managed the design of the study and coordination. EP drafted the manuscript for submission to BMC Psychiatry and participated in its design and coordination management. MF, FDC, GR, SJ participated in coordination and helped to draft the manuscript. FDR, GMG, PKS and BL participated in its design and coordination. DF, AW and FF participated in coordination and helped to draft the manuscript. BTP participated in the design of the study and helped to draft the manuscript. All authors approved the final version of the manuscript.