Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06038136
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2023-08-15
Brief Title:
Post-Stroke Enhancement of Delirium Outcomes With Reduction in Neuro-checks
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Post-Stroke Enhancement of Delirium Outcomes With Reduction in Neuro-checks
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SNDOWN
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 15 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 patients 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
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 15 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None