<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/NCT02246361</url>
  </required_header>
  <id_info>
    <org_study_id>N°IRB 5891</org_study_id>
    <nct_id>NCT02246361</nct_id>
  </id_info>
  <brief_title>Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication</brief_title>
  <acronym>EDIFIP</acronym>
  <official_title>Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication and Adherence in Emergency Ward</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Floralis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Groupe Hospitalier Mutualiste de Grenoble</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Floralis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this &quot;before-after&quot; prospective multicenter study is to assess the impact of&#xD;
      six Patient Information Leaflets (PILs) on Doctor Patient Communication scale (DPC) and&#xD;
      adherence scale for common acute illnesses in emergency ward.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assessing the impact of six Patient Information Leaflets (PILs) on Doctor Patient&#xD;
      Communication scale (DPC) and adherence scale for common acute illnesses (infectious colitis,&#xD;
      diverticulitis, pneumonitis, prostatitis, pyelonephritis , ankle sprain) in two emergency&#xD;
      ward.&#xD;
&#xD;
      For &quot;before&quot; study without intervention : usual consultation without PIL .&#xD;
&#xD;
      For &quot;after study&quot; with intervention : the patient is given a PIL related to his disease&#xD;
      during the consultation.&#xD;
&#xD;
      Data collection will take place the same day as the consultation by self-administered&#xD;
      questionnaire for DPC scale and also between 7 to 10 days after the consultation by phone&#xD;
      survey for DPC scale and adherence scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Doctor Patient Communication score</measure>
    <time_frame>In seven to ten days after delivery</time_frame>
    <description>All patients will be called seven to ten days after the delivery of a PIL during the visit to answer a questionnaire on their perception of Doctor Patient Communication (DPC) since they visit the GP. Il will permit to calculate a DPC score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence score</measure>
    <time_frame>In seven to ten days after the delivery</time_frame>
    <description>All patients will be called seven to ten days after the delivery of a PIL during the visit, to answer a questionnaire on their adherence related to the disease since they visit the GP. Il will permit to calculate a adherence score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction score</measure>
    <time_frame>In seven to ten days after the delivery</time_frame>
    <description>All patients will be called seven to ten days after the visit, to answer a questionnaire on their satisfaction about since they visit the GP. Il will permit to calculate a satisfaction score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Doctor Patient Communication score</measure>
    <time_frame>Just after the visit</time_frame>
    <description>All patients will answer to a self questionnaire on their perception of Doctor Patient Communication (DPC) just after the visit of the GP. Il will permit to calculate a DPC score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">211</enrollment>
  <condition>Ankle Sprain</condition>
  <condition>Infectious Colitis</condition>
  <condition>Diverticulitis</condition>
  <condition>Pyelonephritis</condition>
  <condition>Prostatitis</condition>
  <condition>Pneumonitis</condition>
  <arm_group>
    <arm_group_label>Phase 1 (without PIL)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No particular intervention during consultation for the patient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient Information Leaflet is given to the patient during the consultation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Patient Information Leaflet (PIL)</intervention_name>
    <description>Patient Information Leaflet (PIL) about infectious colitis, diverticulitis, pneumonitis, prostatitis or either pyelonephritis is given to the patient related to his disease during the consultation</description>
    <arm_group_label>Phase 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient.&#xD;
&#xD;
          -  Minor aged over 15 years accompanied by a responsible adult.&#xD;
&#xD;
          -  The patient must be reachable by telephone within seven to ten days following the&#xD;
             consultation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Illiterate patient.&#xD;
&#xD;
          -  Patient refusing follow-up call.&#xD;
&#xD;
          -  Patient with visual or hearing impairment.&#xD;
&#xD;
          -  Patient non-Francophone.&#xD;
&#xD;
          -  Private patient of liberty by judicial or administrative.&#xD;
&#xD;
          -  Person being a measure of legal protection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melanie Sustersic, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Floralis France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Mutualiste, service des urgences</name>
      <address>
        <city>Grenoble</city>
        <state>Isere</state>
        <zip>38000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier</name>
      <address>
        <city>Chambery</city>
        <state>Savoie</state>
        <zip>74000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Sustersic M, Jeannet E, Cozon-Rein L, Marechaux F, Genty C, Foote A, David-Tchouda S, Martinez L, Bosson JL. Impact of information leaflets on behavior of patients with gastroenteritis or tonsillitis: a cluster randomized trial in French primary care. J Gen Intern Med. 2013 Jan;28(1):25-31. doi: 10.1007/s11606-012-2164-8. Epub 2012 Jul 25.</citation>
    <PMID>22829293</PMID>
  </reference>
  <reference>
    <citation>Sustersic M, Meneau A, Dremont R, Paris A, Laborde L, Bosson JL. [Developing patient information sheets in general practice. Proposal for a methodology]. Rev Prat. 2008 Dec 15;58(19 Suppl):17-24. French.</citation>
    <PMID>19253787</PMID>
  </reference>
  <reference>
    <citation>Little P, Moore M, Kelly J, Williamson I, Leydon G, McDermott L, Mullee M, Stuart B; PIPS Investigators. Delayed antibiotic prescribing strategies for respiratory tract infections in primary care: pragmatic, factorial, randomised controlled trial. BMJ. 2014 Mar 6;348:g1606. doi: 10.1136/bmj.g1606.</citation>
    <PMID>24603565</PMID>
  </reference>
  <reference>
    <citation>Coudeyre E, Tubach F, Rannou F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting. PLoS One. 2007 Aug 8;2(8):e706. doi: 10.1371/journal.pone.0000706.</citation>
    <PMID>17684553</PMID>
  </reference>
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    <citation>Grime J, Blenkinsopp A, Raynor DK, Pollock K, Knapp P. The role and value of written information for patients about individual medicines: a systematic review. Health Expect. 2007 Sep;10(3):286-98. doi: 10.1111/j.1369-7625.2007.00454.x.</citation>
    <PMID>17678517</PMID>
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    <citation>Gauchet A, Tarquinio C, Fischer G. Psychosocial predictors of medication adherence among persons living with HIV. Int J Behav Med. 2007;14(3):141-50. doi: 10.1007/BF03000185.</citation>
    <PMID>18062057</PMID>
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    <citation>Nicolson D, Knapp P, Raynor DK, Spoor P. Written information about individual medicines for consumers. Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD002104. doi: 10.1002/14651858.CD002104.pub3.</citation>
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    <citation>Fox R. Informed choice in screening programmes: do leaflets help? A critical literature review. J Public Health (Oxf). 2006 Dec;28(4):309-17. doi: 10.1093/pubmed/fdl066. Epub 2006 Oct 23.</citation>
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  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>August 26, 2015</last_update_submitted>
  <last_update_submitted_qc>August 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ankle sprain</keyword>
  <keyword>Infectious colitis</keyword>
  <keyword>Diverticulitis</keyword>
  <keyword>Pyelonephritis</keyword>
  <keyword>Prostatitis</keyword>
  <keyword>Pneumonitis</keyword>
  <keyword>Patient Information Leaflet (PIL)</keyword>
  <keyword>Doctor Patient Communication</keyword>
  <keyword>Adherence</keyword>
  <keyword>Satisfaction</keyword>
  <keyword>Scale</keyword>
  <keyword>Doctor Patient Communication scale</keyword>
  <keyword>Adherence scale</keyword>
  <keyword>Satisfaction scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Diverticulitis</mesh_term>
    <mesh_term>Prostatitis</mesh_term>
    <mesh_term>Pyelonephritis</mesh_term>
    <mesh_term>Ankle Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT02246361
org study id: N°IRB 5891
nct id: NCT02246361
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this "before-after" prospective multicenter study is to assess the impact of
      six Patient Information Leaflets (PILs) on Doctor Patient Communication scale (DPC) and
      adherence scale for common acute illnesses in emergency ward.
Assessing the impact of six Patient Information Leaflets (PILs) on Doctor Patient
      Communication scale (DPC) and adherence scale for common acute illnesses (infectious colitis,
      diverticulitis, pneumonitis, prostatitis, pyelonephritis , ankle sprain) in two emergency
      ward.

      For "before" study without intervention : usual consultation without PIL .

      For "after study" with intervention : the patient is given a PIL related to his disease
      during the consultation.

      Data collection will take place the same day as the consultation by self-administered
      questionnaire for DPC scale and also between 7 to 10 days after the consultation by phone
      survey for DPC scale and adherence scale.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Doctor Patient Communication score
time frame: In seven to ten days after delivery
description: All patients will be called seven to ten days after the delivery of a PIL during the visit to answer a questionnaire on their perception of Doctor Patient Communication (DPC) since they visit the GP. Il will permit to calculate a DPC score.
measure: Adherence score
time frame: In seven to ten days after the delivery
description: All patients will be called seven to ten days after the delivery of a PIL during the visit, to answer a questionnaire on their adherence related to the disease since they visit the GP. Il will permit to calculate a adherence score.
measure: Satisfaction score
time frame: In seven to ten days after the delivery
description: All patients will be called seven to ten days after the visit, to answer a questionnaire on their satisfaction about since they visit the GP. Il will permit to calculate a satisfaction score.
measure: Doctor Patient Communication score
time frame: Just after the visit
description: All patients will answer to a self questionnaire on their perception of Doctor Patient Communication (DPC) just after the visit of the GP. Il will permit to calculate a DPC score.
arm group label: Phase 1 (without PIL)
arm group type: No Intervention
description: No particular intervention during consultation for the patient
arm group label: Phase 2
arm group type: Experimental
description: Patient Information Leaflet is given to the patient during the consultation
intervention type: Procedure
intervention name: Patient Information Leaflet (PIL)
description: Patient Information Leaflet (PIL) about infectious colitis, diverticulitis, pneumonitis, prostatitis or either pyelonephritis is given to the patient related to his disease during the consultation
arm group label: Phase 2
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Melanie Sustersic, MD
role: Principal Investigator
affiliation: Floralis France
facility: 
facility: 
country: France
citation: Sustersic M, Jeannet E, Cozon-Rein L, Marechaux F, Genty C, Foote A, David-Tchouda S, Martinez L, Bosson JL. Impact of information leaflets on behavior of patients with gastroenteritis or tonsillitis: a cluster randomized trial in French primary care. J Gen Intern Med. 2013 Jan;28(1):25-31. doi: 10.1007/s11606-012-2164-8. Epub 2012 Jul 25.
PMID: 22829293
citation: Sustersic M, Meneau A, Dremont R, Paris A, Laborde L, Bosson JL. [Developing patient information sheets in general practice. Proposal for a methodology]. Rev Prat. 2008 Dec 15;58(19 Suppl):17-24. French.
PMID: 19253787
citation: Little P, Moore M, Kelly J, Williamson I, Leydon G, McDermott L, Mullee M, Stuart B; PIPS Investigators. Delayed antibiotic prescribing strategies for respiratory tract infections in primary care: pragmatic, factorial, randomised controlled trial. BMJ. 2014 Mar 6;348:g1606. doi: 10.1136/bmj.g1606.
PMID: 24603565
citation: Coudeyre E, Tubach F, Rannou F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting. PLoS One. 2007 Aug 8;2(8):e706. doi: 10.1371/journal.pone.0000706.
PMID: 17684553
citation: Grime J, Blenkinsopp A, Raynor DK, Pollock K, Knapp P. The role and value of written information for patients about individual medicines: a systematic review. Health Expect. 2007 Sep;10(3):286-98. doi: 10.1111/j.1369-7625.2007.00454.x.
PMID: 17678517
citation: Gauchet A, Tarquinio C, Fischer G. Psychosocial predictors of medication adherence among persons living with HIV. Int J Behav Med. 2007;14(3):141-50. doi: 10.1007/BF03000185.
PMID: 18062057
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responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Pneumonia
mesh term: Colitis
mesh term: Diverticulitis
mesh term: Prostatitis
mesh term: Pyelonephritis
mesh term: Ankle Injuries