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/NCT06005337</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00116449</org_study_id>
      <nct_id>NCT06005337</nct_id>
    </id_info>
    <brief_title>Supporting Parents to Choose Wisely</brief_title>
    <official_title>Supporting Parents to Choose Wisely: A Multi-Method Study to Increase Knowledge and Manage Expectations for Common Acute Childhood Conditions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alberta</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Women and Children's Health Research Institute, Canada</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Pediatric Parent Advisory Group (ARCHE and ECHO)</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>
        The goal of this multi-method study including a randomized control trial and qualitative&#xD;
        interviews is to see how useful blogshots (an image that summarizes information) are at&#xD;
        helping parents increase their knowledge and manage their expectations for common acute&#xD;
        childhood conditions (e.g. sore throat, ear infection) with respect to Choosing Wisely Canada&#xD;
        recommendations.&#xD;
  &#xD;
        Participants will be randomly assigned to Group A or Group B in this study. Group A will&#xD;
        receive three of six blogshots over a 4-week period (a different blogshot will be sent by&#xD;
        email to them each week for three weeks, then in the final week they will receive the same&#xD;
        three blogshots in one summary email to review). Group B will receive the other three of six&#xD;
        blogshots, following the same email sequence and timing. All participants from both groups&#xD;
        will be asked to complete one baseline questionnaire at the start of the study and a&#xD;
        follow-up questionnaire at week 5, month 3 and month 6 about different common acute childhood&#xD;
        conditions, the blogshots and their content. All participants also have the option to&#xD;
        participate in an optional semi-structured interview to give their thoughts on the blogshots&#xD;
        and their experience in the study.&#xD;
  &#xD;
        Researchers will compared each participant's baseline score to their follow up scores to see&#xD;
        if there was a change in their knowledge and expectations.&#xD;
  &#xD;
        By developing and evaluating evidence-based Choosing Wisely Canada resources, the researchers&#xD;
        aim to make it easier for parents to choose wisely. Empowering parents to be part of&#xD;
        conversations with their child's healthcare provider can improve health decision-making and&#xD;
        reduce health system costs.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Purpose and Justification&#xD;
  &#xD;
        A key driver of inappropriate care is patient expectations; that is, patients want something&#xD;
        done when they seek care, whether that be a diagnostic test or some form of intervention such&#xD;
        as a prescription.There is a growing body of literature providing evidence that increasing&#xD;
        knowledge and awareness among patients can influence their behaviours in terms of deciding to&#xD;
        seek care or expectations of healthcare professionals if they do seek care. Moreover,&#xD;
        behaviour theory indicates that precursors to behaviour change are awareness, knowledge, and&#xD;
        intentions. Knowledge translation (KT) is concerned with the communication of evidence to&#xD;
        improve such outcomes.&#xD;
  &#xD;
        In the context of pediatric healthcare, connecting parents and legal guardians to research&#xD;
        evidence has the power to improve health decision-making and reduce health system costs. The&#xD;
        heaviest users of unscheduled healthcare are children, who also make up a large proportion of&#xD;
        emergency department (ED) attendances that may have been treatable elsewhere (e.g. primary&#xD;
        care or home). There are multiple complex factors and circumstances that can influence&#xD;
        parents' decision-making regarding where, when and why they seek unscheduled healthcare for&#xD;
        their children. A recent systematic review highlighted that pressure to be seen as 'doing the&#xD;
        right thing' as a parent was related to care seeking. However, fear of wasting a doctor's&#xD;
        time for a minor illness was perceived as a barrier for seeking care. Subsequently, parents&#xD;
        and caregivers should be the target of efforts to promote empowerment. Parent empowerment can&#xD;
        be defined as the &quot;process through which parents are able to increase the control they have&#xD;
        over decisions and actions affecting their child's health&quot;. One mechanism for supporting and&#xD;
        empowering parents could be through KT of the Choosing Wisely Canada (CWC) recommendations.&#xD;
  &#xD;
        It has become increasingly clear that parents need knowledge and confidence to be involved in&#xD;
        healthcare decisions. CWC is a national movement launched in 2014 in partnership with the&#xD;
        Canadian Medical Association. The campaign aims to help physicians, patients and families&#xD;
        engage in conversations around unnecessary tests, treatments and procedures, which often do&#xD;
        more harm than good and result in significant waste in the Canadian healthcare system. The&#xD;
        central tenant to the movement is specialty-specific lists of &quot;Things Physicians and Patients&#xD;
        Should Question&quot; aimed to assist physicians and patients in making informed health choices.&#xD;
        Further, parents often seek care for these conditions either from their primary care provider&#xD;
        or through the ED, representing a large burden on healthcare resources. While there are a&#xD;
        number of pediatric specific CWC recommendations, there is currently no outward facing CWC&#xD;
        campaign that targets parents in the community.&#xD;
  &#xD;
        In the pediatric context, conditions such as ear infections, the common cold, sore throat,&#xD;
        bronchiolitis and asthma are extremely common among children in Canada. These are conditions&#xD;
        in which antibiotic treatment is usually unnecessary, however antibiotics are often&#xD;
        prescribed. The goal of this research team is to co-design with parents an intervention and&#xD;
        evaluation of CWC recommendations that align with common childhood conditions. The&#xD;
        investigators have previously evaluated different means of sharing health information with&#xD;
        parents and found that blogshots compared to plain language summaries and Wikipedia pages&#xD;
        showed significant differences in terms of parent preferences, knowledge and usability. This&#xD;
        study will include all four elements of the CWC patient engagement framework. The&#xD;
        investigators will partner and engage with parent stakeholders to design and create blogshots&#xD;
        that are tailored to parents. The investigators will then assess the effectiveness of the&#xD;
        blogshots http://s.nooro.com/choosingwisely at informing and educating parents on CWC&#xD;
        recommendations and empowering them to make educated, evidence-based choices for their&#xD;
        child's health. To the investigators' knowledge, this study will be the first of its kind in&#xD;
        Canada, and has the potential for widespread scale and implementation.&#xD;
  &#xD;
        Objective&#xD;
  &#xD;
        The study objective is to assess the effectiveness of blogshots to increase parent awareness,&#xD;
        knowledge and expectations with respect to CWC recommendations that align with common&#xD;
        childhood conditions.&#xD;
  &#xD;
        Research Methods/Procedures&#xD;
  &#xD;
        This is a multi-method study including a randomized control trial (RCT) and qualitative&#xD;
        interviews. While the RCT will provide quantitative estimates of effectiveness, the&#xD;
        qualitative component will help researchers understand how the intervention works. Ethics&#xD;
        approval will be sought through the University of Alberta Human Research Ethics Board (HREB).&#xD;
  &#xD;
        Recruitment: Recruitment will begin after the study has received ethics approval. The&#xD;
        research team will engage with the Pediatric Parent Advisory Group (P-PAG) to co-develop a&#xD;
        recruitment strategy with the target stakeholders. Parents will be recruited from across&#xD;
        Canada using an online approach. Recruitment will take place primarily via social media and&#xD;
        other networks such as the P-PAG and the Pediatric Parent Consultation Network (P-PCN) with&#xD;
        which there are established connections. The Alberta Research Centre for Health Evidence&#xD;
        (ARCHE) and Evidence in Child Health to enhance Outcomes (ECHO) research teams are well&#xD;
        positioned to perform social media recruitment as they have an established social media&#xD;
        presence on Twitter: @arche4evidence, @echoKTresearch, @ArcheEchoKT, Instagram:&#xD;
        arche4evidence, ArcheEchoKT, Echoktofficial, Facebook: Echo Research and Reddit:&#xD;
        u/ArcheEchoKT.&#xD;
  &#xD;
        A list of stakeholder networks has been developed with social media handles and the research&#xD;
        team will perform an extensive social media recruitment campaign. A recruitment email will be&#xD;
        sent to stakeholder groups in Canada to inform about the study and ask to share the study&#xD;
        materials with their contacts.&#xD;
  &#xD;
        Consent Process: Implied consent by overt action will be sought for the questionnaire portion&#xD;
        of the study. Participants will confirm consent by continuing on and completing the&#xD;
        questionnaire. Participants will be able to access and read the informed consent document and&#xD;
        have the option to download the consent form from the questionnaire platform hosted by Nooro.&#xD;
        For the qualitative interview portion, verbal consent will be obtained on Zoom video&#xD;
        conferencing software prior to starting the interview and documented in the study verbal&#xD;
        consent log.&#xD;
  &#xD;
        Study Design: RCT&#xD;
  &#xD;
        Participants will be randomized to two groups: Group A or Group B: each will receive messages&#xD;
        over 4 weeks that will consist of blogshots for different CWC recommendations. Participants&#xD;
        who complete the baseline questionnaire will receive one blogshot via email every week for&#xD;
        three weeks and the fourth week will include a summary of all three blogshots. This will be&#xD;
        automated through the Nooro platform. Through the Nooro platform, participants will be&#xD;
        monitored if they have opened the email and viewed the blogshots. If an email has not been&#xD;
        opened for 3 days, a reminder email will be sent. At the end of the four-week campaign,&#xD;
        participants will be asked to complete a follow-up questionnaire after the intervention at&#xD;
        week 5 and then at three and six months post-intervention.&#xD;
  &#xD;
        Randomization: Blocked randomization with randomly chosen block sizes will be used to ensure&#xD;
        equal distribution of participants to each study arm. The blocked randomization sequence will&#xD;
        be computer generated. Parents will be randomized to either group A or group B when&#xD;
        completing the demographic and baseline questionnaire on the electronic platform.&#xD;
  &#xD;
        Sample Size: The research team will aim to recruit 180 parents (90 participants per group).&#xD;
        This is based on assuming a 10% difference between groups in knowledge scores and a standard&#xD;
        deviation of 2.0 with 80% power. This would require&#xD;
  &#xD;
        Blogshot Development: Six blogshots were developed with the assistance of a graphic designer.&#xD;
        Members of the P-PAG provided feedback on the language, design and content of the blogshots.&#xD;
  &#xD;
        Online Questionnaire Development: The research team developed four questionnaires (baseline&#xD;
        and 3 follow-up questionnaires). The questionnaires consist of multiple choice knowledge&#xD;
        questions based on the information presented in the blogshots, questions about participant's&#xD;
        intentions for managing common acute childhood conditions and actions participants took if&#xD;
        their child developed symptoms of one of the conditions from the blogshot during the duration&#xD;
        of the study. A series of 7 questions about the usability of the blogshots will be included&#xD;
        in the questionnaire as well.&#xD;
  &#xD;
        The questionnaire is designed and housed in the Nooro platform (https://nooro.com). An&#xD;
        overview of each question category is listed below:&#xD;
  &#xD;
        Baseline Questions: Four baseline questions will be included about parent's experience with&#xD;
        the common acute childhood conditions included in the blogshots as well as number of times&#xD;
        they went to the emergency department or received a prescription for antibiotics for their&#xD;
        child. A question about information seeking is also included. These questions are asked at&#xD;
        baseline.&#xD;
  &#xD;
        Knowledge Questions: Each topic will have three &quot;core&quot; knowledge questions that will be&#xD;
        included at baseline and all three follow-up questionnaires. An additional knowledge question&#xD;
        will be included for each topic in which a participant received a blogshot. For example,&#xD;
        group A will receive one extra question for the sore throat swab, cough and cold medication&#xD;
        and bronchiolitis topic and group B will receive an extra question on acute otitis media,&#xD;
        asthma exacerbations and sore throat. These questions are asked at baseline, follow-up 1,&#xD;
        follow-up 2 and follow-up 3.&#xD;
  &#xD;
        Expectation Questions: Each blogshot topic will have 1 expectation question that asks parents&#xD;
        about their expectations from a healthcare provider on the management and treatment of each&#xD;
        condition. These questions are asked at baseline and follow-up 1.&#xD;
  &#xD;
        Intention Questions: Each blogshot topic will have one intention question that asks parents&#xD;
        about their intentions on the management and treatment of each condition. These questions are&#xD;
        asked at baseline and follow-up 1.&#xD;
  &#xD;
        Actions Questions: Participants will be asked about actions they took during the course of&#xD;
        the study in follow-up 2 and 3. For example if their child had symptoms related to&#xD;
        information in the blogshot and the actions they took i.e. went to a physician, filled a&#xD;
        prescription for antibiotics, etc.&#xD;
  &#xD;
        Usability Questions: Usability questions about the blogshot will be included at follow-up 1.&#xD;
        These are usability questions previously developed by ARCHE ECHO.&#xD;
  &#xD;
        Study Design: Qualitative Interviews&#xD;
  &#xD;
        Qualitative interviews will be conducted with a sub-set of participants (approx. 30). This&#xD;
        sample size is based on qualitative research methodology for performing on-one-one&#xD;
        interviews. Participants will be invited to participate in the semi-structured interview&#xD;
        while completing the week 5 follow-up questionnaire 1. Participants who are interested in&#xD;
        participating in an interview will leave their first name and email address and will be&#xD;
        contacted by the project coordinator to schedule an interview.&#xD;
  &#xD;
        The purpose of the interviews is to further understand and contextualize participant's&#xD;
        responses and perspectives on the efficacy of the blogshots to increase knowledge, influence&#xD;
        intended behaviour and expectations on the common acute childhood conditions. The honeycomb&#xD;
        model of user experience was used to guide the development of the interview questions. Parent&#xD;
        preferences were also explored regarding format and mode of information delivery and study&#xD;
        recruitment, which could inform future campaigns and evaluations.&#xD;
  &#xD;
        Incentives: Participants will be compensated a $10 Canadian (CAD) electronic gift card per&#xD;
        questionnaire completed (not including baseline) to a maximum of a $30 CAD electronic gift&#xD;
        card for completing all three follow-up questionnaires. For the qualitative component,&#xD;
        participants will be compensated an additional $25 CAD electronic gift card for participation&#xD;
        in the interview. This incentive will come in the form of an electronic CAD gift card to the&#xD;
        participant.&#xD;
  &#xD;
        Data Collection&#xD;
  &#xD;
        The following data will be collected over the course of the study:&#xD;
  &#xD;
          1. Baseline questionnaire: Participants will complete a pre-intervention questionnaire that&#xD;
             includes demographics, knowledge about antibiotic use and common acute childhood&#xD;
             conditions, intentions about whether they would seek healthcare for their child for a&#xD;
             common childhood condition and their expectations on management by healthcare providers.&#xD;
  &#xD;
          2. Follow-up questionnaire 1 (5 weeks after baseline): Participants will re-do all&#xD;
             knowledge, intentions and expectation questions as well as provide feedback on the&#xD;
             blogshot design.&#xD;
  &#xD;
          3. Follow-up questionnaire 2 (3 months after baseline): Participants will re-do knowledge&#xD;
             questions (knowledge retention). They will also be asked action questions about whether&#xD;
             their child experienced any of the conditions and what actions they took (e.g. sought&#xD;
             healthcare services, over the counter medications, filled prescriptions.&#xD;
  &#xD;
          4. Follow-up questionnaire 3 (6 months after baseline): Participants will re-do knowledge&#xD;
             questions and action questions.&#xD;
  &#xD;
          5. Qualitative Interviews (post intervention): Interviews will be conducted over zoom video&#xD;
             conferencing software and recorded, and transcribed using a third-party&#xD;
             transcriptionist.&#xD;
  &#xD;
        Plan for Data Analysis&#xD;
  &#xD;
        Questionnaire Data: Demographic data will be collected to evaluate how representative the&#xD;
        sample is to the Canadian population. Descriptive statistics, including numbers, frequencies,&#xD;
        and means will be used to present demographic data. Group differences will be evaluated using&#xD;
        independent t-test or chi squared and baseline and follow-up will be evaluated using paired&#xD;
        t-tests or Wilcoxon signed rank test, dependent on distribution of data. In all analyses,&#xD;
        statistical uncertainties will be expressed in 95% two-sided confidence intervals. A p value&#xD;
        of &lt;0.05 will indicate statistical significance. Analyses will be conducted based on&#xD;
        intention-to-treat.&#xD;
  &#xD;
        Interview Data: The project coordinator will perform and inductive thematic analysis of the&#xD;
        interview data. Interview coding and analysis will occur concurrently with data collection&#xD;
        using an iterative approach. In this approach, data will be categorized into codes, forming&#xD;
        categories that are then combined into themes that can be thoroughly described in the&#xD;
        results. Lincoln and Guba's criteria will be used to establish trustworthiness of the&#xD;
        analytic process. Qualitative data analysis software NVIVO will be used to organize and code&#xD;
        the data.&#xD;
  &#xD;
        Data Storage&#xD;
  &#xD;
        All data will be stored on secure Canadian servers that are compliant with data privacy and&#xD;
        security regulations to safeguard medical information as per the Health Insurance Portability&#xD;
        and Accountability Act of 1996. Data will initially be stored on the Nooro servers. Nooro is&#xD;
        a secure, password protected web application managed by Mr. Edward Knight in Barrie, Ontario.&#xD;
        This company has been used for previous research studies approved by the University of&#xD;
        Alberta Human Research Ethics Board. Data will be stored in locked racks at Pathway&#xD;
        Communications in Markham, ON. This Canadian data center is ISO 27001 certified, SOC2, PCI&#xD;
        and HIPAA compliant. The server is protected by a firewall and encryption technology, and is&#xD;
        backed up daily. Data will be downloaded regularly (e.g., weekly) by the researchers for&#xD;
        quality control, cleaning and analysis, and long term, secure storage. Once data collection&#xD;
        is complete, all data will be deleted from the Nooro servers.&#xD;
  &#xD;
        All digital materials (e.g., audio recordings, electronic documents) will be stored long-term&#xD;
        on a secure server in the PI 's faculty (Faculty of Medicine &amp; Dentistry) at the University&#xD;
        of Alberta. Upon completion of the study, the data will be archived on the Faculty of&#xD;
        Medicine &amp; Dentistry server. The Faculty of Medicine &amp; Dentistry has shared secured drives&#xD;
        accessible by password-protected computers and the data will not be accessible to anyone&#xD;
        outside of the research team. Hard copy files will not be stored. De-identified data will be&#xD;
        kept for a minimum of 5 years. Participants' email addresses and first names will be&#xD;
        collected for purposes of sending the follow-up questionnaire, reminders for completing the&#xD;
        follow-up questionnaire, and links to the blogshots used in the study. Participants' email&#xD;
        addresses and first names will be removed from the data files once data collection is&#xD;
        complete. In reporting of the results, individual participants will not be identified by name&#xD;
        or be identifiable by their responses.&#xD;
  &#xD;
        Zoom interview data will be captured and stored locally, then transferred between the&#xD;
        research team and the third-party, transcription contractor via a secure, online portal.&#xD;
        Transcripts will be de-identified. All data will be transferred to the researchers for&#xD;
        analysis and long term, secure storage, and deleted by the third-party contractor once&#xD;
        transcription is complete. Master participant lists will be stored on a secure Canadian&#xD;
        server only accessible to the research team.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 5, 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>Participants will be randomly assigned to Group A or Group B in this study.&#xD;
  Group A will receive three of six blogshots over a 4-week period (a different blogshot will be sent by email to them each week for three weeks, then in the final week they will receive the same three blogshots in one summary email to review). Group B will receive the other three of six blogshots, following the same email sequence and timing. The reason for assigning them into a group is to help us evenly share the blogshots between all participants. Each group will act as their own control.&#xD;
  All participants from both groups will be asked to complete one baseline questionnaire at the start of the study and a follow-up questionnaire at week 5, month 3 and month 6 about different common acute childhood conditions, the blogshots and their content.&#xD;
  All participants can also participate in an optional semi-structured interview to give their thoughts on the blogshots and their experience in the study.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Knowledge - Quantitative true/false</measure>
      <time_frame>baseline (week 0), follow-up 1 (week 5), follow-up 2 (month 3), follow-up 3 (month 6)</time_frame>
      <description>Primary outcome will be knowledge. Change will be compared from baseline between groups (i.e. average change in knowledge scores specific to Choosing Wisely recommendations, expecting that knowledge will improve with respect to the content received).&#xD;
  There will be 8 'true/false' questions to assess knowledge. Each question is worth 2 points.&#xD;
  Knowledge will be assessed by comparing participant's scores on baseline to follow-up 1 (knowledge change) and comparing scores to follow-up 2 and 3 (knowledge retention).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knowledge - Quantitative Multiple Choice</measure>
      <time_frame>baseline (week 0), follow-up 1 (week 5), follow-up 2 (month 3), follow-up 3 (month 6)</time_frame>
      <description>Primary outcome will be knowledge. Change will be compared from baseline between groups (i.e. average change in knowledge scores specific to Choosing Wisely recommendations, expecting that knowledge will improve with respect to the content received).&#xD;
  There will be 7 'multiple choice' questions to assess knowledge. Each question is worth 2 points.&#xD;
  Knowledge will be assessed by comparing participant's scores on baseline to follow-up 1 (knowledge change) and comparing scores to follow-up 2 and 3 (knowledge retention).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knowledge - Quantitative Select all that apply</measure>
      <time_frame>baseline (week 0), follow-up 1 (week 5), follow-up 2 (month 3), follow-up 3 (month 6)</time_frame>
      <description>Primary outcome will be knowledge. Change will be compared from baseline between groups (i.e. average change in knowledge scores specific to Choosing Wisely recommendations, expecting that knowledge will improve with respect to the content received).&#xD;
  There will be 6 'select all that apply' questions to assess knowledge. Each question is worth 2 points.&#xD;
  Knowledge will be assessed by comparing participant's scores on baseline to follow-up 1 (knowledge change) and comparing scores to follow-up 2 and 3 (knowledge retention).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knowledge - Quantitative</measure>
      <time_frame>baseline (week 0), follow-up 1 (week 5), follow-up 2 (month 3), follow-up 3 (month 6)</time_frame>
      <description>Primary outcome will be knowledge. Change will be compared from baseline between groups (i.e. average change in knowledge scores specific to Choosing Wisely recommendations, expecting that knowledge will improve with respect to the content received). The outcome will be assessed two ways:&#xD;
  1. Quantitatively via questionnaires:&#xD;
  21 knowledge questions with about 8 'true/false', 7 'multiple choice' and 6 'select all that apply' in each questionnaire (baseline, follow-up 1, 2 &amp; 3). Each question is worth 2 points, total score per questionnaire ranging from 0-42 pts.&#xD;
  Knowledge will be assessed by comparing participant's scores on baseline to follow-up 1 (knowledge change) and comparing scores to follow-up 2 and 3 (knowledge retention).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knowledge - Qualitative</measure>
      <time_frame>interviews will be conducted between week 5 - month 3</time_frame>
      <description>Interviews will be used to clarify, expand on and provide to context to the questionnaire responses - two open-ended questions addressing knowledge and will undergo thematic analysis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Intentions - Quantitative Likert</measure>
      <time_frame>week 0 (baseline), week 5 (follow-up 1)</time_frame>
      <description>A secondary outcome will be intentions. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).&#xD;
  Participants will be asked questions about their intentions at baseline and follow-up 1 when they seek healthcare i.e. are they seeking antibiotics from a healthcare professional.&#xD;
  This includes 4 questions based on a five-point Likert scale (strongly agree to strongly disagree)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intentions - Quantitative Multiple Choice</measure>
      <time_frame>week 0 (baseline), week 5 (follow-up 1)</time_frame>
      <description>A secondary outcome will be intentions. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).&#xD;
  Participants will be asked questions about their intentions at baseline and follow-up 1 when they seek healthcare i.e. are they seeking antibiotics from a healthcare professional.&#xD;
  This includes 2 questions that are 'multiple choice'.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intentions - Qualitative</measure>
      <time_frame>interviews will be conducted between week 5 - month 3</time_frame>
      <description>Interviews will be used to clarify, expand on and provide to context to the questionnaire responses - three open-ended questions addressing intentions and will undergo thematic analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Expectations of care - quantitative</measure>
      <time_frame>week 0 (baseline), week 5 (follow-up 1)</time_frame>
      <description>A secondary outcome will be expectations of care. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).&#xD;
  Participants will be asked questions about their expectations of healthcare professionals at baseline and follow-up 1 questionnaires. The research team will compare at baseline and follow up 1 to assess if the blogshots led to a change in expectations of healthcare professionals.&#xD;
  There are 6 expectation questions in each questionnaire for baseline and follow-up 1. All questions are based on a five-point Likert scale (strongly agree to strongly disagree).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Expectations of care - qualitative</measure>
      <time_frame>interviews will be conducted between week 5 - month 3</time_frame>
      <description>A secondary outcome will be expectations of care. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).&#xD;
  Interviews will be used to clarify, expand on and provide to context to the questionnaire responses - one open-ended question addressing expectations and will undergo thematic analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Usability of the blogshots - Likert</measure>
      <time_frame>week 5 (follow-up 1)</time_frame>
      <description>A secondary outcome will be usability of the blogshots. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).&#xD;
  Participants will complete usability questions about the blogshots focusing on topics such as if the blogshots increase knowledge, aid in decision-making and are relevant to parents.&#xD;
  This includes 5 questions based on a five-point Likert scale (strongly agree to strongly disagree)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Usability of the blogshots - open ended questions</measure>
      <time_frame>week 5 (follow-up 1)</time_frame>
      <description>A secondary outcome will be usability of the blogshots. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).&#xD;
  Participants will complete usability questions about the blogshots focusing on topics such as if the blogshots increase knowledge, aid in decision-making and are relevant to parents. This will be completed at follow-up 1.&#xD;
  This includes two open-ended questions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Usability of the blogshots - qualitative</measure>
      <time_frame>interviews will be conducted between week 5 - month 3</time_frame>
      <description>A secondary outcome will be usability of the blogshots. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).&#xD;
  Interviews will be used to clarify, expand on and provide to context to the questionnaire responses - four open-ended questions addressing usability and will undergo thematic analysis.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Common Cold</condition>
    <condition>Pharyngitis</condition>
    <condition>Acute Otitis Media</condition>
    <condition>Acute Asthma</condition>
    <condition>Bronchiolitis</condition>
    <condition>Pediatric ALL</condition>
    <condition>Parents</condition>
    <arm_group>
      <arm_group_label>Group A - Sore Throat Swab, Cough and Cold, Asthma</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group A will receive three of six blogshots (different to Group B) over a 4-week period (a different blogshot will be sent by email to them each week for three weeks, then in the final week they will receive the same three blogshots in one summary email to review). They will act as their own control group.&#xD;
  All participants from both groups will be asked to complete one baseline questionnaire at the start of the study and a follow-up questionnaire at week 5, month 3 and month 6 about different common acute childhood conditions, the blogshots and their content.&#xD;
  All participants can also participate in an optional semi-structured interview to give their thoughts on the blogshots and their experience in the study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B - Ear Infection, Bronchiolitis, Antibiotics for Sore Throat</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group B will receive three of six blogshots (different to Group A) over a 4-week period (a different blogshot will be sent by email to them each week for three weeks, then in the final week they will receive the same three blogshots in one summary email to review). They will act as their own control group.&#xD;
  All participants from both groups will be asked to complete one baseline questionnaire at the start of the study and a follow-up questionnaire at week 5, month 3 and month 6 about different common acute childhood conditions, the blogshots and their content.&#xD;
  All participants can also participate in an optional semi-structured interview to give their thoughts on the blogshots and their experience in the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Blogshots 1-3</intervention_name>
      <description>Don't routinely do a throat swab when children present with a sore throat if they have a cough, rhinitis, or hoarseness&#xD;
  Don't recommend the use of cough and cold remedies in children under six years of age&#xD;
  Don't use antibiotics for acute asthma exacerbations without clear signs of bacterial infection</description>
      <arm_group_label>Group A - Sore Throat Swab, Cough and Cold, Asthma</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Blogshots 4-6</intervention_name>
      <description>Don't routinely use antibiotics in children with uncomplicated sore throats&#xD;
  Don't prescribe antibiotics in adults with bronchitis/asthma and children with bronchiolitis&#xD;
  Don't use antibiotics in adults and children with uncomplicated acute otitis media</description>
      <arm_group_label>Group B - Ear Infection, Bronchiolitis, Antibiotics for Sore Throat</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Over the age of 18 years&#xD;
  &#xD;
            -  Parent or legal guardian of a child under 5 years of age&#xD;
  &#xD;
            -  Live in Canada&#xD;
  &#xD;
            -  Able to complete the questionnaire and interview in English (speak/read)&#xD;
  &#xD;
            -  Access to an electronic device (e.g. computer, tablet or smart phone), Internet and&#xD;
               email.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Under the age of 18 years&#xD;
  &#xD;
            -  Does not identify as a parent or legal guardian of a child under 5 years of age&#xD;
  &#xD;
            -  Does not live in Canada&#xD;
  &#xD;
            -  Unable to complete the interview and questionnaire in English (speak/read)&#xD;
  &#xD;
            -  No access to an electronic device (e.g. computer, tablet or smart phone), Internet and&#xD;
               email.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lisa Hartling, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Alberta</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sarah Elliott, PhD</last_name>
      <phone>(780) 492-1241</phone>
      <email>se2@ualberta.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Samantha Cyrkot, MsC</last_name>
      <email>scyrkot@ualberta.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Alberta</name>
        <address>
          <city>Edmonton</city>
          <state>Alberta</state>
          <zip>T6G 2R3</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lisa Hartling, PhD</last_name>
        <phone>(780) 492-6124</phone>
        <email>hartling@ualberta.ca</email>
      </contact>
      <contact_backup>
        <last_name>Sarah Elliott, PhD</last_name>
        <phone>(780) 492-1241</phone>
        <email>se2@ualberta.ca</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <link>
      <url>http://semanticstudios.com/user_experience_design/</url>
      <description>Morville P. User Experience Design.</description>
    </link>
    <reference>
      <citation>Anzinger H, Elliott SA, Hartling L. Comparative Usability Analysis and Parental Preferences of Three Web-Based Knowledge Translation Tools: Multimethod Study. J Med Internet Res. 2020 Mar 13;22(3):e14562. doi: 10.2196/14562.</citation>
      <PMID>32167478</PMID>
    </reference>
    <reference>
      <citation>Born KB, Coulter A, Han A, Ellen M, Peul W, Myres P, Lindner R, Wolfson D, Bhatia RS, Levinson W. Engaging patients and the public in Choosing Wisely. BMJ Qual Saf. 2017 Aug;26(8):687-691. doi: 10.1136/bmjqs-2017-006595. Epub 2017 Jun 9. No abstract available.</citation>
      <PMID>28600453</PMID>
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      <PMID>7899572</PMID>
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      <citation>Montori VM, Guyatt GH. Intention-to-treat principle. CMAJ. 2001 Nov 13;165(10):1339-41. No abstract available.</citation>
      <PMID>11760981</PMID>
    </reference>
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      <citation>Nisson C, Earl A. The Theories of Reasoned Action and Planned Behavior, in The Wiley Encyclopedia of Health Psychology. 2020. p. 55-761.</citation>
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      <citation>Ogden J, Karim L, Choudry A, Brown K. Understanding successful behaviour change: the role of intentions, attitudes to the target and motivations and the example of diet. Health Educ Res. 2007 Jun;22(3):397-405. doi: 10.1093/her/cyl090. Epub 2006 Sep 13.</citation>
      <PMID>16971672</PMID>
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      <citation>Michie S, Johnson BT, Johnston M. Advancing cumulative evidence on behaviour change techniques and interventions: a comment on Peters, de Bruin, and Crutzen. Health Psychol Rev. 2015;9(1):25-9. doi: 10.1080/17437199.2014.912538. Epub 2014 May 2. No abstract available.</citation>
      <PMID>25793487</PMID>
    </reference>
    <reference>
      <citation>Albrecht L, Scott SD, Hartling L. Knowledge translation tools for parents on child health topics: a scoping review. BMC Health Serv Res. 2017 Sep 29;17(1):686. doi: 10.1186/s12913-017-2632-2.</citation>
      <PMID>28962637</PMID>
    </reference>
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      <citation>Gerolamo AM, Jutel A, Kovalsky D, Gentsch A, Doty AMB, Rising KL. Patient-Identified Needs Related to Seeking a Diagnosis in the Emergency Department. Ann Emerg Med. 2018 Sep;72(3):282-288. doi: 10.1016/j.annemergmed.2018.02.021.</citation>
      <PMID>29764689</PMID>
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      <citation>Lateef F. Patient expectations and the paradigm shift of care in emergency medicine. J Emerg Trauma Shock. 2011 Apr;4(2):163-7. doi: 10.4103/0974-2700.82199.</citation>
      <PMID>21769199</PMID>
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      <citation>Sharot T, Sunstein CR. How people decide what they want to know. Nat Hum Behav. 2020 Jan;4(1):14-19. doi: 10.1038/s41562-019-0793-1. Epub 2020 Jan 13.</citation>
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      <citation>Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.</citation>
      <PMID>23381511</PMID>
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      <citation>McHale P, Wood S, Hughes K, Bellis MA, Demnitz U, Wyke S. Who uses emergency departments inappropriately and when - a national cross-sectional study using a monitoring data system. BMC Med. 2013 Dec 13;11:258. doi: 10.1186/1741-7015-11-258.</citation>
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      <citation>Nicholson E, McDonnell T, De Brun A, Barrett M, Bury G, Collins C, Hensey C, McAuliffe E. Factors that influence family and parental preferences and decision making for unscheduled paediatric healthcare - systematic review. BMC Health Serv Res. 2020 Jul 17;20(1):663. doi: 10.1186/s12913-020-05527-5.</citation>
      <PMID>32680518</PMID>
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      <citation>Nyquist AC, Gonzales R, Steiner JF, Sande MA. Antibiotic prescribing for children with colds, upper respiratory tract infections, and bronchitis. JAMA. 1998 Mar 18;279(11):875-7. doi: 10.1001/jama.279.11.875. Erratum In: JAMA 1998 Jun 3;279(21):1702.</citation>
      <PMID>9516004</PMID>
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      <PMID>29937585</PMID>
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      <citation>Ltd, Q.S.R.I.P., NVivo qualitative data analysis software. Version 10, 2012.</citation>
    </reference>
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      <citation>Ashcraft LE, Asato M, Houtrow AJ, Kavalieratos D, Miller E, Ray KN. Parent Empowerment in Pediatric Healthcare Settings: A Systematic Review of Observational Studies. Patient. 2019 Apr;12(2):199-212. doi: 10.1007/s40271-018-0336-2.</citation>
      <PMID>30328069</PMID>
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      <citation>Hartling L, Elliott SA, Buckreus K, Leung J, Scott SD. Development and evaluation of a parent advisory group to inform a research program for knowledge translation in child health. Res Involv Engagem. 2021 Jun 7;7(1):38. doi: 10.1186/s40900-021-00280-3.</citation>
      <PMID>34099069</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Common Acute Childhood Conditions</keyword>
    <keyword>Choosing Wisely Canada</keyword>
    <keyword>Blogshots</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bronchiolitis</mesh_term>
      <mesh_term>Common Cold</mesh_term>
      <mesh_term>Pharyngitis</mesh_term>
      <mesh_term>Otitis Media</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <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>July 19, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT06005337/Prot_SAP_000.pdf</document_url>
      </provided_document>
      <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>January 19, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT06005337/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06005337
  org study id: Pro00116449
  nct id: NCT06005337
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this multi-method study including a randomized control trial and qualitative
        interviews is to see how useful blogshots (an image that summarizes information) are at
        helping parents increase their knowledge and manage their expectations for common acute
        childhood conditions (e.g. sore throat, ear infection) with respect to Choosing Wisely Canada
        recommendations.
  
        Participants will be randomly assigned to Group A or Group B in this study. Group A will
        receive three of six blogshots over a 4-week period (a different blogshot will be sent by
        email to them each week for three weeks, then in the final week they will receive the same
        three blogshots in one summary email to review). Group B will receive the other three of six
        blogshots, following the same email sequence and timing. All participants from both groups
        will be asked to complete one baseline questionnaire at the start of the study and a
        follow-up questionnaire at week 5, month 3 and month 6 about different common acute childhood
        conditions, the blogshots and their content. All participants also have the option to
        participate in an optional semi-structured interview to give their thoughts on the blogshots
        and their experience in the study.
  
        Researchers will compared each participant's baseline score to their follow up scores to see
        if there was a change in their knowledge and expectations.
  
        By developing and evaluating evidence-based Choosing Wisely Canada resources, the researchers
        aim to make it easier for parents to choose wisely. Empowering parents to be part of
        conversations with their child's healthcare provider can improve health decision-making and
        reduce health system costs.
  Purpose and Justification
  
        A key driver of inappropriate care is patient expectations; that is, patients want something
        done when they seek care, whether that be a diagnostic test or some form of intervention such
        as a prescription.There is a growing body of literature providing evidence that increasing
        knowledge and awareness among patients can influence their behaviours in terms of deciding to
        seek care or expectations of healthcare professionals if they do seek care. Moreover,
        behaviour theory indicates that precursors to behaviour change are awareness, knowledge, and
        intentions. Knowledge translation (KT) is concerned with the communication of evidence to
        improve such outcomes.
  
        In the context of pediatric healthcare, connecting parents and legal guardians to research
        evidence has the power to improve health decision-making and reduce health system costs. The
        heaviest users of unscheduled healthcare are children, who also make up a large proportion of
        emergency department (ED) attendances that may have been treatable elsewhere (e.g. primary
        care or home). There are multiple complex factors and circumstances that can influence
        parents' decision-making regarding where, when and why they seek unscheduled healthcare for
        their children. A recent systematic review highlighted that pressure to be seen as 'doing the
        right thing' as a parent was related to care seeking. However, fear of wasting a doctor's
        time for a minor illness was perceived as a barrier for seeking care. Subsequently, parents
        and caregivers should be the target of efforts to promote empowerment. Parent empowerment can
        be defined as the "process through which parents are able to increase the control they have
        over decisions and actions affecting their child's health". One mechanism for supporting and
        empowering parents could be through KT of the Choosing Wisely Canada (CWC) recommendations.
  
        It has become increasingly clear that parents need knowledge and confidence to be involved in
        healthcare decisions. CWC is a national movement launched in 2014 in partnership with the
        Canadian Medical Association. The campaign aims to help physicians, patients and families
        engage in conversations around unnecessary tests, treatments and procedures, which often do
        more harm than good and result in significant waste in the Canadian healthcare system. The
        central tenant to the movement is specialty-specific lists of "Things Physicians and Patients
        Should Question" aimed to assist physicians and patients in making informed health choices.
        Further, parents often seek care for these conditions either from their primary care provider
        or through the ED, representing a large burden on healthcare resources. While there are a
        number of pediatric specific CWC recommendations, there is currently no outward facing CWC
        campaign that targets parents in the community.
  
        In the pediatric context, conditions such as ear infections, the common cold, sore throat,
        bronchiolitis and asthma are extremely common among children in Canada. These are conditions
        in which antibiotic treatment is usually unnecessary, however antibiotics are often
        prescribed. The goal of this research team is to co-design with parents an intervention and
        evaluation of CWC recommendations that align with common childhood conditions. The
        investigators have previously evaluated different means of sharing health information with
        parents and found that blogshots compared to plain language summaries and Wikipedia pages
        showed significant differences in terms of parent preferences, knowledge and usability. This
        study will include all four elements of the CWC patient engagement framework. The
        investigators will partner and engage with parent stakeholders to design and create blogshots
        that are tailored to parents. The investigators will then assess the effectiveness of the
        blogshots http://s.nooro.com/choosingwisely at informing and educating parents on CWC
        recommendations and empowering them to make educated, evidence-based choices for their
        child's health. To the investigators' knowledge, this study will be the first of its kind in
        Canada, and has the potential for widespread scale and implementation.
  
        Objective
  
        The study objective is to assess the effectiveness of blogshots to increase parent awareness,
        knowledge and expectations with respect to CWC recommendations that align with common
        childhood conditions.
  
        Research Methods/Procedures
  
        This is a multi-method study including a randomized control trial (RCT) and qualitative
        interviews. While the RCT will provide quantitative estimates of effectiveness, the
        qualitative component will help researchers understand how the intervention works. Ethics
        approval will be sought through the University of Alberta Human Research Ethics Board (HREB).
  
        Recruitment: Recruitment will begin after the study has received ethics approval. The
        research team will engage with the Pediatric Parent Advisory Group (P-PAG) to co-develop a
        recruitment strategy with the target stakeholders. Parents will be recruited from across
        Canada using an online approach. Recruitment will take place primarily via social media and
        other networks such as the P-PAG and the Pediatric Parent Consultation Network (P-PCN) with
        which there are established connections. The Alberta Research Centre for Health Evidence
        (ARCHE) and Evidence in Child Health to enhance Outcomes (ECHO) research teams are well
        positioned to perform social media recruitment as they have an established social media
        presence on Twitter: @arche4evidence, @echoKTresearch, @ArcheEchoKT, Instagram:
        arche4evidence, ArcheEchoKT, Echoktofficial, Facebook: Echo Research and Reddit:
        u/ArcheEchoKT.
  
        A list of stakeholder networks has been developed with social media handles and the research
        team will perform an extensive social media recruitment campaign. A recruitment email will be
        sent to stakeholder groups in Canada to inform about the study and ask to share the study
        materials with their contacts.
  
        Consent Process: Implied consent by overt action will be sought for the questionnaire portion
        of the study. Participants will confirm consent by continuing on and completing the
        questionnaire. Participants will be able to access and read the informed consent document and
        have the option to download the consent form from the questionnaire platform hosted by Nooro.
        For the qualitative interview portion, verbal consent will be obtained on Zoom video
        conferencing software prior to starting the interview and documented in the study verbal
        consent log.
  
        Study Design: RCT
  
        Participants will be randomized to two groups: Group A or Group B: each will receive messages
        over 4 weeks that will consist of blogshots for different CWC recommendations. Participants
        who complete the baseline questionnaire will receive one blogshot via email every week for
        three weeks and the fourth week will include a summary of all three blogshots. This will be
        automated through the Nooro platform. Through the Nooro platform, participants will be
        monitored if they have opened the email and viewed the blogshots. If an email has not been
        opened for 3 days, a reminder email will be sent. At the end of the four-week campaign,
        participants will be asked to complete a follow-up questionnaire after the intervention at
        week 5 and then at three and six months post-intervention.
  
        Randomization: Blocked randomization with randomly chosen block sizes will be used to ensure
        equal distribution of participants to each study arm. The blocked randomization sequence will
        be computer generated. Parents will be randomized to either group A or group B when
        completing the demographic and baseline questionnaire on the electronic platform.
  
        Sample Size: The research team will aim to recruit 180 parents (90 participants per group).
        This is based on assuming a 10% difference between groups in knowledge scores and a standard
        deviation of 2.0 with 80% power. This would require
  
        Blogshot Development: Six blogshots were developed with the assistance of a graphic designer.
        Members of the P-PAG provided feedback on the language, design and content of the blogshots.
  
        Online Questionnaire Development: The research team developed four questionnaires (baseline
        and 3 follow-up questionnaires). The questionnaires consist of multiple choice knowledge
        questions based on the information presented in the blogshots, questions about participant's
        intentions for managing common acute childhood conditions and actions participants took if
        their child developed symptoms of one of the conditions from the blogshot during the duration
        of the study. A series of 7 questions about the usability of the blogshots will be included
        in the questionnaire as well.
  
        The questionnaire is designed and housed in the Nooro platform (https://nooro.com). An
        overview of each question category is listed below:
  
        Baseline Questions: Four baseline questions will be included about parent's experience with
        the common acute childhood conditions included in the blogshots as well as number of times
        they went to the emergency department or received a prescription for antibiotics for their
        child. A question about information seeking is also included. These questions are asked at
        baseline.
  
        Knowledge Questions: Each topic will have three "core" knowledge questions that will be
        included at baseline and all three follow-up questionnaires. An additional knowledge question
        will be included for each topic in which a participant received a blogshot. For example,
        group A will receive one extra question for the sore throat swab, cough and cold medication
        and bronchiolitis topic and group B will receive an extra question on acute otitis media,
        asthma exacerbations and sore throat. These questions are asked at baseline, follow-up 1,
        follow-up 2 and follow-up 3.
  
        Expectation Questions: Each blogshot topic will have 1 expectation question that asks parents
        about their expectations from a healthcare provider on the management and treatment of each
        condition. These questions are asked at baseline and follow-up 1.
  
        Intention Questions: Each blogshot topic will have one intention question that asks parents
        about their intentions on the management and treatment of each condition. These questions are
        asked at baseline and follow-up 1.
  
        Actions Questions: Participants will be asked about actions they took during the course of
        the study in follow-up 2 and 3. For example if their child had symptoms related to
        information in the blogshot and the actions they took i.e. went to a physician, filled a
        prescription for antibiotics, etc.
  
        Usability Questions: Usability questions about the blogshot will be included at follow-up 1.
        These are usability questions previously developed by ARCHE ECHO.
  
        Study Design: Qualitative Interviews
  
        Qualitative interviews will be conducted with a sub-set of participants (approx. 30). This
        sample size is based on qualitative research methodology for performing on-one-one
        interviews. Participants will be invited to participate in the semi-structured interview
        while completing the week 5 follow-up questionnaire 1. Participants who are interested in
        participating in an interview will leave their first name and email address and will be
        contacted by the project coordinator to schedule an interview.
  
        The purpose of the interviews is to further understand and contextualize participant's
        responses and perspectives on the efficacy of the blogshots to increase knowledge, influence
        intended behaviour and expectations on the common acute childhood conditions. The honeycomb
        model of user experience was used to guide the development of the interview questions. Parent
        preferences were also explored regarding format and mode of information delivery and study
        recruitment, which could inform future campaigns and evaluations.
  
        Incentives: Participants will be compensated a $10 Canadian (CAD) electronic gift card per
        questionnaire completed (not including baseline) to a maximum of a $30 CAD electronic gift
        card for completing all three follow-up questionnaires. For the qualitative component,
        participants will be compensated an additional $25 CAD electronic gift card for participation
        in the interview. This incentive will come in the form of an electronic CAD gift card to the
        participant.
  
        Data Collection
  
        The following data will be collected over the course of the study:
  
          1. Baseline questionnaire: Participants will complete a pre-intervention questionnaire that
             includes demographics, knowledge about antibiotic use and common acute childhood
             conditions, intentions about whether they would seek healthcare for their child for a
             common childhood condition and their expectations on management by healthcare providers.
  
          2. Follow-up questionnaire 1 (5 weeks after baseline): Participants will re-do all
             knowledge, intentions and expectation questions as well as provide feedback on the
             blogshot design.
  
          3. Follow-up questionnaire 2 (3 months after baseline): Participants will re-do knowledge
             questions (knowledge retention). They will also be asked action questions about whether
             their child experienced any of the conditions and what actions they took (e.g. sought
             healthcare services, over the counter medications, filled prescriptions.
  
          4. Follow-up questionnaire 3 (6 months after baseline): Participants will re-do knowledge
             questions and action questions.
  
          5. Qualitative Interviews (post intervention): Interviews will be conducted over zoom video
             conferencing software and recorded, and transcribed using a third-party
             transcriptionist.
  
        Plan for Data Analysis
  
        Questionnaire Data: Demographic data will be collected to evaluate how representative the
        sample is to the Canadian population. Descriptive statistics, including numbers, frequencies,
        and means will be used to present demographic data. Group differences will be evaluated using
        independent t-test or chi squared and baseline and follow-up will be evaluated using paired
        t-tests or Wilcoxon signed rank test, dependent on distribution of data. In all analyses,
        statistical uncertainties will be expressed in 95% two-sided confidence intervals. A p value
        of <0.05 will indicate statistical significance. Analyses will be conducted based on
        intention-to-treat.
  
        Interview Data: The project coordinator will perform and inductive thematic analysis of the
        interview data. Interview coding and analysis will occur concurrently with data collection
        using an iterative approach. In this approach, data will be categorized into codes, forming
        categories that are then combined into themes that can be thoroughly described in the
        results. Lincoln and Guba's criteria will be used to establish trustworthiness of the
        analytic process. Qualitative data analysis software NVIVO will be used to organize and code
        the data.
  
        Data Storage
  
        All data will be stored on secure Canadian servers that are compliant with data privacy and
        security regulations to safeguard medical information as per the Health Insurance Portability
        and Accountability Act of 1996. Data will initially be stored on the Nooro servers. Nooro is
        a secure, password protected web application managed by Mr. Edward Knight in Barrie, Ontario.
        This company has been used for previous research studies approved by the University of
        Alberta Human Research Ethics Board. Data will be stored in locked racks at Pathway
        Communications in Markham, ON. This Canadian data center is ISO 27001 certified, SOC2, PCI
        and HIPAA compliant. The server is protected by a firewall and encryption technology, and is
        backed up daily. Data will be downloaded regularly (e.g., weekly) by the researchers for
        quality control, cleaning and analysis, and long term, secure storage. Once data collection
        is complete, all data will be deleted from the Nooro servers.
  
        All digital materials (e.g., audio recordings, electronic documents) will be stored long-term
        on a secure server in the PI 's faculty (Faculty of Medicine & Dentistry) at the University
        of Alberta. Upon completion of the study, the data will be archived on the Faculty of
        Medicine & Dentistry server. The Faculty of Medicine & Dentistry has shared secured drives
        accessible by password-protected computers and the data will not be accessible to anyone
        outside of the research team. Hard copy files will not be stored. De-identified data will be
        kept for a minimum of 5 years. Participants' email addresses and first names will be
        collected for purposes of sending the follow-up questionnaire, reminders for completing the
        follow-up questionnaire, and links to the blogshots used in the study. Participants' email
        addresses and first names will be removed from the data files once data collection is
        complete. In reporting of the results, individual participants will not be identified by name
        or be identifiable by their responses.
  
        Zoom interview data will be captured and stored locally, then transferred between the
        research team and the third-party, transcription contractor via a secure, online portal.
        Transcripts will be de-identified. All data will be transferred to the researchers for
        analysis and long term, secure storage, and deleted by the third-party contractor once
        transcription is complete. Master participant lists will be stored on a secure Canadian
        server only accessible to the research team.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomly assigned to Group A or Group B in this study.
  Group A will receive three of six blogshots over a 4-week period (a different blogshot will be sent by email to them each week for three weeks, then in the final week they will receive the same three blogshots in one summary email to review). Group B will receive the other three of six blogshots, following the same email sequence and timing. The reason for assigning them into a group is to help us evenly share the blogshots between all participants. Each group will act as their own control.
  All participants from both groups will be asked to complete one baseline questionnaire at the start of the study and a follow-up questionnaire at week 5, month 3 and month 6 about different common acute childhood conditions, the blogshots and their content.
  All participants can also participate in an optional semi-structured interview to give their thoughts on the blogshots and their experience in the study.
  primary purpose: Other
  masking: None (Open Label)
  measure: Knowledge - Quantitative true/false
  time frame: baseline (week 0), follow-up 1 (week 5), follow-up 2 (month 3), follow-up 3 (month 6)
  description: Primary outcome will be knowledge. Change will be compared from baseline between groups (i.e. average change in knowledge scores specific to Choosing Wisely recommendations, expecting that knowledge will improve with respect to the content received).
  There will be 8 'true/false' questions to assess knowledge. Each question is worth 2 points.
  Knowledge will be assessed by comparing participant's scores on baseline to follow-up 1 (knowledge change) and comparing scores to follow-up 2 and 3 (knowledge retention).
  measure: Knowledge - Quantitative Multiple Choice
  time frame: baseline (week 0), follow-up 1 (week 5), follow-up 2 (month 3), follow-up 3 (month 6)
  description: Primary outcome will be knowledge. Change will be compared from baseline between groups (i.e. average change in knowledge scores specific to Choosing Wisely recommendations, expecting that knowledge will improve with respect to the content received).
  There will be 7 'multiple choice' questions to assess knowledge. Each question is worth 2 points.
  Knowledge will be assessed by comparing participant's scores on baseline to follow-up 1 (knowledge change) and comparing scores to follow-up 2 and 3 (knowledge retention).
  measure: Knowledge - Quantitative Select all that apply
  time frame: baseline (week 0), follow-up 1 (week 5), follow-up 2 (month 3), follow-up 3 (month 6)
  description: Primary outcome will be knowledge. Change will be compared from baseline between groups (i.e. average change in knowledge scores specific to Choosing Wisely recommendations, expecting that knowledge will improve with respect to the content received).
  There will be 6 'select all that apply' questions to assess knowledge. Each question is worth 2 points.
  Knowledge will be assessed by comparing participant's scores on baseline to follow-up 1 (knowledge change) and comparing scores to follow-up 2 and 3 (knowledge retention).
  measure: Knowledge - Quantitative
  time frame: baseline (week 0), follow-up 1 (week 5), follow-up 2 (month 3), follow-up 3 (month 6)
  description: Primary outcome will be knowledge. Change will be compared from baseline between groups (i.e. average change in knowledge scores specific to Choosing Wisely recommendations, expecting that knowledge will improve with respect to the content received). The outcome will be assessed two ways:
  1. Quantitatively via questionnaires:
  21 knowledge questions with about 8 'true/false', 7 'multiple choice' and 6 'select all that apply' in each questionnaire (baseline, follow-up 1, 2 & 3). Each question is worth 2 points, total score per questionnaire ranging from 0-42 pts.
  Knowledge will be assessed by comparing participant's scores on baseline to follow-up 1 (knowledge change) and comparing scores to follow-up 2 and 3 (knowledge retention).
  measure: Knowledge - Qualitative
  time frame: interviews will be conducted between week 5 - month 3
  description: Interviews will be used to clarify, expand on and provide to context to the questionnaire responses - two open-ended questions addressing knowledge and will undergo thematic analysis.
  measure: Intentions - Quantitative Likert
  time frame: week 0 (baseline), week 5 (follow-up 1)
  description: A secondary outcome will be intentions. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).
  Participants will be asked questions about their intentions at baseline and follow-up 1 when they seek healthcare i.e. are they seeking antibiotics from a healthcare professional.
  This includes 4 questions based on a five-point Likert scale (strongly agree to strongly disagree)
  measure: Intentions - Quantitative Multiple Choice
  time frame: week 0 (baseline), week 5 (follow-up 1)
  description: A secondary outcome will be intentions. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).
  Participants will be asked questions about their intentions at baseline and follow-up 1 when they seek healthcare i.e. are they seeking antibiotics from a healthcare professional.
  This includes 2 questions that are 'multiple choice'.
  measure: Intentions - Qualitative
  time frame: interviews will be conducted between week 5 - month 3
  description: Interviews will be used to clarify, expand on and provide to context to the questionnaire responses - three open-ended questions addressing intentions and will undergo thematic analysis.
  measure: Expectations of care - quantitative
  time frame: week 0 (baseline), week 5 (follow-up 1)
  description: A secondary outcome will be expectations of care. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).
  Participants will be asked questions about their expectations of healthcare professionals at baseline and follow-up 1 questionnaires. The research team will compare at baseline and follow up 1 to assess if the blogshots led to a change in expectations of healthcare professionals.
  There are 6 expectation questions in each questionnaire for baseline and follow-up 1. All questions are based on a five-point Likert scale (strongly agree to strongly disagree).
  measure: Expectations of care - qualitative
  time frame: interviews will be conducted between week 5 - month 3
  description: A secondary outcome will be expectations of care. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).
  Interviews will be used to clarify, expand on and provide to context to the questionnaire responses - one open-ended question addressing expectations and will undergo thematic analysis.
  measure: Usability of the blogshots - Likert
  time frame: week 5 (follow-up 1)
  description: A secondary outcome will be usability of the blogshots. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).
  Participants will complete usability questions about the blogshots focusing on topics such as if the blogshots increase knowledge, aid in decision-making and are relevant to parents.
  This includes 5 questions based on a five-point Likert scale (strongly agree to strongly disagree)
  measure: Usability of the blogshots - open ended questions
  time frame: week 5 (follow-up 1)
  description: A secondary outcome will be usability of the blogshots. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).
  Participants will complete usability questions about the blogshots focusing on topics such as if the blogshots increase knowledge, aid in decision-making and are relevant to parents. This will be completed at follow-up 1.
  This includes two open-ended questions.
  measure: Usability of the blogshots - qualitative
  time frame: interviews will be conducted between week 5 - month 3
  description: A secondary outcome will be usability of the blogshots. The research team will explore if the outcome was influenced by whether a child had one of the conditions (and identify actual behaviour).
  Interviews will be used to clarify, expand on and provide to context to the questionnaire responses - four open-ended questions addressing usability and will undergo thematic analysis.
  arm group label: Group A - Sore Throat Swab, Cough and Cold, Asthma
  arm group type: Active Comparator
  description: Group A will receive three of six blogshots (different to Group B) over a 4-week period (a different blogshot will be sent by email to them each week for three weeks, then in the final week they will receive the same three blogshots in one summary email to review). They will act as their own control group.
  All participants from both groups will be asked to complete one baseline questionnaire at the start of the study and a follow-up questionnaire at week 5, month 3 and month 6 about different common acute childhood conditions, the blogshots and their content.
  All participants can also participate in an optional semi-structured interview to give their thoughts on the blogshots and their experience in the study.
  arm group label: Group B - Ear Infection, Bronchiolitis, Antibiotics for Sore Throat
  arm group type: Active Comparator
  description: Group B will receive three of six blogshots (different to Group A) over a 4-week period (a different blogshot will be sent by email to them each week for three weeks, then in the final week they will receive the same three blogshots in one summary email to review). They will act as their own control group.
  All participants from both groups will be asked to complete one baseline questionnaire at the start of the study and a follow-up questionnaire at week 5, month 3 and month 6 about different common acute childhood conditions, the blogshots and their content.
  All participants can also participate in an optional semi-structured interview to give their thoughts on the blogshots and their experience in the study.
  intervention type: Behavioral
  intervention name: Blogshots 1-3
  description: Don't routinely do a throat swab when children present with a sore throat if they have a cough, rhinitis, or hoarseness
  Don't recommend the use of cough and cold remedies in children under six years of age
  Don't use antibiotics for acute asthma exacerbations without clear signs of bacterial infection
  arm group label: Group A - Sore Throat Swab, Cough and Cold, Asthma
  intervention type: Behavioral
  intervention name: Blogshots 4-6
  description: Don't routinely use antibiotics in children with uncomplicated sore throats
  Don't prescribe antibiotics in adults with bronchitis/asthma and children with bronchiolitis
  Don't use antibiotics in adults and children with uncomplicated acute otitis media
  arm group label: Group B - Ear Infection, Bronchiolitis, Antibiotics for Sore Throat
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lisa Hartling, PhD
  role: Principal Investigator
  affiliation: University of Alberta
  last name: Sarah Elliott, PhD
  phone: (780) 492-1241
  email: se2@ualberta.ca
  last name: Samantha Cyrkot, MsC
  email: scyrkot@ualberta.ca
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Canada
  url: http://semanticstudios.com/user_experience_design/
  description: Morville P. User Experience Design.
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  responsible party type: Sponsor
  mesh term: Bronchiolitis
  mesh term: Common Cold
  mesh term: Pharyngitis
  mesh term: Otitis Media
  sharing ipd: No
  provided document: 
  provided document: 