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/NCT06013124</url>
    </required_header>
    <id_info>
      <org_study_id>RC 46/20</org_study_id>
      <nct_id>NCT06013124</nct_id>
    </id_info>
    <brief_title>Patient/Caregiver Perceived Quality of Care</brief_title>
    <official_title>Organizational Environment, Staff Well-being and Patient/Caregiver Perceived Quality of Care in a Maternal and Child Health Hospital in Italy</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>
        Hospitals quality, safety, and staff workload problems are common in all countries. Findings&#xD;
        from the multicountry Nurse forecasting in Europe (RN4CAST) cross sectional study show that&#xD;
        patient risk of mortality within a 30 days of hospital stay increases of 7% when a patient is&#xD;
        added to the nurse-patient 1:6 proportion in a surgical unit; in Italy, the ratio was found&#xD;
        to be 9.5 patients per nurse. Organizational environment, health workers wellbeing and work&#xD;
        satisfaction were also found to impact patient safety and perceived patient satisfaction;&#xD;
        hospitals nurses high workload, work dissatisfaction and burnout were found related to poor&#xD;
        patients outcomes. In a systematic review and meta-analysis, an association of more than 60%&#xD;
        between physicians and nurses development of burnout and patient safety in pediatric settings&#xD;
        was found; when health workers wellness and teamwork in wards was poor lower perceptions of&#xD;
        safety culture was found. Moreover, occupational exposure to medically complex children and&#xD;
        their families along with direct care providers unexpressed grief further increase pediatric&#xD;
        settings staff risk of developing burnout syndrome and compassion fatigue. Recent findings of&#xD;
        Covid-19 pandemic negative impact on health workers well-being worldwide also enhances the&#xD;
        risk of compromising the quality of care provided. The aim of this study is to evaluate&#xD;
        factors that affect health workers well-being, their perception of work environment and&#xD;
        patient/caregiver satisfaction and perceived quality of care in a maternal and child health&#xD;
        hospital.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 26, 2021</start_date>
    <completion_date type="Anticipated">April 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 15, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Hospital Work environment</measure>
      <time_frame>Through study completion, an average of 3 year</time_frame>
      <description>Evaluated by validated questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Staff well-being</measure>
      <time_frame>Through study completion, an average of 3 year</time_frame>
      <description>Evaluated by validated questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patients/caregivers satisfaction</measure>
      <time_frame>Through study completion, an average of 3 year</time_frame>
      <description>Evaluated by validated questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patients/caregivers perceived quality of care</measure>
      <time_frame>Through study completion, an average of 3 year</time_frame>
      <description>Evaluated by validated questionnaire</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Maternal and Child Health</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Work environment, well-being, customer satisfaction</intervention_name>
      <description>Evaluation hospital work environment, staff well-being features and patients/caregivers satisfaction and perceived quality of care</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Health workers, patients (adults and school-aged children), caregivers of children&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Health workers directly involved in patients care and employed for more than 6 months&#xD;
  &#xD;
            -  Patients (adults, school-aged children)&#xD;
  &#xD;
            -  Caregivers of children&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Health workers employed for less than 6 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Raffaella Raffaella, MSC</last_name>
      <role>Principal Investigator</role>
      <affiliation>IRCCS materno infantile Burlo Garofolo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Raffaella Dobrina, MSC</last_name>
      <phone>+39 040 3785111</phone>
      <email>raffaella.dobrina@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>Raffaella Dobrina, MS</last_name>
        <phone>+390403785</phone>
        <email>raffaella.dobrina@burlo.trieste.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Patient safety</keyword>
    <keyword>occupational health</keyword>
    <keyword>health care quality assurance</keyword>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06013124
  org study id: RC 46/20
  nct id: NCT06013124
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Hospitals quality, safety, and staff workload problems are common in all countries. Findings
        from the multicountry Nurse forecasting in Europe (RN4CAST) cross sectional study show that
        patient risk of mortality within a 30 days of hospital stay increases of 7% when a patient is
        added to the nurse-patient 1:6 proportion in a surgical unit; in Italy, the ratio was found
        to be 9.5 patients per nurse. Organizational environment, health workers wellbeing and work
        satisfaction were also found to impact patient safety and perceived patient satisfaction;
        hospitals nurses high workload, work dissatisfaction and burnout were found related to poor
        patients outcomes. In a systematic review and meta-analysis, an association of more than 60%
        between physicians and nurses development of burnout and patient safety in pediatric settings
        was found; when health workers wellness and teamwork in wards was poor lower perceptions of
        safety culture was found. Moreover, occupational exposure to medically complex children and
        their families along with direct care providers unexpressed grief further increase pediatric
        settings staff risk of developing burnout syndrome and compassion fatigue. Recent findings of
        Covid-19 pandemic negative impact on health workers well-being worldwide also enhances the
        risk of compromising the quality of care provided. The aim of this study is to evaluate
        factors that affect health workers well-being, their perception of work environment and
        patient/caregiver satisfaction and perceived quality of care in a maternal and child health
        hospital.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Hospital Work environment
  time frame: Through study completion, an average of 3 year
  description: Evaluated by validated questionnaire
  measure: Staff well-being
  time frame: Through study completion, an average of 3 year
  description: Evaluated by validated questionnaire
  measure: Patients/caregivers satisfaction
  time frame: Through study completion, an average of 3 year
  description: Evaluated by validated questionnaire
  measure: Patients/caregivers perceived quality of care
  time frame: Through study completion, an average of 3 year
  description: Evaluated by validated questionnaire
  intervention type: Other
  intervention name: Work environment, well-being, customer satisfaction
  description: Evaluation hospital work environment, staff well-being features and patients/caregivers satisfaction and perceived quality of care
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 60 Years
  last name: Raffaella Raffaella, MSC
  role: Principal Investigator
  affiliation: IRCCS materno infantile Burlo Garofolo
  last name: Raffaella Dobrina, MSC
  phone: +39 040 3785111
  email: raffaella.dobrina@burlo.trieste.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  sharing ipd: Undecided