Clinical trial NCT06038136: Post-Stroke Enhancement of Delirium Outcomes With Reduction in Neuro-checks
Official title: Post-Stroke Enhancement of Delirium Outcomes With Reduction in Neuro-checks
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke, Acute
Stroke, Ischemic
Delirium
Neuro: Cerebrovascular Accident
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 538
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of delirium as measured as change in Confusion Assessment Method (CAM)
timeFrame: From date of randomization until date of hospital discharge, up to 8 weeks
Secondary outcomes:
measure: Mean Length of Stay
timeFrame: From date of hospital admission to date of hospital discharge, up to 8 weeks
measure: Change in National Institutes of Health Stroke Scale (NIHSS) Score
timeFrame: 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.
measure: Modified Rankin Scale
timeFrame: Within 24 hours of hospital admission, within 24 hours of hospital discharge and at 90 day stroke clinic follow up
measure: Discharge Disposition
timeFrame: On date of hospital discharge , up to 8 weeks from randomization
Other outcomes:
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