<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/NCT03041454</url>
  </required_header>
  <id_info>
    <org_study_id>SMH-312381</org_study_id>
    <nct_id>NCT03041454</nct_id>
  </id_info>
  <brief_title>Testing New Formats for the Presentation of Research Evidence to Health Care Managers and Policy Makers</brief_title>
  <official_title>A Randomized Trial to Compare the Effects of a Novel Versus Traditional Systematic Review Format on the Ability of Health Care Managers and Policy Makers to Understand and Apply Evidence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</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 purpose of this project is to identify and use our knowledge on the barriers and&#xD;
      facilitators to using systematic reviews (SR) by health care managers (HCM) and policy&#xD;
      markers (PM) to develop and test a novel format for presentation of SR for HCM and PM. We&#xD;
      will invite HCM and PM from hospitals and regional authorities in Ontario, Alberta, and&#xD;
      British Columbia to participate in a randomized-control trial. Participants will receive a&#xD;
      link to an online consent survey, and then be randomly allocated to receive access to a novel&#xD;
      SR or its traditional presentation. There is no time limit to completing the task, and&#xD;
      participants are able to save their responses and finish later. Participants are able to&#xD;
      withdraw from the study by not completing the task.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite advances in the conduct and reporting of traditional systematic reviews, current&#xD;
      evidence suggests that they are used infrequently by health care managers and policy makers&#xD;
      in decision making. Managers and policy makers have suggested that concise presentation&#xD;
      positively affects the use of systematic reviews. The purpose of this randomized controlled&#xD;
      trial is to assess the impact of a traditional systematic review format compared with the&#xD;
      innovative format on the ability of health care managers and policy makers to understand the&#xD;
      evidence in the review and apply it to a relevant health care decision making scenario.&#xD;
&#xD;
      The two end-user groups have different formatting needs and we will therefore run 2 parallel&#xD;
      studies, randomizing each group separately. Once participants have consented to participate,&#xD;
      a computer generated randomization process will allocate them to one of 2 arms (1:1 ratio).&#xD;
      Participants will either receive either a traditional format or a novel format. Unequal block&#xD;
      randomization will be used and allocation will be concealed through central assignment.&#xD;
      Outcomes assessors will be blinded and participants will be blinded to the citation of the&#xD;
      review so that the traditional version will not be easily accessible in its original format&#xD;
      from the relevant journal.&#xD;
&#xD;
      This study will be the first study to engage health care managers and policy makers in the&#xD;
      testing of formats for presentation of research evidence relevant to their needs. The results&#xD;
      of the project will help increase the uptake of systematic review results in health care&#xD;
      management policy decision-making, ultimately leading to informed decision making and&#xD;
      positively impacting the health of Canadians.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 16, 2017</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants (health care managers or policy makers) who appropriately consider and apply the evidence from each systematic review format</measure>
    <time_frame>This measure will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).</time_frame>
    <description>The proportion of participants (health care managers or policy makers) who appropriately consider and apply the evidence from each systematic review format to the scenario as measured by agreement with an expert panel's recommendation. A panel of 4 health care managers or policy makers from our research team and 2 content experts. Their answers will provide the definition of appropriate application of the evidence. Two investigators who will be blind to allocation will independently determine if the participant's answer agrees with that from the expert panel. Disagreements will be resolved by a third investigator, independently. Agreement between investigators will be reported using the kappa statistic.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comprehension of the review</measure>
    <time_frame>This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).</time_frame>
    <description>Comprehension of the review - defined as the proportion of participants (health care managers or policy makers) who accurately define the bottom line from the systematic review as defined by an expert panel. A panel of 4 health care managers or policy makers from our research team and 2 content experts. Their answers will provide the definition of the bottom line from the systematic review. Two investigators who will be blind to allocation will independently determine if the participant's answer agrees with that from the expert panel. Disagreements will be resolved by a third investigator, independently. Agreement between investigators will be reported using the kappa statistic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intention to use evidence</measure>
    <time_frame>This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).</time_frame>
    <description>Intention to use evidence - collected through a 12-item likert scale survey. The survey has good face validity amongst policy makers and managers. The mean and SD of each item in the survey will be reported and we will provide a summary score of all items and convert it to a percentage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived tentativeness of research findings</measure>
    <time_frame>This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).</time_frame>
    <description>Perceived tentativeness of research findings - collected through a 6-item likert scale survey. This has been pre-tested to make sure that the items are intelligible to people and to achieve high levels of face validity and reliability. The mean and SD of each item in the survey will be reported and we will provide a summary score of all items and convert it to a percentage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provisional opinion about the intervention</measure>
    <time_frame>This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).</time_frame>
    <description>Provisional opinion about the intervention - collected through a 14-item likert scale survey. This has been pre-tested to make sure that the items are intelligible to people and to achieve high levels of face validity and reliability. The mean and SD of each item in the survey will be reported and we will provide a summary score of all items and convert it to a percentage.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">257</enrollment>
  <condition>Uptake of Systematic Review Evidence</condition>
  <arm_group>
    <arm_group_label>Novel systematic review format</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 2-page summary of systematic review content that has been designed in collaboration with policy makers and health care managers. Participants receiving the intervention will be asked to read and answer questions using a novel systematic review format.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional systematic review format</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control participants will be asked to read and answer questions using a traditional systematic review format.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Novel systematic review format</intervention_name>
    <description>A 2-page summary of systematic review content that has been designed in collaboration with policy makers and health care managers.</description>
    <arm_group_label>Novel systematic review format</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health care managers from the Alberta SCNs, CAHO in Ontario, the RHAs and AQESSS in&#xD;
             Quebec and RHAs from BC will be invited to participate.&#xD;
&#xD;
          -  Policy makers/analysts from the Ontario, BC, Alberta and Quebec Ministries of Health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Health care managers or policy makers who are unwilling or unable to give informed&#xD;
             consent.&#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>Sharon e Straus</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>May 5, 2020</last_update_submitted>
  <last_update_submitted_qc>May 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03041454
org study id: SMH-312381
nct id: NCT03041454
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this project is to identify and use our knowledge on the barriers and
      facilitators to using systematic reviews (SR) by health care managers (HCM) and policy
      markers (PM) to develop and test a novel format for presentation of SR for HCM and PM. We
      will invite HCM and PM from hospitals and regional authorities in Ontario, Alberta, and
      British Columbia to participate in a randomized-control trial. Participants will receive a
      link to an online consent survey, and then be randomly allocated to receive access to a novel
      SR or its traditional presentation. There is no time limit to completing the task, and
      participants are able to save their responses and finish later. Participants are able to
      withdraw from the study by not completing the task.
Despite advances in the conduct and reporting of traditional systematic reviews, current
      evidence suggests that they are used infrequently by health care managers and policy makers
      in decision making. Managers and policy makers have suggested that concise presentation
      positively affects the use of systematic reviews. The purpose of this randomized controlled
      trial is to assess the impact of a traditional systematic review format compared with the
      innovative format on the ability of health care managers and policy makers to understand the
      evidence in the review and apply it to a relevant health care decision making scenario.

      The two end-user groups have different formatting needs and we will therefore run 2 parallel
      studies, randomizing each group separately. Once participants have consented to participate,
      a computer generated randomization process will allocate them to one of 2 arms (1:1 ratio).
      Participants will either receive either a traditional format or a novel format. Unequal block
      randomization will be used and allocation will be concealed through central assignment.
      Outcomes assessors will be blinded and participants will be blinded to the citation of the
      review so that the traditional version will not be easily accessible in its original format
      from the relevant journal.

      This study will be the first study to engage health care managers and policy makers in the
      testing of formats for presentation of research evidence relevant to their needs. The results
      of the project will help increase the uptake of systematic review results in health care
      management policy decision-making, ultimately leading to informed decision making and
      positively impacting the health of Canadians.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Proportion of participants (health care managers or policy makers) who appropriately consider and apply the evidence from each systematic review format
time frame: This measure will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
description: The proportion of participants (health care managers or policy makers) who appropriately consider and apply the evidence from each systematic review format to the scenario as measured by agreement with an expert panel's recommendation. A panel of 4 health care managers or policy makers from our research team and 2 content experts. Their answers will provide the definition of appropriate application of the evidence. Two investigators who will be blind to allocation will independently determine if the participant's answer agrees with that from the expert panel. Disagreements will be resolved by a third investigator, independently. Agreement between investigators will be reported using the kappa statistic.
measure: Comprehension of the review
time frame: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
description: Comprehension of the review - defined as the proportion of participants (health care managers or policy makers) who accurately define the bottom line from the systematic review as defined by an expert panel. A panel of 4 health care managers or policy makers from our research team and 2 content experts. Their answers will provide the definition of the bottom line from the systematic review. Two investigators who will be blind to allocation will independently determine if the participant's answer agrees with that from the expert panel. Disagreements will be resolved by a third investigator, independently. Agreement between investigators will be reported using the kappa statistic.
measure: Intention to use evidence
time frame: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
description: Intention to use evidence - collected through a 12-item likert scale survey. The survey has good face validity amongst policy makers and managers. The mean and SD of each item in the survey will be reported and we will provide a summary score of all items and convert it to a percentage.
measure: Perceived tentativeness of research findings
time frame: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
description: Perceived tentativeness of research findings - collected through a 6-item likert scale survey. This has been pre-tested to make sure that the items are intelligible to people and to achieve high levels of face validity and reliability. The mean and SD of each item in the survey will be reported and we will provide a summary score of all items and convert it to a percentage.
measure: Provisional opinion about the intervention
time frame: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
description: Provisional opinion about the intervention - collected through a 14-item likert scale survey. This has been pre-tested to make sure that the items are intelligible to people and to achieve high levels of face validity and reliability. The mean and SD of each item in the survey will be reported and we will provide a summary score of all items and convert it to a percentage.
arm group label: Novel systematic review format
arm group type: Experimental
description: A 2-page summary of systematic review content that has been designed in collaboration with policy makers and health care managers. Participants receiving the intervention will be asked to read and answer questions using a novel systematic review format.
arm group label: Traditional systematic review format
arm group type: No Intervention
description: Control participants will be asked to read and answer questions using a traditional systematic review format.
intervention type: Other
intervention name: Novel systematic review format
description: A 2-page summary of systematic review content that has been designed in collaboration with policy makers and health care managers.
arm group label: Novel systematic review format
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sharon e Straus
role: Principal Investigator
affiliation: Unity Health Toronto
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No