Quasi-experimental Pre-post Study Assessing the Impact of Non-pharmacological Interventions Based on Nursing Care and of an Educational Programme for Delirium Prevention in Older Adults With Cognitive Frailty During Hospitalization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Presence of Delirium
研究概览
简要总结
Background: Delirium is one of the most frequent, relevant, and increasing geriatric syndromes in hospitalized older adults. It is an indicator of poor prognosis, and its incidence increases with aging. It is a highly prevalent problem (between 10-56% of hospitalized elderly), underdiagnosed (32-66% undetected), with severe consequences and potentially preventable (between 30-40%). It is considered a priority health objective, as it is an indicator of elderly patient safety and an indicator of healthcare quality.
Objective: The objective of this study is to analyze whether a multicomponent nursing-led intervention reduces the incidence of delirium in frail older patients hospitalized in a medical unit.
Design: Pre-post quasi-experimental analytical study. Study setting: The study will be conducted in a polyvalent hospitalization unit at the Germans Trias i Pujol University Hospital during the 2023-2025 period.
Patients: A total of 158 patients will be needed, i.e., 79 for each group. Sampling: Consecutive intentional sampling based on inclusion and exclusion criteria.
Variables: Sociodemographic variables, delirium risk factors, daily presence of delirium using the CAM scale, and hospital stay duration, among others, will be collected.
Procedure: Patients will be selected upon admission, and the presence of delirium will be assessed daily using the CAM scale, with results recorded. Nursing staff will be trained on non-pharmacological measures for delirium prevention and a specific care plan. Subsequently, the second group of patients will receive these specific interventions, and the presence of delirium will be assessed daily using the CAM scale, with results recorded.
Data analysis: Descriptive and inferential analysis using the PSPP statistical package version 22. A significance level of 5% will be applied.
详细描述
A pre-post quasi-experimental study will be conducted with a control group and an intervention group. Consecutive sampling will be performed purposively, using inclusion and exclusion criteria. A total of 158 patients are required, i.e., 79 per group. Granmo software was used to calculate the sample. An alpha risk of 0.05 was assumed, with a two-sided contrast and a beta risk of 0.2. The allocation ratio will be 1, and a 10% loss to follow-up rate and a 20% reduction in the incidence of delirium have been estimated.
Participants Patients over 70 years of age admitted to the HGTIP study units for conditions requiring hospitalization and who meet the established criteria. The inclusion and exclusion criteria for selecting participants for this study are shown in Table 1.
Recruitment of participants Candidates for the study will be identified daily by a member of the research team, who will check the computerized devices used to detect new admissions to the study unit. Those who meet the inclusion criteria will be invited to participate. The study will be explained to them, including their family members. If they agree, they will be provided with an informed consent form, which they will sign.
All patients admitted to the study unit who meet the established criteria will be included in the sample, until the required sample size is reached, estimated at approximately six months for the control group and another six months for the intervention group.
Intervention The study will be conducted in the multipurpose hospitalization unit of the Germans Trias i Pujol University Hospital (HUGTIP) during the period 2024-2025.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >70 years old
- •Conscious mental state. And one of the two criteria described below:
- •Pfeiffer score on admission between 3-7 errors, according to the nursing assessment within the first 24 hours of admission to the ward, suggesting possible mild-moderate cognitive impairment.
- •Any degree of diagnosed dementia, except GDS7.
排除标准
- •Patients unable to communicate, with established aphasia, or with psychiatric illness.
- •Patients with a language barrier.
- •Patients transferred from other units.
- •Terminal situation under palliative treatment.
- •Patients who do not consent to participate
研究组 & 干预措施
Intervention (PREDELENF Multicomponent Intervention)
A multicomponent intervention designed for the prevention of delirium in frail patients.Include different actions (see variables)
干预措施: Multicomponent non-pharmacological interventions (Other)
No intervention (usual medical care)
The usual care will be provided according to the center's protocols.
干预措施: Usual care (Other)
结局指标
主要结局
Presence of Delirium
时间窗: From baseline (day 1) until day 12 (expected date of hospital discharge or death from any cause)
Assessment of the presence of delirium will be performed by trained personnel using the Confusion Assessment Method (CAM). The CAM consists of four items, and a positive CAM (indicating the presence of delirium) is defined as the presence of both of the first two items (1 and 2) and at least one of the last two items (3 or 4).
次要结局
- Current illness/geriatric assessment upon admission. Assess cognition using the Pfeiffer Questionnaire(Baseline)
- Current illness/geriatric assessment upon admission. Degree of frailty(Baseline)
- Sociodemographic Variables(Baseline)
- Current illness/geriatric assessment upon admission. Assess cognition using the Pfeiffer Questionnaire(Baseline)
- Current illness/geriatric assessment upon admission. Diagnosis of Dementia(Baseline)
- Current illness/geriatric assessment upon admission. Degree of frailty(Baseline)