Post-Stroke Enhancement of Delirium Outcomes With Reduction in Neuro-checks

NCT06038136 | Suspended DMC

• 1 other identifier: Pro00130444
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 1

Brief Summary

There have been limited studies on delirium in patients hospitalized with acute stroke. There have been no studies on the potential impact of overnight neuro-checks and resulting sleep disruption on delirium or other outcomes. Additional research is needed to determine if overnight checks are necessary or even harmful. We aim to find out if stopping overnight neuro checks may prevent delirium and benefit the patient.

Conditions

Delirium; Stroke, Ischemic; Neuro: Cerebrovascular Accident; Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium as measured as change in Confusion Assessment Method (CAM)

  The Confusion Assessment Method (CAM) is a standardized evidence-based tool that enables non-psychiatrically trained clinicians to identify and recognize delirium quickly and accurately in both clinical and research settings. The CAM includes four features found to have the greatest ability to distinguish delirium from other types of cognitive impairment. A positive or negative result depends on four criteria: 1. Acute onset and fluctuating course Determined by collateral history or repeated clinic assessment 2. Inattention Counting from 20-1 is a simple (if blunt) test for this 3. Disorganised thinking 4. Altered levels of consciousness The CAM is considered to be positive for the presence of delirium if both features 1 and 2 are present, with at least one of features 3 or 4.The primary outcome will be incidence of delirium as measured as CAM positivity at any point during the hospitalization.

  From date of randomization until date of hospital discharge, up to 8 weeks

Secondary Outcomes (4)

• Mean Length of Stay

  From date of hospital admission to date of hospital discharge, up to 8 weeks

• Change in National Institutes of Health Stroke Scale (NIHSS) Score

  From date of hospital admission to date of hospital discharge. From date of hospital discharge to date of 1month follow up appointment. From date of hospital discharge to date of 3 month follow up appointment.

• Modified Rankin Scale

  Within 24 hours of hospital admission, within 24 hours of hospital discharge and at 90 day stroke clinic follow up

• Discharge Disposition

  On date of hospital discharge , up to 8 weeks from randomization

Study Arms (2)

Standard of Care Neuro Checks

NO INTERVENTION

If a patient is randomized to the control group, they will continue to have neuro-checks conducted every 2-4 hours as ordered by the primary team, as per standard of care on the acute stroke service.

Absence of Neuro Checks

EXPERIMENTAL

If a patient is randomized to the intervention group, the team will discontinue neuro-checks between 8pm and 4am. They will otherwise receive the same care, including overnight vital signs. If the patient has a neurologic or hemodynamic change, the primary team may elect to restart the overnight neuro-checks.

Behavioral: Decreased Neuro Checks overnight

Interventions

Decreased Neuro Checks overnight BEHAVIORAL

If a patient is randomized to the intervention group, the team will discontinue neuro-checks between 8pm and 4am. They will otherwise receive the same care, including overnight vital signs. If the patient has a neurologic or hemodynamic change, the primary team may elect to restart the overnight neuro-checks.

Absence of Neuro Checks

Eligibility Criteria

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

You may qualify if:

• Admitted with acute stroke Age greater or equal to 18 years old Medical and neurologic stability for discontinuation of neuro-checks, determined by the Stroke Service NP and Attending Physician (no uncontrolled fluctuation in vital signs, seizure like activity or worsening neurologic function) Ability to give informed consent, or identifiable surrogate decision maker

You may not qualify if:

• Surgical hemorrhagic stroke Subarachnoid hemorrhage Medical or neurologic instability Pregnancy Inmates

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Delirium

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 14, 2023
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)