<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/NCT03228615</url>
  </required_header>
  <id_info>
    <org_study_id>2016-8792</org_study_id>
    <nct_id>NCT03228615</nct_id>
  </id_info>
  <brief_title>IBD Shared Decision Making Intervention</brief_title>
  <official_title>Pilot Trial of a Multi-Component Decision Making Intervention in IBD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Crohn's and Colitis Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</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>
      The purpose of this clinical trial is to implement a multi-component shared decision making&#xD;
      intervention for families of children with IBD. The main objective of this research will be&#xD;
      to assess the acceptability, feasibility and clinical and decision outcomes of a&#xD;
      multi-component decision support intervention targeted at families of children with IBD who&#xD;
      are making decisions about treatment with TNFαi agents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research has shown that when making decisions about treatment with anti-tumor necrosis&#xD;
      factor-α (TNFαi) agents, parents of children with inflammatory bowel disease (IBD) experience&#xD;
      high levels of decisional conflict. This extreme level of conflict is due to the challenge of&#xD;
      considering an effective treatment that has potentially serious side-effects. Elevated levels&#xD;
      of decisional conflict have been associated with delays in decision making and failures to&#xD;
      implement treatment plans. Given that such delays may lead to worse clinical outcomes, there&#xD;
      is an urgent need to improve the decision-making process around TNFαi therapy. The use of&#xD;
      structured decision support to help inform and guide parents through this challenging&#xD;
      decision may improve the decision-making process. Such structure facilitates high-quality&#xD;
      decision making by providing balanced, accurate information, helping individuals clarify what&#xD;
      is most important to them, and facilitating conversations between families and healthcare&#xD;
      providers. Based the investigators' prior research into the TNFαi decision process, the&#xD;
      investigators developed a multi-component decision support intervention designed to improve&#xD;
      the TNFαi decision process. This intervention will be tested in a controlled pilot trial&#xD;
      designed to assess the acceptability and feasibility of a multi-component intervention and to&#xD;
      determine the effect size of the multi-component intervention on both clinical and decision&#xD;
      outcomes in children and adolescents with IBD and their parents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">July 19, 2019</completion_date>
  <primary_completion_date type="Actual">July 19, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>This clinical trial uses prospective repeated measures in a before-after study design. Following enrollment of the usual care group (i.e., 50% recruitment goal has been reached), physicians will be trained to use the intervention. We will then enroll the intervention group.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of multi-component intervention: OPTION scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Measures observed shared decision making based on review of the video-recorded visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of multi-component intervention: Receipt of intervention components</measure>
    <time_frame>1 month post baseline</time_frame>
    <description>The percentage of participants who receive each individual component (i.e., pre-visit email/letter, in-clinic decision support, follow-up phone call)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of multi-component intervention: Length of clinic visit</measure>
    <time_frame>Baseline</time_frame>
    <description>Measures the length of the clinic visit with in-clinic decision support intervention</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Shared Decision Making Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SDM Intervention</intervention_name>
    <description>Intervention Component A: letter to activate families; Intervention Component B: in-clinic decision support; Intervention Component C: follow-up phone call</description>
    <arm_group_label>Shared Decision Making Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinician anticipates discussing TNFai treatment at clinic visit; parent and patient&#xD;
             willing to have visit video-recorded&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient over age 17; prior use of TNFai; unable to read and speak English; clinic&#xD;
             visit not conducted in English; previous participation in this study; known major&#xD;
             mental illness in parent or adolescent patient; medical instability at scheduled&#xD;
             visit; patient's gastroenterologist is a study investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 7, 2021</last_update_submitted>
  <last_update_submitted_qc>July 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital Medical Center, Cincinnati</investigator_affiliation>
    <investigator_full_name>Ellen A. Lipstein MD, MPH</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>shared decision making</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <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/NCT03228615
org study id: 2016-8792
nct id: NCT03228615
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this clinical trial is to implement a multi-component shared decision making
      intervention for families of children with IBD. The main objective of this research will be
      to assess the acceptability, feasibility and clinical and decision outcomes of a
      multi-component decision support intervention targeted at families of children with IBD who
      are making decisions about treatment with TNFαi agents.
Research has shown that when making decisions about treatment with anti-tumor necrosis
      factor-α (TNFαi) agents, parents of children with inflammatory bowel disease (IBD) experience
      high levels of decisional conflict. This extreme level of conflict is due to the challenge of
      considering an effective treatment that has potentially serious side-effects. Elevated levels
      of decisional conflict have been associated with delays in decision making and failures to
      implement treatment plans. Given that such delays may lead to worse clinical outcomes, there
      is an urgent need to improve the decision-making process around TNFαi therapy. The use of
      structured decision support to help inform and guide parents through this challenging
      decision may improve the decision-making process. Such structure facilitates high-quality
      decision making by providing balanced, accurate information, helping individuals clarify what
      is most important to them, and facilitating conversations between families and healthcare
      providers. Based the investigators' prior research into the TNFαi decision process, the
      investigators developed a multi-component decision support intervention designed to improve
      the TNFαi decision process. This intervention will be tested in a controlled pilot trial
      designed to assess the acceptability and feasibility of a multi-component intervention and to
      determine the effect size of the multi-component intervention on both clinical and decision
      outcomes in children and adolescents with IBD and their parents.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: This clinical trial uses prospective repeated measures in a before-after study design. Following enrollment of the usual care group (i.e., 50% recruitment goal has been reached), physicians will be trained to use the intervention. We will then enroll the intervention group.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Acceptability of multi-component intervention: OPTION scale
time frame: Baseline
description: Measures observed shared decision making based on review of the video-recorded visit
measure: Feasibility of multi-component intervention: Receipt of intervention components
time frame: 1 month post baseline
description: The percentage of participants who receive each individual component (i.e., pre-visit email/letter, in-clinic decision support, follow-up phone call)
measure: Feasibility of multi-component intervention: Length of clinic visit
time frame: Baseline
description: Measures the length of the clinic visit with in-clinic decision support intervention
arm group label: Shared Decision Making Intervention
arm group type: Experimental
arm group label: Usual Care Group
arm group type: No Intervention
intervention type: Other
intervention name: SDM Intervention
description: Intervention Component A: letter to activate families; Intervention Component B: in-clinic decision support; Intervention Component C: follow-up phone call
arm group label: Shared Decision Making Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: 100 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital Medical Center, Cincinnati
investigator full name: Ellen A. Lipstein MD, MPH
investigator title: Assistant Professor
mesh term: Inflammatory Bowel Diseases
sharing ipd: No