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/NCT05986695</url>
    </required_header>
    <id_info>
      <org_study_id>PPO 22-091</org_study_id>
      <nct_id>NCT05986695</nct_id>
    </id_info>
    <brief_title>Informational Nudge to Improve Heart Failure Prescribing</brief_title>
    <acronym>Nudge</acronym>
    <official_title>Preliminary Implementation of an Informational Nudge to Improve Heart Failure Prescribing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Arizona State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>VA Office of Research and Development</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study addresses a critical gap of care for Veterans with heart failure (HF). Only 1/3 or&#xD;
        fewer eligible Veterans are receiving recommended SGLT2 and MRA therapies that save lives and&#xD;
        prevents HF hospitalizations. The investigators will compare the effect of clinician directed&#xD;
        nudges as strategies to improve the health of Veterans with HF.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study addresses a critical gap in quality of care for Veterans with heart failure (HF).&#xD;
        Only 1/3 or fewer eligible Veterans are receiving SGLT2 inhibitors and mineralocorticoid&#xD;
        receptor antagonists, both medications that save lives and prevents HF hospitalizations. The&#xD;
        investigators will combine insights from behavioral science and quality improvement science&#xD;
        to create two types of 'nudges' - informational alerts and peer comparison feedback - to&#xD;
        increase prescribing of these medications. The investigators will create two types of&#xD;
        'nudges' - informational alerts and peer comparison feedback - to increase prescribing of&#xD;
        these medications. The investigators will compare the effect of these two nudge strategies&#xD;
        alone and in combination compared to usual care. This project will develop simple, scalable,&#xD;
        and low-cost strategies to improve the health of Veterans with HF.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 9, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 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>Factorial Assignment</intervention_model>
      <intervention_model_description>This is a type 3 hybrid (implementation focused), four group, pragmatic trial of cardiology and primary care clinicians at a single VA medical center. The trial will include a 3-month preintervention period and 3-month intervention period. Clinicians will be randomized to one of four arms: usual care, informational alert, peer comparison feedback, and combination of alert and peer comparison.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>Statistician will be blinded to treatment assignment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Effectiveness</measure>
      <time_frame>30 days</time_frame>
      <description>The primary effectiveness outcome is the proportion of SGLT2 or MRA prescriptions in eligible HF patients in the three intervention groups compared with the control group within 30 days of appointment. Thirty days is a common time interval for HF outcomes assessment and allows for chart documentation, care coordination, laboratory testing, and medication prescribing that may occur days after a patient encounter. The investigators will record all SGLT2 or MRA prescriptions, including those from non-targeted clinicians, given that nudge interventions, especially the informational alert, may impact other clinicians directly (e.g., view alert in EHR) or indirectly (e.g., referral from targeted clinician).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reach-Clinician</measure>
      <time_frame>6 months</time_frame>
      <description>Reach will be measured at the clinician level as the number of unique clinicians who received an informational alert or peer comparison.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Treatment Emergent Adverse Events</measure>
      <time_frame>30 days</time_frame>
      <description>The investigators will measure safety as the number of discontinued prescribed medicine due to suspected adverse effects within 30 days of the nudge interventions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Implementation-Acceptability</measure>
      <time_frame>6 months</time_frame>
      <description>Implementation will be assessed by clinician-directed survey of Acceptability of intervention Measure. Likert Scale: minimum 1 and maximum 5. 5 being the highest.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reach-Patient</measure>
      <time_frame>6 months</time_frame>
      <description>At the patient level, Reach will be measured as the number of informational alerts delivered for unique patient visits and unique patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reach-Comparison of Strategies</measure>
      <time_frame>6 months</time_frame>
      <description>the investigators will measure the proportion of alerts relative to the total number of eligible patients with HF; this denominator will allow for comparisons of representativeness of the alert strategy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Implementation-Appropriateness</measure>
      <time_frame>6 months</time_frame>
      <description>Implementation will be assessed by clinician direct survey of Intervention Appropriateness Measure. Likert scale: minimum 1 and maximum 5. 5 being the highest.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Implementation-Feasibility</measure>
      <time_frame>6 months</time_frame>
      <description>Implementation will be assessed by clinician direct survey of Feasibility of Intervention Measure. Likert scale: minimum 1 and maximum 5. 5 being the highest.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Heart Failure</condition>
    <arm_group>
      <arm_group_label>Peer Comparison Report</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Clinicians assigned to peer comparison, will receive messages by secure email every two weeks regarding their SGLT2i and MRA prescribing performance.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Alert</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Clinicians in the alert arm will receive an alert two business days prior to a patient's upcoming appointment. Clinicians will receive approximately two alerts per week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Alert and Peer Comparison</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The combined alert and peer comparison arm will receive both interventions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No alert or peer comparison</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Alert</intervention_name>
      <description>Interruptive alert. The prototype alert is in the form of a chart note with evidence-based practice guidelines that will actively display in the clinician's list of daily alerts (like an inbox) that must be cleared daily. It is interruptive because can only be dismissed from the clinician's inbox list after signing the note</description>
      <arm_group_label>Alert</arm_group_label>
      <arm_group_label>Alert and Peer Comparison</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Peer comparison report</intervention_name>
      <description>Clinicians will receive an email describing their recent SGLT2 and MRA prescribing performance relative to their peers.</description>
      <arm_group_label>Alert and Peer Comparison</arm_group_label>
      <arm_group_label>Peer Comparison Report</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Primary care and cardiology clinicians at Southern AZ VA Health Care System working in&#xD;
               outpatient clinic setting&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Clinicians who are in training status (resident, fellow) will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sandesh Dev, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Southern Arizona VA Health Care System, Tucson, AZ</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jenice Ria S Guzman, PhD MSN</last_name>
      <phone>(520) 792-1450</phone>
      <email>JeniceRia.Guzman@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eric E Glenn</last_name>
      <phone>(520) 792-1450</phone>
      <phone_ext>15446</phone_ext>
      <email>Eric.Glenn@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Southern Arizona VA Health Care System, Tucson, AZ</name>
        <address>
          <city>Tucson</city>
          <state>Arizona</state>
          <zip>85723-0001</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rene C Hearns, MPA BBA</last_name>
        <phone>216-791-2300</phone>
        <phone_ext>5835</phone_ext>
        <email>Rene.Hearns@va.gov</email>
      </contact>
      <investigator>
        <last_name>Sandesh Dev, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Sodium-Glucose Transporter 2 Inhibitors</keyword>
    <keyword>Mineralocorticoid Receptor Antagonists</keyword>
    <keyword>Economics, Behavioral</keyword>
    <keyword>feedback</keyword>
    <keyword>medical audit</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>Yes</sharing_ipd>
      <ipd_description>There is a plan to make IPD and related data dictionaries available.&#xD;
  A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
    </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/NCT05986695
  org study id: PPO 22-091
  nct id: NCT05986695
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study addresses a critical gap of care for Veterans with heart failure (HF). Only 1/3 or
        fewer eligible Veterans are receiving recommended SGLT2 and MRA therapies that save lives and
        prevents HF hospitalizations. The investigators will compare the effect of clinician directed
        nudges as strategies to improve the health of Veterans with HF.
  This study addresses a critical gap in quality of care for Veterans with heart failure (HF).
        Only 1/3 or fewer eligible Veterans are receiving SGLT2 inhibitors and mineralocorticoid
        receptor antagonists, both medications that save lives and prevents HF hospitalizations. The
        investigators will combine insights from behavioral science and quality improvement science
        to create two types of 'nudges' - informational alerts and peer comparison feedback - to
        increase prescribing of these medications. The investigators will create two types of
        'nudges' - informational alerts and peer comparison feedback - to increase prescribing of
        these medications. The investigators will compare the effect of these two nudge strategies
        alone and in combination compared to usual care. This project will develop simple, scalable,
        and low-cost strategies to improve the health of Veterans with HF.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: This is a type 3 hybrid (implementation focused), four group, pragmatic trial of cardiology and primary care clinicians at a single VA medical center. The trial will include a 3-month preintervention period and 3-month intervention period. Clinicians will be randomized to one of four arms: usual care, informational alert, peer comparison feedback, and combination of alert and peer comparison.
  primary purpose: Health Services Research
  masking: Single (Investigator)
  masking description: Statistician will be blinded to treatment assignment.
  measure: Effectiveness
  time frame: 30 days
  description: The primary effectiveness outcome is the proportion of SGLT2 or MRA prescriptions in eligible HF patients in the three intervention groups compared with the control group within 30 days of appointment. Thirty days is a common time interval for HF outcomes assessment and allows for chart documentation, care coordination, laboratory testing, and medication prescribing that may occur days after a patient encounter. The investigators will record all SGLT2 or MRA prescriptions, including those from non-targeted clinicians, given that nudge interventions, especially the informational alert, may impact other clinicians directly (e.g., view alert in EHR) or indirectly (e.g., referral from targeted clinician).
  measure: Reach-Clinician
  time frame: 6 months
  description: Reach will be measured at the clinician level as the number of unique clinicians who received an informational alert or peer comparison.
  measure: Incidence of Treatment Emergent Adverse Events
  time frame: 30 days
  description: The investigators will measure safety as the number of discontinued prescribed medicine due to suspected adverse effects within 30 days of the nudge interventions.
  measure: Implementation-Acceptability
  time frame: 6 months
  description: Implementation will be assessed by clinician-directed survey of Acceptability of intervention Measure. Likert Scale: minimum 1 and maximum 5. 5 being the highest.
  measure: Reach-Patient
  time frame: 6 months
  description: At the patient level, Reach will be measured as the number of informational alerts delivered for unique patient visits and unique patients.
  measure: Reach-Comparison of Strategies
  time frame: 6 months
  description: the investigators will measure the proportion of alerts relative to the total number of eligible patients with HF; this denominator will allow for comparisons of representativeness of the alert strategy.
  measure: Implementation-Appropriateness
  time frame: 6 months
  description: Implementation will be assessed by clinician direct survey of Intervention Appropriateness Measure. Likert scale: minimum 1 and maximum 5. 5 being the highest.
  measure: Implementation-Feasibility
  time frame: 6 months
  description: Implementation will be assessed by clinician direct survey of Feasibility of Intervention Measure. Likert scale: minimum 1 and maximum 5. 5 being the highest.
  arm group label: Peer Comparison Report
  arm group type: Active Comparator
  description: Clinicians assigned to peer comparison, will receive messages by secure email every two weeks regarding their SGLT2i and MRA prescribing performance.
  arm group label: Alert
  arm group type: Active Comparator
  description: Clinicians in the alert arm will receive an alert two business days prior to a patient's upcoming appointment. Clinicians will receive approximately two alerts per week.
  arm group label: Alert and Peer Comparison
  arm group type: Active Comparator
  description: The combined alert and peer comparison arm will receive both interventions.
  arm group label: Control
  arm group type: No Intervention
  description: No alert or peer comparison
  intervention type: Behavioral
  intervention name: Alert
  description: Interruptive alert. The prototype alert is in the form of a chart note with evidence-based practice guidelines that will actively display in the clinician's list of daily alerts (like an inbox) that must be cleared daily. It is interruptive because can only be dismissed from the clinician's inbox list after signing the note
  arm group label: Alert
  arm group label: Alert and Peer Comparison
  intervention type: Behavioral
  intervention name: Peer comparison report
  description: Clinicians will receive an email describing their recent SGLT2 and MRA prescribing performance relative to their peers.
  arm group label: Alert and Peer Comparison
  arm group label: Peer Comparison Report
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sandesh Dev, MD
  role: Principal Investigator
  affiliation: Southern Arizona VA Health Care System, Tucson, AZ
  last name: Jenice Ria S Guzman, PhD MSN
  phone: (520) 792-1450
  email: JeniceRia.Guzman@va.gov
  last name: Eric E Glenn
  phone: (520) 792-1450
  phone ext: 15446
  email: Eric.Glenn@va.gov
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Heart Failure
  sharing ipd: Yes
  ipd description: There is a plan to make IPD and related data dictionaries available.
  A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code