Post-stroke Delirium Screening (PSD Screen)

Evaluation of Delirium Screening Tools for the Detection of Post-stroke Delirium

For a long time, delirium was considered a merely temporary dysfunction of the brain. Today, it is established that it is a brain disease associated with network dysfunction, neuroinflammation and impaired transmitter homeostasis in a multicausal model. Following an episode of delirium, many patients do not return to their prior level of cognitive and functional performance. In particular, failed or delayed diagnosis with consecutive inadequate therapy contribute to the development of long-term cognitive decline that may ultimately lead to long-term care. Stroke patients are a particularly common delirium-affected population (10-46% depending on severity). Despite the frequency and clinical relevance of delirium in stroke patients, diagnostic characteristics of common screening methods are unknown. Similarly, the clinical phenotype and risk factors of patients who develop delirium have not been adequately described.

This study primarily aims to evaluate the diagnostic properties of established screening tools for delirium in a prospective cohort of well-characterised patients following ischemic cerebral events (either transient or manifest stroke). Secondary outcome criteria include predictors of post-stroke delirium (PSD) such as stroke location and size, pre-stroke cognitive functioning, ability to participate in daily routine activities and medical conditions.

Study Overview

• Status: Completed
• Conditions: Delirium; Ischemic Stroke; Transient Ischemic Attack
• Intervention / Treatment: Diagnostic test: Stroke screening tools

• Study Type: Observational
• Enrollment (Actual): 141

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg-Vorpommern
    • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
      • Department of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Any patient admitted to the emergency department for a suspected ischemic cerebrovascular event is eligible to participate. A neurologist must then confirm the diagnosis and necessity for stroke unit monitoring.

Description

Inclusion Criteria:

• stroke unit admission for a high-risk transient ischemic attack (ABCD2 score >= 6) or stroke within the last 24 hours

Exclusion Criteria:

• hemorrhagic stroke

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PSD; Patients fulfilling DSM-5 criteria of PSD within 7 days of admission.	Diagnostic test: Stroke screening tools; Patients are evaluated for the presence of PSD using DSM-5 criteria ("gold standard"). Established delirium detection tools are evaluated for their diagnostic accuracy compared to the gold standard.
No PSD; Patients NOT fulfilling DSM-5 criteria of PSD within 7 days of admission.	Diagnostic test: Stroke screening tools; Patients are evaluated for the presence of PSD using DSM-5 criteria ("gold standard"). Established delirium detection tools are evaluated for their diagnostic accuracy compared to the gold standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic accuracy of established delirium detection tools as compared to Diagnostic and Statistical Manual - 5th Version (DSM-5) criteria	Binary outcomes of delirium screening tests will be compared, i.e. if they characterize an individual patient as delirious at any of two time points during the 7 day observation period. Instruments include: Nursing Delirium Screening Scale (Nu-DESC), Confusion Assessment Method (CAM), rapid assessment test for delirium (4-AT). Binary outcomes ("yes" or "no" according to each of the scales) are then aggregated in one test that compares the observed frequency of delirious patients (according the above mentioned tests) with the actual number of delirious patients as assessed by the DSM-5 standard.	two times daily for 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSD prevalence	DSM-5 criteria and chart review are used to assess the occurence of PSD among included patients over the complete study period	three times daily for 7 days
pre-stroke modified Rankin Scale	functional status before stroke	once on admission
pre-stroke Barthel Index	ability to take care of personal daily routine before stroke	once on admission
pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)	cognitive impairment before stroke	once on admission
pre-stroke Groningen Frailty Index (GFI)	presence of a frailty syndrome before stroke	once on admission
National Institutes of Health Stroke Scale (NIHSS)	estimate of clinical stroke severity	three times daily for three days starting on the day of admission
Critical Care Pain Observation Tool (CPOT)	pain during stroke unit treatment	once daily for three days starting on the day of admission
Stroke location - clinical (classification of the OxfordshireCommunity Stroke Project (OCSP))	clinical characterisation based on phenotype as either total anterior, partial anterior, partial posterior or lacunar stroke	once on admission
Stroke location - imaging (based on an atlas of anatomical regions of the human brain (aal MNI V4))	in patients with imaging of the definite stroke location, differences of mean locations between groups will be calculated	once on admission

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
demographic data	exploratory outcome required to adjust for confounding variates such as age, socioeconomic status and education	once on admission
complications during stroke unit treatment	any complication that arises during the study period (e.g. pneumonia, dysphagia)	continuously during the study period and up to 7 days

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Investigators: Principal Investigator: Robert Fleischmann, MD, Department of Neurology

Publications and helpful links

General Publications

• Fleischmann R, Warwas S, Andrasch T, Kunz R, Witt C, Mengel A, von Sarnowski B. Course and Recognition of Poststroke Delirium: A Prospective Noninferiority Trial of Delirium Screening Tools. Stroke. 2021 Jan;52(2):471-478. doi: 10.1161/STROKEAHA.120.031019. Epub 2020 Dec 31.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): July 21, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: delirium; stroke; screening tool
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Brain Ischemia; Stroke; Delirium; Ischemic Stroke; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: BB 031-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No