<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/NCT01715389</url>
  </required_header>
  <id_info>
    <org_study_id>12-009407</org_study_id>
    <nct_id>NCT01715389</nct_id>
  </id_info>
  <brief_title>Evaluation of a Shared Decision Making Portal for Pediatric Asthma</brief_title>
  <official_title>Evaluation of a Shared Decision Making Portal for Pediatric Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Philadelphia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot intervention study will test the feasibility and acceptability and explore the&#xD;
      outcomes of a primary care-based shared decision making (SDM) electronic medical record&#xD;
      (EMR)-based portal that provides education, elicits and tracks patients/families' treatment&#xD;
      concerns and goals, assesses symptoms and asthma control over time, and provides decision&#xD;
      support to clinicians and families.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of the intervention to parents and clinicians</measure>
    <time_frame>24 months</time_frame>
    <description>Parents and clinicians will be asked a series of open-ended questions regarding themes including satisfaction, acceptability and unintended consequences of using the portal for intervention subjects and using MyChart in general for control subjects. Subjects will also be asked a series of Likert-scaled questions related to satisfaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shared decision making</measure>
    <time_frame>Baseline</time_frame>
    <description>Joint participation in decision-making will be measured by the Observing Parent Involvement (OPTION) scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent Activation</measure>
    <time_frame>0 months, 3 months, 6 months</time_frame>
    <description>Parent activation will be measured by the Parent Patient Activation Measure (PPAM).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Goal Attainment</measure>
    <time_frame>0 months, 3 months, 6 months then Monthly</time_frame>
    <description>Parents will identify one or more goals at the study start. Progress toward the goal(s) will be assessed at 3 and 6 month follow-up using Likert-scaled items for the control group, and monthly through use of the portal for the intervention group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma-Related Quality of Life</measure>
    <time_frame>0 months, 6 months</time_frame>
    <description>Asthma-related quality of life will be measured using The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Control</measure>
    <time_frame>0 months, 6 months</time_frame>
    <description>Asthma control will be assessed using the Pediatric Asthma Control Tool (PACT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma-related Utilization</measure>
    <time_frame>3 months, 6 months</time_frame>
    <description>Utilization will be measured by parent report and chart review by the research team of the following:&#xD;
Any primary care or subspecialty outpatient encounters relevant to asthma care, asthma-specific acute primary care visits or Urgent Care Center visits, asthma-specific Emergency Room visits, asthma-specific hospital admissions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Medication Adherence/Receipt</measure>
    <time_frame>6 months</time_frame>
    <description>Prescribed medications for the treatment and management of asthma Type and number of prescriptions for asthma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of Recruitment</measure>
    <time_frame>24 months</time_frame>
    <description>The feasibility of recruitment will be assessed by examining the proportion of all families contacted who meet enrollment criteria and the proportion of families meeting enrollment criteria who enroll.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of Follow-up</measure>
    <time_frame>24 months</time_frame>
    <description>The feasibility of follow-up will be assessed by the proportion of enrolled families who complete each study measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of Portal Use</measure>
    <time_frame>24 months</time_frame>
    <description>The feasibility of portal use will be assessed by the level of research team/other outside support needed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents in the intervention group will use the MyAsthma Patient Portal to receive enhanced educational information on asthma and its treatment, identify concerns and goals related to asthma treatment, track progress toward goals and management of concerns monthly, and track asthma symptoms monthly.&#xD;
Clinicians seeing intervention families at office visits will have access to information from the portal including concerns, goals, progress toward goals, and tracking of asthma symptoms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will be signed up for MyChart but not use the MyAsthma Patient Portal. This group will be referred to asthma educational content on the CHOP website, complete study measures and otherwise, receive standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MyAsthma Patient Portal</intervention_name>
    <description>Parents in the intervention group will use the MyAsthma Patient Portal to receive enhanced educational information on asthma and its treatment, identify concerns and goals related to asthma treatment, track progress toward goals and management of concerns monthly, and track asthma symptoms monthly.&#xD;
Clinicians seeing intervention families at office visits will have access to information from the portal including concerns, goals, progress toward goals, and tracking of asthma symptoms.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents/legal guardians of children aged 6-12 with persistent asthma, currently&#xD;
             receiving chronic maintenance therapy, cared for at a study practice, with consistent&#xD;
             access to a computer with an internet connection where they feel comfortable accessing&#xD;
             MyChart (patient portal)&#xD;
&#xD;
          -  Clinician at study site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parents non-english speaking&#xD;
&#xD;
          -  child's primary care provider at the time of enrollment is a pediatric resident&#xD;
&#xD;
          -  not meeting inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander G Fiks, MD, MSCF</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>June 26, 2015</last_update_submitted>
  <last_update_submitted_qc>June 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Goals</keyword>
  <keyword>Shared Decision Making</keyword>
  <keyword>Patient Portal</keyword>
  <keyword>Electronic Medical Record</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <!-- 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/NCT01715389
org study id: 12-009407
nct id: NCT01715389
lead sponsor: 
has dmc: No
This pilot intervention study will test the feasibility and acceptability and explore the
      outcomes of a primary care-based shared decision making (SDM) electronic medical record
      (EMR)-based portal that provides education, elicits and tracks patients/families' treatment
      concerns and goals, assesses symptoms and asthma control over time, and provides decision
      support to clinicians and families.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acceptability of the intervention to parents and clinicians
time frame: 24 months
description: Parents and clinicians will be asked a series of open-ended questions regarding themes including satisfaction, acceptability and unintended consequences of using the portal for intervention subjects and using MyChart in general for control subjects. Subjects will also be asked a series of Likert-scaled questions related to satisfaction.
measure: Shared decision making
time frame: Baseline
description: Joint participation in decision-making will be measured by the Observing Parent Involvement (OPTION) scale.
measure: Parent Activation
time frame: 0 months, 3 months, 6 months
description: Parent activation will be measured by the Parent Patient Activation Measure (PPAM).
measure: Goal Attainment
time frame: 0 months, 3 months, 6 months then Monthly
description: Parents will identify one or more goals at the study start. Progress toward the goal(s) will be assessed at 3 and 6 month follow-up using Likert-scaled items for the control group, and monthly through use of the portal for the intervention group.
measure: Asthma-Related Quality of Life
time frame: 0 months, 6 months
description: Asthma-related quality of life will be measured using The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF)
measure: Asthma Control
time frame: 0 months, 6 months
description: Asthma control will be assessed using the Pediatric Asthma Control Tool (PACT)
measure: Asthma-related Utilization
time frame: 3 months, 6 months
description: Utilization will be measured by parent report and chart review by the research team of the following:
Any primary care or subspecialty outpatient encounters relevant to asthma care, asthma-specific acute primary care visits or Urgent Care Center visits, asthma-specific Emergency Room visits, asthma-specific hospital admissions.
measure: Asthma Medication Adherence/Receipt
time frame: 6 months
description: Prescribed medications for the treatment and management of asthma Type and number of prescriptions for asthma
measure: Feasibility of Recruitment
time frame: 24 months
description: The feasibility of recruitment will be assessed by examining the proportion of all families contacted who meet enrollment criteria and the proportion of families meeting enrollment criteria who enroll.
measure: Feasibility of Follow-up
time frame: 24 months
description: The feasibility of follow-up will be assessed by the proportion of enrolled families who complete each study measure.
measure: Feasibility of Portal Use
time frame: 24 months
description: The feasibility of portal use will be assessed by the level of research team/other outside support needed.
arm group label: Intervention
arm group type: Experimental
description: Parents in the intervention group will use the MyAsthma Patient Portal to receive enhanced educational information on asthma and its treatment, identify concerns and goals related to asthma treatment, track progress toward goals and management of concerns monthly, and track asthma symptoms monthly.
Clinicians seeing intervention families at office visits will have access to information from the portal including concerns, goals, progress toward goals, and tracking of asthma symptoms.
arm group label: Control
arm group type: No Intervention
description: The control group will be signed up for MyChart but not use the MyAsthma Patient Portal. This group will be referred to asthma educational content on the CHOP website, complete study measures and otherwise, receive standard care.
intervention type: Other
intervention name: MyAsthma Patient Portal
description: Parents in the intervention group will use the MyAsthma Patient Portal to receive enhanced educational information on asthma and its treatment, identify concerns and goals related to asthma treatment, track progress toward goals and management of concerns monthly, and track asthma symptoms monthly.
Clinicians seeing intervention families at office visits will have access to information from the portal including concerns, goals, progress toward goals, and tracking of asthma symptoms.
arm group label: Intervention
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Alexander G Fiks, MD, MSCF
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma