<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/NCT04434638</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0621</org_study_id>
    <nct_id>NCT04434638</nct_id>
  </id_info>
  <brief_title>Stroke Transitions of Care to Reduce Hospital Length of Stay</brief_title>
  <acronym>TOCC</acronym>
  <official_title>Stroke Transitions of Care to Reduce Hospital Length of Stay</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Georgetown University</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>
      The purpose of this prospective pilot study is to access the feasibility of Transitions of&#xD;
      Care Coordinator (TOCC) program, to determine if the use of a TOCC will decrease hospital&#xD;
      length of stay (LOS), and determine if utilization of a TOCC will improve patient and family&#xD;
      satisfaction. Patients are admitted to MedStar Georgetown University Hospital (MGUH) for&#xD;
      primary diagnosis of acute ischemic stroke.&#xD;
&#xD;
        1. Access the feasibility of TOCC program&#xD;
&#xD;
        2. Determine if the use of a TOCC will decrease hospital length of stay (LOS) in patients&#xD;
           admitted to MGUH for primary diagnosis of acute ischemic stroke&#xD;
&#xD;
        3. Determine if utilization of a TOCC will improve the satisfaction for family and patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Goals and Objectives&#xD;
&#xD;
      The primary objective of this study is to access the feasibility of TOCC program and to&#xD;
      determine if the use of a TOCC will decrease length of stay (LOS) in patients admitted to&#xD;
      MedStar Georgetown University Hospital (MGU) for primary diagnosis of acute ischemic stroke&#xD;
      and discharged to an acute rehabilitation facility. Secondary objectives for this study&#xD;
      include determining if utilization of a TOCC will improve patient and family satisfaction.&#xD;
&#xD;
      Study Design/Setting&#xD;
&#xD;
      This will be a single-center, prospective, randomized pilot study. It will involve patients&#xD;
      admitted to the MGUH Department of Neurology stroke service for primary diagnosis of acute&#xD;
      ischemic stroke and discharged to an acute rehabilitation facility or home. The study will&#xD;
      start after IRB approval. It will end once all required data has been obtained and analyzed.&#xD;
      It is estimated that this pilot study will be finished over a three-month period.&#xD;
&#xD;
      Transition of Care Coordinator (TOCC) Program and Usual Care Group&#xD;
&#xD;
      The TOCC will be a registered nurse who will help facilitate the process of care transition&#xD;
      from the day of admission. The TOCC's intervention will include meeting the patient and&#xD;
      family within 48 hours of admission, identifying their home location and insurance status,&#xD;
      following up the echocardiogram results, following up with physical, occupational, and speech&#xD;
      therapy recommendations for rehabilitation after acute care hospitalization, attending daily&#xD;
      multi-disciplinary rounds, attending bedside rounds with the physician team, facilitating&#xD;
      referrals to rehab facilities, providing tailored discharge education to patients, and&#xD;
      arranging stroke clinic follow-up assignments. The usual care group will receive care&#xD;
      coordination by the primary stroke service of the Georgetown Neurology Department, which is&#xD;
      the current method.&#xD;
&#xD;
      Both groups will receive the same content of care, which includes initial and supportive&#xD;
      diagnostic studies as well as evidenced-based treatment of ischemic stroke, physical,&#xD;
      occupational, and speech therapy, and case management for referral and transportation to an&#xD;
      acute rehabilitation facility. The major difference between the two groups will be the method&#xD;
      of care delivery.&#xD;
&#xD;
      Patient Population and Procedure&#xD;
&#xD;
      Participants in this study will be derived from the pool of patients admitted for ischemic&#xD;
      stroke to MGUH. Patients admitted for a primary diagnosis of ischemic stroke with discharge&#xD;
      plan for acute rehab or home will be included in this study.&#xD;
&#xD;
      Upon admission, patients will be randomized to receive the standard diagnostic studies and&#xD;
      treatment for ischemic stroke under the care of either a TOCC (TOCC group) or the usual&#xD;
      care/standard evidenced-based protocol of transitioning from acute care hospital to acute&#xD;
      rehab setting (Control group). Due to the prospective nature of the study protocol,&#xD;
      randomization will be performed based on the order in which the patients are enrolled in the&#xD;
      trial. Every other patient admitted to the stroke service (i.e. those enrolled first, third,&#xD;
      fifth, seventh, etc.) will be allocated to receive the intervention whereas patients falling&#xD;
      between those admissions will be allocated to the usual care group (control) Length of stay&#xD;
      for patients in TOCC group and control group will be recorded for comparison at the end of&#xD;
      the study period. Patient and family satisfaction in each group will also be measured using&#xD;
      HCAHPS scores for comparison at the end of the study period.&#xD;
&#xD;
      Study Sample Size&#xD;
&#xD;
      Based on the volumes of patients admitted for ischemic stroke to MGUH, it is estimated that&#xD;
      at least 20 patients can be enrolled for each group, and at least 40 patients in total can be&#xD;
      enrolled over a three-month period.&#xD;
&#xD;
      Data Analysis Plan&#xD;
&#xD;
      Descriptive statistics will be used to describe the baseline characteristics of all enrolled&#xD;
      patients; mean and standard deviation will be reported for continuous variables; frequency&#xD;
      and percentage will be reported for categorical variables.&#xD;
&#xD;
      The data analysis for this pilot study will be descriptive due to the small sample size. The&#xD;
      proportion of patients who are in the TOCC group receive the complete transition of care&#xD;
      intervention will be the primary feasibility metric. We will calculate the mean (SD) of the&#xD;
      LOS at the end of study for patients of TOCC group and control group, respectively.&#xD;
      Difference in mean of LOS between two groups will be calculated. Student's T-test or Wilcoxon&#xD;
      Rank Sum test will be performed to test the difference in mean of LOS between TOCC group and&#xD;
      control group, where appropriate. One-day decrease in hospital LOS is considered of clinical&#xD;
      relevance. Generalized linear model will be utilized for the correlative analysis of LOS and&#xD;
      TOCC program, adjusted for age, NHISS and other possible confounders.&#xD;
&#xD;
      For the patients and family satisfaction, measured by HCAHPS score, the percentage of&#xD;
      satisfaction for each question will be reported, and the difference in percentage of&#xD;
      satisfaction between TOCC group and control group will be summarized.&#xD;
&#xD;
      Safety Considerations&#xD;
&#xD;
      The treatment of patients with acute ischemic stroke will not be altered by this study&#xD;
      protocol. Participants will receive the current evidenced-supported standard treatment for&#xD;
      ischemic stroke and post-discharge recommendations will be made by the physical,&#xD;
      occupational, and speech therapists of MGUH based on the patient's capabilities. As a quality&#xD;
      improvement study, the intervention proposed would only serve improve the efficacy in&#xD;
      transitioning patients back to living in the community.&#xD;
&#xD;
      The only possible perceived risk to participants is loss of confidentiality since personal&#xD;
      health information (PHI) from the Electronic Medical Record (EMR) system will be used for&#xD;
      eventual data analyses. To decrease this risk, this information will be distributed only&#xD;
      amongst study investigators with the use of limited patient identifiers. In addition, any&#xD;
      stored information will be in a password-secured database only accessible by the study&#xD;
      investigators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</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>
    <intervention_model_description>Participants in this study will be derived from the pool of patients admitted for ischemic stroke to Georgetown University Medical Center. Patients admitted for a primary diagnosis of ischemic stroke with discharge plan for acute rehab or home will be included in this study.&#xD;
Upon admission, patients will be randomized to receive the standard diagnostic studies and treatment for ischemic stroke under the care of either a transitions of care coordinatory (TOCC group) or the standard evidenced-based protocol of transitioning from acute care hospital to acute rehab setting (Control group). Due to the prospective nature of the study protocol, randomization will be performed based on the order in which the patients are enrolled in the trial.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Every other patient admitted to the stroke service (i.e. those enrolled first, third, fifth, seventh, etc.) will be allocated to receive the intervention whereas patients falling between those admissions will be allocated to the control group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Study Feasibility</measure>
    <time_frame>Through length of study, an average of 1 year</time_frame>
    <description>The primary outcome was feasibility of implementing a TOCC program, which was defined as completion of all eight TOCC program tasks by the stroke nurse navigator in at least 75% of the intervention group patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>Through length of study, an average of 1 year</time_frame>
    <description>Measured as number of days from admission to time of discharge from hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Through length of study, an average of 1 year</time_frame>
    <description>Patient satisfaction was determined using a questionnaire that assesses multiple facets of inpatient care and discharge logistics, including key variables such as: overall care, secondary stroke prevention education, blood pressure management, and follow up arrangements. Scores in the individual categories ranged from 1-5, with 1 representative of unsatisfied, and 5, representative of very satisfied.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Transitions of Care Coordinator Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We developed the Transition of Care Coordinator (TOCC) program to aid in the completion of the diagnostic evaluations as well as in the transition out of the acute care hospital setting. In the TOCC intervention, the stroke nurse navigator completed eight specific tasks: (1) met the patient and family within 48 hours of admission, (2) identified patient home location and insurance status, (3) coordinated communication between treating providers (neurologists, cardiologists, etc.) regarding pending diagnostic tests, (4) followed up physical, occupational, and speech therapy teams' recommendations for rehabilitation, (5) attended daily multi-disciplinary rounds, (6) facilitated referrals to acute and subacute rehabilitation facilities with case managers, (7) assisted beside nurses in providing tailored stroke education and discharge instructions to patients and families, and (8) arranged stroke clinic follow-up appointments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the usual care group, which served as the control, received the current, ongoing method of care coordination by members of the multi-disciplinary stroke team. The current practice is that members of this multi-disciplinary team meet with each other every weekday morning to discuss the discharge plan of care for each stroke patient on the inpatient stroke service. Physicians, nurses, rehabilitation therapists and case managers are then individually responsible for talking to patients and their families/caregivers about the different aspects of the plan of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transitions of Care Coordinator</intervention_name>
    <description>We developed the Transition of Care Coordinator (TOCC) program to aid in the completion of the diagnostic evaluations as well as in the transition out of the acute care hospital setting. In the TOCC intervention, the stroke nurse navigator completed eight specific tasks: (1) met the patient and family within 48 hours of admission, (2) identified patient home location and insurance status, (3) coordinated communication between treating providers (neurologists, cardiologists, etc.) regarding pending diagnostic tests, (4) followed up physical, occupational, and speech therapy teams' recommendations for rehabilitation, (5) attended daily multi-disciplinary rounds, (6) facilitated referrals to acute and subacute rehabilitation facilities with case managers, (7) assisted beside nurses in providing tailored stroke education and discharge instructions to patients and families, and (8) arranged stroke clinic follow-up appointments.</description>
    <arm_group_label>Transitions of Care Coordinator Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Patients received the current, ongoing method of care coordination by members of the multi-disciplinary stroke team. The current practice is that members of this multi-disciplinary team meet with each other every weekday morning to discuss the discharge plan of care for each stroke patient on the inpatient stroke service. Physicians, nurses, rehabilitation therapists and case managers are then individually responsible for talking to patients and their families/caregivers about the different aspects of the plan of care.</description>
    <arm_group_label>Usual Care Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary diagnosis of acute ischemic stroke&#xD;
&#xD;
          -  patients admitted to the MGUH Stroke service&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of subarachnoid hemorrhage&#xD;
&#xD;
          -  Diagnosis of intracerebral hemorrhage&#xD;
&#xD;
          -  Diagnosis of transient ischemic attack&#xD;
&#xD;
          -  Diagnosis of stroke mimic&#xD;
&#xD;
          -  admitted under observational status&#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>Mary C Denny, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Georgetown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MedStar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Agency for Healthcare Research and Quality. &quot;The Six Domains of Health Care Quality&quot;. Reviewed March 2016: Rockville, MD. http://www.ahrq.gov/professionals/quality-patient-safety/talkingquality/create/sixdomains.html</citation>
  </reference>
  <reference>
    <citation>Coleman EA, Rosenbek SA, Roman SP. Disseminating evidence-based care into practice. Popul Health Manag. 2013 Aug;16(4):227-34. doi: 10.1089/pop.2012.0069. Epub 2013 Mar 28.</citation>
    <PMID>23537156</PMID>
  </reference>
  <reference>
    <citation>Institute of Medicine (IOM). &quot;To Err Is Human: Building A Safer Health System&quot;. National Academy of Sciences; 2000. Web Access: May 1 2017. http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf</citation>
  </reference>
  <reference>
    <citation>Frelick R, Strusowski P, Petrelli N, and Grusenmeyer P. &quot;Oncology Nurse Care Coordinators as 'Navigators': Improving cancer disease management and the patient experience&quot;. Oncology Issues. (2006); 26-30.</citation>
  </reference>
  <reference>
    <citation>Kwan JL, Morgan MW, Stewart TE, Bell CM. Impact of an innovative inpatient patient navigator program on length of stay and 30-day readmission. J Hosp Med. 2015 Dec;10(12):799-803. doi: 10.1002/jhm.2442. Epub 2015 Aug 10.</citation>
    <PMID>26259201</PMID>
  </reference>
  <reference>
    <citation>Raines, D,</citation>
  </reference>
  <reference>
    <citation>Hall MJ, Levant S, DeFrances CJ. Hospitalization for stroke in U.S. hospitals, 1989-2009. NCHS Data Brief. 2012 May;(95):1-8.</citation>
    <PMID>22617404</PMID>
  </reference>
  <reference>
    <citation>Mayo NE, Wood-Dauphinee S, Cote R, Gayton D, Carlton J, Buttery J, Tamblyn R. There's no place like home : an evaluation of early supported discharge for stroke. Stroke. 2000 May;31(5):1016-23. doi: 10.1161/01.str.31.5.1016.</citation>
    <PMID>10797160</PMID>
  </reference>
  <reference>
    <citation>Bushnell C, Arnan M, Han S. A new model for secondary prevention of stroke: transition coaching for stroke. Front Neurol. 2014 Oct 27;5:219. doi: 10.3389/fneur.2014.00219. eCollection 2014.</citation>
    <PMID>25386161</PMID>
  </reference>
  <reference>
    <citation>Condon C, Lycan S, Duncan P, Bushnell C. Reducing Readmissions After Stroke With a Structured Nurse Practitioner/Registered Nurse Transitional Stroke Program. Stroke. 2016 Jun;47(6):1599-604. doi: 10.1161/STROKEAHA.115.012524. Epub 2016 Apr 28.</citation>
    <PMID>27125528</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 13, 2020</last_update_submitted>
  <last_update_submitted_qc>June 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Nurse Navigator</keyword>
  <keyword>Transitions of care</keyword>
  <keyword>Length of Stay</keyword>
  <keyword>Patient Satisfaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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>


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/NCT04434638
org study id: 2017-0621
nct id: NCT04434638
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this prospective pilot study is to access the feasibility of Transitions of
      Care Coordinator (TOCC) program, to determine if the use of a TOCC will decrease hospital
      length of stay (LOS), and determine if utilization of a TOCC will improve patient and family
      satisfaction. Patients are admitted to MedStar Georgetown University Hospital (MGUH) for
      primary diagnosis of acute ischemic stroke.

        1. Access the feasibility of TOCC program

        2. Determine if the use of a TOCC will decrease hospital length of stay (LOS) in patients
           admitted to MGUH for primary diagnosis of acute ischemic stroke

        3. Determine if utilization of a TOCC will improve the satisfaction for family and patient.
Study Goals and Objectives

      The primary objective of this study is to access the feasibility of TOCC program and to
      determine if the use of a TOCC will decrease length of stay (LOS) in patients admitted to
      MedStar Georgetown University Hospital (MGU) for primary diagnosis of acute ischemic stroke
      and discharged to an acute rehabilitation facility. Secondary objectives for this study
      include determining if utilization of a TOCC will improve patient and family satisfaction.

      Study Design/Setting

      This will be a single-center, prospective, randomized pilot study. It will involve patients
      admitted to the MGUH Department of Neurology stroke service for primary diagnosis of acute
      ischemic stroke and discharged to an acute rehabilitation facility or home. The study will
      start after IRB approval. It will end once all required data has been obtained and analyzed.
      It is estimated that this pilot study will be finished over a three-month period.

      Transition of Care Coordinator (TOCC) Program and Usual Care Group

      The TOCC will be a registered nurse who will help facilitate the process of care transition
      from the day of admission. The TOCC's intervention will include meeting the patient and
      family within 48 hours of admission, identifying their home location and insurance status,
      following up the echocardiogram results, following up with physical, occupational, and speech
      therapy recommendations for rehabilitation after acute care hospitalization, attending daily
      multi-disciplinary rounds, attending bedside rounds with the physician team, facilitating
      referrals to rehab facilities, providing tailored discharge education to patients, and
      arranging stroke clinic follow-up assignments. The usual care group will receive care
      coordination by the primary stroke service of the Georgetown Neurology Department, which is
      the current method.

      Both groups will receive the same content of care, which includes initial and supportive
      diagnostic studies as well as evidenced-based treatment of ischemic stroke, physical,
      occupational, and speech therapy, and case management for referral and transportation to an
      acute rehabilitation facility. The major difference between the two groups will be the method
      of care delivery.

      Patient Population and Procedure

      Participants in this study will be derived from the pool of patients admitted for ischemic
      stroke to MGUH. Patients admitted for a primary diagnosis of ischemic stroke with discharge
      plan for acute rehab or home will be included in this study.

      Upon admission, patients will be randomized to receive the standard diagnostic studies and
      treatment for ischemic stroke under the care of either a TOCC (TOCC group) or the usual
      care/standard evidenced-based protocol of transitioning from acute care hospital to acute
      rehab setting (Control group). Due to the prospective nature of the study protocol,
      randomization will be performed based on the order in which the patients are enrolled in the
      trial. Every other patient admitted to the stroke service (i.e. those enrolled first, third,
      fifth, seventh, etc.) will be allocated to receive the intervention whereas patients falling
      between those admissions will be allocated to the usual care group (control) Length of stay
      for patients in TOCC group and control group will be recorded for comparison at the end of
      the study period. Patient and family satisfaction in each group will also be measured using
      HCAHPS scores for comparison at the end of the study period.

      Study Sample Size

      Based on the volumes of patients admitted for ischemic stroke to MGUH, it is estimated that
      at least 20 patients can be enrolled for each group, and at least 40 patients in total can be
      enrolled over a three-month period.

      Data Analysis Plan

      Descriptive statistics will be used to describe the baseline characteristics of all enrolled
      patients; mean and standard deviation will be reported for continuous variables; frequency
      and percentage will be reported for categorical variables.

      The data analysis for this pilot study will be descriptive due to the small sample size. The
      proportion of patients who are in the TOCC group receive the complete transition of care
      intervention will be the primary feasibility metric. We will calculate the mean (SD) of the
      LOS at the end of study for patients of TOCC group and control group, respectively.
      Difference in mean of LOS between two groups will be calculated. Student's T-test or Wilcoxon
      Rank Sum test will be performed to test the difference in mean of LOS between TOCC group and
      control group, where appropriate. One-day decrease in hospital LOS is considered of clinical
      relevance. Generalized linear model will be utilized for the correlative analysis of LOS and
      TOCC program, adjusted for age, NHISS and other possible confounders.

      For the patients and family satisfaction, measured by HCAHPS score, the percentage of
      satisfaction for each question will be reported, and the difference in percentage of
      satisfaction between TOCC group and control group will be summarized.

      Safety Considerations

      The treatment of patients with acute ischemic stroke will not be altered by this study
      protocol. Participants will receive the current evidenced-supported standard treatment for
      ischemic stroke and post-discharge recommendations will be made by the physical,
      occupational, and speech therapists of MGUH based on the patient's capabilities. As a quality
      improvement study, the intervention proposed would only serve improve the efficacy in
      transitioning patients back to living in the community.

      The only possible perceived risk to participants is loss of confidentiality since personal
      health information (PHI) from the Electronic Medical Record (EMR) system will be used for
      eventual data analyses. To decrease this risk, this information will be distributed only
      amongst study investigators with the use of limited patient identifiers. In addition, any
      stored information will be in a password-secured database only accessible by the study
      investigators.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants in this study will be derived from the pool of patients admitted for ischemic stroke to Georgetown University Medical Center. Patients admitted for a primary diagnosis of ischemic stroke with discharge plan for acute rehab or home will be included in this study.
Upon admission, patients will be randomized to receive the standard diagnostic studies and treatment for ischemic stroke under the care of either a transitions of care coordinatory (TOCC group) or the standard evidenced-based protocol of transitioning from acute care hospital to acute rehab setting (Control group). Due to the prospective nature of the study protocol, randomization will be performed based on the order in which the patients are enrolled in the trial.
primary purpose: Health Services Research
masking: Single (Participant)
masking description: Every other patient admitted to the stroke service (i.e. those enrolled first, third, fifth, seventh, etc.) will be allocated to receive the intervention whereas patients falling between those admissions will be allocated to the control group.
measure: Study Feasibility
time frame: Through length of study, an average of 1 year
description: The primary outcome was feasibility of implementing a TOCC program, which was defined as completion of all eight TOCC program tasks by the stroke nurse navigator in at least 75% of the intervention group patients.
measure: Hospital Length of Stay
time frame: Through length of study, an average of 1 year
description: Measured as number of days from admission to time of discharge from hospital
measure: Patient Satisfaction
time frame: Through length of study, an average of 1 year
description: Patient satisfaction was determined using a questionnaire that assesses multiple facets of inpatient care and discharge logistics, including key variables such as: overall care, secondary stroke prevention education, blood pressure management, and follow up arrangements. Scores in the individual categories ranged from 1-5, with 1 representative of unsatisfied, and 5, representative of very satisfied.
arm group label: Transitions of Care Coordinator Group
arm group type: Experimental
description: We developed the Transition of Care Coordinator (TOCC) program to aid in the completion of the diagnostic evaluations as well as in the transition out of the acute care hospital setting. In the TOCC intervention, the stroke nurse navigator completed eight specific tasks: (1) met the patient and family within 48 hours of admission, (2) identified patient home location and insurance status, (3) coordinated communication between treating providers (neurologists, cardiologists, etc.) regarding pending diagnostic tests, (4) followed up physical, occupational, and speech therapy teams' recommendations for rehabilitation, (5) attended daily multi-disciplinary rounds, (6) facilitated referrals to acute and subacute rehabilitation facilities with case managers, (7) assisted beside nurses in providing tailored stroke education and discharge instructions to patients and families, and (8) arranged stroke clinic follow-up appointments.
arm group label: Usual Care Group
arm group type: Active Comparator
description: Patients in the usual care group, which served as the control, received the current, ongoing method of care coordination by members of the multi-disciplinary stroke team. The current practice is that members of this multi-disciplinary team meet with each other every weekday morning to discuss the discharge plan of care for each stroke patient on the inpatient stroke service. Physicians, nurses, rehabilitation therapists and case managers are then individually responsible for talking to patients and their families/caregivers about the different aspects of the plan of care.
intervention type: Other
intervention name: Transitions of Care Coordinator
description: We developed the Transition of Care Coordinator (TOCC) program to aid in the completion of the diagnostic evaluations as well as in the transition out of the acute care hospital setting. In the TOCC intervention, the stroke nurse navigator completed eight specific tasks: (1) met the patient and family within 48 hours of admission, (2) identified patient home location and insurance status, (3) coordinated communication between treating providers (neurologists, cardiologists, etc.) regarding pending diagnostic tests, (4) followed up physical, occupational, and speech therapy teams' recommendations for rehabilitation, (5) attended daily multi-disciplinary rounds, (6) facilitated referrals to acute and subacute rehabilitation facilities with case managers, (7) assisted beside nurses in providing tailored stroke education and discharge instructions to patients and families, and (8) arranged stroke clinic follow-up appointments.
arm group label: Transitions of Care Coordinator Group
intervention type: Other
intervention name: Usual Care
description: Patients received the current, ongoing method of care coordination by members of the multi-disciplinary stroke team. The current practice is that members of this multi-disciplinary team meet with each other every weekday morning to discuss the discharge plan of care for each stroke patient on the inpatient stroke service. Physicians, nurses, rehabilitation therapists and case managers are then individually responsible for talking to patients and their families/caregivers about the different aspects of the plan of care.
arm group label: Usual Care Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mary C Denny, MD
role: Principal Investigator
affiliation: Georgetown University
facility: 
country: United States
citation: Agency for Healthcare Research and Quality. "The Six Domains of Health Care Quality". Reviewed March 2016: Rockville, MD. http://www.ahrq.gov/professionals/quality-patient-safety/talkingquality/create/sixdomains.html
citation: Coleman EA, Rosenbek SA, Roman SP. Disseminating evidence-based care into practice. Popul Health Manag. 2013 Aug;16(4):227-34. doi: 10.1089/pop.2012.0069. Epub 2013 Mar 28.
PMID: 23537156
citation: Institute of Medicine (IOM). "To Err Is Human: Building A Safer Health System". National Academy of Sciences; 2000. Web Access: May 1 2017. http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf
citation: Frelick R, Strusowski P, Petrelli N, and Grusenmeyer P. "Oncology Nurse Care Coordinators as 'Navigators': Improving cancer disease management and the patient experience". Oncology Issues. (2006); 26-30.
citation: Kwan JL, Morgan MW, Stewart TE, Bell CM. Impact of an innovative inpatient patient navigator program on length of stay and 30-day readmission. J Hosp Med. 2015 Dec;10(12):799-803. doi: 10.1002/jhm.2442. Epub 2015 Aug 10.
PMID: 26259201
citation: Raines, D,
citation: Hall MJ, Levant S, DeFrances CJ. Hospitalization for stroke in U.S. hospitals, 1989-2009. NCHS Data Brief. 2012 May;(95):1-8.
PMID: 22617404
citation: Mayo NE, Wood-Dauphinee S, Cote R, Gayton D, Carlton J, Buttery J, Tamblyn R. There's no place like home : an evaluation of early supported discharge for stroke. Stroke. 2000 May;31(5):1016-23. doi: 10.1161/01.str.31.5.1016.
PMID: 10797160
citation: Bushnell C, Arnan M, Han S. A new model for secondary prevention of stroke: transition coaching for stroke. Front Neurol. 2014 Oct 27;5:219. doi: 10.3389/fneur.2014.00219. eCollection 2014.
PMID: 25386161
citation: Condon C, Lycan S, Duncan P, Bushnell C. Reducing Readmissions After Stroke With a Structured Nurse Practitioner/Registered Nurse Transitional Stroke Program. Stroke. 2016 Jun;47(6):1599-604. doi: 10.1161/STROKEAHA.115.012524. Epub 2016 Apr 28.
PMID: 27125528
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No