<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/NCT02240095</url>
  </required_header>
  <id_info>
    <org_study_id>FRN86465-B</org_study_id>
    <secondary_id>FRN86465</secondary_id>
    <nct_id>NCT02240095</nct_id>
  </id_info>
  <brief_title>Increasing Medical and Nursing Students Searching of Current Best Evidence to Answer Clinical Questions</brief_title>
  <acronym>MPFS-2</acronym>
  <official_title>Multifaceted Online Interventions to Increase Medical and Nursing Students Searching of Current Best Evidence to Answer Clinical Questions (MPFS-2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Translation of new knowledge from research into evidence-informed health care is a shared&#xD;
      obligation of the clinical and the scientific communities. Unfortunately, studies of quality&#xD;
      of care continue to show that this goal is substantially unrealized. One main barrier is lack&#xD;
      of quick and easy identification, appraisal and synthesis of current best evidence. This&#xD;
      start with medical and nursing students, which have numerous clinical-related questions&#xD;
      daily, but face a large volume of 3000 articles published every day, accessible in many&#xD;
      scattered resources.&#xD;
&#xD;
      To address theses problems, McMaster's Health Information Research Unit (Hamilton, Ontario,&#xD;
      Canada) has developed and implemented &quot;McMaster Premium LiteratUre Service Federated Search&quot;&#xD;
      (MPFS), an online search engine that provides a unique 1-stop search and organized access to&#xD;
      current best evidence in daily practice. However additional barriers need to be overcome for&#xD;
      students to actually search and use this evidence in their learning and practice. Theses&#xD;
      include logistical barriers (time constraints, forgotten questions), as well as educational&#xD;
      barriers (eg, lack of awareness of the &quot;architecture&quot; of evidence, limited searching skills,&#xD;
      and lack of reference standards among peers for finding best evidence).&#xD;
&#xD;
      In a previous trial, the investigators tested 3 innovative online interventions among&#xD;
      clinicians registered to MPFS to overcome these barriers and increase the quantity and&#xD;
      quality of searching for current best evidence to answer clinical questions (NCT02038439).&#xD;
      The investigators seek to conduct a second randomized trial testing the same 3 interventions,&#xD;
      this time among medical and nursing students registered in MPFS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Rationale &amp; Objectives&#xD;
&#xD;
           One main barrier to achieving evidence-informed care by clinicians is lack of quick and&#xD;
           easy identification, appraisal and synthesis of current best evidence. Clinicians and&#xD;
           students information needs are considerable - but about 3000 articles are published in&#xD;
           Medline every day. Numerous evidence-based resources have been developed to filter and&#xD;
           process the evidence, but although increasingly used, each offer a fragmented and&#xD;
           scattered view of information, and none provides comprehensive topic coverage or&#xD;
           satisfactory updating.&#xD;
&#xD;
           To address theses problems, McMaster's Health Information Research Unit (Hamilton,&#xD;
           Ontario, Canada) has developed and implemented &quot;McMaster Premium LiteratUre Service&#xD;
           Federated Search (MPFS)&quot;, an online search engine that provides a unique 1-stop search&#xD;
           and organized access to current best evidence in daily practice. MPFS provides both&#xD;
           alerts to users about new research, and a novel federated search function, with the&#xD;
           particular feature of organizing information according to the &quot;pyramid of evidence-based&#xD;
           resources&quot;, with the most clinically applicable evidence at the top. Thus MPFS&#xD;
           simultaneously retrieves evidence from Studies (&quot;Medline&quot;, both filtered and unfiltered,&#xD;
           at the bottom), then Systematic reviews; Synopses of studies and systematic reviews&#xD;
           (selected for methodological rigor and clinical relevance), and, at the top level,&#xD;
           online widely used Summaries (e.g.&quot;Best Practice&quot;).&#xD;
&#xD;
           Combining features of the current best evidence-based resources is not enough to&#xD;
           increase access and use of current best evidence. Additional well-known barriers that&#xD;
           need to be overcome include logistical barriers (time constraints, forgotten questions,&#xD;
           and simplicity of using one single albeit limited resource), as well as educational&#xD;
           barriers (eg, lack of awareness of the &quot;architecture&quot; of evidence and limits of other&#xD;
           single resources, lack of knowledge and experience of what federated searches can offer,&#xD;
           limited searching skills, and lack of reference standards among peers for finding best&#xD;
           evidence).&#xD;
&#xD;
        2. Hypothesis&#xD;
&#xD;
           This trial seeks to test 3 innovative online interventions among medical and nursing&#xD;
           students registered to MPFS to overcome these barriers and increase the quantity and&#xD;
           quality of searching for current best evidence to answer the learning needs and clinical&#xD;
           questions. These interventions build on effective models for the teaching of clinical&#xD;
           skills at the point of care, so that they are facilitated in using the search engine as&#xD;
           a clinical tool, and perceive evidence retrieval skills as true clinical skills.&#xD;
&#xD;
        3. Methods&#xD;
&#xD;
             1. Study design: Randomized Factorial Controlled Trial.&#xD;
&#xD;
             2. Setting and Participants: The trial will be conducted among medical and nursing&#xD;
                students registered in MPFS and working in the teaching hospitals and clinics of&#xD;
                McMaster University (see eligibility criteria below)&#xD;
&#xD;
             3. Participating clinicians will be randomized to 3 online interventions (see&#xD;
                description below) in a factorial design (A x B x C), whose permutation results in&#xD;
                8 allocation arms (A+B+C, A+B, A+C, B+C, A, B, C, no intervention, see details&#xD;
                below)&#xD;
&#xD;
             4. Randomization: will be computer-generated, and stratified for medical vs. nursing&#xD;
                students. Registrants will be randomly allocated to each study arms. Allocation&#xD;
                will be concealed from research staff.&#xD;
&#xD;
             5. Blinding and control group: Although participants cannot be blinded to the&#xD;
                interventions, they will not be told of the different features offered, and all&#xD;
                will receive usual searching features of MPFS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">October 22, 2017</completion_date>
  <primary_completion_date type="Actual">October 22, 2017</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>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Utilization of evidence-based resources on MPFS as measured by rate of searches/month/user</measure>
    <time_frame>6 months</time_frame>
    <description>Each students participating in the trial has a personal online account in MPFS. When they are signed on their account, the system continuously tracks their searches and utilization of individual resources. We will record their utilization over the full duration of the trial (6 months) and analyze it in the end.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Utility (satisfaction in meeting users' information needs) as assessed by the Impact Assessment Measure questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>This Impact Assessment Measure questionnaire will be sent to students after a random sample of searches and completed online for a random sample of searches.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use (application of evidence in practice) as assessed by the Impact Assessment Measure questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>This Impact Assessment Measure questionnaire will be sent to students after a random sample of searches and completed online for a random sample of searches.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Usefulness in patient care and outcomes as assessed by the Impact Assessment Measure questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>This Impact Assessment Measure questionnaire will be sent to students after a random sample of searches and completed online for a random sample of searches.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">960</enrollment>
  <condition>Medical and Nursing Students' Evidence Retrieval Skills</condition>
  <arm_group>
    <arm_group_label>Interventions: A + B + C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See Interventions Description. In this arm, students will be offered all 3 online interventions combined:&#xD;
Intervention A - Online Clinical Questions Recorder&#xD;
Intervention B - Online Evidence Retrieval Coach&#xD;
Intervention C - Online Audit and Feedback</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interventions A + B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See Interventions Description. In this arm, students will be offered the 2 following interventions combined:&#xD;
Intervention A - Online Clinical Questions Recorder&#xD;
Intervention B - Online Evidence Retrieval Coach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interventions A + C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, students will be offered the 2 following online interventions combined:&#xD;
Intervention A - Online Clinical Questions Recorder&#xD;
Intervention C - Online Audit and Feedback</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interventions B + C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See Interventions Description. In this arm, students will be offered the 2 following online interventions combined:&#xD;
Intervention B - Online Evidence Retrieval Coach&#xD;
Intervention C - Online Audit and Feedback</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention A alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See Interventions Description. In this arm, students will be offered only the following intervention:&#xD;
* Intervention A - Online Clinical Questions Recorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention B alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See Interventions Description. In this arm, students will be offered only the following intervention:&#xD;
* Intervention B - Online Evidence Retrieval Coach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention C alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See Interventions Description. In this arm, students will be offered only the following intervention:&#xD;
* Intervention C - Online Audit and Feedback</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this arm, students will be offered none of the 3 online interventions, but will just be using the usual features of the search engine available to all users.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention A - Online Clinical Questions Recorder</intervention_name>
    <description>Students allocated to this intervention will receive access to an online recorder for the clinical questions at the point of care. The recorder is accessible across a wide range of devices including phones, tablets, and desktop computers.</description>
    <arm_group_label>Intervention A alone</arm_group_label>
    <arm_group_label>Interventions A + B</arm_group_label>
    <arm_group_label>Interventions A + C</arm_group_label>
    <arm_group_label>Interventions: A + B + C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention B - Online Evidence Retrieval Coach</intervention_name>
    <description>Students allocated to this intervention will receive online guidance, embedded in the MPFS search engine, in the form of short videos, animations, demos and tips and tricks regarding evidence retrieval.</description>
    <arm_group_label>Intervention B alone</arm_group_label>
    <arm_group_label>Interventions A + B</arm_group_label>
    <arm_group_label>Interventions B + C</arm_group_label>
    <arm_group_label>Interventions: A + B + C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention C - Online Audit and Feedback</intervention_name>
    <description>Students allocated to this intervention will receive feedback on their current search performance compared to their peers, both online when using MPFS as well as by e-mail.</description>
    <arm_group_label>Intervention C alone</arm_group_label>
    <arm_group_label>Interventions A + C</arm_group_label>
    <arm_group_label>Interventions B + C</arm_group_label>
    <arm_group_label>Interventions: A + B + C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All medical and nursing students currently registered for more than one month in the&#xD;
             MPFS search engine,&#xD;
&#xD;
          -  And learning in the teaching hospitals and clinics of the Faculty of Health Sciences,&#xD;
             McMaster University, Hamilton, Ontario.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Registrants that are no longer working or training at McMaster University,&#xD;
&#xD;
          -  Registrants that never logged in MPFS during the last 12 months counting back from the&#xD;
             beginning of the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Agoritsas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McMaster University</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://plus.mcmaster.ca/MacPLUSFS/</url>
    <description>online MPFS search engine</description>
  </link>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>October 23, 2017</last_update_submitted>
  <last_update_submitted_qc>October 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02240095
org study id: FRN86465-B
secondary id: FRN86465
nct id: NCT02240095
lead sponsor: 
collaborator: 
has dmc: No
Translation of new knowledge from research into evidence-informed health care is a shared
      obligation of the clinical and the scientific communities. Unfortunately, studies of quality
      of care continue to show that this goal is substantially unrealized. One main barrier is lack
      of quick and easy identification, appraisal and synthesis of current best evidence. This
      start with medical and nursing students, which have numerous clinical-related questions
      daily, but face a large volume of 3000 articles published every day, accessible in many
      scattered resources.

      To address theses problems, McMaster's Health Information Research Unit (Hamilton, Ontario,
      Canada) has developed and implemented "McMaster Premium LiteratUre Service Federated Search"
      (MPFS), an online search engine that provides a unique 1-stop search and organized access to
      current best evidence in daily practice. However additional barriers need to be overcome for
      students to actually search and use this evidence in their learning and practice. Theses
      include logistical barriers (time constraints, forgotten questions), as well as educational
      barriers (eg, lack of awareness of the "architecture" of evidence, limited searching skills,
      and lack of reference standards among peers for finding best evidence).

      In a previous trial, the investigators tested 3 innovative online interventions among
      clinicians registered to MPFS to overcome these barriers and increase the quantity and
      quality of searching for current best evidence to answer clinical questions (NCT02038439).
      The investigators seek to conduct a second randomized trial testing the same 3 interventions,
      this time among medical and nursing students registered in MPFS.
1. Rationale & Objectives

           One main barrier to achieving evidence-informed care by clinicians is lack of quick and
           easy identification, appraisal and synthesis of current best evidence. Clinicians and
           students information needs are considerable - but about 3000 articles are published in
           Medline every day. Numerous evidence-based resources have been developed to filter and
           process the evidence, but although increasingly used, each offer a fragmented and
           scattered view of information, and none provides comprehensive topic coverage or
           satisfactory updating.

           To address theses problems, McMaster's Health Information Research Unit (Hamilton,
           Ontario, Canada) has developed and implemented "McMaster Premium LiteratUre Service
           Federated Search (MPFS)", an online search engine that provides a unique 1-stop search
           and organized access to current best evidence in daily practice. MPFS provides both
           alerts to users about new research, and a novel federated search function, with the
           particular feature of organizing information according to the "pyramid of evidence-based
           resources", with the most clinically applicable evidence at the top. Thus MPFS
           simultaneously retrieves evidence from Studies ("Medline", both filtered and unfiltered,
           at the bottom), then Systematic reviews; Synopses of studies and systematic reviews
           (selected for methodological rigor and clinical relevance), and, at the top level,
           online widely used Summaries (e.g."Best Practice").

           Combining features of the current best evidence-based resources is not enough to
           increase access and use of current best evidence. Additional well-known barriers that
           need to be overcome include logistical barriers (time constraints, forgotten questions,
           and simplicity of using one single albeit limited resource), as well as educational
           barriers (eg, lack of awareness of the "architecture" of evidence and limits of other
           single resources, lack of knowledge and experience of what federated searches can offer,
           limited searching skills, and lack of reference standards among peers for finding best
           evidence).

        2. Hypothesis

           This trial seeks to test 3 innovative online interventions among medical and nursing
           students registered to MPFS to overcome these barriers and increase the quantity and
           quality of searching for current best evidence to answer the learning needs and clinical
           questions. These interventions build on effective models for the teaching of clinical
           skills at the point of care, so that they are facilitated in using the search engine as
           a clinical tool, and perceive evidence retrieval skills as true clinical skills.

        3. Methods

             1. Study design: Randomized Factorial Controlled Trial.

             2. Setting and Participants: The trial will be conducted among medical and nursing
                students registered in MPFS and working in the teaching hospitals and clinics of
                McMaster University (see eligibility criteria below)

             3. Participating clinicians will be randomized to 3 online interventions (see
                description below) in a factorial design (A x B x C), whose permutation results in
                8 allocation arms (A+B+C, A+B, A+C, B+C, A, B, C, no intervention, see details
                below)

             4. Randomization: will be computer-generated, and stratified for medical vs. nursing
                students. Registrants will be randomly allocated to each study arms. Allocation
                will be concealed from research staff.

             5. Blinding and control group: Although participants cannot be blinded to the
                interventions, they will not be told of the different features offered, and all
                will receive usual searching features of MPFS.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Utilization of evidence-based resources on MPFS as measured by rate of searches/month/user
time frame: 6 months
description: Each students participating in the trial has a personal online account in MPFS. When they are signed on their account, the system continuously tracks their searches and utilization of individual resources. We will record their utilization over the full duration of the trial (6 months) and analyze it in the end.
measure: Utility (satisfaction in meeting users' information needs) as assessed by the Impact Assessment Measure questionnaire
time frame: 6 months
description: This Impact Assessment Measure questionnaire will be sent to students after a random sample of searches and completed online for a random sample of searches.
measure: Use (application of evidence in practice) as assessed by the Impact Assessment Measure questionnaire
time frame: 6 months
description: This Impact Assessment Measure questionnaire will be sent to students after a random sample of searches and completed online for a random sample of searches.
measure: Perceived Usefulness in patient care and outcomes as assessed by the Impact Assessment Measure questionnaire
time frame: 6 months
description: This Impact Assessment Measure questionnaire will be sent to students after a random sample of searches and completed online for a random sample of searches.
arm group label: Interventions: A + B + C
arm group type: Experimental
description: See Interventions Description. In this arm, students will be offered all 3 online interventions combined:
Intervention A - Online Clinical Questions Recorder
Intervention B - Online Evidence Retrieval Coach
Intervention C - Online Audit and Feedback
arm group label: Interventions A + B
arm group type: Experimental
description: See Interventions Description. In this arm, students will be offered the 2 following interventions combined:
Intervention A - Online Clinical Questions Recorder
Intervention B - Online Evidence Retrieval Coach
arm group label: Interventions A + C
arm group type: Experimental
description: In this arm, students will be offered the 2 following online interventions combined:
Intervention A - Online Clinical Questions Recorder
Intervention C - Online Audit and Feedback
arm group label: Interventions B + C
arm group type: Experimental
description: See Interventions Description. In this arm, students will be offered the 2 following online interventions combined:
Intervention B - Online Evidence Retrieval Coach
Intervention C - Online Audit and Feedback
arm group label: Intervention A alone
arm group type: Experimental
description: See Interventions Description. In this arm, students will be offered only the following intervention:
* Intervention A - Online Clinical Questions Recorder
arm group label: Intervention B alone
arm group type: Experimental
description: See Interventions Description. In this arm, students will be offered only the following intervention:
* Intervention B - Online Evidence Retrieval Coach
arm group label: Intervention C alone
arm group type: Experimental
description: See Interventions Description. In this arm, students will be offered only the following intervention:
* Intervention C - Online Audit and Feedback
arm group label: No intervention
arm group type: No Intervention
description: In this arm, students will be offered none of the 3 online interventions, but will just be using the usual features of the search engine available to all users.
intervention type: Behavioral
intervention name: Intervention A - Online Clinical Questions Recorder
description: Students allocated to this intervention will receive access to an online recorder for the clinical questions at the point of care. The recorder is accessible across a wide range of devices including phones, tablets, and desktop computers.
arm group label: Intervention A alone
arm group label: Interventions A + B
arm group label: Interventions A + C
arm group label: Interventions: A + B + C
intervention type: Behavioral
intervention name: Intervention B - Online Evidence Retrieval Coach
description: Students allocated to this intervention will receive online guidance, embedded in the MPFS search engine, in the form of short videos, animations, demos and tips and tricks regarding evidence retrieval.
arm group label: Intervention B alone
arm group label: Interventions A + B
arm group label: Interventions B + C
arm group label: Interventions: A + B + C
intervention type: Behavioral
intervention name: Intervention C - Online Audit and Feedback
description: Students allocated to this intervention will receive feedback on their current search performance compared to their peers, both online when using MPFS as well as by e-mail.
arm group label: Intervention C alone
arm group label: Interventions A + C
arm group label: Interventions B + C
arm group label: Interventions: A + B + C
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Thomas Agoritsas, MD
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
url: http://plus.mcmaster.ca/MacPLUSFS/
description: online MPFS search engine
responsible party type: Sponsor