<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/NCT04403737</url>
  </required_header>
  <id_info>
    <org_study_id>2000027462</org_study_id>
    <nct_id>NCT04403737</nct_id>
  </id_info>
  <brief_title>Assessing Efficacy of the Rothman Index</brief_title>
  <official_title>A Pragmatic Randomized Trial Assessing Efficacy of the Rothman Index</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PeraHealth</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to assess the efficacy of the Rothman Index in combination with a set&#xD;
      of recommended-use protocols to improve rates of mortality and/or rates of discharge to&#xD;
      hospice care in hospitalized patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Rothman Index (RI), created by PeraHealth, Inc., is a clinical support system used to&#xD;
      recognize the early stages of clinical deterioration. It uses time-updated physiological data&#xD;
      (vital signs, lab values, nursing assessments) to calculate a single score that objectively&#xD;
      quantifies a patient's condition in real-time. The score is used to detect a patient's&#xD;
      declining health and predict risk of decompensation and death. Various risk thresholds exist&#xD;
      to describe a patient's status. &quot;Medium&quot; risk is defined by a 30% reduction in a patient's RI&#xD;
      score over 24 hours, &quot;high&quot; risk is defined by a 40% drop in the RI score over 12 hours, and&#xD;
      &quot;very high&quot; risk&quot; is having a score less than or equal to 20 on the RI. Some institutions&#xD;
      have created protocols to be followed by providers when an RI risk threshold is reached (such&#xD;
      as triggering rapid response team mobilization), however, there are no standardized protocols&#xD;
      shared between hospitals, and none which have been rigorously tested to determine whether&#xD;
      they effectively reduce mortality and adverse outcomes.&#xD;
&#xD;
      This is a randomized controlled trial to determine the efficacy of the Rothman Index and an&#xD;
      associated set of RI-triggered recommended-use protocol sin improving rates of mortality&#xD;
      and/or discharge to hospice care among inpatients of two hospitals within the Yale New Haven&#xD;
      Health System. All inpatients admitted to any unit within the study sites who generate at&#xD;
      least 2 RI index scores will be automatically enrolled and randomized to either usual care,&#xD;
      in which the patient's RI score is calculated but remains unavailable to providers (and&#xD;
      available only to the study team), or to the intervention group in which the RI is calculated&#xD;
      and visible to providers who will be encouraged to follow recommended protocols appropriate&#xD;
      to the RI risk threshold achieved.&#xD;
&#xD;
      The primary outcome is the rates of mortality and/or discharge to hospice care. Secondary&#xD;
      outcomes include rates of inpatient mortality, ICU transfer, length of hospital stay,&#xD;
      incurred costs, 30 day readmission and mortality rates, and rates of transfer to home.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not started&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 2021</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality and/or discharge to hospice care</measure>
    <time_frame>Assessed from the date of randomization to the date of the first documented death or discharge to hospice during patient's current hospitalization, up to 365 days</time_frame>
    <description>A composite outcome of mortality and discharge to hospice care as determined by medical record review. Either will be adequate to meet this endpoint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU transfer</measure>
    <time_frame>Assessed from the date of randomization to the date of first documented ICU transfer during patient's current hospitalization, up to 365 days</time_frame>
    <description>ICU transfer as determined by medical record review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>Assessed as the number of days from the date of randomization to the first documented discharge, up to 365 days</time_frame>
    <description>Patient's length of stay with a start time beginning immediately post-randomization and ending at discharge of the present admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incurred hospital costs</measure>
    <time_frame>Assessed as costs accrued from the date of randomization to the patient's first documented discharge, up to 365 days</time_frame>
    <description>Hospital costs incurred from post-randomization to discharge, as determined by review of hospital billing records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>30 days post-randomization</time_frame>
    <description>Readmission within 30 days post-randomization as determined by medical record review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 day mortality</measure>
    <time_frame>30 days post-randomization</time_frame>
    <description>Mortality within 30 days of randomization as determined by medical record review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge to home</measure>
    <time_frame>Assessed from the date of randomization to the date of the first document discharge to home, up to 365 days</time_frame>
    <description>As determined by medical record review</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Inpatients Who Generate at Least Two Rothman Index Scores</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the control arm will have a Rothman Index calculated but this will not be visible to providers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the intervention arm will have a Rothman Index calculated and will be visible to providers. Providers will be given a set of clinician-specific recommended-use protocols that they will be encouraged to follow based on the RI thresholds achieved by patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rothman Index</intervention_name>
    <description>The Rothman Index score will be calculated and visible to providers. Providers will be encouraged to follow a set of recommended-use protocols in response to different levels of the RI threshold.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults inpatients greater than or equal to 18 years of age&#xD;
&#xD;
          -  Admitted to any inpatient unit at two study sites within the Yale New Haven Health&#xD;
             System&#xD;
&#xD;
          -  Has generated at least 2 Rothman Index scores during the present hospital admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior admission in which patient was randomized&#xD;
&#xD;
          -  Patient has opted out of electronic health record consent&#xD;
&#xD;
          -  Patient in observation status&#xD;
&#xD;
          -  Patient admitted to hospice service&#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>Francis P Wilson, MD MSCE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Greenwich Hospital</name>
      <address>
        <city>Greenwich</city>
        <state>Connecticut</state>
        <zip>06830</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawrence + Memorial Hospital</name>
      <address>
        <city>New London</city>
        <state>Connecticut</state>
        <zip>06320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>February 3, 2022</last_update_submitted>
  <last_update_submitted_qc>February 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified data underlying results for publication will be made available upon publication of results.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>After publication of results; indefinitely.</ipd_time_frame>
  </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/NCT04403737
org study id: 2000027462
nct id: NCT04403737
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study is designed to assess the efficacy of the Rothman Index in combination with a set
      of recommended-use protocols to improve rates of mortality and/or rates of discharge to
      hospice care in hospitalized patients.
The Rothman Index (RI), created by PeraHealth, Inc., is a clinical support system used to
      recognize the early stages of clinical deterioration. It uses time-updated physiological data
      (vital signs, lab values, nursing assessments) to calculate a single score that objectively
      quantifies a patient's condition in real-time. The score is used to detect a patient's
      declining health and predict risk of decompensation and death. Various risk thresholds exist
      to describe a patient's status. "Medium" risk is defined by a 30% reduction in a patient's RI
      score over 24 hours, "high" risk is defined by a 40% drop in the RI score over 12 hours, and
      "very high" risk" is having a score less than or equal to 20 on the RI. Some institutions
      have created protocols to be followed by providers when an RI risk threshold is reached (such
      as triggering rapid response team mobilization), however, there are no standardized protocols
      shared between hospitals, and none which have been rigorously tested to determine whether
      they effectively reduce mortality and adverse outcomes.

      This is a randomized controlled trial to determine the efficacy of the Rothman Index and an
      associated set of RI-triggered recommended-use protocol sin improving rates of mortality
      and/or discharge to hospice care among inpatients of two hospitals within the Yale New Haven
      Health System. All inpatients admitted to any unit within the study sites who generate at
      least 2 RI index scores will be automatically enrolled and randomized to either usual care,
      in which the patient's RI score is calculated but remains unavailable to providers (and
      available only to the study team), or to the intervention group in which the RI is calculated
      and visible to providers who will be encouraged to follow recommended protocols appropriate
      to the RI risk threshold achieved.

      The primary outcome is the rates of mortality and/or discharge to hospice care. Secondary
      outcomes include rates of inpatient mortality, ICU transfer, length of hospital stay,
      incurred costs, 30 day readmission and mortality rates, and rates of transfer to home.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Mortality and/or discharge to hospice care
time frame: Assessed from the date of randomization to the date of the first documented death or discharge to hospice during patient's current hospitalization, up to 365 days
description: A composite outcome of mortality and discharge to hospice care as determined by medical record review. Either will be adequate to meet this endpoint.
measure: ICU transfer
time frame: Assessed from the date of randomization to the date of first documented ICU transfer during patient's current hospitalization, up to 365 days
description: ICU transfer as determined by medical record review.
measure: Length of stay
time frame: Assessed as the number of days from the date of randomization to the first documented discharge, up to 365 days
description: Patient's length of stay with a start time beginning immediately post-randomization and ending at discharge of the present admission.
measure: Incurred hospital costs
time frame: Assessed as costs accrued from the date of randomization to the patient's first documented discharge, up to 365 days
description: Hospital costs incurred from post-randomization to discharge, as determined by review of hospital billing records.
measure: Readmission
time frame: 30 days post-randomization
description: Readmission within 30 days post-randomization as determined by medical record review.
measure: 30 day mortality
time frame: 30 days post-randomization
description: Mortality within 30 days of randomization as determined by medical record review.
measure: Discharge to home
time frame: Assessed from the date of randomization to the date of the first document discharge to home, up to 365 days
description: As determined by medical record review
arm group label: Usual Care
arm group type: No Intervention
description: Patients in the control arm will have a Rothman Index calculated but this will not be visible to providers.
arm group label: Intervention
arm group type: Experimental
description: Patients in the intervention arm will have a Rothman Index calculated and will be visible to providers. Providers will be given a set of clinician-specific recommended-use protocols that they will be encouraged to follow based on the RI thresholds achieved by patients.
intervention type: Device
intervention name: Rothman Index
description: The Rothman Index score will be calculated and visible to providers. Providers will be encouraged to follow a set of recommended-use protocols in response to different levels of the RI threshold.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francis P Wilson, MD MSCE
role: Principal Investigator
affiliation: Yale University
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Deidentified data underlying results for publication will be made available upon publication of results.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: After publication of results; indefinitely.