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/NCT06007287</url>
    </required_header>
    <id_info>
      <org_study_id>RC 15/19</org_study_id>
      <nct_id>NCT06007287</nct_id>
    </id_info>
    <brief_title>WHO Standards for Improving the Quality of Child Hospital Care</brief_title>
    <acronym>CHOICE</acronym>
    <official_title>Implementation of World Health Organization Standards for Improving the Quality of Pediatric Hospital Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>IRCCS Burlo Garofolo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>IRCCS Burlo Garofolo</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>
        Even in high-income countries, quality of pediatric health care has been described as&#xD;
        substandard in many settings, resulting in worst health outcomes and increased cost for the&#xD;
        health system. Nevertheless, still there is a paucity of studies documenting the quality of&#xD;
        care for children in a comprehensive and systematic manner, using international standards,&#xD;
        and validated data collection tools. The World Health Organization (WHO) developed three sets&#xD;
        standards for improving the quality of maternal newborn and child health care. The aim of&#xD;
        this study is to test the use of the WHO Pediatric standards for improving the quality of&#xD;
        child hospital care, as summarized by a score of total mean quality score for patients (range&#xD;
        0-100 points).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Achieving the Sustainable Development Goal (SDG) goal 3 targets as elaborated in the WHO&#xD;
        Global Strategy for Women's, Children's, and Adolescent's Health (2016-2030) will require&#xD;
        ensuring universal access to safe, effective, quality and affordable care for women, children&#xD;
        and adolescents. Despite the progress made in the last two decades, an estimated 6.6 million&#xD;
        infants, children and young adults still died in 2016 (5.6 million children under five and 1&#xD;
        million children aged 5-14) mostly from preventable causes. To provide universal health&#xD;
        coverage with quality, every woman, child and adolescent should receive quality care&#xD;
        throughout their life course and during care. This requires institutionalization of safe,&#xD;
        effective, quality service delivery.&#xD;
  &#xD;
        Studies have shown that most often children do not receive basic elements of care or are&#xD;
        often inappropriately managed, and their rights as patients are not respected. Therefore,&#xD;
        urgent actions are required to ensure that the care given to all children in health&#xD;
        facilities is evidence-based, safe, effective, timely, efficient, equitable and appropriate&#xD;
        for their age and stage of development, and that care provided is child and family centred,&#xD;
        and that all rights of children are respected. WHO recently launched (May 2018) the&#xD;
        &quot;Standards for improving quality of care for children and young adolescents in health&#xD;
        facilities&quot;, to address the quality of care for children 0-15 years of age in health&#xD;
        facilities. These pediatric Standards complement previous standards addressing quality of&#xD;
        maternal and newborn care.&#xD;
  &#xD;
        The WHO standards are based on a WHO paediatric quality of care framework, which highlights 8&#xD;
        specific domains of care that are critical to providing quality care for children (Fig. 1).&#xD;
        These domains are organized into three main categories: provision of care (including: 1.&#xD;
        Evidenced based practices; 2. Actionable information system; 3. Functioning referral system),&#xD;
        experience of care (including: 4. Effective communication; 5. Respect, protection and&#xD;
        fulfilment of child rights; 6. Emotional and psychological support) and availability of&#xD;
        child- and adolescent-friendly resources (including 7. Competent, motivated, empathetic human&#xD;
        resources and 8. Essential child and adolescent-friendly physical resources). The framework&#xD;
        takes into account children's right to health and recognizes that their needs are different&#xD;
        from those of adults.&#xD;
  &#xD;
        Currently there is very limited field experience in the use of the WHO Standards for&#xD;
        improving Quality of Care. More in general, routine use of data to improve case management&#xD;
        and organization of care is still not a common practice, even in countries with&#xD;
        well-established data collection systems. Despite there are some good examples of how routine&#xD;
        data collection systems are used to shape health policies and strategies in the pediatric&#xD;
        field in low and middle-income countries, these are quite limited in number, with most of the&#xD;
        experience being conducted in a research/project setting.&#xD;
  &#xD;
        he aim of this study is to test the use of the WHO Pediatric standards for improving the&#xD;
        quality of child hospital care, as summarized by a score of total mean quality score for&#xD;
        patients (range 0-100 points).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 7, 2019</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Quality of Maternal and Newborn Care Index</measure>
      <time_frame>At hospital discharge (assessed up to day 5)</time_frame>
      <description>Evaluation of total mean quality score for patients (range 0-100 points)</description>
    </primary_outcome>
    <enrollment type="Anticipated">880</enrollment>
    <condition>Pediatric Hospital Care</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Service users (ie, parents of children hospitalized and their children) and service&#xD;
          providers (ie, clinical staff working providing care to children).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Service Users: parents/ other caretakers of children hospitalised in the Pediatric&#xD;
               ward (ordinary hospitalization) and the pediatric emergency unit (brief intensive&#xD;
               observation) between 0-15 years in all participating hospital&#xD;
  &#xD;
            -  Service Providers: all healthcare providers routinely assisting children in the&#xD;
               participating units of the hospitals, namely: doctors, doctors in training, nurses&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Service Users&#xD;
  &#xD;
            -  Parents/ caretakers with age &lt; 18 years&#xD;
  &#xD;
            -  Parents/caretakers of a child &gt; 15 years of age (WHO standards cover up to 15 years)&#xD;
  &#xD;
            -  Parents/ caretakers of deceased child or of a child admitted to intensive care at the&#xD;
               time of administration of the questionnaire&#xD;
  &#xD;
            -  Parents/caretakers with concomitant serious psychiatric disorders&#xD;
  &#xD;
            -  Parents/caretakers of a child hospitalized at Child Neuropsychiatry or Surgery&#xD;
               Department&#xD;
  &#xD;
            -  Parents/caretakers of a child hospitalized as a Day Hospital&#xD;
  &#xD;
            -  Parents/caretakers in surgery department/beds of neuro/psychiatric department/beds&#xD;
  &#xD;
            -  Parents//caretakers with primarily surgery serious psychiatric disorders&#xD;
  &#xD;
            -  Refusal to participate.&#xD;
  &#xD;
          Service Providers&#xD;
  &#xD;
            -  Personnel not routinely involved in the overall clinical care&#xD;
  &#xD;
            -  Prolonged absence from work (eg maternity leave) and/or unavailability during the&#xD;
               study period&#xD;
  &#xD;
            -  Personnel working only on surgical conditions or neuro/psychiatric, or other special&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marzia Lazzerini, MD</last_name>
      <role>Study Chair</role>
      <affiliation>IRCCS materno infantile Burlo Garofolo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marzia Lazzerini, MD</last_name>
      <phone>+390403785555</phone>
      <email>marzia.lazzerini@burlo.trieste.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>IRCCS Burlo Garofolo</name>
        <address>
          <city>Trieste</city>
          <zip>34137</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marzia Lazzerini, MD</last_name>
        <phone>+390403785555</phone>
        <email>marzia.lazzerini@burlo.trieste.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Quality of Care</keyword>
    <keyword>WHO standards</keyword>
    <keyword>Children</keyword>
    <!-- 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/NCT06007287
  org study id: RC 15/19
  nct id: NCT06007287
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Even in high-income countries, quality of pediatric health care has been described as
        substandard in many settings, resulting in worst health outcomes and increased cost for the
        health system. Nevertheless, still there is a paucity of studies documenting the quality of
        care for children in a comprehensive and systematic manner, using international standards,
        and validated data collection tools. The World Health Organization (WHO) developed three sets
        standards for improving the quality of maternal newborn and child health care. The aim of
        this study is to test the use of the WHO Pediatric standards for improving the quality of
        child hospital care, as summarized by a score of total mean quality score for patients (range
        0-100 points).
  Achieving the Sustainable Development Goal (SDG) goal 3 targets as elaborated in the WHO
        Global Strategy for Women's, Children's, and Adolescent's Health (2016-2030) will require
        ensuring universal access to safe, effective, quality and affordable care for women, children
        and adolescents. Despite the progress made in the last two decades, an estimated 6.6 million
        infants, children and young adults still died in 2016 (5.6 million children under five and 1
        million children aged 5-14) mostly from preventable causes. To provide universal health
        coverage with quality, every woman, child and adolescent should receive quality care
        throughout their life course and during care. This requires institutionalization of safe,
        effective, quality service delivery.
  
        Studies have shown that most often children do not receive basic elements of care or are
        often inappropriately managed, and their rights as patients are not respected. Therefore,
        urgent actions are required to ensure that the care given to all children in health
        facilities is evidence-based, safe, effective, timely, efficient, equitable and appropriate
        for their age and stage of development, and that care provided is child and family centred,
        and that all rights of children are respected. WHO recently launched (May 2018) the
        "Standards for improving quality of care for children and young adolescents in health
        facilities", to address the quality of care for children 0-15 years of age in health
        facilities. These pediatric Standards complement previous standards addressing quality of
        maternal and newborn care.
  
        The WHO standards are based on a WHO paediatric quality of care framework, which highlights 8
        specific domains of care that are critical to providing quality care for children (Fig. 1).
        These domains are organized into three main categories: provision of care (including: 1.
        Evidenced based practices; 2. Actionable information system; 3. Functioning referral system),
        experience of care (including: 4. Effective communication; 5. Respect, protection and
        fulfilment of child rights; 6. Emotional and psychological support) and availability of
        child- and adolescent-friendly resources (including 7. Competent, motivated, empathetic human
        resources and 8. Essential child and adolescent-friendly physical resources). The framework
        takes into account children's right to health and recognizes that their needs are different
        from those of adults.
  
        Currently there is very limited field experience in the use of the WHO Standards for
        improving Quality of Care. More in general, routine use of data to improve case management
        and organization of care is still not a common practice, even in countries with
        well-established data collection systems. Despite there are some good examples of how routine
        data collection systems are used to shape health policies and strategies in the pediatric
        field in low and middle-income countries, these are quite limited in number, with most of the
        experience being conducted in a research/project setting.
  
        he aim of this study is to test the use of the WHO Pediatric standards for improving the
        quality of child hospital care, as summarized by a score of total mean quality score for
        patients (range 0-100 points).
  observational model: Ecologic or Community
  time perspective: Prospective
  measure: Quality of Maternal and Newborn Care Index
  time frame: At hospital discharge (assessed up to day 5)
  description: Evaluation of total mean quality score for patients (range 0-100 points)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Marzia Lazzerini, MD
  role: Study Chair
  affiliation: IRCCS materno infantile Burlo Garofolo
  last name: Marzia Lazzerini, MD
  phone: +390403785555
  email: marzia.lazzerini@burlo.trieste.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor