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/NCT05990296</url>
    </required_header>
    <id_info>
      <org_study_id>2023-1031</org_study_id>
      <nct_id>NCT05990296</nct_id>
    </id_info>
    <brief_title>Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education &amp; Assist Trial for Heart Failure Care</brief_title>
    <acronym>GREAT-HF Care</acronym>
    <official_title>Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education &amp; Assist Trial for Heart Failure Care (GREAT-HF Care)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Geisinger Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Geisinger Clinic</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>
        Heart failure with reduced ejection fraction (HFrEF) is associated with high mortality and&#xD;
        adverse events (hospitalization or urgent outpatient visits for HF), along with diminished&#xD;
        quality of life. Despite convincing data that evidenced-based, guideline-directed medical&#xD;
        therapies (GDMT) improve mortality and heart failure-related events, there remains&#xD;
        insufficient utilization of these life-saving drugs (evidence-based beta-blockers (EBBB),&#xD;
        angiotensin-neprilysin inhibitors (ARNI)/ angiotensin converting enzyme inhibitors (ACEi)/&#xD;
        angiotensin receptor blockers (ARB), mineralocorticoid receptor antagonists (MRA) and&#xD;
        sodium-glucose cotransporter 2 inhibitors (SGLT2i)) in patients with HFrEF. The primary&#xD;
        objective of this study is to implement and evaluate a multifaceted, interdisciplinary&#xD;
        intervention to improve GDMT use, reduce mortality, and reduce future heart failure events in&#xD;
        patients with HFrEF.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The intervention will involve and evaluate the following components: (1) focused clinician&#xD;
        education, (2) multi-pronged clinical decision support (CDS), and (3) integrated clinical&#xD;
        pharmacist care. The primary study design and evaluation will focus on clinician&#xD;
        randomization to different CDS arms, including an arm that facilitates coordination with&#xD;
        clinical pharmacists embedded within cardiology practices. Secondarily, two sets of clinics&#xD;
        of roughly equal HFrEF patient loads will be assigned to either an early or delayed education&#xD;
        rollout, such that clinical outcomes can be compared across patients whose clinicians have&#xD;
        versus have not yet received the focused education. Exploratory analyses will look to&#xD;
        determine the independent and incremental benefits of education and CDS (including pharmacist&#xD;
        referrals). CDS will automatically be triggered within the electronic health record (EHR) and&#xD;
        will include clinician-facing components, such as a best practice advisory (BPA) and custom&#xD;
        order set, and patient-facing components, such as patient portal messaging directly to&#xD;
        patients in advance of upcoming appointments.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>This is a cluster randomized (at clinician level) design in terms of assignment to no-intervention control, CDS, and CDS + pharmacist-co-management arms, and non-randomized (at clinic level) in terms of assignment to education versus delayed education arms.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>HF GDMT prescription increased (yes/no)</measure>
      <time_frame>Within 30 days of index visit</time_frame>
      <description>New GDMT HF medication class added, or upward dose titration of existing GDMT HF medication.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>HF GDMT prescription increased (yes/no)</measure>
      <time_frame>Within 60 and 90 days of index visit</time_frame>
      <description>New GDMT HF medication class added, or upward dose titration of existing GDMT HF medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Addition of SGLT2i or ARNI for HFrEF (yes/no)</measure>
      <time_frame>Within 30, 60 and 90 days of index visit</time_frame>
      <description>New prescriptions for SGLT2i and/or ARNI or switch from ACEi/ARB to ARNI</description>
    </secondary_outcome>
    <other_outcome>
      <measure>All-cause mortality, emergency visit for heart failure or hospitalization for heart failure</measure>
      <time_frame>Within 365 days of index visit</time_frame>
      <description>Patient death (yes/no), patient with emergency visit with a primary diagnosis of heart failure (yes/no) or admitted for inpatient hospitalization with primary diagnosis of heart failure (yes/no)</description>
    </other_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">4300</enrollment>
    <condition>Heart Failure</condition>
    <condition>Heart Failure With Reduced Ejection Fraction</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Clinicians in this arm will not receive CDS or focused education and will experience usual care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Clinical Decision Support (CDS)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Clinicians and patients with HFrEF in this arm will receive electronic notification of GDMT care gaps encouraging treatment options. The CDS will inform, encourage, and facilitate prescribing of GDMT.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CDS + Pharmacist Co-Management</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Clinicians/patients in this arm will receive CDS for their eligible patients with HFrEF. The clinician-facing BPA will include an option to refer patients to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Focused Education</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Clinicians in this arm will receive focused education and no CDS.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Focused Education + CDS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Clinicians in this arm will receive focused education in addition to clinician/patient CDS for their eligible patients with HFrEF.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Focused Education + CDS + Pharmacist Co-Management</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Clinicians in this arm will receive focused education along with clinicians/patient CDS. The clinician-facing BPA will include an option to refer patients to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Pharmacist co-management</intervention_name>
      <description>Eligible patients within this arm will be referred to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians.</description>
      <arm_group_label>CDS + Pharmacist Co-Management</arm_group_label>
      <arm_group_label>Focused Education + CDS + Pharmacist Co-Management</arm_group_label>
      <other_name>Opt-out default</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CDS</intervention_name>
      <description>Accepting the clinician-facing BPA default recommendation will open an order set for GDMT that lists common recommended options in such a way that facilitates optimal prescribing. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the BPA.</description>
      <arm_group_label>CDS + Pharmacist Co-Management</arm_group_label>
      <arm_group_label>Clinical Decision Support (CDS)</arm_group_label>
      <arm_group_label>Focused Education + CDS</arm_group_label>
      <arm_group_label>Focused Education + CDS + Pharmacist Co-Management</arm_group_label>
      <other_name>Opt-out default</other_name>
      <other_name>Active choice</other_name>
      <other_name>Default order of options</other_name>
      <other_name>Advisory</other_name>
      <other_name>Alert</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Focused Education</intervention_name>
      <description>A series of focused, interactive education sessions will train clinicians in why, when, and how to prescribe GDMT to patients, with incentives such as continuing medical education (CME) credits, and with virtual and recorded options available to those who are unable to attend in-person meetings.</description>
      <arm_group_label>Focused Education</arm_group_label>
      <arm_group_label>Focused Education + CDS</arm_group_label>
      <arm_group_label>Focused Education + CDS + Pharmacist Co-Management</arm_group_label>
      <other_name>Education</other_name>
      <other_name>Training</other_name>
      <other_name>Interactive</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 18 years or older AND&#xD;
  &#xD;
            -  Completed visit at included Geisinger cardiology outpatient clinics (office visit,&#xD;
               telemedicine, or telephone) AND&#xD;
  &#xD;
            -  Clinicians are on a list of currently active Geisinger clinicians in outpatient&#xD;
               cardiology clinics who can prescribe heart failure medications AND&#xD;
  &#xD;
            -  Active problem list diagnosis of HFrEF at time of Cardiology clinic encounter OR Left&#xD;
               Ventricular Ejection Fraction (LVEF) ≤ 40: most recent to the cardiology clinic&#xD;
               encounter within 2 years of the visit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently in hospice or palliative care (ICD 10 code: Z51.5)&#xD;
  &#xD;
            -  Patient is allergic to or prescribed medications from all four categories of GDMT&#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_contact>
      <last_name>Stephen J Voyce</last_name>
      <phone>5707034830</phone>
      <email>svoyce@geisinger.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Vanessa A Hayduk</last_name>
      <email>vhayduk@geisinger.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Geisinger Cardiology Clinics</name>
        <address>
          <city>Danville</city>
          <state>Pennsylvania</state>
          <zip>17822</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Stephen J Voyce</last_name>
        <phone>570-703-4830</phone>
        <email>svoyce@geisinger.edu</email>
      </contact>
      <contact_backup>
        <last_name>Vanessa Hayduk</last_name>
        <phone>5707146682</phone>
        <email>vhayduk@geisinger.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Eric Wright, PharmD, MPH</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Amir Goren, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Geisinger Clinic</investigator_affiliation>
      <investigator_full_name>Stephen Voyce</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Heart Failure with Reduced Ejection Fraction</keyword>
    <keyword>Guideline Directed Medical Therapy</keyword>
    <keyword>Angiotensin-neprilysin inhibitors (ARNI)</keyword>
    <keyword>Sodium-glucose cotransporter 2 inhibitors (SGLT2i)</keyword>
    <keyword>Clinical Decision Support</keyword>
    <keyword>Best Practice Alert</keyword>
    <keyword>Pharmacist</keyword>
    <keyword>Education</keyword>
    <keyword>Behavioral Economics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</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/NCT05990296
  org study id: 2023-1031
  nct id: NCT05990296
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Heart failure with reduced ejection fraction (HFrEF) is associated with high mortality and
        adverse events (hospitalization or urgent outpatient visits for HF), along with diminished
        quality of life. Despite convincing data that evidenced-based, guideline-directed medical
        therapies (GDMT) improve mortality and heart failure-related events, there remains
        insufficient utilization of these life-saving drugs (evidence-based beta-blockers (EBBB),
        angiotensin-neprilysin inhibitors (ARNI)/ angiotensin converting enzyme inhibitors (ACEi)/
        angiotensin receptor blockers (ARB), mineralocorticoid receptor antagonists (MRA) and
        sodium-glucose cotransporter 2 inhibitors (SGLT2i)) in patients with HFrEF. The primary
        objective of this study is to implement and evaluate a multifaceted, interdisciplinary
        intervention to improve GDMT use, reduce mortality, and reduce future heart failure events in
        patients with HFrEF.
  The intervention will involve and evaluate the following components: (1) focused clinician
        education, (2) multi-pronged clinical decision support (CDS), and (3) integrated clinical
        pharmacist care. The primary study design and evaluation will focus on clinician
        randomization to different CDS arms, including an arm that facilitates coordination with
        clinical pharmacists embedded within cardiology practices. Secondarily, two sets of clinics
        of roughly equal HFrEF patient loads will be assigned to either an early or delayed education
        rollout, such that clinical outcomes can be compared across patients whose clinicians have
        versus have not yet received the focused education. Exploratory analyses will look to
        determine the independent and incremental benefits of education and CDS (including pharmacist
        referrals). CDS will automatically be triggered within the electronic health record (EHR) and
        will include clinician-facing components, such as a best practice advisory (BPA) and custom
        order set, and patient-facing components, such as patient portal messaging directly to
        patients in advance of upcoming appointments.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a cluster randomized (at clinician level) design in terms of assignment to no-intervention control, CDS, and CDS + pharmacist-co-management arms, and non-randomized (at clinic level) in terms of assignment to education versus delayed education arms.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: HF GDMT prescription increased (yes/no)
  time frame: Within 30 days of index visit
  description: New GDMT HF medication class added, or upward dose titration of existing GDMT HF medication.
  measure: HF GDMT prescription increased (yes/no)
  time frame: Within 60 and 90 days of index visit
  description: New GDMT HF medication class added, or upward dose titration of existing GDMT HF medication.
  measure: Addition of SGLT2i or ARNI for HFrEF (yes/no)
  time frame: Within 30, 60 and 90 days of index visit
  description: New prescriptions for SGLT2i and/or ARNI or switch from ACEi/ARB to ARNI
  measure: All-cause mortality, emergency visit for heart failure or hospitalization for heart failure
  time frame: Within 365 days of index visit
  description: Patient death (yes/no), patient with emergency visit with a primary diagnosis of heart failure (yes/no) or admitted for inpatient hospitalization with primary diagnosis of heart failure (yes/no)
  arm group label: Control
  arm group type: No Intervention
  description: Clinicians in this arm will not receive CDS or focused education and will experience usual care.
  arm group label: Clinical Decision Support (CDS)
  arm group type: Experimental
  description: Clinicians and patients with HFrEF in this arm will receive electronic notification of GDMT care gaps encouraging treatment options. The CDS will inform, encourage, and facilitate prescribing of GDMT.
  arm group label: CDS + Pharmacist Co-Management
  arm group type: Experimental
  description: Clinicians/patients in this arm will receive CDS for their eligible patients with HFrEF. The clinician-facing BPA will include an option to refer patients to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians.
  arm group label: Focused Education
  arm group type: Experimental
  description: Clinicians in this arm will receive focused education and no CDS.
  arm group label: Focused Education + CDS
  arm group type: Experimental
  description: Clinicians in this arm will receive focused education in addition to clinician/patient CDS for their eligible patients with HFrEF.
  arm group label: Focused Education + CDS + Pharmacist Co-Management
  arm group type: Experimental
  description: Clinicians in this arm will receive focused education along with clinicians/patient CDS. The clinician-facing BPA will include an option to refer patients to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians.
  intervention type: Behavioral
  intervention name: Pharmacist co-management
  description: Eligible patients within this arm will be referred to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians.
  arm group label: CDS + Pharmacist Co-Management
  arm group label: Focused Education + CDS + Pharmacist Co-Management
  other name: Opt-out default
  intervention type: Behavioral
  intervention name: CDS
  description: Accepting the clinician-facing BPA default recommendation will open an order set for GDMT that lists common recommended options in such a way that facilitates optimal prescribing. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the BPA.
  arm group label: CDS + Pharmacist Co-Management
  arm group label: Clinical Decision Support (CDS)
  arm group label: Focused Education + CDS
  arm group label: Focused Education + CDS + Pharmacist Co-Management
  other name: Opt-out default
  other name: Active choice
  other name: Default order of options
  other name: Advisory
  other name: Alert
  intervention type: Behavioral
  intervention name: Focused Education
  description: A series of focused, interactive education sessions will train clinicians in why, when, and how to prescribe GDMT to patients, with incentives such as continuing medical education (CME) credits, and with virtual and recorded options available to those who are unable to attend in-person meetings.
  arm group label: Focused Education
  arm group label: Focused Education + CDS
  arm group label: Focused Education + CDS + Pharmacist Co-Management
  other name: Education
  other name: Training
  other name: Interactive
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Stephen J Voyce
  phone: 5707034830
  email: svoyce@geisinger.edu
  last name: Vanessa A Hayduk
  email: vhayduk@geisinger.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Geisinger Clinic
  investigator full name: Stephen Voyce
  investigator title: Associate Professor
  mesh term: Heart Failure
  sharing ipd: No