<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/NCT03832868</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00107168</org_study_id>
    <nct_id>NCT03832868</nct_id>
  </id_info>
  <brief_title>Syngery-Evaluating the Impact of Decision Aid</brief_title>
  <official_title>Evaluating the Impact of Decision Aid Timing on Mandatory Shared Decision Making for Defibrillator Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</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 this study is to determine whether it is better to give patients an implantable&#xD;
      cardioverter-defibrillators (ICDs) decision aid before they have their first consultation&#xD;
      with an implanting cardiac electrophysiologist or after the consult.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are many unanswered questions about how shared decision making should be executed and&#xD;
      how decision aids should be employed. The aim of this study is to determine whether it is&#xD;
      better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before&#xD;
      they have their first consultation with an implanting cardiac electrophysiologist or after&#xD;
      the consult.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">September 6, 2019</completion_date>
  <primary_completion_date type="Actual">September 6, 2019</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>Clinic sites will be block-randomized to eliminate contamination induced by individual-level randomization for a system-level intervention. Each site will rotate on a monthly basis whether the decision aid is administered pre- or post-office visit, and this will be applied to all ICD patients. Each site will have a minimum of 2 months exposure to each &quot;arm.&quot; No blinding will occur.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants</measure>
    <time_frame>Date of ICD implantation (up to 60 days from the date of receiving the decision aid)</time_frame>
    <description>Patients will receive a survey including 11 questions to gauge decisional knowledge about ICDs. The survey is expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decision Conflict Scale score among pre-visit arm participants compare to post-visit arm participants</measure>
    <time_frame>Date of ICD implantation (up to 60 days from the date of receiving the decision aid)</time_frame>
    <description>Patients will receive a survey including 12 questions to measure decisional conflict. The surveys are expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Values-choice ICDs concordance score among pre-visit arm participants compare to post-visit arm participants</measure>
    <time_frame>Date of ICD implantation (up to 60 days from the date of receiving the decision aid)</time_frame>
    <description>Patients will receive a survey including 12 questions to measure values-choice concordance. The surveys are expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Implantable Cardioverter-defibrillators (ICDs)</condition>
  <arm_group>
    <arm_group_label>Pre-visit decision aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the decision aid pre-visit will be given a paper copy of the decision aid in the waiting room and will have a minimum of 15 minutes to review it - either in the waiting room or in the exam room while waiting for the electrophysiologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-visit decision aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the decision aid after the encounter will meet with the electrophysiologist first and receive the aid afterward.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pre-visit timing of receipt of the ICDs implantation decision aid</intervention_name>
    <description>The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.</description>
    <arm_group_label>Pre-visit decision aid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Post-visit timing of receipt of the ICDs implantation decision aid</intervention_name>
    <description>The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.</description>
    <arm_group_label>Post-visit decision aid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old and older&#xD;
&#xD;
          -  evaluated for primary prevention implantable cardioverter-defibrillators (ICDs)&#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>Faisal Merchant, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory St. Joseph's Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital Midtown</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Faisal Merchant MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Decision aid</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data is being collected in REDCAP and is deidentified. The study team will have the tool to match subjects if needed. The team has no current plans to share data, but can if necessary (including the data dictionaries). All data can be shared after being deidentified.The study team can share the protocol, statistical plan, ICF, and survey tool. The decision tool is already available. Data will be available immediately following publication and for 3 years after. Those requesting access to data should contact the principal investigator (Dr. Faisal Merchant). Requests will be evaluated based on need and data usage agreement.</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_time_frame>Data will be available immediately following publication and for 3 years after.</ipd_time_frame>
    <ipd_access_criteria>Those requesting access to data should contact the principal investigator (Dr. Faisal Merchant). Requests will be evaluated based on need and data usage agreement.</ipd_access_criteria>
  </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/NCT03832868
org study id: IRB00107168
nct id: NCT03832868
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine whether it is better to give patients an implantable
      cardioverter-defibrillators (ICDs) decision aid before they have their first consultation
      with an implanting cardiac electrophysiologist or after the consult.
There are many unanswered questions about how shared decision making should be executed and
      how decision aids should be employed. The aim of this study is to determine whether it is
      better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before
      they have their first consultation with an implanting cardiac electrophysiologist or after
      the consult.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Clinic sites will be block-randomized to eliminate contamination induced by individual-level randomization for a system-level intervention. Each site will rotate on a monthly basis whether the decision aid is administered pre- or post-office visit, and this will be applied to all ICD patients. Each site will have a minimum of 2 months exposure to each "arm." No blinding will occur.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants
time frame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
description: Patients will receive a survey including 11 questions to gauge decisional knowledge about ICDs. The survey is expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.
measure: Decision Conflict Scale score among pre-visit arm participants compare to post-visit arm participants
time frame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
description: Patients will receive a survey including 12 questions to measure decisional conflict. The surveys are expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.
measure: Values-choice ICDs concordance score among pre-visit arm participants compare to post-visit arm participants
time frame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
description: Patients will receive a survey including 12 questions to measure values-choice concordance. The surveys are expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.
arm group label: Pre-visit decision aid
arm group type: Experimental
description: Patients receiving the decision aid pre-visit will be given a paper copy of the decision aid in the waiting room and will have a minimum of 15 minutes to review it - either in the waiting room or in the exam room while waiting for the electrophysiologist.
arm group label: Post-visit decision aid
arm group type: Experimental
description: Patients receiving the decision aid after the encounter will meet with the electrophysiologist first and receive the aid afterward.
intervention type: Behavioral
intervention name: Pre-visit timing of receipt of the ICDs implantation decision aid
description: The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.
arm group label: Pre-visit decision aid
intervention type: Behavioral
intervention name: Post-visit timing of receipt of the ICDs implantation decision aid
description: The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.
arm group label: Post-visit decision aid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Faisal Merchant, MD
role: Principal Investigator
affiliation: Emory University
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Faisal Merchant MD
investigator title: Assistant Professor
sharing ipd: Yes
ipd description: Data is being collected in REDCAP and is deidentified. The study team will have the tool to match subjects if needed. The team has no current plans to share data, but can if necessary (including the data dictionaries). All data can be shared after being deidentified.The study team can share the protocol, statistical plan, ICF, and survey tool. The decision tool is already available. Data will be available immediately following publication and for 3 years after. Those requesting access to data should contact the principal investigator (Dr. Faisal Merchant). Requests will be evaluated based on need and data usage agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be available immediately following publication and for 3 years after.
ipd access criteria: Those requesting access to data should contact the principal investigator (Dr. Faisal Merchant). Requests will be evaluated based on need and data usage agreement.