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

Primary Purpose

Stroke, Acute, Stroke, Ischemic, Delirium

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Decreased Neuro Checks overnight
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard of Care Neuro Checks

    Absence of Neuro Checks

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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: Acute onset and fluctuating course Determined by collateral history or repeated clinic assessment Inattention Counting from 20-1 is a simple (if blunt) test for this Disorganised thinking 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.

    Secondary Outcome Measures

    Mean Length of Stay
    Average hospitalization (measured in days)
    Change in National Institutes of Health Stroke Scale (NIHSS) Score
    The scale measures the severity of symptoms associated with patient's stroke. It assesses the severity of impairements related to stroke. The impairments are graded on a 3-4 point scale wtih scores that range from 0-42. Patients with a higher score have a more severe impauirment, and patients with a lower score have a less severe impairment.
    Modified Rankin Scale
    Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
    Discharge Disposition
    Location patients are discharged to from the hospital (home vs rehab)

    Full Information

    First Posted
    August 15, 2023
    Last Updated
    September 12, 2023
    Sponsor
    Medical University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06038136
    Brief Title
    Post-Stroke Enhancement of Delirium Outcomes With Reduction in Neuro-checks
    Acronym
    SNDOWN
    Official Title
    Post-Stroke Enhancement of Delirium Outcomes With Reduction in Neuro-checks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2024 (Anticipated)
    Study Completion Date
    April 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of South Carolina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Acute, Stroke, Ischemic, Delirium, Neuro: Cerebrovascular Accident

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    538 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard of Care Neuro Checks
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Absence of Neuro Checks
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Name(s)
    Decreased Neuro Checks overnight
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incidence of delirium as measured as change in Confusion Assessment Method (CAM)
    Description
    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: Acute onset and fluctuating course Determined by collateral history or repeated clinic assessment Inattention Counting from 20-1 is a simple (if blunt) test for this Disorganised thinking 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.
    Time Frame
    From date of randomization until date of hospital discharge, up to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Mean Length of Stay
    Description
    Average hospitalization (measured in days)
    Time Frame
    From date of hospital admission to date of hospital discharge, up to 8 weeks
    Title
    Change in National Institutes of Health Stroke Scale (NIHSS) Score
    Description
    The scale measures the severity of symptoms associated with patient's stroke. It assesses the severity of impairements related to stroke. The impairments are graded on a 3-4 point scale wtih scores that range from 0-42. Patients with a higher score have a more severe impauirment, and patients with a lower score have a less severe impairment.
    Time Frame
    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.
    Title
    Modified Rankin Scale
    Description
    Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
    Time Frame
    Within 24 hours of hospital admission, within 24 hours of hospital discharge and at 90 day stroke clinic follow up
    Title
    Discharge Disposition
    Description
    Location patients are discharged to from the hospital (home vs rehab)
    Time Frame
    On date of hospital discharge , up to 8 weeks from randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Benjamin Kalivas, MD
    Phone
    843-792-2900
    Email
    kalivas@musc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sinead Farrelly, DPT
    Email
    farrelsi@musc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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