A Pilot Study of the Psychometric Properties of the "Stanford Proxy Test for Delirium" (S-PTD): a New Screening Tool for the Detection of Delirium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of delirium
研究概览
简要总结
Although there are several tools available for the screening of delirium among the medically ill, they all have some limitations. First, none of the available tools have been validated against newly developed and published DSM-5 (Diagnostic and Statistical Manual) or ICD-10 (International Statistical Classification of Diseases and Related Health Problems) criteria. Additionally, all the screening/diagnostic tools presently available have the same limitation, they all require significant patient involvement and participation (e.g., questions and activities) in order to complete the assessment. By definition, delirium is a neuropsychiatric disorder characterized by disturbance in attention and awareness, and additional disturbance in cognition (e.g., memory deficit, disorientation), language, visuospatial ability, or perception. The intrinsic characteristics of delirium seem to interfere with the patient's ability to participate and complete many of the tasks associated with delirium evaluation itself. Finally, most available tools seem to narrowly focus on some neurocognitive areas of delirium, but not being comprehensive enough.
In contrast, the S-PTD is designed so it can be completed by the nursing staff caring for the patients, the medical personnel most intimately involved with the care and aware of the behaviors exhibited by the patient during the course of their hospital stay. The idea is that nurses will complete the screening tool (hence the term "by proxy"), based on the behaviors and interactions observed during the course of a conventional "nursing shift", to determine whether the patient meets current neuropsychiatric criteria for the diagnosis of delirium.
详细描述
Patients admitted to Stanford Hospital and Clinics medical and surgical units meeting the study's inclusion and exclusion criteria will be considered for enrollment during the recruitment phase.
The research personnel, under the supervision of the study PI (an expert in delirium), will perform daily study procedures as follows:
A member of the research team will obtain a list of all newly admitted patients from the prior 24 hours each Monday through Friday morning from the unit's nurse manager. A member of the research team will also look at daily operating room schedules for patients to be admitted to participating units post-operatively, having received permission to do so from the directors of participating medical/surgical services. Given that the purpose of this tool is to screen for a condition that may occur in medically ill patients, every newly admitted patient or their surrogate (for those lacking decisional making capacity), meeting inclusion criteria will be approached for participation in the study and asked to provide consent. Patients lacking capacity for consent will not be automatically excluded, given that the inclusion of delirious patients is critical for adequate evaluation of the S-PTD, and most delirious patients, by definition, lack capacity to provide informed consent. We will ask for the consent from surrogate decision makers in these cases.
In addition, it is anticipated that some patients who meet eligibility will be unable to sign a consent form due to physical limitations related to their hospitalization (e.g. patients recovering from recent surgery). If a patient is unable to sign the consent form due to physical limitations, oral consent will be obtained. Oral consent will also be used in the event that a patient lacks capacity and has no surrogate decision-maker at bedside, but a surrogate decision-maker is available by phone. For Spanish-speaking patients, consent will be obtained by the same procedures utilizing Spanish-language written/oral consent, with the help of SHC interpreter services.
For each patient that consents to participate in the study, the nurse assigned to that patient during the shift will be approached. These nurses will additionally be asked to provide consent, as they are also subjects of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for enrolled patients:
- •all inpatients admitted to Stanford Hospital's selected general medical and surgical units
- •patients must be able to communicate and read English and/or Spanish
- •ages 18 and older
- •Inclusion criteria for enrolled nurses:
- •All nurses assigned to each enrolled patient for the shift during which that patient is enrolled, will be invited to participate in the study to assess the tool's acceptability and ease of use.
排除标准
- •For enrolled patients:
- •unable to speak English or Spanish.
- •unwillingness to participate in the study
- •for patients who are unable to consent (i.e., lack capacity), either the lack of availability of a suitable surrogate or the surrogate's unwillingness to provide consent
- •For enrolled nurses: unwillingness to participate in the study.
结局指标
主要结局
Incidence of delirium
时间窗: The study will be carried out over a 2-year period; patients will be followed throughout the hospital stay, for a maximum of 2-weeks from the time of admission, or until discharge.
Every day, enrolled patients will undergo two evaluations: (1) At the end of the nursing shift, nurses will complete the S-PTD based on the entirety of the interactions with the patient throughout the course of their shift, estimated to take about 2-3 minutes; (2) then, within 1-hour of the nurse's S-PTD assessment a member of the Psychosomatic Medicine Service will conduct a blinded clinical neuropsychiatric examination (the gold standard for delirium diagnosis). At the end of their nursing shift (either 8 or 12 hours).
次要结局
未报告次要终点
研究者
Jose R Maldonado, MD
Associate Professor
Stanford University