<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/NCT03819933</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00030146</org_study_id>
    <nct_id>NCT03819933</nct_id>
  </id_info>
  <brief_title>Optimizing Family Counseling for Anticipated Extremely Preterm Delivery</brief_title>
  <official_title>Optimizing Family Counseling for Anticipated Extremely Preterm Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>South Shore Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</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>
      Antenatal family counseling for anticipated extremely preterm deliveries remains ethically&#xD;
      and practically challenging for maternal-fetal medicine specialists and neonatologists alike.&#xD;
      The overall goal of this project is to improve antenatal counseling and counseling outcomes&#xD;
      for families facing anticipated extremely preterm delivery through innovative,&#xD;
      interdisciplinary simulation-based education for maternal fetal medicine specialists and&#xD;
      neonatologists, using language preferred by families, and focusing on eliciting values and&#xD;
      building partnerships through advanced communication and relational skills.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Extremely preterm birth near the limit of viability, defined broadly as birth between 20 and&#xD;
      26 weeks' gestation, accounts for substantial infant morbidity and mortality as well as both&#xD;
      parental and provider distress. Prenatal counseling for families anticipating extremely&#xD;
      preterm delivery remains ethically and practically challenging for both Maternal Fetal&#xD;
      Medicine (MFM) specialists and neonatologists. Physicians must quickly establish a trusting&#xD;
      relationship with families and convey complex medical information. They must sensitively&#xD;
      elicit family preferences and values regarding life and death, carefully explain management&#xD;
      options and potential outcomes such as long-term disability, and arrive at a mutually&#xD;
      agreeable plan for delivery and resuscitation. However, prenatal counseling may be disjointed&#xD;
      or even contradictory. It has been shown that suboptimal counseling is partially explained by&#xD;
      differences in training, practice and perspectives between the specialties, as well as in&#xD;
      framing and unconscious biases, time constraints and poor communication. Physicians also&#xD;
      often emphasize cognitive information versus parental values when counseling. Preferred&#xD;
      language and counseling approaches are largely unknown. This can lead to poor family&#xD;
      understanding, inadequate shared decision making, decreased satisfaction and increased&#xD;
      anxiety.&#xD;
&#xD;
      There is a need to determine best approaches using language and terminology preferred by&#xD;
      families, not physicians. There is also a need to develop new methods to educate MFM and&#xD;
      Neonatology providers to improve antenatal counseling. Simulation and enactments are&#xD;
      effective in teaching patient-physician communication, ethical dilemmas in medicine, and&#xD;
      prenatal counseling. This mixed-methods behavioral intervention study will first determine&#xD;
      preferred language and approaches by families, then redefine current training for prenatal&#xD;
      counseling at extreme prematurity by developing and implementing two novel, interdisciplinary&#xD;
      simulation-based educational programs for MFM and Neonatology, focusing on eliciting values&#xD;
      and building partnerships through advanced communication and relational skills, to improve&#xD;
      counseling practices and outcomes.&#xD;
&#xD;
      The overall hypothesis is that family-focused counseling at extreme prematurity by providers&#xD;
      trained in using language and approaches preferred by families will more effectively address&#xD;
      parents' values and preferences central to decision making and improve counseling practices&#xD;
      and outcomes. In this mixed-methods study, the investigators will enroll ~130 families and&#xD;
      their counseling providers from MFM and Neonatology and compare family-focused counseling&#xD;
      outcomes after educational interventions to baseline. Investigators will collaborate with&#xD;
      Family Faculty advisors from study design through publication to incorporate the parental&#xD;
      perspective.&#xD;
&#xD;
      Aim 1a: To determine, via semi-structured interviews of up to 30 families, preferred&#xD;
      language, terminology and approach, including maternal/paternal differences, during family&#xD;
      counseling for impending extremely preterm delivery, following standard counseling. Aim 1b:&#xD;
      To establish baseline understanding, perceptions, decision making, and anxiety of 50 families&#xD;
      and their counseling providers measured via survey, including the Controlled Preferences&#xD;
      Scale-Pediatrics, Decisional Conflict Scale, and State Trait Anxiety Inventory (STAI).&#xD;
      Secondary hypothesis: maternal/paternal preferences for language, involvement and decision&#xD;
      making differ.&#xD;
&#xD;
      Aim 2a: To develop a novel, joint-specialty simulation-based workshop for MFMs and&#xD;
      neonatologists through Boston Children Hospital's (BCH) established Simulation Pediatric&#xD;
      Program and Institute for Professionalism and Ethical Practice (IPEP). Aim 2b: To create an&#xD;
      innovative, multi-media online training module for MFMs and neonatologists through BCH&#xD;
      Simulation Pediatric/IPEP and Open PediatricsTM, a free and globally accessible web-based&#xD;
      teaching platform to enable widespread dissemination. Both products will use preferred&#xD;
      language and approaches from a national survey by investigators (in progress) and Aim 1,&#xD;
      while emphasizing interdisciplinary communication, ethical and relational skills, addressing&#xD;
      biases, and focusing on family values and preferences central to decision making.&#xD;
&#xD;
      Aim 3: To evaluate whether developed educational interventions improve counseling practices&#xD;
      and outcomes on repeat surveys of 50 families and trained counseling providers using&#xD;
      comparative statistical analyses. Primary hypothesis: counseling by trained providers will&#xD;
      improve parental 1) understanding, 2) perceptions, 3) decision making, and 4) anxiety, by&#xD;
      improving communication and more effectively addressing parents' values and preferences&#xD;
      central to decision making. Secondary hypotheses: 1) the online module will be as effective&#xD;
      as the workshop; 2) trained providers will report increased comfort and decreased anxiety&#xD;
      when counseling.&#xD;
&#xD;
      Given the weight of decisions resulting from family counseling for impending extremely&#xD;
      preterm delivery, joint-specialty interventions using preferred language and approach to&#xD;
      optimize counseling are urgently needed. These innovative educational interventions present a&#xD;
      feasible and effective approach that can be widely disseminated to improve interdisciplinary&#xD;
      family-focused counseling for anticipated extremely preterm deliveries and counseling&#xD;
      outcomes, representing a direct and immediate clinical impact.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 17, 2019</start_date>
  <completion_date type="Anticipated">August 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2024</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>Factorial Assignment</intervention_model>
    <intervention_model_description>This pre/post, mixed method behavioral intervention study will enroll ~130 families (pregnant women and their partners) at extreme prematurity and their counseling providers from Maternal Fetal Medicine (MFM) and Neonatology (total possible participants ~460) to determine whether developed educational interventions for providers (workshop, online module or both) improve counseling practices and outcomes using comparative statistical analyses.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>There will be no masking in this behavioral intervention trial.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Parental knowledge</measure>
    <time_frame>5 years</time_frame>
    <description>The Parental Questionnaire includes questions asking about parental knowledge and understanding about extremely preterm deliveries and clinical outcomes post-counseling to assess parental knowledge and compare pre/post educational interventions. Question format includes Yes/No (which will be averaged and compared pre/post), 5-point Likert scales (ranging &quot;Not at all&quot; to &quot;Extremely&quot; for various topics) as well as free text boxes for qualitative analyses. Likert scale responses will be collapsed into 2 or 3 levels for analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parental satisfaction: The Parental Questionnaire</measure>
    <time_frame>5 years</time_frame>
    <description>The Parental Questionnaire includes questions asking about parental satisfaction and perceptions post-counseling to compare pre/post educational interventions. Question format includes Yes/No (which will be averaged and compared pre/post), 5-point Likert scales (ranging &quot;Not at all&quot; to &quot;Extremely&quot; for various topics) as well as free text boxes for qualitative analyses. Likert scale responses will be collapsed into 2 or 3 levels for analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parental decision making</measure>
    <time_frame>5 years</time_frame>
    <description>The Parental Questionnaire includes the Controlled Preferences Scale-Pediatrics (CPS-P) and the Ottawa Decisional Conflict Scale (ODCS) to assess parental decision making and compare pre/post educational interventions. The CPS-P is a validated, reliable tool adapted for use in pediatrics to assess parental preferences for participation in decision making and consists of 5 statements describing various roles in decision making, ranging from passive (&quot;I prefer to leave all decisions regarding my child's treatment to my doctor&quot;) to active (&quot;I prefer to make the final decision about which treatment my child will receive&quot;), to collaborative. The ODCS is a validated 16-item tool with 5 response categories that measures personal perceptions of decision making. Each of the 16 DCS items is given a score value ranging 0-4, which are summed, divided by 16, and multiplied by 25, yielding a total score ranging from 0-100 (no decisional conflict - extremely high decisional conflict).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parental anxiety</measure>
    <time_frame>5 years</time_frame>
    <description>The Parental Questionnaire includes the State Trait Anxiety Inventory (STAI) to assess parental anxiety and compare pre/post educational interventions. The Spielberger State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait (baseline) and state (present) anxiety, used in clinical research to detect patient and caregiver changes in state of anxiety.58-61 In the third section of the Parental Questionnaire, participants will be asked 20 questions from the STAI, which is appropriate for participants with at least a 6th grade reading level, to measure current levels of anxiety, as opposed to a tendency towards anxiety at baseline. State anxiety items include: &quot;I am tense; I am worried&quot; and &quot;I feel calm; I feel secure.&quot; All items are rated on a 4-point scale, ranging from &quot;Almost Never&quot; to &quot;Almost Always,&quot; with higher scores indicating greater anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parental preferred language and terminology</measure>
    <time_frame>5 years</time_frame>
    <description>The Parental Questionnaire includes questions asking about preferred parental language and terminology when counseling at extreme prematurity. Question format includes Yes/No (which will be averaged and compared pre/post), 5-point Likert scales (ranging &quot;Not at all&quot; to &quot;Extremely&quot; for various topics) as well as free text boxes for qualitative analyses. Likert scale responses will be collapsed into 2 or 3 levels for analyses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal versus Paternal/Partner preferences</measure>
    <time_frame>3 years</time_frame>
    <description>The Parental Questionnaire includes questions asking about parental preferences for language, involvement and decision making at extreme prematurity, including the CPS-P and ODCS (see above), to detect any maternal versus paternal/partner differences. Question format includes Yes/No (which will be averaged and compared pre/post), 5-point Likert scales (ranging &quot;Not at all&quot; to &quot;Extremely&quot; for various topics) as well as free text boxes for qualitative analyses. Likert scale responses will be collapsed into 2 or 3 levels for analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Educational Interventions</measure>
    <time_frame>2 years</time_frame>
    <description>The Parental and Provider Questionnaires include questions asking about parental and provider knowledge, satisfaction, decision making, anxiety (tools described above) regarding counseling at extreme prematurity to determine whether developed educational interventions for providers (workshop, online module or both) improve counseling practices and outcomes using comparative statistical analyses. Question format includes Yes/No (which will be averaged and compared pre/post), 5-point Likert scales (ranging &quot;Not at all&quot; to &quot;Extremely&quot; for various topics) as well as free text boxes for qualitative analyses. Likert scale responses will be collapsed into 2 or 3 levels for analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider anxiety</measure>
    <time_frame>5 years</time_frame>
    <description>The Provider Questionnaire includes the State Trait Anxiety Inventory (STAI) to assess provider anxiety when counseling at extreme prematurity and compare pre/post educational interventions. The Spielberger State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait (baseline) and state (present) anxiety, used in clinical research to detect patient and caregiver changes in state of anxiety.58-61 In the third section of the Parental Questionnaire, participants will be asked 20 questions from the STAI, which is appropriate for participants with at least a 6th grade reading level, to measure current levels of anxiety, as opposed to a tendency towards anxiety at baseline. State anxiety items include: &quot;I am tense; I am worried&quot; and &quot;I feel calm; I feel secure.&quot; All items are rated on a 4-point scale, ranging from &quot;Almost Never&quot; to &quot;Almost Always,&quot; with higher scores indicating greater anxiety.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">460</enrollment>
  <condition>Preterm Pregnancy</condition>
  <condition>Premature Birth</condition>
  <arm_group>
    <arm_group_label>Pregnant women and their partners</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>For the qualitative arm of this mixed method study, using an exploratory sequential design, investigators will enroll ~ 30 adult pregnant women admitted estimated 22 0/7-25 6/7 weeks' estimated gestation and their partners to participate in a post-counseling semi-structured interview to explore preferred language and approaches, and better inform questionnaire development. Sample size will be up to 30 families, or until thematic saturation is achieved (total up to 60 if all partners agree to participate).&#xD;
For the quantitative arm of this study, investigators will enroll ~100 adult pregnant women admitted between estimated 22 0/7-25 6/7 weeks' estimated gestation and their partners (up to total ~200 if all partners present and agree to participate).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Counseling MFM and Neonatology providers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Investigators will enroll ~100 counseling Maternal-Fetal Medicine (MFM) specialists and 100 counseling Neonatologists (total ~200 providers), who provided counseling to the enrolled pregnant women between 22 0/7-25 6/7 weeks' estimated gestation for anticipated extremely preterm delivery. This assumes 1 counseling provider from MFM and 1 from Neonatology per pregnant woman, although there could be more if a consult is performed by both an attending physician and a training fellow or practitioner, or less, if a counseling provider declines to participate in the study. There will be anticipated repetition of counseling providers, accounted for in the statistical analysis. Providers will be asked to complete educational interventions to improve counseling at extreme prematurity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational intervention</intervention_name>
    <description>Investigators will first determine preferred language and approaches by families, then redefine current training for prenatal counseling at extreme prematurity by developing and implementing two novel, interdisciplinary simulation-based educational programs for MFM and Neonatology (a workshop and an online module), focusing on eliciting values and building partnerships through advanced communication and relational skills, to improve counseling practices and outcomes</description>
    <arm_group_label>Counseling MFM and Neonatology providers</arm_group_label>
    <arm_group_label>Pregnant women and their partners</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Pregnant women and their partners&#xD;
&#xD;
             Inclusion Criteria:&#xD;
&#xD;
               -  English-proficient adult pregnant woman admitted between 22 0/7-25 6/7 weeks'&#xD;
                  estimated gestation for anticipated extremely preterm delivery and her adult&#xD;
                  partner (if available) for whom an antenatal neonatal intensive care unit (NICU)&#xD;
                  consultation was requested and performed&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
               -  Non-English proficient&#xD;
&#xD;
               -  Fetal congenital malformation(s)&#xD;
&#xD;
               -  &lt;18y old&#xD;
&#xD;
               -  &lt;22 0/7 or &gt; 25 6/7 weeks' estimated gestation&#xD;
&#xD;
               -  Repeat consultation&#xD;
&#xD;
          2. Counseling MFM and Neonatology providers&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Practicing MFM or Neonatology provider (attending, fellow, resident, practitioner or&#xD;
             RN) from the 3 participating sites: Brigham &amp; Women's Hospital (BWH), Beth Israel&#xD;
             Deaconess Medical Center (BIDMC), South Shore Hospital (SSH)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christy Cummings</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christy L Cummings, MD</last_name>
    <phone>617-355-2539</phone>
    <email>christy.cummings@childrens.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vanessa J Young, RN, BA</last_name>
    <phone>617-355-8330</phone>
    <email>vanessa.young@childrens.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston Children's Hosptial</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christy Cummings, MD</last_name>
      <phone>617-355-2539</phone>
      <email>Christy.Cummings@childrens.harvard.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Zupancic, MD</last_name>
      <phone>617-667-3276</phone>
      <email>jzupanci@bidmc.harvard.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>South Shore Hospital</name>
      <address>
        <city>Weymouth</city>
        <state>Massachusetts</state>
        <zip>02190</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bonnie Arzuaga, MD</last_name>
      <phone>617-355-4647</phone>
      <email>Bonnie.Arzuaga@childrens.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Christy Cummings</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Counseling</keyword>
  <keyword>Extreme Prematurity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</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/NCT03819933
org study id: IRB-P00030146
nct id: NCT03819933
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Antenatal family counseling for anticipated extremely preterm deliveries remains ethically
      and practically challenging for maternal-fetal medicine specialists and neonatologists alike.
      The overall goal of this project is to improve antenatal counseling and counseling outcomes
      for families facing anticipated extremely preterm delivery through innovative,
      interdisciplinary simulation-based education for maternal fetal medicine specialists and
      neonatologists, using language preferred by families, and focusing on eliciting values and
      building partnerships through advanced communication and relational skills.
Extremely preterm birth near the limit of viability, defined broadly as birth between 20 and
      26 weeks' gestation, accounts for substantial infant morbidity and mortality as well as both
      parental and provider distress. Prenatal counseling for families anticipating extremely
      preterm delivery remains ethically and practically challenging for both Maternal Fetal
      Medicine (MFM) specialists and neonatologists. Physicians must quickly establish a trusting
      relationship with families and convey complex medical information. They must sensitively
      elicit family preferences and values regarding life and death, carefully explain management
      options and potential outcomes such as long-term disability, and arrive at a mutually
      agreeable plan for delivery and resuscitation. However, prenatal counseling may be disjointed
      or even contradictory. It has been shown that suboptimal counseling is partially explained by
      differences in training, practice and perspectives between the specialties, as well as in
      framing and unconscious biases, time constraints and poor communication. Physicians also
      often emphasize cognitive information versus parental values when counseling. Preferred
      language and counseling approaches are largely unknown. This can lead to poor family
      understanding, inadequate shared decision making, decreased satisfaction and increased
      anxiety.

      There is a need to determine best approaches using language and terminology preferred by
      families, not physicians. There is also a need to develop new methods to educate MFM and
      Neonatology providers to improve antenatal counseling. Simulation and enactments are
      effective in teaching patient-physician communication, ethical dilemmas in medicine, and
      prenatal counseling. This mixed-methods behavioral intervention study will first determine
      preferred language and approaches by families, then redefine current training for prenatal
      counseling at extreme prematurity by developing and implementing two novel, interdisciplinary
      simulation-based educational programs for MFM and Neonatology, focusing on eliciting values
      and building partnerships through advanced communication and relational skills, to improve
      counseling practices and outcomes.

      The overall hypothesis is that family-focused counseling at extreme prematurity by providers
      trained in using language and approaches preferred by families will more effectively address
      parents' values and preferences central to decision making and improve counseling practices
      and outcomes. In this mixed-methods study, the investigators will enroll ~130 families and
      their counseling providers from MFM and Neonatology and compare family-focused counseling
      outcomes after educational interventions to baseline. Investigators will collaborate with
      Family Faculty advisors from study design through publication to incorporate the parental
      perspective.

      Aim 1a: To determine, via semi-structured interviews of up to 30 families, preferred
      language, terminology and approach, including maternal/paternal differences, during family
      counseling for impending extremely preterm delivery, following standard counseling. Aim 1b:
      To establish baseline understanding, perceptions, decision making, and anxiety of 50 families
      and their counseling providers measured via survey, including the Controlled Preferences
      Scale-Pediatrics, Decisional Conflict Scale, and State Trait Anxiety Inventory (STAI).
      Secondary hypothesis: maternal/paternal preferences for language, involvement and decision
      making differ.

      Aim 2a: To develop a novel, joint-specialty simulation-based workshop for MFMs and
      neonatologists through Boston Children Hospital's (BCH) established Simulation Pediatric
      Program and Institute for Professionalism and Ethical Practice (IPEP). Aim 2b: To create an
      innovative, multi-media online training module for MFMs and neonatologists through BCH
      Simulation Pediatric/IPEP and Open PediatricsTM, a free and globally accessible web-based
      teaching platform to enable widespread dissemination. Both products will use preferred
      language and approaches from a national survey by investigators (in progress) and Aim 1,
      while emphasizing interdisciplinary communication, ethical and relational skills, addressing
      biases, and focusing on family values and preferences central to decision making.

      Aim 3: To evaluate whether developed educational interventions improve counseling practices
      and outcomes on repeat surveys of 50 families and trained counseling providers using
      comparative statistical analyses. Primary hypothesis: counseling by trained providers will
      improve parental 1) understanding, 2) perceptions, 3) decision making, and 4) anxiety, by
      improving communication and more effectively addressing parents' values and preferences
      central to decision making. Secondary hypotheses: 1) the online module will be as effective
      as the workshop; 2) trained providers will report increased comfort and decreased anxiety
      when counseling.

      Given the weight of decisions resulting from family counseling for impending extremely
      preterm delivery, joint-specialty interventions using preferred language and approach to
      optimize counseling are urgently needed. These innovative educational interventions present a
      feasible and effective approach that can be widely disseminated to improve interdisciplinary
      family-focused counseling for anticipated extremely preterm deliveries and counseling
      outcomes, representing a direct and immediate clinical impact.
allocation: Non-Randomized
intervention model: Factorial Assignment
intervention model description: This pre/post, mixed method behavioral intervention study will enroll ~130 families (pregnant women and their partners) at extreme prematurity and their counseling providers from Maternal Fetal Medicine (MFM) and Neonatology (total possible participants ~460) to determine whether developed educational interventions for providers (workshop, online module or both) improve counseling practices and outcomes using comparative statistical analyses.
primary purpose: Other
masking: None (Open Label)
masking description: There will be no masking in this behavioral intervention trial.
measure: Parental knowledge
time frame: 5 years
description: The Parental Questionnaire includes questions asking about parental knowledge and understanding about extremely preterm deliveries and clinical outcomes post-counseling to assess parental knowledge and compare pre/post educational interventions. Question format includes Yes/No (which will be averaged and compared pre/post), 5-point Likert scales (ranging "Not at all" to "Extremely" for various topics) as well as free text boxes for qualitative analyses. Likert scale responses will be collapsed into 2 or 3 levels for analyses.
measure: Parental satisfaction: The Parental Questionnaire
time frame: 5 years
description: The Parental Questionnaire includes questions asking about parental satisfaction and perceptions post-counseling to compare pre/post educational interventions. Question format includes Yes/No (which will be averaged and compared pre/post), 5-point Likert scales (ranging "Not at all" to "Extremely" for various topics) as well as free text boxes for qualitative analyses. Likert scale responses will be collapsed into 2 or 3 levels for analyses.
measure: Parental decision making
time frame: 5 years
description: The Parental Questionnaire includes the Controlled Preferences Scale-Pediatrics (CPS-P) and the Ottawa Decisional Conflict Scale (ODCS) to assess parental decision making and compare pre/post educational interventions. The CPS-P is a validated, reliable tool adapted for use in pediatrics to assess parental preferences for participation in decision making and consists of 5 statements describing various roles in decision making, ranging from passive ("I prefer to leave all decisions regarding my child's treatment to my doctor") to active ("I prefer to make the final decision about which treatment my child will receive"), to collaborative. The ODCS is a validated 16-item tool with 5 response categories that measures personal perceptions of decision making. Each of the 16 DCS items is given a score value ranging 0-4, which are summed, divided by 16, and multiplied by 25, yielding a total score ranging from 0-100 (no decisional conflict - extremely high decisional conflict).
measure: Parental anxiety
time frame: 5 years
description: The Parental Questionnaire includes the State Trait Anxiety Inventory (STAI) to assess parental anxiety and compare pre/post educational interventions. The Spielberger State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait (baseline) and state (present) anxiety, used in clinical research to detect patient and caregiver changes in state of anxiety.58-61 In the third section of the Parental Questionnaire, participants will be asked 20 questions from the STAI, which is appropriate for participants with at least a 6th grade reading level, to measure current levels of anxiety, as opposed to a tendency towards anxiety at baseline. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." All items are rated on a 4-point scale, ranging from "Almost Never" to "Almost Always," with higher scores indicating greater anxiety.
measure: Parental preferred language and terminology
time frame: 5 years
description: The Parental Questionnaire includes questions asking about preferred parental language and terminology when counseling at extreme prematurity. Question format includes Yes/No (which will be averaged and compared pre/post), 5-point Likert scales (ranging "Not at all" to "Extremely" for various topics) as well as free text boxes for qualitative analyses. Likert scale responses will be collapsed into 2 or 3 levels for analyses.
measure: Maternal versus Paternal/Partner preferences
time frame: 3 years
description: The Parental Questionnaire includes questions asking about parental preferences for language, involvement and decision making at extreme prematurity, including the CPS-P and ODCS (see above), to detect any maternal versus paternal/partner differences. Question format includes Yes/No (which will be averaged and compared pre/post), 5-point Likert scales (ranging "Not at all" to "Extremely" for various topics) as well as free text boxes for qualitative analyses. Likert scale responses will be collapsed into 2 or 3 levels for analyses.
measure: Effect of Educational Interventions
time frame: 2 years
description: The Parental and Provider Questionnaires include questions asking about parental and provider knowledge, satisfaction, decision making, anxiety (tools described above) regarding counseling at extreme prematurity to determine whether developed educational interventions for providers (workshop, online module or both) improve counseling practices and outcomes using comparative statistical analyses. Question format includes Yes/No (which will be averaged and compared pre/post), 5-point Likert scales (ranging "Not at all" to "Extremely" for various topics) as well as free text boxes for qualitative analyses. Likert scale responses will be collapsed into 2 or 3 levels for analyses.
measure: Provider anxiety
time frame: 5 years
description: The Provider Questionnaire includes the State Trait Anxiety Inventory (STAI) to assess provider anxiety when counseling at extreme prematurity and compare pre/post educational interventions. The Spielberger State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait (baseline) and state (present) anxiety, used in clinical research to detect patient and caregiver changes in state of anxiety.58-61 In the third section of the Parental Questionnaire, participants will be asked 20 questions from the STAI, which is appropriate for participants with at least a 6th grade reading level, to measure current levels of anxiety, as opposed to a tendency towards anxiety at baseline. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." All items are rated on a 4-point scale, ranging from "Almost Never" to "Almost Always," with higher scores indicating greater anxiety.
arm group label: Pregnant women and their partners
arm group type: Other
description: For the qualitative arm of this mixed method study, using an exploratory sequential design, investigators will enroll ~ 30 adult pregnant women admitted estimated 22 0/7-25 6/7 weeks' estimated gestation and their partners to participate in a post-counseling semi-structured interview to explore preferred language and approaches, and better inform questionnaire development. Sample size will be up to 30 families, or until thematic saturation is achieved (total up to 60 if all partners agree to participate).
For the quantitative arm of this study, investigators will enroll ~100 adult pregnant women admitted between estimated 22 0/7-25 6/7 weeks' estimated gestation and their partners (up to total ~200 if all partners present and agree to participate).
arm group label: Counseling MFM and Neonatology providers
arm group type: Other
description: Investigators will enroll ~100 counseling Maternal-Fetal Medicine (MFM) specialists and 100 counseling Neonatologists (total ~200 providers), who provided counseling to the enrolled pregnant women between 22 0/7-25 6/7 weeks' estimated gestation for anticipated extremely preterm delivery. This assumes 1 counseling provider from MFM and 1 from Neonatology per pregnant woman, although there could be more if a consult is performed by both an attending physician and a training fellow or practitioner, or less, if a counseling provider declines to participate in the study. There will be anticipated repetition of counseling providers, accounted for in the statistical analysis. Providers will be asked to complete educational interventions to improve counseling at extreme prematurity.
intervention type: Behavioral
intervention name: Educational intervention
description: Investigators will first determine preferred language and approaches by families, then redefine current training for prenatal counseling at extreme prematurity by developing and implementing two novel, interdisciplinary simulation-based educational programs for MFM and Neonatology (a workshop and an online module), focusing on eliciting values and building partnerships through advanced communication and relational skills, to improve counseling practices and outcomes
arm group label: Counseling MFM and Neonatology providers
arm group label: Pregnant women and their partners
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Christy Cummings
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: Christy L Cummings, MD
phone: 617-355-2539
email: christy.cummings@childrens.harvard.edu
last name: Vanessa J Young, RN, BA
phone: 617-355-8330
email: vanessa.young@childrens.harvard.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Christy Cummings
investigator title: Assistant Professor of Pediatrics
mesh term: Premature Birth