<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/NCT04463355</url>
  </required_header>
  <id_info>
    <org_study_id>GEA01</org_study_id>
    <nct_id>NCT04463355</nct_id>
  </id_info>
  <brief_title>Video Discharge Instructions for Pediatric Gastroenteritis in an Emergency Department</brief_title>
  <official_title>Video Discharge Instructions for Pediatric Gastroenteritis in an Emergency Department: a Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario Gregorio Marañon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Gregorio Marañon</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>
      Video discharge instructions (VDI) have been suggested as a useful strategy to improve&#xD;
      discharge instructions in pediatric emergency units. The goal of this study is to evaluate if&#xD;
      the addition of VDI to usual verbal information improved the comprehension of information&#xD;
      provided to caregivers of patients who consult for acute gastroenteritis (AGE). An&#xD;
      open-label, parallel, randomized trial was designed, enrolling patients who consult for AGE.&#xD;
      First, caregivers answer a written test concerning AGE characteristics and management. They&#xD;
      are randomly allocated to a control group, which receives verbal discharge instructions, or&#xD;
      to an intervention group, which additionally receives video discharge instructions. After&#xD;
      discharge, caregivers are contacted by telephone and answer the same test. Main outcome&#xD;
      measure is difference between test scores in the first and the second tests, secondary&#xD;
      endpoints are how many caregivers score 5/5 on the second test, as well as rate of return&#xD;
      visits and caregivers satisfaction with the information received.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Video discharge instructions (VDI) have been suggested as a useful strategy to improve&#xD;
      discharge instructions in pediatric emergency units. This study is designed to evaluate if&#xD;
      the addition of VDI to usual verbal information improves the comprehension of the information&#xD;
      provided to caregivers of patients who consult in pediatric emergency department for acute&#xD;
      gastroenteritis (AGE). Secondary objectives are evaluating if video instructions improve&#xD;
      satisfaction with the information received and decrease return visits.&#xD;
&#xD;
      The study is an open-label, parallel, randomized trial which takes place between June 2019&#xD;
      and June 2020 in the pediatric emergency department of a third-level Spanish hospital which&#xD;
      receives 58000 emergencies annually. Up to 3 eligible patients are enrolled every shift when&#xD;
      one of the main investigators is present. Simple, 1:1 randomization is performed using R&#xD;
      software. Patients are randomly assigned to a group by opening sequentially numbered paper&#xD;
      envelopes which contain the group in which the patient will be allocated, ensuring thus&#xD;
      allocation concealment. Written informed consent is provided before trial enrollment.&#xD;
&#xD;
      Interventions&#xD;
&#xD;
      The trial is developed in three steps: an initial written test, an information phase and a&#xD;
      second follow-up test after discharge. After enrollment, all patients fill-in a written test&#xD;
      before discharge, which consists of 5 questions about AGE, 1 point per correct answer.&#xD;
      Enrolled subjects are randomly assigned to the control or intervention group. In the first&#xD;
      group of subjects (control group) caregivers receive, after completing the test and prior to&#xD;
      discharge, the usual verbal information and recommendations about AGE following the&#xD;
      guidelines of the Spanish Society of Pediatric Emergencies. In the second group (intervention&#xD;
      group) patients are shown a short 2-minute video providing the same information about AGE, in&#xD;
      addition to verbal instructions. In both groups, instructions are given by one of the main&#xD;
      investigators in order to provide homogeneous and consistent information. Both sets of&#xD;
      instructions explicitly include the information that had been previously asked in the test.&#xD;
      All patients additionally receive a discharge report which includes instructions concerning&#xD;
      aftercare treatment.&#xD;
&#xD;
      After discharge, all caregivers are contacted by telephone and asked the same 5 questions&#xD;
      from the initial test. The questionnaire has to be completed by the same caregiver as in the&#xD;
      previous test. This test also includes questions about subsequent visits to either emergency&#xD;
      units or outpatient pediatric clinics and satisfaction with the information. The first&#xD;
      telephonic contact is established 72 hours after discharge, and if unable to contact,&#xD;
      repeated every 1-2 days up to a total of 5 days before excluding them and considering them as&#xD;
      lost in follow-up.&#xD;
&#xD;
      Statistical Analysis The sample size was calculated to provide a statistical power of 80% at&#xD;
      an alpha level of 5% to detect a two-tailed difference of 0.5 points between the two groups.&#xD;
      It was calculated that with an estimated loss rate of 15% of patients between randomization&#xD;
      and follow-up test, assuming a 1-point variance in test results based on previous studies,&#xD;
      this statistical power would be reached by enrolling 75 patients in each group.&#xD;
&#xD;
      All randomized patients who complete both tests are included in the primary-end point&#xD;
      analysis as part of the group in which they were randomized, following intention-to-treat&#xD;
      principle. The differences in test points and satisfaction between groups are analyzed using&#xD;
      Student's T-test, and the differences in proportions are analyzed using Chi-square test.&#xD;
      Statistical significance is set at p&lt;0.05. Analysis are performed using Rv3.6.1 and SPSS.25&#xD;
      statistical softwares.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</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>
    <intervention_model_description>Open-label, parallel trial with a control group and an intervention group.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in test score</measure>
    <time_frame>From 3 days to 10 days after first emergency care visit</time_frame>
    <description>We calculated the difference between the score obtained in the initial test and the score obteined in the follow-up test and compared between groups. Scores are based on a 5-question test, minimum score is 0 points and maximum score (best score) is 5 points</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of caregivers getting a total score of 5 points</measure>
    <time_frame>From 3 days to 10 days after first emergency care visit</time_frame>
    <description>We measured how many caregivers got a 5-score (perfect) in the follow up test after interventions, and compared between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of return visits</measure>
    <time_frame>72 hours from from the first emergency care visit</time_frame>
    <description>We asked caregivers whether they had returned to emergency care or to pediatric outpatient clinics for the same problem after the first visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction score with the information received</measure>
    <time_frame>From 3 days to 10 days after first emergency care visit</time_frame>
    <description>We asked caregivers to give a score between 1 and 10 (1 very unsatisfied, 10 very satisfied) regarding how useful they felt that the information given to them had been.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Acute Gastroenteritis</condition>
  <arm_group>
    <arm_group_label>Control group: usual verbal instructions</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this group, caregivers receive, after completing the test and prior to discharge, the usual verbal information and recommendations about AGE following the guidelines of the Spanish Society of Pediatric Emergencies. The instructions are always given by one of the main investigators to provide homogeneity in the information</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group: video discharge instructions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Additionally to the verbal information, patients are shown a short 2-minute video providing the same information about AGE that would be given by verbal information.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Video discharge instructions</intervention_name>
    <description>Short video (2 minutes) including information about clinical features, management and follow up of pediatric patients with acute gastroenteritis</description>
    <arm_group_label>Intervention group: video discharge instructions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who met ESPGHAN criteria for AGE: decreased stool consistency and/or&#xD;
             increased evacuation frequency during a period &lt;7 days, associated or not to fever or&#xD;
             vomiting.&#xD;
&#xD;
          -  Patients accompanied by a usual caregiver.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe dehydration&#xD;
&#xD;
          -  Patients with chronic comorbidities needing special instructions (i.e. neurologic,&#xD;
             respiratory or cardiologic)&#xD;
&#xD;
          -  Patients whose caregivers were not able to communicate in Spanish&#xD;
&#xD;
          -  Patients who were admitted for hospitalization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gonzalo Solís, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital General Universitario Gregorio Marañón</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Gregorio Marañon</investigator_affiliation>
    <investigator_full_name>Gonzalo Solis Garcia</investigator_full_name>
    <investigator_title>Dr. Gonzalo Solís García, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>discharge instructions</keyword>
  <keyword>video</keyword>
  <keyword>acute gastroenteritis</keyword>
  <keyword>pediatric emergency department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroenteritis</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected IPD are available under request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available as soon as published. It will be available for 20 years (year 2040)</ipd_time_frame>
    <ipd_access_criteria>Investigators with research accepted by a research ethics committee conducting research in this area.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT04463355/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT04463355/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04463355
org study id: GEA01
nct id: NCT04463355
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Video discharge instructions (VDI) have been suggested as a useful strategy to improve
      discharge instructions in pediatric emergency units. The goal of this study is to evaluate if
      the addition of VDI to usual verbal information improved the comprehension of information
      provided to caregivers of patients who consult for acute gastroenteritis (AGE). An
      open-label, parallel, randomized trial was designed, enrolling patients who consult for AGE.
      First, caregivers answer a written test concerning AGE characteristics and management. They
      are randomly allocated to a control group, which receives verbal discharge instructions, or
      to an intervention group, which additionally receives video discharge instructions. After
      discharge, caregivers are contacted by telephone and answer the same test. Main outcome
      measure is difference between test scores in the first and the second tests, secondary
      endpoints are how many caregivers score 5/5 on the second test, as well as rate of return
      visits and caregivers satisfaction with the information received.
Video discharge instructions (VDI) have been suggested as a useful strategy to improve
      discharge instructions in pediatric emergency units. This study is designed to evaluate if
      the addition of VDI to usual verbal information improves the comprehension of the information
      provided to caregivers of patients who consult in pediatric emergency department for acute
      gastroenteritis (AGE). Secondary objectives are evaluating if video instructions improve
      satisfaction with the information received and decrease return visits.

      The study is an open-label, parallel, randomized trial which takes place between June 2019
      and June 2020 in the pediatric emergency department of a third-level Spanish hospital which
      receives 58000 emergencies annually. Up to 3 eligible patients are enrolled every shift when
      one of the main investigators is present. Simple, 1:1 randomization is performed using R
      software. Patients are randomly assigned to a group by opening sequentially numbered paper
      envelopes which contain the group in which the patient will be allocated, ensuring thus
      allocation concealment. Written informed consent is provided before trial enrollment.

      Interventions

      The trial is developed in three steps: an initial written test, an information phase and a
      second follow-up test after discharge. After enrollment, all patients fill-in a written test
      before discharge, which consists of 5 questions about AGE, 1 point per correct answer.
      Enrolled subjects are randomly assigned to the control or intervention group. In the first
      group of subjects (control group) caregivers receive, after completing the test and prior to
      discharge, the usual verbal information and recommendations about AGE following the
      guidelines of the Spanish Society of Pediatric Emergencies. In the second group (intervention
      group) patients are shown a short 2-minute video providing the same information about AGE, in
      addition to verbal instructions. In both groups, instructions are given by one of the main
      investigators in order to provide homogeneous and consistent information. Both sets of
      instructions explicitly include the information that had been previously asked in the test.
      All patients additionally receive a discharge report which includes instructions concerning
      aftercare treatment.

      After discharge, all caregivers are contacted by telephone and asked the same 5 questions
      from the initial test. The questionnaire has to be completed by the same caregiver as in the
      previous test. This test also includes questions about subsequent visits to either emergency
      units or outpatient pediatric clinics and satisfaction with the information. The first
      telephonic contact is established 72 hours after discharge, and if unable to contact,
      repeated every 1-2 days up to a total of 5 days before excluding them and considering them as
      lost in follow-up.

      Statistical Analysis The sample size was calculated to provide a statistical power of 80% at
      an alpha level of 5% to detect a two-tailed difference of 0.5 points between the two groups.
      It was calculated that with an estimated loss rate of 15% of patients between randomization
      and follow-up test, assuming a 1-point variance in test results based on previous studies,
      this statistical power would be reached by enrolling 75 patients in each group.

      All randomized patients who complete both tests are included in the primary-end point
      analysis as part of the group in which they were randomized, following intention-to-treat
      principle. The differences in test points and satisfaction between groups are analyzed using
      Student's T-test, and the differences in proportions are analyzed using Chi-square test.
      Statistical significance is set at p<0.05. Analysis are performed using Rv3.6.1 and SPSS.25
      statistical softwares.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Open-label, parallel trial with a control group and an intervention group.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in test score
time frame: From 3 days to 10 days after first emergency care visit
description: We calculated the difference between the score obtained in the initial test and the score obteined in the follow-up test and compared between groups. Scores are based on a 5-question test, minimum score is 0 points and maximum score (best score) is 5 points
measure: Number of caregivers getting a total score of 5 points
time frame: From 3 days to 10 days after first emergency care visit
description: We measured how many caregivers got a 5-score (perfect) in the follow up test after interventions, and compared between groups
measure: Rate of return visits
time frame: 72 hours from from the first emergency care visit
description: We asked caregivers whether they had returned to emergency care or to pediatric outpatient clinics for the same problem after the first visit.
measure: Satisfaction score with the information received
time frame: From 3 days to 10 days after first emergency care visit
description: We asked caregivers to give a score between 1 and 10 (1 very unsatisfied, 10 very satisfied) regarding how useful they felt that the information given to them had been.
arm group label: Control group: usual verbal instructions
arm group type: No Intervention
description: In this group, caregivers receive, after completing the test and prior to discharge, the usual verbal information and recommendations about AGE following the guidelines of the Spanish Society of Pediatric Emergencies. The instructions are always given by one of the main investigators to provide homogeneity in the information
arm group label: Intervention group: video discharge instructions
arm group type: Experimental
description: Additionally to the verbal information, patients are shown a short 2-minute video providing the same information about AGE that would be given by verbal information.
intervention type: Behavioral
intervention name: Video discharge instructions
description: Short video (2 minutes) including information about clinical features, management and follow up of pediatric patients with acute gastroenteritis
arm group label: Intervention group: video discharge instructions
criteria: 
gender: All
minimum age: 1 Month
maximum age: 16 Years
healthy volunteers: No
last name: Gonzalo Solís, M.D.
role: Principal Investigator
affiliation: Hospital General Universitario Gregorio Marañón
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario Gregorio Marañon
investigator full name: Gonzalo Solis Garcia
investigator title: Dr. Gonzalo Solís García, Principal Investigator
mesh term: Gastroenteritis
mesh term: Emergencies
sharing ipd: Yes
ipd description: All collected IPD are available under request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available as soon as published. It will be available for 20 years (year 2040)
ipd access criteria: Investigators with research accepted by a research ethics committee conducting research in this area.
provided document: 
provided document: 