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/NCT05986110</url>
    </required_header>
    <id_info>
      <org_study_id>IBYAP22/00008</org_study_id>
      <nct_id>NCT05986110</nct_id>
    </id_info>
    <brief_title>Analysis of the Results Obtained in the Regular Clinical Practice of a Clinical Ultrasound Classroom For Primary Care Physicians As a Formative Intervention System</brief_title>
    <official_title>Analysis of the Results Obtained in the Regular Clinical Practice of a Clinical Ultrasound Classroom For Primary Care Physicians As a Formative Intervention System</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fundacion para la Investigacion y Formacion en Ciencias de la Salud</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fundacion para la Investigacion y Formacion en Ciencias de la Salud</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>
        The objectives of the project are to evaluate the theoretical-practical knowledge acquired&#xD;
        and the degree of satisfaction of a methodology based on theoretical-practical training in&#xD;
        abdominal and thyroid clinical ultrasound of family doctors, in the urban area of Primary&#xD;
        Health Care, and to evaluate the benefit obtained by patients over 60 years of age included&#xD;
        in the program, analyzing the degree of satisfaction, resolution time of the reason for&#xD;
        consultation and decrease in the number of referrals to the second level of care, analyzing&#xD;
        the differences by gender.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objectives of the project are to evaluate the theoretical-practical knowledge acquired&#xD;
        and the degree of satisfaction of a methodology based on theoretical-practical training in&#xD;
        abdominal and thyroid clinical ultrasound of family doctors, in the urban area of Primary&#xD;
        Health Care, and to evaluate the benefit obtained by patients over 60 years of age included&#xD;
        in the program, analyzing the degree of satisfaction, resolution time of the reason for&#xD;
        consultation and decrease in the number of referrals to the second level of care, analyzing&#xD;
        the differences by gender.&#xD;
  &#xD;
        The expected impact is that the doctors participating in the project learn to perform&#xD;
        abdominal and thyroid ultrasound and continue to perform them during the year that their&#xD;
        participation in the project lasts, and independently thereafter. In addition, this will&#xD;
        allow the reduction of interconsultations to the specialized care and emergencies of their&#xD;
        patients whose primary care physicians perform ultrasound scans in their health center.&#xD;
  &#xD;
        Its application in clinical practice will be reflected because doctors who perform ultrasound&#xD;
        scans in their primary care centers will increase their diagnostic certainty in real&#xD;
        consultation time on many occasions, thereby reducing interconsultations at the second level&#xD;
        of care, and when they have to refer a patient at this level, they will do so in a more&#xD;
        documented manner.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of knowledge and skills</measure>
      <time_frame>1 year</time_frame>
      <description>An initial evaluation of knowledge will be carried out prior to the start of the training intervention, which will consist of 10 multiple choice questions with four possible answers with only 1 correct one (5 theoretical questions on the fundamentals and use of ultrasound, and interpretation of 5 images of pathologies or ultrasound anatomy). For the final evaluation, a new test will be carried out, with 10 questions similar to those of the initial test (5 theoretical questions and 5 common images).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Family Medicine</condition>
    <condition>Clinical Ultrasound</condition>
    <condition>Primary Care</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>A training intervention on clinical ultrasound</intervention_name>
      <description>To train 20 primary care family doctors in clinical ultrasound so that they have greater power of resolution and allow them to limit the diagnostic and surgical times on the waiting lists of their patients.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To work in selected health centers.&#xD;
  &#xD;
            -  To have assigned to more than 800 patients.&#xD;
  &#xD;
            -  Not have previous training in regulated clinical ultrasound.&#xD;
  &#xD;
            -  Sign a commitment to Attendance at least 80% of the training program sessions.&#xD;
  &#xD;
            -  Sign the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not meeting any of the inclusion criteria.&#xD;
  &#xD;
            -  Not signing the informed consent.&#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>Fernando Pérez Escanilla</last_name>
      <phone>923177831</phone>
      <email>fperezes@saludcastillayleon.es</email>
    </overall_contact>
    <location>
      <facility>
        <name>Primary Care Research Unit of Salamanca</name>
        <address>
          <city>Salamanca</city>
          <zip>37006</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Luis García Ortiz, MD</last_name>
        <phone>0034923231859</phone>
        <email>lgarciao@usal.es</email>
      </contact>
      <contact_backup>
        <last_name>Fernando Perez Escanilla, MD</last_name>
        <email>fperezes@saludcastillayleon.es</email>
      </contact_backup>
      <investigator>
        <last_name>Luis Garcia-Ortiz, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Fernando Perez-Escanilla, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Family medicine</keyword>
    <keyword>Clinical ultrasound</keyword>
    <keyword>Primary care</keyword>
    <keyword>Resolution improvement</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/NCT05986110
  org study id: IBYAP22/00008
  nct id: NCT05986110
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objectives of the project are to evaluate the theoretical-practical knowledge acquired
        and the degree of satisfaction of a methodology based on theoretical-practical training in
        abdominal and thyroid clinical ultrasound of family doctors, in the urban area of Primary
        Health Care, and to evaluate the benefit obtained by patients over 60 years of age included
        in the program, analyzing the degree of satisfaction, resolution time of the reason for
        consultation and decrease in the number of referrals to the second level of care, analyzing
        the differences by gender.
  The objectives of the project are to evaluate the theoretical-practical knowledge acquired
        and the degree of satisfaction of a methodology based on theoretical-practical training in
        abdominal and thyroid clinical ultrasound of family doctors, in the urban area of Primary
        Health Care, and to evaluate the benefit obtained by patients over 60 years of age included
        in the program, analyzing the degree of satisfaction, resolution time of the reason for
        consultation and decrease in the number of referrals to the second level of care, analyzing
        the differences by gender.
  
        The expected impact is that the doctors participating in the project learn to perform
        abdominal and thyroid ultrasound and continue to perform them during the year that their
        participation in the project lasts, and independently thereafter. In addition, this will
        allow the reduction of interconsultations to the specialized care and emergencies of their
        patients whose primary care physicians perform ultrasound scans in their health center.
  
        Its application in clinical practice will be reflected because doctors who perform ultrasound
        scans in their primary care centers will increase their diagnostic certainty in real
        consultation time on many occasions, thereby reducing interconsultations at the second level
        of care, and when they have to refer a patient at this level, they will do so in a more
        documented manner.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Assessment of knowledge and skills
  time frame: 1 year
  description: An initial evaluation of knowledge will be carried out prior to the start of the training intervention, which will consist of 10 multiple choice questions with four possible answers with only 1 correct one (5 theoretical questions on the fundamentals and use of ultrasound, and interpretation of 5 images of pathologies or ultrasound anatomy). For the final evaluation, a new test will be carried out, with 10 questions similar to those of the initial test (5 theoretical questions and 5 common images).
  arm group label: Intervention Group
  arm group type: Experimental
  arm group label: Control Group
  arm group type: No Intervention
  intervention type: Procedure
  intervention name: A training intervention on clinical ultrasound
  description: To train 20 primary care family doctors in clinical ultrasound so that they have greater power of resolution and allow them to limit the diagnostic and surgical times on the waiting lists of their patients.
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Fernando Pérez Escanilla
  phone: 923177831
  email: fperezes@saludcastillayleon.es
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Spain
  responsible party type: Sponsor
  sharing ipd: No