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/NCT05997420</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00087673</org_study_id>
      <secondary_id>7056-SP</secondary_id>
      <nct_id>NCT05997420</nct_id>
    </id_info>
    <brief_title>Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up</brief_title>
    <acronym>ASTROS</acronym>
    <official_title>Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wake Forest University Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Duke Endowment</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Wake Forest University Health Sciences</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 Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS) study is&#xD;
        an effectiveness-implementation hybrid design. The effectiveness evaluation is designed as a&#xD;
        multiple interrupted time series (mITS) analysis to test the impact of implementing an&#xD;
        adapted Sepsis Transition and Recovery (STAR) program on enhancing post sepsis outcomes in&#xD;
        new hospital settings.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Approximately 1.4 million survivors of sepsis (life-threatening organ dysfunction due to&#xD;
        infection) are discharged from U.S. hospitals annually, facing high rates of long-term&#xD;
        mortality and morbidity as well as incurring high costs to healthcare systems. To improve&#xD;
        outcomes and address disparities, this study developed a multicomponent Sepsis Transition and&#xD;
        Recovery (STAR) intervention that leverages real-time advanced analytics to identify&#xD;
        high-risk patients who are most likely to benefit from sepsis-specific transitional support.&#xD;
        STAR is a 90-day, nurse-navigator-led program designed to facilitate transition/recovery&#xD;
        after sepsis hospitalization. Navigators provide disease education, help patients overcome&#xD;
        medical-system barriers to recommended care, and bridge gaps in service that serve as points&#xD;
        of failure for complex sepsis patients. STAR specifically targets delivery of best-practice&#xD;
        post-sepsis care including: i) medication optimization, ii) screening for new impairments,&#xD;
        iii) anticipation/mitigation of risk for health deterioration, and iv) palliative care when&#xD;
        appropriate. STAR is the only intervention to date supported by randomized, controlled trial&#xD;
        evidence to improve outcomes for sepsis survivors.&#xD;
  &#xD;
        Despite rigorous data supporting STAR program effectiveness in its initial context, there are&#xD;
        significant differences in healthcare infrastructure and resources at different sites that&#xD;
        require careful adaptation prior to implementation to retain effectiveness. More research is&#xD;
        needed to identify STAR's core functions (i.e., the subset of an intervention's features that&#xD;
        are causally related to outcomes; to be distinguished from features that may be adapted&#xD;
        without compromising intervention's effectiveness and may enhance effectiveness by promoting&#xD;
        proficient/consistent use in new contexts), study the implementation process, and evaluate&#xD;
        STAR performance in new contexts. The goal of this project is to examine strategies to&#xD;
        optimize the STAR program to fit well in other settings.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>All hospitals begin the study under the usual care condition. The STAR intervention will be introduced to groups of hospitals at two separate time points approximately six months apart. The sequence of intervention introduction will not be randomized. Once STAR has been introduced at a study hospital, eligible patients will receive STAR during their index hospitalization and extending through 90 days from discharge or date of death.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>All-cause mortality and hospital readmission rate</measure>
      <time_frame>day 90</time_frame>
      <description>Binary composite endpoint of mortality and hospital readmission assessed 90 days post index hospital discharge</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of hospital free days</measure>
      <time_frame>day 90</time_frame>
      <description>Continuous composite endpoint of days alive and outside of the hospital assessed 90 days post index hospital discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause mortality rate</measure>
      <time_frame>day 90</time_frame>
      <description>Binary endpoint of all-cause mortality rate assessed 90 days post index hospital discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause hospital readmission rate</measure>
      <time_frame>day 90</time_frame>
      <description>Binary endpoint of all-cause readmission rate assessed 90 days post index hospital discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute care-related costs</measure>
      <time_frame>day 90</time_frame>
      <description>Healthcare costs attributed to care received at emergency department, observation, and inpatient encounters during follow-up</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Qualitative assessment of the core functions of the STAR program</measure>
      <time_frame>Pre-implementation</time_frame>
      <description>Open-ended, qualitative evaluation to identify core functions necessary to maintain program effectiveness when implementing the STAR program in new settings</description>
    </other_outcome>
    <other_outcome>
      <measure>Qualitative assessment of the adaptable &quot;forms&quot; for implementing the STAR program</measure>
      <time_frame>Pre-implementation</time_frame>
      <description>Open-ended, qualitative evaluation to identify potential adaptations that are important to implementing the STAR program in new settings</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of providers included in STAR program adoption</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Number of hospital attending providers with patients enrolled in STAR</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of eligible patients reached by STAR program</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Total number of patients who received the intervention</description>
    </other_outcome>
    <other_outcome>
      <measure>Proportion of patients with STAR program intervention delivered as intended</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Quantitative assessment of fidelity to completion of key intervention components (e.g., medication reconciliation, physical and mental health screenings, goals-of-care documentation)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1280</enrollment>
    <condition>Sepsis</condition>
    <arm_group>
      <arm_group_label>Sepsis Transition and Recovery (STAR) program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Virtual sepsis navigation delivered across the peri-hospital discharge interval</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard of care received through each facility for patients hospitalized with sepsis. Aspects of usual care will be determined by treating clinicians independent of trial assignment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>STAR Program</intervention_name>
      <description>In the STAR program intervention, a centrally located nurse navigator facilitates the application of four evidence-based core components of post-sepsis care (i.e., review of medications, new impairments, comorbidities, and palliative care) to patients prior to and during the 90 days after hospital discharge. The STAR navigator will provide telephone and EHR-based support within the hospitalization and to patients across all discharge settings with remote monitoring at specified intervals following hospital discharge. Patients will continue to receive STAR directed services for 90 days following their discharge and then will be transitioned back to the next appropriate care location.</description>
      <arm_group_label>Sepsis Transition and Recovery (STAR) program</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Usual Care</intervention_name>
      <description>Hospitals and their patients will not have access to the STAR program. Patients will continue to receive usual care throughout their stay and discharge, consisting of: patient education and follow-up instructions at discharge, which are not specific to sepsis; routine recommendations for follow-up visits with primary care providers; arrangements for home health services or care management follow-up based on each patient's needs but not specifically tailored to the sepsis population; discharge to post-acute setting with no sepsis-specific follow-up. All aspects of usual care will be determined by treating clinicians independent of trial assignment.</description>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adults 18 years of age and older;&#xD;
  &#xD;
            -  clinically suspected infection&#xD;
  &#xD;
                 1. two or more markers of systemic inflammatory response syndrome within 24 h of&#xD;
                    presentation; AND&#xD;
  &#xD;
                 2. antibiotics initiated within 24 hours and continued for at least one additional&#xD;
                    day&#xD;
  &#xD;
            -  organ dysfunction&#xD;
  &#xD;
                 1. two or more points on admission Sequential Organ Failure Assessment (SOFA); OR&#xD;
  &#xD;
                 2. two or more points on admission quick-SOFA&#xD;
  &#xD;
            -  deemed to be at high risk of hospital readmission within 90 days, defined as&#xD;
               readmission risk probability of at least 25%&#xD;
  &#xD;
            -  not discharged from the hospital at the time of patient identification each morning.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  change in code status (i.e., initially full code followed by change to do not&#xD;
               resuscitate and/or do not intubate) within 24 hours after index presentation due to&#xD;
               presumed limitation of aggressive treatment and exposure to STAR program components;&#xD;
  &#xD;
            -  reside &gt; 2.5 hours drive time from the treating hospital due to the maximum reach of&#xD;
               the community services leveraged within the STAR program and the general assumption&#xD;
               that these patients may have less comprehensive utilization tracking within available&#xD;
               electronic record systems for study outcomes;&#xD;
  &#xD;
            -  are actively participating in a different care management program (e.g., cancer care&#xD;
               patient navigation) documented in the electronic health record (EHR) at time of&#xD;
               hospital admission.&#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>Marc A. Kowalkowski, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wake Forest University Health Sciences</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sarah Birken, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wake Forest University Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marc Kowalkowski, PhD</last_name>
      <phone>(704) 355-9902</phone>
      <email>Marc.Kowalkowski@AtriumHealth.org</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>critical illness recovery</keyword>
    <keyword>care transitions</keyword>
    <keyword>survivorship</keyword>
    <keyword>mortality</keyword>
    <keyword>hospital readmission</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sepsis</mesh_term>
      <mesh_term>Toxemia</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/NCT05997420
  org study id: IRB00087673
  secondary id: 7056-SP
  nct id: NCT05997420
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS) study is
        an effectiveness-implementation hybrid design. The effectiveness evaluation is designed as a
        multiple interrupted time series (mITS) analysis to test the impact of implementing an
        adapted Sepsis Transition and Recovery (STAR) program on enhancing post sepsis outcomes in
        new hospital settings.
  Approximately 1.4 million survivors of sepsis (life-threatening organ dysfunction due to
        infection) are discharged from U.S. hospitals annually, facing high rates of long-term
        mortality and morbidity as well as incurring high costs to healthcare systems. To improve
        outcomes and address disparities, this study developed a multicomponent Sepsis Transition and
        Recovery (STAR) intervention that leverages real-time advanced analytics to identify
        high-risk patients who are most likely to benefit from sepsis-specific transitional support.
        STAR is a 90-day, nurse-navigator-led program designed to facilitate transition/recovery
        after sepsis hospitalization. Navigators provide disease education, help patients overcome
        medical-system barriers to recommended care, and bridge gaps in service that serve as points
        of failure for complex sepsis patients. STAR specifically targets delivery of best-practice
        post-sepsis care including: i) medication optimization, ii) screening for new impairments,
        iii) anticipation/mitigation of risk for health deterioration, and iv) palliative care when
        appropriate. STAR is the only intervention to date supported by randomized, controlled trial
        evidence to improve outcomes for sepsis survivors.
  
        Despite rigorous data supporting STAR program effectiveness in its initial context, there are
        significant differences in healthcare infrastructure and resources at different sites that
        require careful adaptation prior to implementation to retain effectiveness. More research is
        needed to identify STAR's core functions (i.e., the subset of an intervention's features that
        are causally related to outcomes; to be distinguished from features that may be adapted
        without compromising intervention's effectiveness and may enhance effectiveness by promoting
        proficient/consistent use in new contexts), study the implementation process, and evaluate
        STAR performance in new contexts. The goal of this project is to examine strategies to
        optimize the STAR program to fit well in other settings.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  intervention model description: All hospitals begin the study under the usual care condition. The STAR intervention will be introduced to groups of hospitals at two separate time points approximately six months apart. The sequence of intervention introduction will not be randomized. Once STAR has been introduced at a study hospital, eligible patients will receive STAR during their index hospitalization and extending through 90 days from discharge or date of death.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: All-cause mortality and hospital readmission rate
  time frame: day 90
  description: Binary composite endpoint of mortality and hospital readmission assessed 90 days post index hospital discharge
  measure: Number of hospital free days
  time frame: day 90
  description: Continuous composite endpoint of days alive and outside of the hospital assessed 90 days post index hospital discharge
  measure: All-cause mortality rate
  time frame: day 90
  description: Binary endpoint of all-cause mortality rate assessed 90 days post index hospital discharge
  measure: All-cause hospital readmission rate
  time frame: day 90
  description: Binary endpoint of all-cause readmission rate assessed 90 days post index hospital discharge
  measure: Acute care-related costs
  time frame: day 90
  description: Healthcare costs attributed to care received at emergency department, observation, and inpatient encounters during follow-up
  measure: Qualitative assessment of the core functions of the STAR program
  time frame: Pre-implementation
  description: Open-ended, qualitative evaluation to identify core functions necessary to maintain program effectiveness when implementing the STAR program in new settings
  measure: Qualitative assessment of the adaptable "forms" for implementing the STAR program
  time frame: Pre-implementation
  description: Open-ended, qualitative evaluation to identify potential adaptations that are important to implementing the STAR program in new settings
  measure: Number of providers included in STAR program adoption
  time frame: Up to 2 years
  description: Number of hospital attending providers with patients enrolled in STAR
  measure: Number of eligible patients reached by STAR program
  time frame: Up to 2 years
  description: Total number of patients who received the intervention
  measure: Proportion of patients with STAR program intervention delivered as intended
  time frame: Up to 2 years
  description: Quantitative assessment of fidelity to completion of key intervention components (e.g., medication reconciliation, physical and mental health screenings, goals-of-care documentation)
  arm group label: Sepsis Transition and Recovery (STAR) program
  arm group type: Experimental
  description: Virtual sepsis navigation delivered across the peri-hospital discharge interval
  arm group label: Usual Care
  arm group type: Active Comparator
  description: Standard of care received through each facility for patients hospitalized with sepsis. Aspects of usual care will be determined by treating clinicians independent of trial assignment.
  intervention type: Behavioral
  intervention name: STAR Program
  description: In the STAR program intervention, a centrally located nurse navigator facilitates the application of four evidence-based core components of post-sepsis care (i.e., review of medications, new impairments, comorbidities, and palliative care) to patients prior to and during the 90 days after hospital discharge. The STAR navigator will provide telephone and EHR-based support within the hospitalization and to patients across all discharge settings with remote monitoring at specified intervals following hospital discharge. Patients will continue to receive STAR directed services for 90 days following their discharge and then will be transitioned back to the next appropriate care location.
  arm group label: Sepsis Transition and Recovery (STAR) program
  intervention type: Behavioral
  intervention name: Usual Care
  description: Hospitals and their patients will not have access to the STAR program. Patients will continue to receive usual care throughout their stay and discharge, consisting of: patient education and follow-up instructions at discharge, which are not specific to sepsis; routine recommendations for follow-up visits with primary care providers; arrangements for home health services or care management follow-up based on each patient's needs but not specifically tailored to the sepsis population; discharge to post-acute setting with no sepsis-specific follow-up. All aspects of usual care will be determined by treating clinicians independent of trial assignment.
  arm group label: Usual Care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marc A. Kowalkowski, PhD
  role: Principal Investigator
  affiliation: Wake Forest University Health Sciences
  last name: Sarah Birken, PhD
  role: Principal Investigator
  affiliation: Wake Forest University Health Sciences
  last name: Marc Kowalkowski, PhD
  phone: (704) 355-9902
  email: Marc.Kowalkowski@AtriumHealth.org
  responsible party type: Sponsor
  mesh term: Sepsis
  mesh term: Toxemia
  sharing ipd: No