<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/NCT03768596</url>
  </required_header>
  <id_info>
    <org_study_id>ABarbaroux</org_study_id>
    <secondary_id>2018-A02939-46</secondary_id>
    <nct_id>NCT03768596</nct_id>
  </id_info>
  <brief_title>Nudging for Vaccination : Efficacity and Acceptability Among Medical Students</brief_title>
  <official_title>Nudging for Vaccination : Efficacity and Acceptability Among Medical Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adriaan Barbaroux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Université de Nice Sophia Antipolis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Barbaroux, Adriaan, M.D.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Nudge is a set of methods aimed at helping people adopt a behavior by a gentle prompt,&#xD;
      conscious or not. Classically, Nudges rely on heuristics and cognitive biases. These methods&#xD;
      have been studied for years in social psychology and are receiving renewed attention since&#xD;
      the awarding of the Nobel Prize in economics to Richard Thaler for his work on the&#xD;
      application of Nudge to the economy.&#xD;
&#xD;
      Health professionals are very inadequately vaccinated (25 to 45% of the population). Some&#xD;
      studies have shown that a Nudge based on intent implementation can significantly increase&#xD;
      vaccination coverage. However, few studies evaluate the acceptability of Nudge or its&#xD;
      application to health professionals.&#xD;
&#xD;
      The investigators sought to apply a Nudge based on availability heuristics to health&#xD;
      professionals, in order to evaluate its effectiveness and terms of behavior adoption&#xD;
      (influenza vaccination) and its acceptability.&#xD;
&#xD;
      The investigator's hypothesis is that Nudging is both effective and acceptable and that&#xD;
      people found nudging more acceptable if they have been exposed to a nudge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators asked residents in general medicine to pass a questionnaire including a&#xD;
      Nudge. This Nudge was the influenza vaccine prescription form accompanied on the back of the&#xD;
      telephone numbers of the occupational health centers of the hospitals where residents were on&#xD;
      probation.&#xD;
&#xD;
      The interns of the group &quot;Nudge&quot; saw at the end of their questionnaire the following&#xD;
      statement: &quot;If you are not vaccinated against the flu so far, you can get the form stapled to&#xD;
      this questionnaire, it will allow you to get the vaccine in pharmacy. On the back you will&#xD;
      also find practical information about immunization services at your place of training. &quot; A&#xD;
      group will receive an implemented Nudge questionnaire, a group will receive a questionnaire&#xD;
      without Nudge and a control group will not be asked. (Phase 1) The 3 groups will receive a&#xD;
      month later a questionnaire evaluating the effectiveness in terms of immunization coverage,&#xD;
      and the acceptability of the Nudge, for oneself and for others. (Phase 2) The control group&#xD;
      will only receive the Phase 2 questionnaire to control the Hawthorne effect.&#xD;
&#xD;
      The difference between the 3 groups will consist exclusively in the exposure of the&#xD;
      participants to:&#xD;
&#xD;
        -  A questionnaire on their attitude (opinion) towards vaccination;&#xD;
&#xD;
        -  The numbers of the occupational health vaccination centers of their places of training;&#xD;
&#xD;
        -  The flu vaccine prescription form, to be signed and stamped by a doctor (also already&#xD;
           freely available on the internet)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2018</start_date>
  <completion_date type="Actual">December 20, 2018</completion_date>
  <primary_completion_date type="Actual">December 20, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>one group receives a form with the nudge, one group receives the same form without nudge and another group doesn't receive any form</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>In the first pat of the study, participants are unaware of the fact we are trying to nudge them. In the second part, they are explained and asked what they feel about nudging</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Efficiency: vaccination rate</measure>
    <time_frame>1 month</time_frame>
    <description>vaccination rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>acceptability: scale</measure>
    <time_frame>One month</time_frame>
    <description>likert based acceptability form</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Influenza, Human</condition>
  <condition>Vaccination; Sepsis</condition>
  <arm_group>
    <arm_group_label>Nudge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>receiving nudge and form</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No nudge</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>receiving the same form without nudge (only questions about their opinion/attitudes about vaccination)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>receiving no nudge nor form</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nudge</intervention_name>
    <description>Influenza Vaccine Prescription Form accompanied on the back of telephone numbers of occupational health centers of different hospitals where interns are likely to be on probation.</description>
    <arm_group_label>Nudge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>vaccination form</intervention_name>
    <description>a form about vaccination</description>
    <arm_group_label>No nudge</arm_group_label>
    <arm_group_label>Nudge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medical students&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabelle MILHABET, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>LAPCOS-UCA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNSA</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Barbaroux, Adriaan, M.D.</investigator_affiliation>
    <investigator_full_name>Adriaan Barbaroux</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Nudge</keyword>
  <keyword>acceptability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>starting 6 months after publication</ipd_time_frame>
    <ipd_access_criteria>OK for meta analysis, please contact directly Dr Adriaan BARBAROUX.</ipd_access_criteria>
  </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/NCT03768596
org study id: ABarbaroux
secondary id: 2018-A02939-46
nct id: NCT03768596
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Nudge is a set of methods aimed at helping people adopt a behavior by a gentle prompt,
      conscious or not. Classically, Nudges rely on heuristics and cognitive biases. These methods
      have been studied for years in social psychology and are receiving renewed attention since
      the awarding of the Nobel Prize in economics to Richard Thaler for his work on the
      application of Nudge to the economy.

      Health professionals are very inadequately vaccinated (25 to 45% of the population). Some
      studies have shown that a Nudge based on intent implementation can significantly increase
      vaccination coverage. However, few studies evaluate the acceptability of Nudge or its
      application to health professionals.

      The investigators sought to apply a Nudge based on availability heuristics to health
      professionals, in order to evaluate its effectiveness and terms of behavior adoption
      (influenza vaccination) and its acceptability.

      The investigator's hypothesis is that Nudging is both effective and acceptable and that
      people found nudging more acceptable if they have been exposed to a nudge.
The investigators asked residents in general medicine to pass a questionnaire including a
      Nudge. This Nudge was the influenza vaccine prescription form accompanied on the back of the
      telephone numbers of the occupational health centers of the hospitals where residents were on
      probation.

      The interns of the group "Nudge" saw at the end of their questionnaire the following
      statement: "If you are not vaccinated against the flu so far, you can get the form stapled to
      this questionnaire, it will allow you to get the vaccine in pharmacy. On the back you will
      also find practical information about immunization services at your place of training. " A
      group will receive an implemented Nudge questionnaire, a group will receive a questionnaire
      without Nudge and a control group will not be asked. (Phase 1) The 3 groups will receive a
      month later a questionnaire evaluating the effectiveness in terms of immunization coverage,
      and the acceptability of the Nudge, for oneself and for others. (Phase 2) The control group
      will only receive the Phase 2 questionnaire to control the Hawthorne effect.

      The difference between the 3 groups will consist exclusively in the exposure of the
      participants to:

        -  A questionnaire on their attitude (opinion) towards vaccination;

        -  The numbers of the occupational health vaccination centers of their places of training;

        -  The flu vaccine prescription form, to be signed and stamped by a doctor (also already
           freely available on the internet)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: one group receives a form with the nudge, one group receives the same form without nudge and another group doesn't receive any form
primary purpose: Basic Science
masking: None (Open Label)
masking description: In the first pat of the study, participants are unaware of the fact we are trying to nudge them. In the second part, they are explained and asked what they feel about nudging
measure: Efficiency: vaccination rate
time frame: 1 month
description: vaccination rate
measure: acceptability: scale
time frame: One month
description: likert based acceptability form
arm group label: Nudge
arm group type: Experimental
description: receiving nudge and form
arm group label: No nudge
arm group type: Active Comparator
description: receiving the same form without nudge (only questions about their opinion/attitudes about vaccination)
arm group label: No intervention
arm group type: No Intervention
description: receiving no nudge nor form
intervention type: Behavioral
intervention name: Nudge
description: Influenza Vaccine Prescription Form accompanied on the back of telephone numbers of occupational health centers of different hospitals where interns are likely to be on probation.
arm group label: Nudge
intervention type: Other
intervention name: vaccination form
description: a form about vaccination
arm group label: No nudge
arm group label: Nudge
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Isabelle MILHABET, MD, PhD
role: Study Chair
affiliation: LAPCOS-UCA
facility: 
country: France
responsible party type: Sponsor-Investigator
investigator affiliation: Barbaroux, Adriaan, M.D.
investigator full name: Adriaan Barbaroux
investigator title: Principal Investigator
mesh term: Influenza, Human
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: starting 6 months after publication
ipd access criteria: OK for meta analysis, please contact directly Dr Adriaan BARBAROUX.