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/NCT06011720</url>
    </required_header>
    <id_info>
      <org_study_id>Pro2019000095</org_study_id>
      <nct_id>NCT06011720</nct_id>
    </id_info>
    <brief_title>Transitions of Care for Stroke Patients</brief_title>
    <official_title>Collaborative Study to Reduce Length of Stay and Improve Transitions of Care for Stroke Patients at Robert Wood Johnson University Hospital &amp; JFK Johnson Rehabilitation Institute</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kiwon Lee MD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>JFK Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Rutgers, The State University of New Jersey</source>
    <oversight_info>
      <has_dmc>No</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>
        For stroke patients, early initiation of therapy typically yields the best functional&#xD;
        outcomes. Rehabilitation of stroke patients immediately after hospitalization minimizes&#xD;
        deleterious effects of immobility and facilitates restoration of function. The investigators&#xD;
        are testing if coordinated efforts between the medical and rehabilitation disciplines may&#xD;
        improve stroke patient's functional recovery and subsequent follow-ups after discharge.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Stroke is the fifth leading cause of mortality, claiming the lives of 133,000 individuals in&#xD;
        the United States annually. Approximately one-quarter of the 795,000 annual strokes are&#xD;
        recurrent. It is estimated that up to 80% of all strokes can be prevented. Forty percent of&#xD;
        stroke survivors sustain moderate functional impairments and 15% to 30% sustain severe&#xD;
        disability. Approximately 25% of adult stroke patients are readmitted to the hospital within&#xD;
        six to twelve months of their preliminary stroke. Identifying and implementing effective&#xD;
        medical and rehabilitation interventions is critical in providing care to stroke patients.&#xD;
        The goal is to provide optimal, cost-effective care that: 1) prevents secondary medical&#xD;
        complications, readmissions, and recurrent disease, and 2) maximizes patient function&#xD;
        physically, cognitively, and socially. JFK Johnson Rehabilitation Institute (JRI) proposes a&#xD;
        collaborative study with Robert Wood Johnson University Hospital (RWJUH) that addresses this&#xD;
        issue while proving beneficial to stroke patients at both institutions. Streamlining the&#xD;
        physiatry consult process will improve access to rehabilitation medicine specialty care for&#xD;
        acute patients at RWJUH and help facilitate the transfer of stroke patients to the next most&#xD;
        appropriate level of care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2019</start_date>
    <completion_date type="Anticipated">July 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Length of stay (in hours and days).</measure>
      <time_frame>Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.</time_frame>
      <description>We standardized the placement of early physiatry consults during patient admission. We will determine the effect this has on overall acute care length of stay in ischemic and hemorrhagic stroke patients.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rehospitalization rate.</measure>
      <time_frame>Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.</time_frame>
      <description>We standardized placement of early physiatry consults during patient admission, and will determine the effect this has on acute care readmission rates (for the same stroke related problems). This will be measured as absolute value and mean number of readmissions in the preintervention group and the post-intervention group, as well as percent of patients with readmissions in each group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional independence</measure>
      <time_frame>Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.</time_frame>
      <description>We standardized placement of early physiatry consults during patient admission, and will determine any differences in long term functional independence by means of a 90 day modified Rankin Scale (mRS) - a standard rater driven scale that characterizes patient's level of independence on a scale of 0-6 (0 being without symptoms and 6 being deceased).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroke clinic outpatient follow-up.</measure>
      <time_frame>Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.</time_frame>
      <description>We standardized placement of early physiatry consulted during patient admission, and will determine the rate of stroke clinic outpatient follow-up, as measured by absolute number of patients who follow-up at least once. We will further determine the relative percentage of patients who follow-up in stroke clinic for the preintervention and postintervention group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pre-specified subanalyses for effect on primary outcome measures.</measure>
      <time_frame>Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.</time_frame>
      <description>We will assess the independent effects of multiple variables on length of stay, functional independence and stroke clinic outpatient follow-up. The pre-specified variables include: presence/number/nature of medical comorbidities, stroke type (i.e. ischemic vs. hemorrhagic), insurance type (i.e. private insurance, Medicaid, managed Medicaid, etc.), severity of stroke on admission (measured by NIHSS or ICH score), prior antithrombotic use.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pre-specified subanalyses for effect on functional independence.</measure>
      <time_frame>Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.</time_frame>
      <description>We will assess the independent effects of multiple variables on functional independence (mRS). The variables include: time between discharge and rehab admittance (days and hours), rehab length of stay (days and hours), and presence of outpatient follow-up.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">3000</enrollment>
    <condition>Stroke</condition>
    <condition>Ischemic Stroke</condition>
    <condition>Intracerebral Hemorrhage</condition>
    <arm_group>
      <arm_group_label>Stroke Patients July 1st 2015 - June 30th 2017</arm_group_label>
      <description>Stroke patients that have undergone hospitalization within the time frame July 1st 2015 - June 30th 2017 to be used as a baseline.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Stroke Patients January 1st 2018 - December 31st 2019</arm_group_label>
      <description>Stroke patients that have undergone hospitalization and undergone improvements to transition of care within the time frame January 1st 2018 - December 31st 2019.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Improved transition of care.</intervention_name>
      <description>Evaluation of how early physiatry consultation after acute stroke affects length of stay and resulting outcomes.</description>
      <arm_group_label>Stroke Patients January 1st 2018 - December 31st 2019</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Stroke patients hospitalized within Robert Wood Johnson University Hospital system for&#xD;
          Ischemic Stroke or Intracerebral Hemorrhage within the two time frames, July 1st 2015 -&#xD;
          June 30th 2017 and January 1st 2018 - December 31st 2019.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Stroke patients hospitalized within Robert Wood Johnson University Hospital system for&#xD;
               Ischemic Stroke or Intracerebral Hemorrhage.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those not in the Robert Wood Johnson University Hospital system.&#xD;
  &#xD;
            -  Those with a Subarachnoid Hemorrhage or Transient Ischemic Attack (&lt; 24 hours).&#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_official>
      <last_name>Kiwon Lee, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rutgers, The State University of New Jersey</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michelle Moccio, APN-C</last_name>
      <phone>732 235 8582</phone>
      <email>mocciomi@rutgers.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Rutgers-RWJMS Department of Neurology</name>
        <address>
          <city>New Brunswick</city>
          <state>New Jersey</state>
          <zip>08901</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 18, 2022</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
      <investigator_full_name>Kiwon Lee MD</investigator_full_name>
      <investigator_title>Professor of Neurology</investigator_title>
    </responsible_party>
    <keyword>Stroke</keyword>
    <keyword>physiatry</keyword>
    <keyword>rehabilitation</keyword>
    <keyword>PM&amp;R consultation</keyword>
    <keyword>Transient Ischemic Attack</keyword>
    <keyword>Intracerebral Hemorrhage</keyword>
    <keyword>Ischemic Stroke</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Cerebral Hemorrhage</mesh_term>
      <mesh_term>Hemorrhage</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/NCT06011720
  org study id: Pro2019000095
  nct id: NCT06011720
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  For stroke patients, early initiation of therapy typically yields the best functional
        outcomes. Rehabilitation of stroke patients immediately after hospitalization minimizes
        deleterious effects of immobility and facilitates restoration of function. The investigators
        are testing if coordinated efforts between the medical and rehabilitation disciplines may
        improve stroke patient's functional recovery and subsequent follow-ups after discharge.
  Stroke is the fifth leading cause of mortality, claiming the lives of 133,000 individuals in
        the United States annually. Approximately one-quarter of the 795,000 annual strokes are
        recurrent. It is estimated that up to 80% of all strokes can be prevented. Forty percent of
        stroke survivors sustain moderate functional impairments and 15% to 30% sustain severe
        disability. Approximately 25% of adult stroke patients are readmitted to the hospital within
        six to twelve months of their preliminary stroke. Identifying and implementing effective
        medical and rehabilitation interventions is critical in providing care to stroke patients.
        The goal is to provide optimal, cost-effective care that: 1) prevents secondary medical
        complications, readmissions, and recurrent disease, and 2) maximizes patient function
        physically, cognitively, and socially. JFK Johnson Rehabilitation Institute (JRI) proposes a
        collaborative study with Robert Wood Johnson University Hospital (RWJUH) that addresses this
        issue while proving beneficial to stroke patients at both institutions. Streamlining the
        physiatry consult process will improve access to rehabilitation medicine specialty care for
        acute patients at RWJUH and help facilitate the transfer of stroke patients to the next most
        appropriate level of care.
  observational model: Case-Only
  time perspective: Retrospective
  measure: Length of stay (in hours and days).
  time frame: Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.
  description: We standardized the placement of early physiatry consults during patient admission. We will determine the effect this has on overall acute care length of stay in ischemic and hemorrhagic stroke patients.
  measure: Rehospitalization rate.
  time frame: Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.
  description: We standardized placement of early physiatry consults during patient admission, and will determine the effect this has on acute care readmission rates (for the same stroke related problems). This will be measured as absolute value and mean number of readmissions in the preintervention group and the post-intervention group, as well as percent of patients with readmissions in each group.
  measure: Functional independence
  time frame: Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.
  description: We standardized placement of early physiatry consults during patient admission, and will determine any differences in long term functional independence by means of a 90 day modified Rankin Scale (mRS) - a standard rater driven scale that characterizes patient's level of independence on a scale of 0-6 (0 being without symptoms and 6 being deceased).
  measure: Stroke clinic outpatient follow-up.
  time frame: Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.
  description: We standardized placement of early physiatry consulted during patient admission, and will determine the rate of stroke clinic outpatient follow-up, as measured by absolute number of patients who follow-up at least once. We will further determine the relative percentage of patients who follow-up in stroke clinic for the preintervention and postintervention group.
  measure: Pre-specified subanalyses for effect on primary outcome measures.
  time frame: Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.
  description: We will assess the independent effects of multiple variables on length of stay, functional independence and stroke clinic outpatient follow-up. The pre-specified variables include: presence/number/nature of medical comorbidities, stroke type (i.e. ischemic vs. hemorrhagic), insurance type (i.e. private insurance, Medicaid, managed Medicaid, etc.), severity of stroke on admission (measured by NIHSS or ICH score), prior antithrombotic use.
  measure: Pre-specified subanalyses for effect on functional independence.
  time frame: Data from 1/1/2018-12/31/2019, collected under updated standard of care compared to baseline data from 7/1/2015-6/30/2017.
  description: We will assess the independent effects of multiple variables on functional independence (mRS). The variables include: time between discharge and rehab admittance (days and hours), rehab length of stay (days and hours), and presence of outpatient follow-up.
  arm group label: Stroke Patients July 1st 2015 - June 30th 2017
  description: Stroke patients that have undergone hospitalization within the time frame July 1st 2015 - June 30th 2017 to be used as a baseline.
  arm group label: Stroke Patients January 1st 2018 - December 31st 2019
  description: Stroke patients that have undergone hospitalization and undergone improvements to transition of care within the time frame January 1st 2018 - December 31st 2019.
  intervention type: Other
  intervention name: Improved transition of care.
  description: Evaluation of how early physiatry consultation after acute stroke affects length of stay and resulting outcomes.
  arm group label: Stroke Patients January 1st 2018 - December 31st 2019
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kiwon Lee, MD
  role: Principal Investigator
  affiliation: Rutgers, The State University of New Jersey
  last name: Michelle Moccio, APN-C
  phone: 732 235 8582
  email: mocciomi@rutgers.edu
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Rutgers, The State University of New Jersey
  investigator full name: Kiwon Lee MD
  investigator title: Professor of Neurology
  mesh term: Stroke
  mesh term: Ischemic Stroke
  mesh term: Cerebral Hemorrhage
  mesh term: Hemorrhage
  sharing ipd: No