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NCT03954769 · ClinicalTrials.gov registry record
A Pilot Study of "Stanford Proxy Test for Delirium" (S-PTD)
A clinical trial, sponsored by Stanford University.
- Completed
- Registry status
- 300
- Enrollment target
NCT03954769: Completed study, sponsored by Stanford University.
NCT03954769 is a clinical trial that has completed, run by Stanford University. The registered enrollment target is 300 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03954769 has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- 300 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 shi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-05 |
What the finished NCT03954769 record still lists
NCT03954769 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03954769 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03954769 about?
NCT03954769 is a clinical study titled "A Pilot Study of "Stanford Proxy Test for Delirium" (S-PTD)". 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 Statistica...
What is the current status of trial NCT03954769?
This trial is currently completed. The enrollment target is 300 participants. The study started on 2014-02. Estimated completion is 2016-05.
Who is sponsoring clinical trial NCT03954769?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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