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

NCT ID: NCT06038136

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 538 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-12-31

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.

Detailed Description

This study hopes to challenge the clinical paradigm that all patients with acute stroke need around-the-clock neuro-checks. The practice of conducting an NIHSS every 4 hours on patients with acute stroke has never been validated, particularly in clinically stable patients, but is the standard of care. This practice potentially comes at the cost of inducing delirium due to poor sleep which can result in numerous adverse outcomes.

This study hopes to identify the impact of eliminating overnight neuro-checks and prioritize sleep and rest. We hypothesize that increased emphasis on sleep will reduce the incidence of delirium and thereby improve the deleterious effects of delirium such as prolonged length of stay and increased likelihood of being discharged to a facility.

A quality improvement project was undertaken to at MUSC to begin to understand the impact of eliminating overnight neuro-checks. This project was focused on patients on the Inpatient Stroke Service, admitted to 9 East. Starting in October 2022, the Stroke team would identify patients who were medically and neurologically stable and place an order to discontinue overnight neuro-checks. Incidence of delirium, LOS, NIHSS, and mRS were compared using data from 4 months prior (June-September 2022) and 8 months after initiation of the project. Compared to pre-intervention, there was a reduction in patients who were delirious from 34-24% and a reduction in average length of stay by 1.5 days. This preliminary data suggests a positive impact of the intervention. There was no change in NIHSS at discharge or the mRS at discharge suggesting there was no negative impact on the patient's neurologic function by eliminating overnight neuro-checks.

The data collect from this preliminary study is exciting, however, warrants more a more scientific evaluation. The proposed study will be a randomized control trial that will help answer these questions more definitively.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standard of Care Neuro Checks

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Absence of Neuro Checks

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.

Group Type: EXPERIMENTAL

Decreased Neuro Checks overnight

Intervention Type: 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.

Interventions

Decreased Neuro Checks overnight

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

Surgical hemorrhagic stroke Subarachnoid hemorrhage Medical or neurologic instability Pregnancy Inmates

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro00130444

Identifier Type: -

Identifier Source: org_study_id