<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/NCT02989090</url>
  </required_header>
  <id_info>
    <org_study_id>PRC13-0113 ePHR-ICD SJM</org_study_id>
    <nct_id>NCT02989090</nct_id>
  </id_info>
  <brief_title>Electronic Patient Notification of Remote ICD Data: Impact of Patient Engagement on Outcomes in the Merlin.Net™</brief_title>
  <acronym>ePHR-ICD-SJM</acronym>
  <official_title>Electronic Patient Notification of Remote Implantable Cardioverter-Defibrillator (ICD) Monitoring Data: Impact of Patient Engagement on Outcomes in the Merlin.Net™ System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Parkview Hospital, Indiana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Parkview Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Remote monitoring of implantable cardioverter-defibrillators (ICDs) for patients has led to&#xD;
      efficient, safe, and satisfying analysis of their device and cardiac status; resulting in an&#xD;
      overall improvement in the quality of care for such patients. Despite the efficacy of remote&#xD;
      monitoring of ICDs and the satisfaction of patients and providers with the process, there is&#xD;
      a desire from patients to have access and view ability of the data their ICD is transmitting.&#xD;
      However, methods for making ICD device data directly available to the patients are not&#xD;
      currently in place. This study aims to elicit the impact of standardized remote monitoring&#xD;
      ICD data to patients through an electronic personal health record (ePHR) on patient&#xD;
      engagement, healthcare utilization, and patient-provider communication. For this study,&#xD;
      patients with an ICD manufactured by St. Jude Medical and that are undergoing remote&#xD;
      monitoring through the remote management system, Merlin.net™, will receive a standardized&#xD;
      format of their electronic remote monitoring ICD data in MyChart, the ePHR used at Parkview&#xD;
      Health. The standard format for the electronic remote monitoring ICD data, as it is delivered&#xD;
      to the patient, will be termed the ICD Patient Notification Summary. Additionally, provider&#xD;
      attitudes and perceptions regarding the value of the Patient Notification Summary, its impact&#xD;
      on clinic workflow, and patient-provider communication will be collected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, patients receive a letter by postal mail from their physician's office with a&#xD;
      statement about their ICD status. The St. Jude Medical ICD data is managed by the Merlin.net™&#xD;
      remote monitoring system and maintained in the database with periodic transfer to the&#xD;
      healthcare providers EHR system.&#xD;
&#xD;
      This is the first large study that will evaluate the impact of transferring information from&#xD;
      the ICD manufacturer's remote monitoring system directly into a patient's ePHR for the&#xD;
      purpose of making select information readily available to patients in the form of a report,&#xD;
      called the ICD Patient Notification Summary.&#xD;
&#xD;
      The ICD Patient Notification Summary will be transmitted to the healthcare providers' EHR&#xD;
      system (Epic) from Merlin.net™ as part of the data flow pathway to the patients' ePHR&#xD;
      (MyChart). This will ensure that the Arrhythmia Diagnostic Center (ADC) clinic and other&#xD;
      healthcare providers will be able to view the same information that the patients will&#xD;
      receive.&#xD;
&#xD;
      Baseline:&#xD;
&#xD;
      Patients from the intervention group and control groups will answer a baseline survey. The&#xD;
      baseline survey will assess socio-demographic characteristics, patient engagement, and&#xD;
      patient satisfaction with the current standard of care as well as patient perceptions about&#xD;
      receiving remote monitoring ICD data in their ePHR. The survey will be administered either&#xD;
      paper-based or online, using a secure online survey program, Survey Monkey. Patient&#xD;
      engagement will be assessed using the short form Patient Activation Measure (PAM) survey&#xD;
      copyrighted by Insignia Health.&#xD;
&#xD;
      The Patient Activation Measure (PAM) is a validated survey tool developed by Judith Hibbard,&#xD;
      PhD, MPH of the University of Oregon, which assesses the degree a patient acts as an active&#xD;
      agent in their own health care. PAM is associated with improved health outcomes6.&#xD;
&#xD;
      Follow-up:&#xD;
&#xD;
      Patients will respond to two follow up surveys in approximately 3 months and 6 months from&#xD;
      the baseline survey. The follow up surveys will assess patient engagement, patient&#xD;
      satisfaction and perceptions with the ICD Patient Notification Summary or current standard of&#xD;
      care as well as technology acceptance, depending on the group randomization. Technology&#xD;
      acceptance will be assessed using the Technology Acceptance Model as a framework and will&#xD;
      explore patient attitudes regarding ease of use, usefulness and intentions to use the ePHR&#xD;
      and ICD Patient Notification Summary.&#xD;
&#xD;
      The Technology Acceptance Model is a commonly used model, originally developed by Fred Davis&#xD;
      and Richard Bagozzi, which predicts technology acceptance based on the user's perceived&#xD;
      usefulness and perceived ease of use of the technology for a specific purpose 7,8.&#xD;
&#xD;
      Data Collection:&#xD;
&#xD;
      Chart review will be performed to collect past and current data regarding patient's&#xD;
      socio-demographic characteristics, comorbidities, laboratory and interventions, and&#xD;
      healthcare utilization. These data points will help provide background and descriptive&#xD;
      information to supplement the other components of the study. ICD-related data and events as&#xD;
      well as measurement and classification of clinic calls will be assessed starting six months&#xD;
      prior to the study period and continuing throughout the study period. The amount and type of&#xD;
      healthcare utilization in relation to cardiac care will be collected. Data related to the use&#xD;
      of MyChart will also be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Patient Engagement evaluated through Patient Activation Measure (PAM)</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
    <description>This validated survey instrument will be utilized in the patient survey to evaluate patient engagement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in health outcomes and healthcare utilization</measure>
    <time_frame>6 months retrospective and 6 months prospective</time_frame>
    <description>The number of and reason for ER visits, Hospitalization, Office Visits, and Calls to Clinic will be recorded to evaluate patient health outcomes and healthcare utilization before and during the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Technology Acceptance evaluated through Technology Acceptance Model (TAM)</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
    <description>This validated survey instrument will be utilized in the patient survey to evaluate technology acceptance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Providers' attitudes and perceptions evaluated through survey</measure>
    <time_frame>At study conclusion (approximately 1 year post deployment)</time_frame>
    <description>This survey will be utilized to evaluate providers' attitudes and perceptions of the intervention</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">191</enrollment>
  <condition>Implantable Cardioverter-Defibrillator</condition>
  <condition>Health Information Exchange</condition>
  <condition>Electronic Health Records</condition>
  <condition>Patient Participation</condition>
  <arm_group>
    <arm_group_label>Group A (Intervention Group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive Detailed ICD Information-electronic: Receive ICD Patient Notification Summary via MyChart Patient Portal Account - Receive training to familiarize yourself with using the ePHR, MyChart Complete baseline, 3 month and 6 months survey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (Intervention Group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receive Detailed ICD Information-paper: Receive ICD Patient Notification Summary via paper Receive training to familiarize yourself with using the ePHR, MyChart Complete baseline, 3 month and 6 months survey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C (Control Group)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Receives Standard of Care-No Report Complete baseline, 3 month and 6 months survey</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Receive Detailed ICD Information-electronic</intervention_name>
    <description>Receive Detailed ICD Information (Patient Notification Summary Report) via an electronic Patient Portal vs control</description>
    <arm_group_label>Group A (Intervention Group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Receive Detailed ICD Information-paper</intervention_name>
    <description>Receive Detailed ICD Information (Patient Notification Summary Report) via paper vs control</description>
    <arm_group_label>Group B (Intervention Group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age and older&#xD;
&#xD;
          2. Physically and mentally capable of providing an informed consent&#xD;
&#xD;
          3. Patient of PPG-Cardiology&#xD;
&#xD;
          4. Implanted with a St. Jude Medical ICD&#xD;
&#xD;
          5. Undergoing remote monitoring by the Merlin.net™ system&#xD;
&#xD;
          6. Ability to read, write and understand English&#xD;
&#xD;
          7. Have access to computer and/or Internet (Group A and B only)&#xD;
&#xD;
          8. Patient has a scheduled ICD download within the study period at the time of&#xD;
             enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Does not meet inclusion criteria&#xD;
&#xD;
          2. Unable to physically or cognitively carry out the tasks necessary for activating&#xD;
             and/or utilizing an ePHR such as; blindness, loss of function of arms, cognitive&#xD;
             impairments (per chart review) that would interfere in learning a new task&#xD;
&#xD;
          3. Designated as part of a vulnerable subject population that the investigator or&#xD;
             designee identifies to have compromised autonomy related to potential study&#xD;
             participation&#xD;
&#xD;
          4. Currently participating in another Parkview study that involves other ePHR use.&#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>Michael J Mirro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Parkview Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parkview Health</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, Aliot E, Boursier M, Bizeau O, Kacet S; ECOST trial Investigators. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J. 2013 Feb;34(8):605-14. doi: 10.1093/eurheartj/ehs425. Epub 2012 Dec 13.</citation>
    <PMID>23242192</PMID>
  </reference>
  <reference>
    <citation>Landolina M, Perego GB, Lunati M, Curnis A, Guenzati G, Vicentini A, Parati G, Borghi G, Zanaboni P, Valsecchi S, Marzegalli M. Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study. Circulation. 2012 Jun 19;125(24):2985-92. doi: 10.1161/CIRCULATIONAHA.111.088971. Epub 2012 May 24.</citation>
    <PMID>22626743</PMID>
  </reference>
  <reference>
    <citation>Buntin MB, Jain SH, Blumenthal D. Health information technology: laying the infrastructure for national health reform. Health Aff (Millwood). 2010 Jun;29(6):1214-9. doi: 10.1377/hlthaff.2010.0503.</citation>
    <PMID>20530358</PMID>
  </reference>
  <reference>
    <citation>Carman KL, Dardess P, Maurer M, Sofaer S, Adams K, Bechtel C, Sweeney J. Patient and family engagement: a framework for understanding the elements and developing interventions and policies. Health Aff (Millwood). 2013 Feb;32(2):223-31. doi: 10.1377/hlthaff.2012.1133.</citation>
    <PMID>23381514</PMID>
  </reference>
  <reference>
    <citation>Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.</citation>
    <PMID>15230939</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 18, 2015</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Parkview Hospital, Indiana</investigator_affiliation>
    <investigator_full_name>Michael Mirro</investigator_full_name>
    <investigator_title>Chief Academic-Research Officer : Parkview Health System</investigator_title>
  </responsible_party>
  <keyword>Patient Engagement</keyword>
  <keyword>Defibrillators</keyword>
  <keyword>Health Records, Personal</keyword>
  <keyword>Patient Portal</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02989090
org study id: PRC13-0113 ePHR-ICD SJM
nct id: NCT02989090
lead sponsor: 
collaborator: 
has dmc: No
Remote monitoring of implantable cardioverter-defibrillators (ICDs) for patients has led to
      efficient, safe, and satisfying analysis of their device and cardiac status; resulting in an
      overall improvement in the quality of care for such patients. Despite the efficacy of remote
      monitoring of ICDs and the satisfaction of patients and providers with the process, there is
      a desire from patients to have access and view ability of the data their ICD is transmitting.
      However, methods for making ICD device data directly available to the patients are not
      currently in place. This study aims to elicit the impact of standardized remote monitoring
      ICD data to patients through an electronic personal health record (ePHR) on patient
      engagement, healthcare utilization, and patient-provider communication. For this study,
      patients with an ICD manufactured by St. Jude Medical and that are undergoing remote
      monitoring through the remote management system, Merlin.net™, will receive a standardized
      format of their electronic remote monitoring ICD data in MyChart, the ePHR used at Parkview
      Health. The standard format for the electronic remote monitoring ICD data, as it is delivered
      to the patient, will be termed the ICD Patient Notification Summary. Additionally, provider
      attitudes and perceptions regarding the value of the Patient Notification Summary, its impact
      on clinic workflow, and patient-provider communication will be collected.
Currently, patients receive a letter by postal mail from their physician's office with a
      statement about their ICD status. The St. Jude Medical ICD data is managed by the Merlin.net™
      remote monitoring system and maintained in the database with periodic transfer to the
      healthcare providers EHR system.

      This is the first large study that will evaluate the impact of transferring information from
      the ICD manufacturer's remote monitoring system directly into a patient's ePHR for the
      purpose of making select information readily available to patients in the form of a report,
      called the ICD Patient Notification Summary.

      The ICD Patient Notification Summary will be transmitted to the healthcare providers' EHR
      system (Epic) from Merlin.net™ as part of the data flow pathway to the patients' ePHR
      (MyChart). This will ensure that the Arrhythmia Diagnostic Center (ADC) clinic and other
      healthcare providers will be able to view the same information that the patients will
      receive.

      Baseline:

      Patients from the intervention group and control groups will answer a baseline survey. The
      baseline survey will assess socio-demographic characteristics, patient engagement, and
      patient satisfaction with the current standard of care as well as patient perceptions about
      receiving remote monitoring ICD data in their ePHR. The survey will be administered either
      paper-based or online, using a secure online survey program, Survey Monkey. Patient
      engagement will be assessed using the short form Patient Activation Measure (PAM) survey
      copyrighted by Insignia Health.

      The Patient Activation Measure (PAM) is a validated survey tool developed by Judith Hibbard,
      PhD, MPH of the University of Oregon, which assesses the degree a patient acts as an active
      agent in their own health care. PAM is associated with improved health outcomes6.

      Follow-up:

      Patients will respond to two follow up surveys in approximately 3 months and 6 months from
      the baseline survey. The follow up surveys will assess patient engagement, patient
      satisfaction and perceptions with the ICD Patient Notification Summary or current standard of
      care as well as technology acceptance, depending on the group randomization. Technology
      acceptance will be assessed using the Technology Acceptance Model as a framework and will
      explore patient attitudes regarding ease of use, usefulness and intentions to use the ePHR
      and ICD Patient Notification Summary.

      The Technology Acceptance Model is a commonly used model, originally developed by Fred Davis
      and Richard Bagozzi, which predicts technology acceptance based on the user's perceived
      usefulness and perceived ease of use of the technology for a specific purpose 7,8.

      Data Collection:

      Chart review will be performed to collect past and current data regarding patient's
      socio-demographic characteristics, comorbidities, laboratory and interventions, and
      healthcare utilization. These data points will help provide background and descriptive
      information to supplement the other components of the study. ICD-related data and events as
      well as measurement and classification of clinic calls will be assessed starting six months
      prior to the study period and continuing throughout the study period. The amount and type of
      healthcare utilization in relation to cardiac care will be collected. Data related to the use
      of MyChart will also be collected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Patient Engagement evaluated through Patient Activation Measure (PAM)
time frame: Baseline, 3 months, and 6 months
description: This validated survey instrument will be utilized in the patient survey to evaluate patient engagement.
measure: Change in health outcomes and healthcare utilization
time frame: 6 months retrospective and 6 months prospective
description: The number of and reason for ER visits, Hospitalization, Office Visits, and Calls to Clinic will be recorded to evaluate patient health outcomes and healthcare utilization before and during the study.
measure: Change in Technology Acceptance evaluated through Technology Acceptance Model (TAM)
time frame: Baseline, 3 months, and 6 months
description: This validated survey instrument will be utilized in the patient survey to evaluate technology acceptance.
measure: Providers' attitudes and perceptions evaluated through survey
time frame: At study conclusion (approximately 1 year post deployment)
description: This survey will be utilized to evaluate providers' attitudes and perceptions of the intervention
arm group label: Group A (Intervention Group)
arm group type: Experimental
description: Receive Detailed ICD Information-electronic: Receive ICD Patient Notification Summary via MyChart Patient Portal Account - Receive training to familiarize yourself with using the ePHR, MyChart Complete baseline, 3 month and 6 months survey
arm group label: Group B (Intervention Group)
arm group type: Active Comparator
description: Receive Detailed ICD Information-paper: Receive ICD Patient Notification Summary via paper Receive training to familiarize yourself with using the ePHR, MyChart Complete baseline, 3 month and 6 months survey
arm group label: Group C (Control Group)
arm group type: No Intervention
description: Receives Standard of Care-No Report Complete baseline, 3 month and 6 months survey
intervention type: Other
intervention name: Receive Detailed ICD Information-electronic
description: Receive Detailed ICD Information (Patient Notification Summary Report) via an electronic Patient Portal vs control
arm group label: Group A (Intervention Group)
intervention type: Other
intervention name: Receive Detailed ICD Information-paper
description: Receive Detailed ICD Information (Patient Notification Summary Report) via paper vs control
arm group label: Group B (Intervention Group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael J Mirro, MD
role: Principal Investigator
affiliation: Parkview Health
facility: 
country: United States
citation: Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, Aliot E, Boursier M, Bizeau O, Kacet S; ECOST trial Investigators. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J. 2013 Feb;34(8):605-14. doi: 10.1093/eurheartj/ehs425. Epub 2012 Dec 13.
PMID: 23242192
citation: Landolina M, Perego GB, Lunati M, Curnis A, Guenzati G, Vicentini A, Parati G, Borghi G, Zanaboni P, Valsecchi S, Marzegalli M. Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study. Circulation. 2012 Jun 19;125(24):2985-92. doi: 10.1161/CIRCULATIONAHA.111.088971. Epub 2012 May 24.
PMID: 22626743
citation: Buntin MB, Jain SH, Blumenthal D. Health information technology: laying the infrastructure for national health reform. Health Aff (Millwood). 2010 Jun;29(6):1214-9. doi: 10.1377/hlthaff.2010.0503.
PMID: 20530358
citation: Carman KL, Dardess P, Maurer M, Sofaer S, Adams K, Bechtel C, Sweeney J. Patient and family engagement: a framework for understanding the elements and developing interventions and policies. Health Aff (Millwood). 2013 Feb;32(2):223-31. doi: 10.1377/hlthaff.2012.1133.
PMID: 23381514
citation: Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
PMID: 15230939
responsible party type: Principal Investigator
investigator affiliation: Parkview Hospital, Indiana
investigator full name: Michael Mirro
investigator title: Chief Academic-Research Officer : Parkview Health System
sharing ipd: No