A Pilot Study of "Stanford Proxy Test for Delirium" (S-PTD)

NCT03954769 | Completed

• 1 other identifier: 28327
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperactive Delirium; Hypoactive Delirium; Mixed Type Delirium

Keywords

Delirium,; Confusion Assessment Method; Proxy Test of Delirium; DSM-V; Hyperactive Delirium; Hypoactive Delirium; Mixed-type delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium

  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).

  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.

Study Arms (1)

Inpatients

Patients admitted to Stanford Hospital and Clinics medical and surgical units

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to selected Stanford Hospital and Clinics general medical/surgical units, for any diagnosis. Both female and male patients, English or Spanish-speaking subjects, age 18 and above, of any ethnic background will be recruited.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

Related Publications (4)

• Maldonado JR. Delirium in the acute care setting: characteristics, diagnosis and treatment. Crit Care Clin. 2008 Oct;24(4):657-722, vii. doi: 10.1016/j.ccc.2008.05.008.

  PMID: 18929939 BACKGROUND

• Siddiqi N, House AO, Holmes JD. Occurrence and outcome of delirium in medical in-patients: a systematic literature review. Age Ageing. 2006 Jul;35(4):350-64. doi: 10.1093/ageing/afl005. Epub 2006 Apr 28.

  PMID: 16648149 BACKGROUND

• Ryan DJ, O'Regan NA, Caoimh RO, Clare J, O'Connor M, Leonard M, McFarland J, Tighe S, O'Sullivan K, Trzepacz PT, Meagher D, Timmons S. Delirium in an adult acute hospital population: predictors, prevalence and detection. BMJ Open. 2013 Jan 7;3(1):e001772. doi: 10.1136/bmjopen-2012-001772.

  PMID: 23299110 BACKGROUND

• Norbaek J, Glipstrup E. Delirium is seen in one-third of patients in an acute hospital setting. Identification, pharmacologic and non-pharmacologic treatment is inadequate. Dan Med J. 2016 Nov;63(11):A5293.

  PMID: 27808035 BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jose R Maldonado, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: May 17, 2019
• Study Start: February 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 17, 2019

Record last verified: 2019-04

Locations

US (1)