<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/NCT03234777</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00073867</org_study_id>
    <nct_id>NCT03234777</nct_id>
  </id_info>
  <brief_title>Evaluating a Knowledge Translation Tool for Parents</brief_title>
  <official_title>Evaluating a Knowledge Translation Tool for Parents: A Pilot Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stollery Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</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>
      Diarrhea and vomiting in children is a common reason to visit the emergency department. There&#xD;
      has been a lot of research on how best to treat children with diarrhea and vomiting who visit&#xD;
      the emergency department; however, the care children receive varies by healthcare provider&#xD;
      and across hospitals. Additionally, there are things parents can do at home to help manage&#xD;
      childhood diarrhea and vomiting and potentially avoid a trip to the emergency department.&#xD;
      This shows an urgent need for knowledge translation, that is, efforts to align research&#xD;
      knowledge and healthcare practice. Actively involving parents in healthcare decisions has the&#xD;
      potential to bridge this gap; however, there is little research on the best ways to&#xD;
      communicate complex health information to parents of sick kids. In 2013, a national needs&#xD;
      assessment was conducted with parents seeking care for their kids in general emergency&#xD;
      departments (trekk.ca). This survey showed that 39% of parents looked for information about&#xD;
      their child's health prior to coming to the emergency department and that 44% of these&#xD;
      parents looked for this information on the internet. This means that the development and&#xD;
      evaluation of digital tools to give parents timely and effective child health information has&#xD;
      the potential to reduce unnecessary emergency department visits, empower parents in health&#xD;
      decision-making, and ultimately improve child health outcomes. In this project, parents will&#xD;
      be actively involved in the evaluation of a digital tool, a whiteboard animation video,&#xD;
      designed to communicate the best research evidence on the treatment and management of&#xD;
      vomiting and diarrhea in children. In this pilot trial, parents in two emergency departments&#xD;
      will be randomized to view the video or a sham video, and then provide quantitative and&#xD;
      qualitative data on the potential effectiveness of the video, the perceived benefit and value&#xD;
      of the knowledge translation intervention for pediatric vomiting and diarrhea, the&#xD;
      feasibility of using iPads and an electronic data collection platform to conduct research&#xD;
      with this population, the time required to complete data collection, and parents' willingness&#xD;
      to participate in future, similar research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY PURPOSE: The purpose of this pilot randomized trial is to use quantitative and&#xD;
      qualitative approaches to achieve the following objectives in the four key pilot trial&#xD;
      domains:&#xD;
&#xD;
      1. Scientific domain objectives:&#xD;
&#xD;
      1.a.) To determine the potential effectiveness of a digital knowledge translation tool for&#xD;
      parents/caregivers about pediatric acute gastroenteritis (AGE). KT tools are intended to&#xD;
      impact end-user experience, including increasing knowledge, influencing healthcare decision&#xD;
      making, and use of healthcare resources/services. Comprehension and retention of health&#xD;
      information is a key component of the patient experience, a determinant of care instruction&#xD;
      follow-through, and the cornerstone of health literacy; therefore, parental knowledge over&#xD;
      time will be assessed. In addition to comprehension, educational materials may also influence&#xD;
      health decision making; therefore, parental decision regret over time will be assessed to&#xD;
      examine this impact in light of the decision to bring their child to the ED for care.&#xD;
      Additionally, minimal clinically important differences (MCIDs) will be identified for both&#xD;
      knowledge and decision regret outcome measures. Finally, healthcare utilization post-ED visit&#xD;
      will be explored as a potential future outcome.&#xD;
&#xD;
        1. b.) To understand the perceived benefit and value of KT tools for parents/caregivers of&#xD;
           a child with pediatric AGE, including important components that enhance knowledge and&#xD;
           decision making.&#xD;
&#xD;
        2. Process domain objectives:&#xD;
&#xD;
      2.a.) To examine the feasibility of using an electronic, web-based platform for intervention&#xD;
      delivery and data collection with this population.&#xD;
&#xD;
      3. Management domain objectives: 3.a.) To assess parent/caregivers' willingness to&#xD;
      participate in future, similar research (i.e., full-scale trial).&#xD;
&#xD;
      4. Resource domain objectives: 4.a.) To determine time required for participants to complete&#xD;
      data collection forms.&#xD;
&#xD;
      4.b.) To examine the feasibility of using iPads to collect data with parents/caregivers in&#xD;
      the ED.&#xD;
&#xD;
      HYPOTHESIS: This pilot trial is not designed to test hypotheses, but rather to gather initial&#xD;
      data to justify and inform a future, full-scale trial.&#xD;
&#xD;
      METHODS &amp; DESIGN: This is a parallel-arm, pilot randomized trial.&#xD;
&#xD;
      Recruitment: Consecutive individuals will be approached in the ED waiting room post-triage&#xD;
      assessment during data collection recruitment hours (7 days/week, 0700 - 2300). A member of&#xD;
      the study team (Research Coordinator, Research Assistant, etc.) will assess&#xD;
      inclusion/exclusion criteria and review the information letter. Informed consent will be&#xD;
      indicated on iPads as part of the electronic data collection platform.&#xD;
&#xD;
      Interventions: Participants will view the experimental (3 minute, whiteboard animation video&#xD;
      on pediatric acute gastroenteritis) and sham control (3 minute, CDC video on hand washing for&#xD;
      infection control) interventions on an iPad in the ED waiting room post-triage assessment.&#xD;
      Headphones will be provided with the iPad to both groups in the ED to maintain blinding. At&#xD;
      the end of data collection in the ED (post-intervention questionnaire 1), participants can&#xD;
      select to receive a link to their allocated video via email. Participants from the&#xD;
      experimental intervention group that are participating in the qualitative interview will view&#xD;
      the whiteboard animation video again at the start of the interview.&#xD;
&#xD;
      Randomization: Blocked randomization with randomly chosen block sizes will be used to ensure&#xD;
      equal distribution of participants to intervention and standard care intervention study arms.&#xD;
      The blocked randomization sequence will be computer generated. Following sequence generation,&#xD;
      the randomization sequence will be entered into a confidential module on the electronic&#xD;
      platform. Once the sequence is entered, the randomization module will only be accessible&#xD;
      using a confidential password. The randomization sequence will be kept confidential. It will&#xD;
      be inaccessible to data collectors/outcome assessors and to the study participants.&#xD;
&#xD;
      After completing the pre-intervention questionnaire, including demographic information and&#xD;
      baseline outcome data, on the electronic data collection platform, participants will&#xD;
      automatically be randomized to one of the study conditions (i.e., intervention or sham&#xD;
      control) based on the randomization sequence. This process will be seamless to participants.&#xD;
      After viewing the study condition materials, participants will be automatically directed to&#xD;
      the first post-intervention questionnaire.&#xD;
&#xD;
      Blinding: Using an electronic platform for data collection, study group allocation, and&#xD;
      intervention viewing will allow participants to access the interventions and provide data&#xD;
      independent of the research team. Participants will know they are viewing information on an&#xD;
      iPad, but won't know how the content differs between groups because they will be using&#xD;
      headphones. Participants and outcome assessors will not be able to determine group allocation&#xD;
      and since all data is collected electronically there is no risk of unblinding during data&#xD;
      collection, data cleaning and data analysis.&#xD;
&#xD;
      Sample size estimate: Sample size calculations are not required for pilot/feasibility studies&#xD;
      as hypothesis testing is not the focus of this research design. Rather, recruitment will take&#xD;
      place over a 6-month period and will be evaluated for quantitative and qualitative components&#xD;
      as part of the identified process outcome measures. This 6-month period is intended to&#xD;
      reflect the seasonal nature of viral gastroenteritis, the most common cause of infection, in&#xD;
      temperate climates. Recruitment will take place over the peak infection time of late winter.&#xD;
&#xD;
      Philosophically, qualitative methods do not conduct prospective determinations of a sample&#xD;
      size; instead, an adequate sample permits a deep, case oriented analysis that results in a&#xD;
      new understanding of experience. In this study, 12-20 interviews with participants are&#xD;
      anticipated to see patterns in experiences.&#xD;
&#xD;
      Data collection:&#xD;
&#xD;
        1. Pre-intervention questionnaire (baseline): Participants will complete a pre-intervention&#xD;
           questionnaire that includes demographics, knowledge questionnaire, and Decision Regret&#xD;
           Scale within the iCare Adventure platform on the iPad.&#xD;
&#xD;
           **Participants will then be randomized to view the study intervention or the sham&#xD;
           control intervention within the electronic platform on the iPad. This process will be&#xD;
           seamless for the participants.&#xD;
&#xD;
        2. Post-intervention questionnaire 1 (immediate): After viewing the intervention,&#xD;
           participants will complete the knowledge questionnaire and Decision Regret Scale a&#xD;
           second time. In addition, participants will complete 2 items assessing their own&#xD;
           performance on the knowledge questionnaire and Decision Regret Scale and 1 item&#xD;
           regarding the perceived value and benefit of the KT tool. They will also be asked if&#xD;
           they would like a video link emailed to them. At the end of this questionnaire, parents&#xD;
           will be informed that the post-intervention questionnaire 2 will be emailed to them 4&#xD;
           days after this ED visit for completion at their earliest convenience. Experimental&#xD;
           intervention group parents will be asked about participation in a qualitative focus&#xD;
           group at this time.&#xD;
&#xD;
        3. Post-intervention questionnaire 2 (4-14 days post-ED visit): Participants will be&#xD;
           emailed a secure link on day 4 post-ED discharge to complete the knowledge questionnaire&#xD;
           and Decision Regret Scale a third time 2 items assessing their own performance on the&#xD;
           knowledge questionnaire and Decision Regret Scale, 3 items related to healthcare&#xD;
           utilization, and 3 items related to the perceived value and benefit of the KT tool (if&#xD;
           applicable). Reminders to complete post-intervention questionnaire 2 will be sent every&#xD;
           third day (day 7, day 10, day 13). The last day for follow-up questionnaire completion&#xD;
           will be 14 days post ED visit (10 days after follow-up survey sent to participant).&#xD;
           Previous research has demonstrated that 82% of AGE cases are resolved in three days or&#xD;
           less and 14 days represents the outer limit for pediatric AGE resolution.&#xD;
&#xD;
        4. Post-intervention semi-structured interview (sub-sample of experimental group):&#xD;
           Participants in the experimental group indicating willingness to participate in an&#xD;
           in-depth, semi-structured, qualitative interview will be contacted via telephone after&#xD;
           completion of post-intervention questionnaire 2. Up to three phone calls will be made to&#xD;
           establish interview date/time. Qualitative interviews will take 30-60 minutes to&#xD;
           complete and focus on satisfaction with the electronic data collection platform,&#xD;
           perceived benefit and value of the KT intervention, and willingness to participate in&#xD;
           future, similar research.&#xD;
&#xD;
      Data analysis: All data will be aggregated and analyzed as per the Alberta Health Information&#xD;
      Act. Quantitative data will be downloaded from a secure Canadian server to SPSS for data&#xD;
      cleaning and analysis. Data cleaning measures may include recoding into categorical variables&#xD;
      and comparing and recoding free text responses where appropriate. Descriptive statistics and&#xD;
      estimation are the recommended focus of pilot/feasibility trials. Descriptive statistics&#xD;
      (e.g., frequencies, measures of variation and spread, etc.) will be calculated to describe&#xD;
      the study groups. Analyses will be conducted based on intention-to-treat overall and by site&#xD;
      (Stollery, IWK) to identify any differences in the pattern of results.&#xD;
&#xD;
      Qualitative data will be de-identified during verbatim transcription. Prior to analysis,&#xD;
      transcripts will be verified by a member of the research team. Qualitative data will be&#xD;
      managed and analyzed using NVivo data management software. Qualitative outcomes will be&#xD;
      analyzed using thematic analysis by breaking interview text into small units for a detailed,&#xD;
      nuanced account of the data. This iterative process will be concurrent to data collection.&#xD;
      Thematic analysis will be guided by the hybrid approach of inductive and deductive coding and&#xD;
      theme development described by Fereday &amp; Muir-Cochrane (2006). Deductive coding of the&#xD;
      interview transcripts will be done first using the semi-structured interview guide as a&#xD;
      framework; smaller units of data that emerge inductively will be coded for increased&#xD;
      granularity and specificity. To ensure analytic rigor, field notes will be collected during&#xD;
      the data collection and analysis process and coded alongside interview data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2017</start_date>
  <completion_date type="Actual">March 10, 2018</completion_date>
  <primary_completion_date type="Actual">March 10, 2018</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>Health Services Research</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>knowledge questionnaire</measure>
    <time_frame>0-14 days (x3)</time_frame>
    <description>Measure 1 (quantitative) of potential effectiveness of the knowledge translation intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decision Regret Scale</measure>
    <time_frame>0-14 days (x3)</time_frame>
    <description>Measure 2 (quantitative) of potential effectiveness of the knowledge translation intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health care utilization</measure>
    <time_frame>4-14 days</time_frame>
    <description>Measure 3 (quantitative) of potential effectiveness of the knowledge translation intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived benefit and value of the knowledge translation intervention for pediatric AGE</measure>
    <time_frame>0-14 days (x2) and qualitative interview (experimental group only) after post-intervention 2 questionnaire</time_frame>
    <description>Measure 4 (qualitative) of potential effectiveness of the knowledge translation intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Consent rate</measure>
    <time_frame>3 months</time_frame>
    <description>Measure 1 (quantitative) Feasibility of using an electronic data collection platform to conduct research with parents/caregivers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>3 months</time_frame>
    <description>Measure 2 (quantitative) Feasibility of using an electronic data collection platform to conduct research with parents/caregivers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Data completion rate</measure>
    <time_frame>3 months</time_frame>
    <description>Measure 3 (quantitative) Feasibility of using an electronic data collection platform to conduct research with parents/caregivers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with electronic platform</measure>
    <time_frame>Assessed during qualitative interview (experimental group only) after post-intervention 2 questionnaire</time_frame>
    <description>Measure 4 (qualitative) Feasibility of using an electronic data collection platform to conduct research with parents/caregivers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time (minutes) to complete study forms</measure>
    <time_frame>0-14 days</time_frame>
    <description>Measure 1 (quantitative) time to complete data collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time (days) to complete follow-up questionnaire post-discharge</measure>
    <time_frame>0-14 days</time_frame>
    <description>Measure 2 (quantitative) time to complete data collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of technical problems with electronic platform during study period</measure>
    <time_frame>3 months</time_frame>
    <description>Data quality measure (quantitative)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of technical problems as well as lost, stolen or damaged equipment during study period</measure>
    <time_frame>3 months</time_frame>
    <description>Measure 1 (quantitative) feasibility of using iPads to collect data in the emergency department with parents/caregivers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Willingness to participate in future similar research</measure>
    <time_frame>Assessed during qualitative interview after post-intervention 2 questionnaire</time_frame>
    <description>Qualitative measure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Acute Gastroenteritis</condition>
  <condition>Pediatric ALL</condition>
  <condition>Knowledge Translation</condition>
  <arm_group>
    <arm_group_label>Whiteboard animation video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 minute video on treatment, management of pediatric acute gastroenteritis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular video</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>3 minute video on hand washing for infection control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Whiteboard animation video</intervention_name>
    <description>Developed via qualitative research with parents of children with acute gastroenteritis.</description>
    <arm_group_label>Whiteboard animation video</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Regular video</intervention_name>
    <description>Developed by CDC</description>
    <arm_group_label>Regular video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Parent or caregiver of a child 16 years old or younger&#xD;
&#xD;
          2. Child is presenting to the ED with vomiting and diarrhea&#xD;
&#xD;
          3. Parent is fluent in English&#xD;
&#xD;
          4. Parent is willing to be contacted for follow-up data collection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Child has significant chronic gastrointestinal problem or inflammatory bowel disease&#xD;
             (i.e., Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis, chronic&#xD;
             constipation)&#xD;
&#xD;
          2. Child is taking immunosuppressive therapy or known history of immunodeficiency&#xD;
&#xD;
          3. Child has undergone oral or gastrointestinal surgery within the preceding 7 days&#xD;
&#xD;
          4. Child has had a prior visit to ED for vomiting and diarrhea within the preceding 14&#xD;
             days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andre Grace, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta (Supervisor)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stollery Children's Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>November 8, 2019</last_update_submitted>
  <last_update_submitted_qc>November 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alberta</investigator_affiliation>
    <investigator_full_name>Lauren Albrecht</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroenteritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03234777
org study id: Pro00073867
nct id: NCT03234777
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diarrhea and vomiting in children is a common reason to visit the emergency department. There
      has been a lot of research on how best to treat children with diarrhea and vomiting who visit
      the emergency department; however, the care children receive varies by healthcare provider
      and across hospitals. Additionally, there are things parents can do at home to help manage
      childhood diarrhea and vomiting and potentially avoid a trip to the emergency department.
      This shows an urgent need for knowledge translation, that is, efforts to align research
      knowledge and healthcare practice. Actively involving parents in healthcare decisions has the
      potential to bridge this gap; however, there is little research on the best ways to
      communicate complex health information to parents of sick kids. In 2013, a national needs
      assessment was conducted with parents seeking care for their kids in general emergency
      departments (trekk.ca). This survey showed that 39% of parents looked for information about
      their child's health prior to coming to the emergency department and that 44% of these
      parents looked for this information on the internet. This means that the development and
      evaluation of digital tools to give parents timely and effective child health information has
      the potential to reduce unnecessary emergency department visits, empower parents in health
      decision-making, and ultimately improve child health outcomes. In this project, parents will
      be actively involved in the evaluation of a digital tool, a whiteboard animation video,
      designed to communicate the best research evidence on the treatment and management of
      vomiting and diarrhea in children. In this pilot trial, parents in two emergency departments
      will be randomized to view the video or a sham video, and then provide quantitative and
      qualitative data on the potential effectiveness of the video, the perceived benefit and value
      of the knowledge translation intervention for pediatric vomiting and diarrhea, the
      feasibility of using iPads and an electronic data collection platform to conduct research
      with this population, the time required to complete data collection, and parents' willingness
      to participate in future, similar research.
STUDY PURPOSE: The purpose of this pilot randomized trial is to use quantitative and
      qualitative approaches to achieve the following objectives in the four key pilot trial
      domains:

      1. Scientific domain objectives:

      1.a.) To determine the potential effectiveness of a digital knowledge translation tool for
      parents/caregivers about pediatric acute gastroenteritis (AGE). KT tools are intended to
      impact end-user experience, including increasing knowledge, influencing healthcare decision
      making, and use of healthcare resources/services. Comprehension and retention of health
      information is a key component of the patient experience, a determinant of care instruction
      follow-through, and the cornerstone of health literacy; therefore, parental knowledge over
      time will be assessed. In addition to comprehension, educational materials may also influence
      health decision making; therefore, parental decision regret over time will be assessed to
      examine this impact in light of the decision to bring their child to the ED for care.
      Additionally, minimal clinically important differences (MCIDs) will be identified for both
      knowledge and decision regret outcome measures. Finally, healthcare utilization post-ED visit
      will be explored as a potential future outcome.

        1. b.) To understand the perceived benefit and value of KT tools for parents/caregivers of
           a child with pediatric AGE, including important components that enhance knowledge and
           decision making.

        2. Process domain objectives:

      2.a.) To examine the feasibility of using an electronic, web-based platform for intervention
      delivery and data collection with this population.

      3. Management domain objectives: 3.a.) To assess parent/caregivers' willingness to
      participate in future, similar research (i.e., full-scale trial).

      4. Resource domain objectives: 4.a.) To determine time required for participants to complete
      data collection forms.

      4.b.) To examine the feasibility of using iPads to collect data with parents/caregivers in
      the ED.

      HYPOTHESIS: This pilot trial is not designed to test hypotheses, but rather to gather initial
      data to justify and inform a future, full-scale trial.

      METHODS & DESIGN: This is a parallel-arm, pilot randomized trial.

      Recruitment: Consecutive individuals will be approached in the ED waiting room post-triage
      assessment during data collection recruitment hours (7 days/week, 0700 - 2300). A member of
      the study team (Research Coordinator, Research Assistant, etc.) will assess
      inclusion/exclusion criteria and review the information letter. Informed consent will be
      indicated on iPads as part of the electronic data collection platform.

      Interventions: Participants will view the experimental (3 minute, whiteboard animation video
      on pediatric acute gastroenteritis) and sham control (3 minute, CDC video on hand washing for
      infection control) interventions on an iPad in the ED waiting room post-triage assessment.
      Headphones will be provided with the iPad to both groups in the ED to maintain blinding. At
      the end of data collection in the ED (post-intervention questionnaire 1), participants can
      select to receive a link to their allocated video via email. Participants from the
      experimental intervention group that are participating in the qualitative interview will view
      the whiteboard animation video again at the start of the interview.

      Randomization: Blocked randomization with randomly chosen block sizes will be used to ensure
      equal distribution of participants to intervention and standard care intervention study arms.
      The blocked randomization sequence will be computer generated. Following sequence generation,
      the randomization sequence will be entered into a confidential module on the electronic
      platform. Once the sequence is entered, the randomization module will only be accessible
      using a confidential password. The randomization sequence will be kept confidential. It will
      be inaccessible to data collectors/outcome assessors and to the study participants.

      After completing the pre-intervention questionnaire, including demographic information and
      baseline outcome data, on the electronic data collection platform, participants will
      automatically be randomized to one of the study conditions (i.e., intervention or sham
      control) based on the randomization sequence. This process will be seamless to participants.
      After viewing the study condition materials, participants will be automatically directed to
      the first post-intervention questionnaire.

      Blinding: Using an electronic platform for data collection, study group allocation, and
      intervention viewing will allow participants to access the interventions and provide data
      independent of the research team. Participants will know they are viewing information on an
      iPad, but won't know how the content differs between groups because they will be using
      headphones. Participants and outcome assessors will not be able to determine group allocation
      and since all data is collected electronically there is no risk of unblinding during data
      collection, data cleaning and data analysis.

      Sample size estimate: Sample size calculations are not required for pilot/feasibility studies
      as hypothesis testing is not the focus of this research design. Rather, recruitment will take
      place over a 6-month period and will be evaluated for quantitative and qualitative components
      as part of the identified process outcome measures. This 6-month period is intended to
      reflect the seasonal nature of viral gastroenteritis, the most common cause of infection, in
      temperate climates. Recruitment will take place over the peak infection time of late winter.

      Philosophically, qualitative methods do not conduct prospective determinations of a sample
      size; instead, an adequate sample permits a deep, case oriented analysis that results in a
      new understanding of experience. In this study, 12-20 interviews with participants are
      anticipated to see patterns in experiences.

      Data collection:

        1. Pre-intervention questionnaire (baseline): Participants will complete a pre-intervention
           questionnaire that includes demographics, knowledge questionnaire, and Decision Regret
           Scale within the iCare Adventure platform on the iPad.

           **Participants will then be randomized to view the study intervention or the sham
           control intervention within the electronic platform on the iPad. This process will be
           seamless for the participants.

        2. Post-intervention questionnaire 1 (immediate): After viewing the intervention,
           participants will complete the knowledge questionnaire and Decision Regret Scale a
           second time. In addition, participants will complete 2 items assessing their own
           performance on the knowledge questionnaire and Decision Regret Scale and 1 item
           regarding the perceived value and benefit of the KT tool. They will also be asked if
           they would like a video link emailed to them. At the end of this questionnaire, parents
           will be informed that the post-intervention questionnaire 2 will be emailed to them 4
           days after this ED visit for completion at their earliest convenience. Experimental
           intervention group parents will be asked about participation in a qualitative focus
           group at this time.

        3. Post-intervention questionnaire 2 (4-14 days post-ED visit): Participants will be
           emailed a secure link on day 4 post-ED discharge to complete the knowledge questionnaire
           and Decision Regret Scale a third time 2 items assessing their own performance on the
           knowledge questionnaire and Decision Regret Scale, 3 items related to healthcare
           utilization, and 3 items related to the perceived value and benefit of the KT tool (if
           applicable). Reminders to complete post-intervention questionnaire 2 will be sent every
           third day (day 7, day 10, day 13). The last day for follow-up questionnaire completion
           will be 14 days post ED visit (10 days after follow-up survey sent to participant).
           Previous research has demonstrated that 82% of AGE cases are resolved in three days or
           less and 14 days represents the outer limit for pediatric AGE resolution.

        4. Post-intervention semi-structured interview (sub-sample of experimental group):
           Participants in the experimental group indicating willingness to participate in an
           in-depth, semi-structured, qualitative interview will be contacted via telephone after
           completion of post-intervention questionnaire 2. Up to three phone calls will be made to
           establish interview date/time. Qualitative interviews will take 30-60 minutes to
           complete and focus on satisfaction with the electronic data collection platform,
           perceived benefit and value of the KT intervention, and willingness to participate in
           future, similar research.

      Data analysis: All data will be aggregated and analyzed as per the Alberta Health Information
      Act. Quantitative data will be downloaded from a secure Canadian server to SPSS for data
      cleaning and analysis. Data cleaning measures may include recoding into categorical variables
      and comparing and recoding free text responses where appropriate. Descriptive statistics and
      estimation are the recommended focus of pilot/feasibility trials. Descriptive statistics
      (e.g., frequencies, measures of variation and spread, etc.) will be calculated to describe
      the study groups. Analyses will be conducted based on intention-to-treat overall and by site
      (Stollery, IWK) to identify any differences in the pattern of results.

      Qualitative data will be de-identified during verbatim transcription. Prior to analysis,
      transcripts will be verified by a member of the research team. Qualitative data will be
      managed and analyzed using NVivo data management software. Qualitative outcomes will be
      analyzed using thematic analysis by breaking interview text into small units for a detailed,
      nuanced account of the data. This iterative process will be concurrent to data collection.
      Thematic analysis will be guided by the hybrid approach of inductive and deductive coding and
      theme development described by Fereday & Muir-Cochrane (2006). Deductive coding of the
      interview transcripts will be done first using the semi-structured interview guide as a
      framework; smaller units of data that emerge inductively will be coded for increased
      granularity and specificity. To ensure analytic rigor, field notes will be collected during
      the data collection and analysis process and coded alongside interview data.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: knowledge questionnaire
time frame: 0-14 days (x3)
description: Measure 1 (quantitative) of potential effectiveness of the knowledge translation intervention
measure: Decision Regret Scale
time frame: 0-14 days (x3)
description: Measure 2 (quantitative) of potential effectiveness of the knowledge translation intervention
measure: Health care utilization
time frame: 4-14 days
description: Measure 3 (quantitative) of potential effectiveness of the knowledge translation intervention
measure: Perceived benefit and value of the knowledge translation intervention for pediatric AGE
time frame: 0-14 days (x2) and qualitative interview (experimental group only) after post-intervention 2 questionnaire
description: Measure 4 (qualitative) of potential effectiveness of the knowledge translation intervention
measure: Consent rate
time frame: 3 months
description: Measure 1 (quantitative) Feasibility of using an electronic data collection platform to conduct research with parents/caregivers
measure: Recruitment rate
time frame: 3 months
description: Measure 2 (quantitative) Feasibility of using an electronic data collection platform to conduct research with parents/caregivers
measure: Data completion rate
time frame: 3 months
description: Measure 3 (quantitative) Feasibility of using an electronic data collection platform to conduct research with parents/caregivers
measure: Satisfaction with electronic platform
time frame: Assessed during qualitative interview (experimental group only) after post-intervention 2 questionnaire
description: Measure 4 (qualitative) Feasibility of using an electronic data collection platform to conduct research with parents/caregivers
measure: Time (minutes) to complete study forms
time frame: 0-14 days
description: Measure 1 (quantitative) time to complete data collection
measure: Time (days) to complete follow-up questionnaire post-discharge
time frame: 0-14 days
description: Measure 2 (quantitative) time to complete data collection
measure: Number of technical problems with electronic platform during study period
time frame: 3 months
description: Data quality measure (quantitative)
measure: Number of technical problems as well as lost, stolen or damaged equipment during study period
time frame: 3 months
description: Measure 1 (quantitative) feasibility of using iPads to collect data in the emergency department with parents/caregivers
measure: Willingness to participate in future similar research
time frame: Assessed during qualitative interview after post-intervention 2 questionnaire
description: Qualitative measure
arm group label: Whiteboard animation video
arm group type: Experimental
description: 3 minute video on treatment, management of pediatric acute gastroenteritis
arm group label: Regular video
arm group type: Sham Comparator
description: 3 minute video on hand washing for infection control
intervention type: Behavioral
intervention name: Whiteboard animation video
description: Developed via qualitative research with parents of children with acute gastroenteritis.
arm group label: Whiteboard animation video
intervention type: Behavioral
intervention name: Regular video
description: Developed by CDC
arm group label: Regular video
criteria: 
gender: All
minimum age: N/A
maximum age: 16 Years
healthy volunteers: No
last name: Andre Grace, PhD
role: Principal Investigator
affiliation: University of Alberta (Supervisor)
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Alberta
investigator full name: Lauren Albrecht
investigator title: PhD Student
mesh term: Gastroenteritis
sharing ipd: No