xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06038136</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00130444</org_study_id>
      <nct_id>NCT06038136</nct_id>
    </id_info>
    <brief_title>Post-Stroke Enhancement of Delirium Outcomes With Reduction in Neuro-checks</brief_title>
    <acronym>SNDOWN</acronym>
    <official_title>Post-Stroke Enhancement of Delirium Outcomes With Reduction in Neuro-checks</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of South Carolina</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        There have been limited studies on delirium in patients hospitalized with acute stroke. There&#xD;
        have been no studies on the potential impact of overnight neuro-checks and resulting sleep&#xD;
        disruption on delirium or other outcomes. Additional research is needed to determine if&#xD;
        overnight checks are necessary or even harmful. We aim to find out if stopping overnight&#xD;
        neuro checks may prevent delirium and benefit the patient.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study hopes to challenge the clinical paradigm that all patients with acute stroke need&#xD;
        around-the-clock neuro-checks. The practice of conducting an NIHSS every 4 hours on patients&#xD;
        with acute stroke has never been validated, particularly in clinically stable patients, but&#xD;
        is the standard of care. This practice potentially comes at the cost of inducing delirium due&#xD;
        to poor sleep which can result in numerous adverse outcomes.&#xD;
  &#xD;
        This study hopes to identify the impact of eliminating overnight neuro-checks and prioritize&#xD;
        sleep and rest. We hypothesize that increased emphasis on sleep will reduce the incidence of&#xD;
        delirium and thereby improve the deleterious effects of delirium such as prolonged length of&#xD;
        stay and increased likelihood of being discharged to a facility.&#xD;
  &#xD;
        A quality improvement project was undertaken to at MUSC to begin to understand the impact of&#xD;
        eliminating overnight neuro-checks. This project was focused on patients on the Inpatient&#xD;
        Stroke Service, admitted to 9 East. Starting in October 2022, the Stroke team would identify&#xD;
        patients who were medically and neurologically stable and place an order to discontinue&#xD;
        overnight neuro-checks. Incidence of delirium, LOS, NIHSS, and mRS were compared using data&#xD;
        from 4 months prior (June-September 2022) and 8 months after initiation of the project.&#xD;
        Compared to pre-intervention, there was a reduction in patients who were delirious from&#xD;
        34-24% and a reduction in average length of stay by 1.5 days. This preliminary data suggests&#xD;
        a positive impact of the intervention. There was no change in NIHSS at discharge or the mRS&#xD;
        at discharge suggesting there was no negative impact on the patient's neurologic function by&#xD;
        eliminating overnight neuro-checks.&#xD;
  &#xD;
        The data collect from this preliminary study is exciting, however, warrants more a more&#xD;
        scientific evaluation. The proposed study will be a randomized control trial that will help&#xD;
        answer these questions more definitively.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of delirium as measured as change in Confusion Assessment Method (CAM)</measure>
      <time_frame>From date of randomization until date of hospital discharge, up to 8 weeks</time_frame>
      <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:&#xD;
  Acute onset and fluctuating course Determined by collateral history or repeated clinic assessment&#xD;
  Inattention Counting from 20-1 is a simple (if blunt) test for this&#xD;
  Disorganised thinking&#xD;
  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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean Length of Stay</measure>
      <time_frame>From date of hospital admission to date of hospital discharge, up to 8 weeks</time_frame>
      <description>Average hospitalization (measured in days)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in National Institutes of Health Stroke Scale (NIHSS) Score</measure>
      <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.</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin Scale</measure>
      <time_frame>Within 24 hours of hospital admission, within 24 hours of hospital discharge and at 90 day stroke clinic follow up</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Discharge Disposition</measure>
      <time_frame>On date of hospital discharge , up to 8 weeks from randomization</time_frame>
      <description>Location patients are discharged to from the hospital (home vs rehab)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">538</enrollment>
    <condition>Stroke, Acute</condition>
    <condition>Stroke, Ischemic</condition>
    <condition>Delirium</condition>
    <condition>Neuro: Cerebrovascular Accident</condition>
    <arm_group>
      <arm_group_label>Standard of Care Neuro Checks</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Absence of Neuro Checks</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Decreased Neuro Checks overnight</intervention_name>
      <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.</description>
      <arm_group_label>Absence of Neuro Checks</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Admitted with acute stroke Age greater or equal to 18 years old Medical and neurologic&#xD;
               stability for discontinuation of neuro-checks, determined by the Stroke Service NP and&#xD;
               Attending Physician (no uncontrolled fluctuation in vital signs, seizure like activity&#xD;
               or worsening neurologic function) Ability to give informed consent, or identifiable&#xD;
               surrogate decision maker&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Surgical hemorrhagic stroke Subarachnoid hemorrhage Medical or neurologic instability&#xD;
          Pregnancy Inmates&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Benjamin Kalivas, MD</last_name>
      <phone>843-792-2900</phone>
      <email>kalivas@musc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sinead Farrelly, DPT</last_name>
      <email>farrelsi@musc.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
      <investigator_full_name>Benjamin Kalivas</investigator_full_name>
      <investigator_title>Principle Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Delirium</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06038136
  org study id: Pro00130444
  nct id: NCT06038136
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Incidence of delirium as measured as change in Confusion Assessment Method (CAM)
  time frame: From date of randomization until date of hospital discharge, up to 8 weeks
  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.
  measure: Mean Length of Stay
  time frame: From date of hospital admission to date of hospital discharge, up to 8 weeks
  description: Average hospitalization (measured in days)
  measure: Change in National Institutes of Health Stroke Scale (NIHSS) Score
  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.
  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.
  measure: Modified Rankin Scale
  time frame: Within 24 hours of hospital admission, within 24 hours of hospital discharge and at 90 day stroke clinic follow up
  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.
  measure: Discharge Disposition
  time frame: On date of hospital discharge , up to 8 weeks from randomization
  description: Location patients are discharged to from the hospital (home vs rehab)
  arm group label: Standard of Care Neuro Checks
  arm group type: No Intervention
  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 group label: Absence of Neuro Checks
  arm group type: Experimental
  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: Decreased Neuro Checks overnight
  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.
  arm group label: Absence of Neuro Checks
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Benjamin Kalivas, MD
  phone: 843-792-2900
  email: kalivas@musc.edu
  last name: Sinead Farrelly, DPT
  email: farrelsi@musc.edu
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of South Carolina
  investigator full name: Benjamin Kalivas
  investigator title: Principle Investigator
  mesh term: Stroke
  mesh term: Delirium
  mesh term: Ischemic Stroke
  sharing ipd: No