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/NCT05967273</url>
    </required_header>
    <id_info>
      <org_study_id>23-39379</org_study_id>
      <nct_id>NCT05967273</nct_id>
    </id_info>
    <brief_title>CirrhosisRx CDS System</brief_title>
    <official_title>Pragmatic Randomized Controlled Trial to Evaluate the Effect of CirrhosisRx, a Novel Clinical Decision Support System, on Guideline-adherence and Clinical Outcomes for Patients With Cirrhosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, San Francisco</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>
        The aim of the study is to compare the effect of CirrhosisRx, a novel clinical decision&#xD;
        support (CDS) system for inpatient cirrhosis care, versus &quot;usual care&quot; on adherence to&#xD;
        national quality measures and clinical outcomes for hospitalized patients with cirrhosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Each year, there over 200,000 hospitalizations for cirrhosis in the United States. Over&#xD;
        one-third of these patients are readmitted within 30 days, and up to 10% will die in the&#xD;
        hospital. Despite national quality measures and care guidelines, cirrhosis care remains&#xD;
        suboptimal and highly variable.&#xD;
  &#xD;
        Clinical Decision Support (CDS) systems present an attractive strategy to improve&#xD;
        guideline-adherence due to low implementation costs. These systems, however, remain largely&#xD;
        untested in cirrhosis care and it remains unknown whether they are effective at improving&#xD;
        guideline-adherence and whether improving guideline-adherence changes clinical outcomes in&#xD;
        cirrhosis care. The investigators have designed &quot;CirrhosisRx,&quot; a cirrhosis-specific CDS&#xD;
        system, to address these evidence gaps.&#xD;
  &#xD;
        This study intends to compare effect of CirrhosisRx versus &quot;usual care&quot; on adherence to&#xD;
        quality measures and clinical outcomes through a pragmatic randomized controlled trial&#xD;
        (pRCT). Randomization will be based on stepped-wedge cluster randomization of treatment teams&#xD;
        at our institution.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 2024</start_date>
    <completion_date type="Anticipated">June 2027</completion_date>
    <primary_completion_date type="Anticipated">June 2027</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>Crossover Assignment</intervention_model>
      <intervention_model_description>This will be a stepped-wedge cluster randomization of primary treatment teams. We will have 8 clusters consisting of at least one teaching medicine team, one non-teaching medicine team, one intensive care team, and equal numbers of other teams. The clusters will be assigned to the CirrhosisRx CDS intervention versus &quot;usual care&quot; with clusters crossing over from &quot;usual care&quot; to CirrhosisRx at 4 month intervals. All clusters will eventually be exposed to both arms of the study.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Aggregate adherence to quality measures</measure>
      <time_frame>During the hospitalization, approximately 7 days</time_frame>
      <description>This outcome is the aggregate adherence to five American Gastroenterological Association (AGA) and American Association for the Study of Liver Disease (AASLD) quality measures applicable to hospitalized patients with cirrhosis. The calculation for the measure will be the total number of admissions satisfying the five AGA/AASLD quality measures divided by the total number of addressable admissions (e.g. hospitalizations in which these quality metrics could be applied). In the cases which an admission could satisfying two or more metrics, this single admission will be multiple times per the number of times metrics could be potentially applied.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Inpatient mortality</measure>
      <time_frame>During the hospitalization, approximately 7 days</time_frame>
      <description>This outcome is death during the admission</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Reach of CirrhosisRx</measure>
      <time_frame>Through study completetion, approximately 36 months</time_frame>
      <description>Number of patients and clinicians randomized to CirrhosisRx</description>
    </other_outcome>
    <other_outcome>
      <measure>Adoption of CirrhosisRx</measure>
      <time_frame>Through study completetion, approximately 36 months</time_frame>
      <description>Proportion of clinicians using CirrhosisRx in the intervention arm</description>
    </other_outcome>
    <other_outcome>
      <measure>Implementation of CirrhosisRx</measure>
      <time_frame>Through study completetion, approximately 36 months</time_frame>
      <description>Proportions of clinicians implementing an order set through CirrhosisRx</description>
    </other_outcome>
    <other_outcome>
      <measure>Maintenance of CirrhosisRx</measure>
      <time_frame>Through study completetion, approximately 36 months</time_frame>
      <description>Rate of use over time and contamination rate</description>
    </other_outcome>
    <other_outcome>
      <measure>Average time spent on CirrhosisRx</measure>
      <time_frame>Through study completetion, approximately 36 months</time_frame>
      <description>Average time spent on CirrhosisRx - defined as the total time all clinicians spent on the system divided by the number of clinicians using the system</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2106</enrollment>
    <condition>Cirrhosis</condition>
    <condition>Decision Support Systems, Clinical</condition>
    <arm_group>
      <arm_group_label>CirrhosisRx</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Providers in this arm will have access to the CirrhosisRx CDS system, which aggregates and organizes clinical data, presents them in clinically relevant/intuitive fashion for cirrhosis care, and linked to order sets consistent with national guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Providers in this arm will not have access to the CirrhosisRx CDS system.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>CirrhosisRx CDS</intervention_name>
      <description>CirrhosisRx is a cirrhosis-specific CDS that organizes clinical data into clinically relevant groupings and links them to order sets consistent with national practice guidelines for inpatient cirrhosis care.</description>
      <arm_group_label>CirrhosisRx</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All adult (age ≥ 18 years) patients who have a previous history of cirrhosis&#xD;
               identified based on 1+ chronic liver disease and 1+ cirrhosis (or its complications)&#xD;
               International Classification of Diseases, Revision 10 diagnosis codes admitted at our&#xD;
               institution.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children (age &lt; 18 years)&#xD;
  &#xD;
            -  patients who do not meet the cirrhosis definition criteria as noted above&#xD;
  &#xD;
            -  ambulatory patients&#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>Jin Ge, MD, MBA</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jin Ge, MD, MBA</last_name>
      <phone>415-502-8070</phone>
      <email>jin.ge@ucsf.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of California San Francisco Medical Center</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94143</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jin Ge, MD, MBA</last_name>
        <phone>415-502-8070</phone>
        <email>jin.ge@ucsf.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 8, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Cirrhosis</mesh_term>
      <mesh_term>Fibrosis</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/NCT05967273
  org study id: 23-39379
  nct id: NCT05967273
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to compare the effect of CirrhosisRx, a novel clinical decision
        support (CDS) system for inpatient cirrhosis care, versus "usual care" on adherence to
        national quality measures and clinical outcomes for hospitalized patients with cirrhosis.
  Each year, there over 200,000 hospitalizations for cirrhosis in the United States. Over
        one-third of these patients are readmitted within 30 days, and up to 10% will die in the
        hospital. Despite national quality measures and care guidelines, cirrhosis care remains
        suboptimal and highly variable.
  
        Clinical Decision Support (CDS) systems present an attractive strategy to improve
        guideline-adherence due to low implementation costs. These systems, however, remain largely
        untested in cirrhosis care and it remains unknown whether they are effective at improving
        guideline-adherence and whether improving guideline-adherence changes clinical outcomes in
        cirrhosis care. The investigators have designed "CirrhosisRx," a cirrhosis-specific CDS
        system, to address these evidence gaps.
  
        This study intends to compare effect of CirrhosisRx versus "usual care" on adherence to
        quality measures and clinical outcomes through a pragmatic randomized controlled trial
        (pRCT). Randomization will be based on stepped-wedge cluster randomization of treatment teams
        at our institution.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: This will be a stepped-wedge cluster randomization of primary treatment teams. We will have 8 clusters consisting of at least one teaching medicine team, one non-teaching medicine team, one intensive care team, and equal numbers of other teams. The clusters will be assigned to the CirrhosisRx CDS intervention versus "usual care" with clusters crossing over from "usual care" to CirrhosisRx at 4 month intervals. All clusters will eventually be exposed to both arms of the study.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Aggregate adherence to quality measures
  time frame: During the hospitalization, approximately 7 days
  description: This outcome is the aggregate adherence to five American Gastroenterological Association (AGA) and American Association for the Study of Liver Disease (AASLD) quality measures applicable to hospitalized patients with cirrhosis. The calculation for the measure will be the total number of admissions satisfying the five AGA/AASLD quality measures divided by the total number of addressable admissions (e.g. hospitalizations in which these quality metrics could be applied). In the cases which an admission could satisfying two or more metrics, this single admission will be multiple times per the number of times metrics could be potentially applied.
  measure: Inpatient mortality
  time frame: During the hospitalization, approximately 7 days
  description: This outcome is death during the admission
  measure: Reach of CirrhosisRx
  time frame: Through study completetion, approximately 36 months
  description: Number of patients and clinicians randomized to CirrhosisRx
  measure: Adoption of CirrhosisRx
  time frame: Through study completetion, approximately 36 months
  description: Proportion of clinicians using CirrhosisRx in the intervention arm
  measure: Implementation of CirrhosisRx
  time frame: Through study completetion, approximately 36 months
  description: Proportions of clinicians implementing an order set through CirrhosisRx
  measure: Maintenance of CirrhosisRx
  time frame: Through study completetion, approximately 36 months
  description: Rate of use over time and contamination rate
  measure: Average time spent on CirrhosisRx
  time frame: Through study completetion, approximately 36 months
  description: Average time spent on CirrhosisRx - defined as the total time all clinicians spent on the system divided by the number of clinicians using the system
  arm group label: CirrhosisRx
  arm group type: Experimental
  description: Providers in this arm will have access to the CirrhosisRx CDS system, which aggregates and organizes clinical data, presents them in clinically relevant/intuitive fashion for cirrhosis care, and linked to order sets consistent with national guidelines.
  arm group label: Usual Care
  arm group type: No Intervention
  description: Providers in this arm will not have access to the CirrhosisRx CDS system.
  intervention type: Other
  intervention name: CirrhosisRx CDS
  description: CirrhosisRx is a cirrhosis-specific CDS that organizes clinical data into clinically relevant groupings and links them to order sets consistent with national practice guidelines for inpatient cirrhosis care.
  arm group label: CirrhosisRx
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jin Ge, MD, MBA
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Jin Ge, MD, MBA
  phone: 415-502-8070
  email: jin.ge@ucsf.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Liver Cirrhosis
  mesh term: Fibrosis
  sharing ipd: No