<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/NCT04410029</url>
  </required_header>
  <id_info>
    <org_study_id>842526</org_study_id>
    <nct_id>NCT04410029</nct_id>
  </id_info>
  <brief_title>Evaluation of a Decision Aid for Early Pregnancy Loss</brief_title>
  <official_title>Evaluation of a Decision Aid for Early Pregnancy Loss: a Pilot RCT Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Society of Family Planning</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</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>
      This study aims to determine the effect of the Healthwise decision aid on shared decision&#xD;
      making in women undergoing management of early pregnancy loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Early pregnancy loss (EPL) or miscarriage is a common problem occurring in 15-20% of&#xD;
      pregnancies. EPL can safely be managed surgically, medically, or expectantly; patient&#xD;
      preferences, together with provider recommendations, should be used to guide treatment&#xD;
      decisions. The three management options differ substantially experientially for patients.&#xD;
      Previous literature has shown that patients have preferences for treatment and higher&#xD;
      satisfaction when treated according to their preferences. Decision aids provide&#xD;
      individualized information to help patients clarify their priorities and personal values.&#xD;
      There is good evidence that decision aids compared to usual care resulted in greater&#xD;
      knowledge, more realistic expectations, lower decisional conflict relating to feeling&#xD;
      informed, more active decision making, less people remaining undecided, and greater effect&#xD;
      agreement on value and choice. Despite this, there is limited research on the extent of&#xD;
      decisional conflict experienced by women undergoing treatment for EPL, or the effect of&#xD;
      decision aids on decisional conflict. Furthermore, only a few decision aid tools are publicly&#xD;
      available for this indication. The Healthwise decision aid tool receives high scores by the&#xD;
      International Patient Decision Aid Standards Scale, and is readily available to patients&#xD;
      within the clinical site's electronic medical record.&#xD;
&#xD;
      The investigators propose a pilot randomized control trial, enrolling 50 participants with&#xD;
      EPL. The study will measure baseline decisional conflict, and randomize participants to&#xD;
      counseling with or without the decision aid. The investigators intend to study the Decisional&#xD;
      Conflict Scale at baseline and after counseling, knowledge scores, Decision Regret and the&#xD;
      9-item Shared Decision Making Questionnaire (SDM-Q9) after counseling. Study data can be used&#xD;
      to inform future research and to identify patients with predictors for high decisional&#xD;
      conflict. This study is the first step towards validation of a high-quality decision aid tool&#xD;
      for patients undergoing EPL management. It will also be the first study to report on&#xD;
      decisional conflict and regret in patients with early pregnancy loss.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Actual">March 25, 2021</completion_date>
  <primary_completion_date type="Actual">March 23, 2021</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>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decision Conflict Scale (DCS)</measure>
    <time_frame>Post-counseling (one day)</time_frame>
    <description>Low-literacy version of Decision Conflict Scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Early Pregnancy Loss</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard counseling + Healthwise Decision Aid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard counseling + a control informational handout.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Healthwise Decision Aid</intervention_name>
    <description>Healthwise, a non-profit company that develops health content and patient information for hospitals, has created a decision aid for EPL management that is available through the EPIC Systems, an electronic medical record. Participants will be given this decision aid after EPL diagnosis and prior to options consultation with a provider.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control informational handout</intervention_name>
    <description>Participants randomized to the control arm will be given an informational handout of treatment options after EPL diagnosis and prior to options consultation with a provider.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Definitive diagnosis of early intrauterine pregnancy loss (including anembryonic&#xD;
             pregnancy and missed abortion [ultrasound examination demonstrates fetal pole without&#xD;
             cardiac activity measuring between 5.3 and 7mm or an abnormal growth pattern&#xD;
             diagnostic of EPL])&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Willing and able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy of unknown anatomic location&#xD;
&#xD;
          -  Unable to read English&#xD;
&#xD;
          -  Prior options counseling with a Family Planning provider&#xD;
&#xD;
          -  Clinically unstable requiring emergent surgical management with uterine evacuation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>March 26, 2021</last_update_submitted>
  <last_update_submitted_qc>March 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</mesh_term>
    <mesh_term>Fetal Death</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/NCT04410029
org study id: 842526
nct id: NCT04410029
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to determine the effect of the Healthwise decision aid on shared decision
      making in women undergoing management of early pregnancy loss.
Early pregnancy loss (EPL) or miscarriage is a common problem occurring in 15-20% of
      pregnancies. EPL can safely be managed surgically, medically, or expectantly; patient
      preferences, together with provider recommendations, should be used to guide treatment
      decisions. The three management options differ substantially experientially for patients.
      Previous literature has shown that patients have preferences for treatment and higher
      satisfaction when treated according to their preferences. Decision aids provide
      individualized information to help patients clarify their priorities and personal values.
      There is good evidence that decision aids compared to usual care resulted in greater
      knowledge, more realistic expectations, lower decisional conflict relating to feeling
      informed, more active decision making, less people remaining undecided, and greater effect
      agreement on value and choice. Despite this, there is limited research on the extent of
      decisional conflict experienced by women undergoing treatment for EPL, or the effect of
      decision aids on decisional conflict. Furthermore, only a few decision aid tools are publicly
      available for this indication. The Healthwise decision aid tool receives high scores by the
      International Patient Decision Aid Standards Scale, and is readily available to patients
      within the clinical site's electronic medical record.

      The investigators propose a pilot randomized control trial, enrolling 50 participants with
      EPL. The study will measure baseline decisional conflict, and randomize participants to
      counseling with or without the decision aid. The investigators intend to study the Decisional
      Conflict Scale at baseline and after counseling, knowledge scores, Decision Regret and the
      9-item Shared Decision Making Questionnaire (SDM-Q9) after counseling. Study data can be used
      to inform future research and to identify patients with predictors for high decisional
      conflict. This study is the first step towards validation of a high-quality decision aid tool
      for patients undergoing EPL management. It will also be the first study to report on
      decisional conflict and regret in patients with early pregnancy loss.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Health Services Research
masking: None (Open Label)
measure: Decision Conflict Scale (DCS)
time frame: Post-counseling (one day)
description: Low-literacy version of Decision Conflict Scale
arm group label: Intervention
arm group type: Experimental
description: Standard counseling + Healthwise Decision Aid
arm group label: Control
arm group type: Active Comparator
description: Standard counseling + a control informational handout.
intervention type: Other
intervention name: Healthwise Decision Aid
description: Healthwise, a non-profit company that develops health content and patient information for hospitals, has created a decision aid for EPL management that is available through the EPIC Systems, an electronic medical record. Participants will be given this decision aid after EPL diagnosis and prior to options consultation with a provider.
arm group label: Intervention
intervention type: Other
intervention name: Control informational handout
description: Participants randomized to the control arm will be given an informational handout of treatment options after EPL diagnosis and prior to options consultation with a provider.
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Abortion, Spontaneous
mesh term: Fetal Death
sharing ipd: No