xml: <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/NCT06035640</url>
    </required_header>
    <id_info>
      <org_study_id>2022/CTU2/NEONAT</org_study_id>
      <nct_id>NCT06035640</nct_id>
    </id_info>
    <brief_title>Improving Shared Decision Making on the Neonatal Unit Through Assessment of Parental Experiences</brief_title>
    <acronym>ShAPE</acronym>
    <official_title>Improving Shared Decision Making on the Neonatal Unit Through Assessment of Parental Experiences (The ShAPE Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>East Kent Hospitals University NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>East Kent Hospitals University NHS Foundation Trust</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>
        1 in 7 infants born in the United Kingdom will require treatment on a Neonatal unit to treat&#xD;
        conditions, which vary in there level of severity. Treatments and interventions aimed at&#xD;
        supporting the unwell neonate have associated risks and the evidence underpinning them can&#xD;
        range from limited to substantial. There is a degree of uncertainty in Neonatology, which can&#xD;
        be very stressful for parents and clinicians alike. Parents need to be supported by the&#xD;
        clinical team in making many complicated clinical decisions, a skill that requires robust&#xD;
        communication of risks, benefits and alternatives.&#xD;
  &#xD;
        In 2019 the British Association of Perinatal Medicine released a framework of care advocating&#xD;
        Shared Decision Making (SDM) as the optimal process for making clinical decisions on neonatal&#xD;
        units. This model builds upon the &quot;informed decision&quot; models by putting a greater emphasis on&#xD;
        involving parents in key decisions regarding the treatment of their babies medical condition.&#xD;
        Evidence has demonstrated that SDM can improve parental satisfaction and reduce anxiety and&#xD;
        the likelihood of feeling regret.&#xD;
  &#xD;
        In order to support parents in the SDM process, clinicians need to be able to provide&#xD;
        impartial information encompassing the proposed intervention, intended benefit, potential&#xD;
        risks and alternatives. Whilst clinicians may have preconceptions on the information that&#xD;
        they think should be provided, there is limited evidence in the literature of what are the&#xD;
        most important concepts and themes that parents would expect to be conveyed during the SDM&#xD;
        process.&#xD;
  &#xD;
        ShAPE is a qualitative study that aims to&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>What are the main communicative, environmental and informative factors that support the facilitation of effective shared decision making on the neonatal unit? We aim to identify common themes that highlight aspects of the decision making process.</measure>
      <time_frame>Interviews will focus on encounters with clinical staff, whilst their infant was an inpatient on a Neonatal Unit. Interviews will be performed over the 1year period of the recruitment window.</time_frame>
      <description>We aim to identify common themes that highlight aspects of the decision making process, which are the most important to parents.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>How does the quality of the shared decision process, experienced by parents on neonatal units in the UK, impact their level of satisfaction with the care their infant received?</measure>
      <time_frame>Interviews will focus on encounters with clinical staff, whilst their infant was an inpatient on a Neonatal Unit. Interviews will be performed over the 1year period of the recruitment window.</time_frame>
      <description>We aim to identify common themes that highlight aspects of the decision making process, which influence parent satisfaction with the care received by their infant.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Communication</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Interview</intervention_name>
      <description>Participants will be engaged in a semi-structured interview.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study will recruit parents of infants who have received care on a Neonatal Unit within&#xD;
          the past 2years. Given the nature of interventions being studied, these are most likely to&#xD;
          be (but not limited to) premature infants.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Parent of an Infant who, whilst on a neonatal unit, has received either; a transfusion&#xD;
               of blood products, pharmacotherapy for persistent ductus arteriosus or corticosteroid&#xD;
               therapy for chronic lung disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The infant must have received the above treatments within the last 6 months prior to&#xD;
               interview AND have been discharged from neonatal care for at least 4 weeks&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Daniel Keen</last_name>
      <phone>01233633331</phone>
      <email>danielkeen@nhs.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Vimal Vasu</last_name>
      <phone>01233633331</phone>
      <email>vimal.vasu@nhs.net</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>William Harvey Hospital</name>
        <address>
          <city>Ashford</city>
          <state>Kent</state>
          <zip>TN24 0LZ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniel Keen</last_name>
        <phone>01233633331</phone>
        <email>danielkeen@nhs.net</email>
      </contact>
      <contact_backup>
        <last_name>Vimal Vasu</last_name>
        <phone>01233633331</phone>
        <email>vimal.vasu@nhs.net</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>February 15, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Neonatal Care</keyword>
    <keyword>Shared Decision Making</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035640
  org study id: 2022/CTU2/NEONAT
  nct id: NCT06035640
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  1 in 7 infants born in the United Kingdom will require treatment on a Neonatal unit to treat
        conditions, which vary in there level of severity. Treatments and interventions aimed at
        supporting the unwell neonate have associated risks and the evidence underpinning them can
        range from limited to substantial. There is a degree of uncertainty in Neonatology, which can
        be very stressful for parents and clinicians alike. Parents need to be supported by the
        clinical team in making many complicated clinical decisions, a skill that requires robust
        communication of risks, benefits and alternatives.
  
        In 2019 the British Association of Perinatal Medicine released a framework of care advocating
        Shared Decision Making (SDM) as the optimal process for making clinical decisions on neonatal
        units. This model builds upon the "informed decision" models by putting a greater emphasis on
        involving parents in key decisions regarding the treatment of their babies medical condition.
        Evidence has demonstrated that SDM can improve parental satisfaction and reduce anxiety and
        the likelihood of feeling regret.
  
        In order to support parents in the SDM process, clinicians need to be able to provide
        impartial information encompassing the proposed intervention, intended benefit, potential
        risks and alternatives. Whilst clinicians may have preconceptions on the information that
        they think should be provided, there is limited evidence in the literature of what are the
        most important concepts and themes that parents would expect to be conveyed during the SDM
        process.
  
        ShAPE is a qualitative study that aims to
  observational model: Other
  time perspective: Retrospective
  measure: What are the main communicative, environmental and informative factors that support the facilitation of effective shared decision making on the neonatal unit? We aim to identify common themes that highlight aspects of the decision making process.
  time frame: Interviews will focus on encounters with clinical staff, whilst their infant was an inpatient on a Neonatal Unit. Interviews will be performed over the 1year period of the recruitment window.
  description: We aim to identify common themes that highlight aspects of the decision making process, which are the most important to parents.
  measure: How does the quality of the shared decision process, experienced by parents on neonatal units in the UK, impact their level of satisfaction with the care their infant received?
  time frame: Interviews will focus on encounters with clinical staff, whilst their infant was an inpatient on a Neonatal Unit. Interviews will be performed over the 1year period of the recruitment window.
  description: We aim to identify common themes that highlight aspects of the decision making process, which influence parent satisfaction with the care received by their infant.
  intervention type: Other
  intervention name: Interview
  description: Participants will be engaged in a semi-structured interview.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Daniel Keen
  phone: 01233633331
  email: danielkeen@nhs.net
  last name: Vimal Vasu
  phone: 01233633331
  email: vimal.vasu@nhs.net
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United Kingdom
  responsible party type: Sponsor
  sharing ipd: No