<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/NCT02237573</url>
  </required_header>
  <id_info>
    <org_study_id>DMG003</org_study_id>
    <nct_id>NCT02237573</nct_id>
  </id_info>
  <brief_title>Impact of Handing to Patients a Copy of the Consultation Report on Their Medicine Consumption</brief_title>
  <official_title>Impact of Handing to Patients With Viral Gastroenteritis or Upper Respiratory Tract Infections a Copy of the Consultation Report on Their Medicine Consumption: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Paris 7 - Denis Diderot</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Paris 7 - Denis Diderot</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In France, patients with benign viral infections (ie: gastro enteritis and/or&#xD;
      rhinopharyngitis, etc.) often receive several prescriptions from their doctors, although&#xD;
      there is evidence that these medicines are not efficient.&#xD;
&#xD;
      We hypothesize that patients could be reassured by health advices, especially if they are&#xD;
      written. In addition, we believe that doctors would feel less guilty for not prescribing&#xD;
      drugs if they could hand written consultation reports to patients, in these situations.&#xD;
&#xD;
      We aim to assess the impact of handing to patients with viral gastroenteritis or upper&#xD;
      respiratory tract infections, a copy of the consultation report on their medicine&#xD;
      consumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In France, 90% of General practitioners' (GPs) consultations end with prescription of drugs&#xD;
      (versus only 43,2% in Netherlands). A french medical thesis published in 2013 showed that&#xD;
      drugs prescriptions were not a priority for patients. Rather than medicine's prescription,&#xD;
      patients preferred attentive listening associated with personalized advices from their GPs.&#xD;
      Several studies also showed that a commercial relationship exists between doctors and&#xD;
      patients. The prescription is like an exchange currency against the patient money.&#xD;
&#xD;
      We aim to assess the impact of handing to patients with viral gastroenteritis or upper&#xD;
      respiratory tract infections, a copy of the consultation report on their medicine&#xD;
      consumption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean number of medications prescribed by the physician</measure>
    <time_frame>1 day</time_frame>
    <description>We will assess the mean number of medications prescribed by the physician during the consultation.&#xD;
Two independent investigators will assess, aposteriori from medical records, each prescription to determine the number of prescribed drugs (including rhino pharyngeal desobstruction). In case of discrepancy in their assessments, a third investigator will help in consensus.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number (Proportion) of each class of prescribed drug</measure>
    <time_frame>1 day</time_frame>
    <description>We will assess the frequency of each class of medications prescribed by the physician during the consultation.&#xD;
Classes will be: 1)paracetamol, 2)non steroidal anti inflammatory drug, 3)antibiotics, 4)physiological serum, 5)vasoconstrictor nasal spray, 6)oral spray, 7)cough syrup, 8)loperamide, 9)phloroglucinol, 10)antiemetic drugs, 11) antiseptic lozenges.&#xD;
Two independent investigators will assess each prescription made by physicians to determine the different prescribed drugs (including rhinopharyngeal desobstruction). In case of discrepancy in their assessments, a third investigator will help in consensus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number (Proportion) of reconsultation</measure>
    <time_frame>30 days</time_frame>
    <description>A single investigator will recontact all included patients by telephone to assess if they reconsulted a doctor for the same motive in the period. If they cannot be contacted by phone, they will be contacted by e-mail. A second call will be done after 7 days in case they did not answer the first call.&#xD;
We will compare proportion of reconsultation between the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number (Proportion) of patients resorting to self-treatment</measure>
    <time_frame>30 days</time_frame>
    <description>A single investigator will recontact all included patients by telephone to assess if included patients self treated themselves using drugs they had at their disposal or using non prescription drugs. If they cannot be contacted by phone, they will be contacted by e-mail. A second call will be done after 7 days in case they did not answer the first call.&#xD;
We will compare proportion of self treatment between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number (Proportion) of adverse effects</measure>
    <time_frame>30 days</time_frame>
    <description>One investigator will assess, aposteriori from medical records, if patients reconsulted for a motive that could be associated with an aggravation of the viral infection (gastro enteritis or rhinopharyngitis).&#xD;
In addition, all included patients will be recontacted by telephone (or e-mail in case they do not answer the phone) We will assess nature and number of cases.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Viral Gastro Enteritis</condition>
  <condition>Pharyngitis</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Written medical report and standardized medical advices</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standardized medical advice only</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Written medical report and standardized medical advices</intervention_name>
    <description>The intervention will include: 1) handing the patient at the end of the consultation a copy of the consultation report which will be composed of:&#xD;
a detailed report of the consultation (motive, case history, clinical examination, conclusion)&#xD;
written standardized medical advices from evidence published in the literature. Interventions will be designed by several general practitioners and tested by few patients.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Other:&#xD;
Oral standardized medical advices from evidence published in the literature. Physicians will be trained by a single investigator.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All consecutive patients with &gt;18 ans Diagnosis of gastroenteritis or rhinopharyngitis by&#xD;
        the physician Written consent by patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who have already visited the doctor in the last 15 days A given patient can only&#xD;
        be included once Diagnostic uncertainty or need of laboratory tests Cognitive impairment&#xD;
        Only one patient by family or visit&#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>Viet-Thi Tran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Paris Diderot University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculté Xavier Bichat</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Macfarlane J, Holmes W, Gard P, Thornhill D, Macfarlane R, Hubbard R. Reducing antibiotic use for acute bronchitis in primary care: blinded, randomised controlled trial of patient information leaflet. BMJ. 2002 Jan 12;324(7329):91-4. doi: 10.1136/bmj.324.7329.91.</citation>
    <PMID>11786454</PMID>
  </reference>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>June 19, 2015</last_update_submitted>
  <last_update_submitted_qc>June 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Paris 7 - Denis Diderot</investigator_affiliation>
    <investigator_full_name>TRAN Viet thi</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>general practice</keyword>
  <keyword>viral infections</keyword>
  <keyword>consultation reports</keyword>
  <keyword>drug prescription</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</mesh_term>
    <mesh_term>Enteritis</mesh_term>
    <mesh_term>Gastroenteritis</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/NCT02237573
org study id: DMG003
nct id: NCT02237573
lead sponsor: 
has dmc: No
In France, patients with benign viral infections (ie: gastro enteritis and/or
      rhinopharyngitis, etc.) often receive several prescriptions from their doctors, although
      there is evidence that these medicines are not efficient.

      We hypothesize that patients could be reassured by health advices, especially if they are
      written. In addition, we believe that doctors would feel less guilty for not prescribing
      drugs if they could hand written consultation reports to patients, in these situations.

      We aim to assess the impact of handing to patients with viral gastroenteritis or upper
      respiratory tract infections, a copy of the consultation report on their medicine
      consumption.
In France, 90% of General practitioners' (GPs) consultations end with prescription of drugs
      (versus only 43,2% in Netherlands). A french medical thesis published in 2013 showed that
      drugs prescriptions were not a priority for patients. Rather than medicine's prescription,
      patients preferred attentive listening associated with personalized advices from their GPs.
      Several studies also showed that a commercial relationship exists between doctors and
      patients. The prescription is like an exchange currency against the patient money.

      We aim to assess the impact of handing to patients with viral gastroenteritis or upper
      respiratory tract infections, a copy of the consultation report on their medicine
      consumption.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean number of medications prescribed by the physician
time frame: 1 day
description: We will assess the mean number of medications prescribed by the physician during the consultation.
Two independent investigators will assess, aposteriori from medical records, each prescription to determine the number of prescribed drugs (including rhino pharyngeal desobstruction). In case of discrepancy in their assessments, a third investigator will help in consensus.
measure: Number (Proportion) of each class of prescribed drug
time frame: 1 day
description: We will assess the frequency of each class of medications prescribed by the physician during the consultation.
Classes will be: 1)paracetamol, 2)non steroidal anti inflammatory drug, 3)antibiotics, 4)physiological serum, 5)vasoconstrictor nasal spray, 6)oral spray, 7)cough syrup, 8)loperamide, 9)phloroglucinol, 10)antiemetic drugs, 11) antiseptic lozenges.
Two independent investigators will assess each prescription made by physicians to determine the different prescribed drugs (including rhinopharyngeal desobstruction). In case of discrepancy in their assessments, a third investigator will help in consensus.
measure: Number (Proportion) of reconsultation
time frame: 30 days
description: A single investigator will recontact all included patients by telephone to assess if they reconsulted a doctor for the same motive in the period. If they cannot be contacted by phone, they will be contacted by e-mail. A second call will be done after 7 days in case they did not answer the first call.
We will compare proportion of reconsultation between the two groups.
measure: Number (Proportion) of patients resorting to self-treatment
time frame: 30 days
description: A single investigator will recontact all included patients by telephone to assess if included patients self treated themselves using drugs they had at their disposal or using non prescription drugs. If they cannot be contacted by phone, they will be contacted by e-mail. A second call will be done after 7 days in case they did not answer the first call.
We will compare proportion of self treatment between the two groups
measure: Number (Proportion) of adverse effects
time frame: 30 days
description: One investigator will assess, aposteriori from medical records, if patients reconsulted for a motive that could be associated with an aggravation of the viral infection (gastro enteritis or rhinopharyngitis).
In addition, all included patients will be recontacted by telephone (or e-mail in case they do not answer the phone) We will assess nature and number of cases.
arm group label: Intervention
arm group type: Experimental
description: Written medical report and standardized medical advices
arm group label: Control
arm group type: Active Comparator
description: Standardized medical advice only
intervention type: Other
intervention name: Written medical report and standardized medical advices
description: The intervention will include: 1) handing the patient at the end of the consultation a copy of the consultation report which will be composed of:
a detailed report of the consultation (motive, case history, clinical examination, conclusion)
written standardized medical advices from evidence published in the literature. Interventions will be designed by several general practitioners and tested by few patients.
arm group label: Intervention
intervention type: Other
intervention name: Control
description: Other:
Oral standardized medical advices from evidence published in the literature. Physicians will be trained by a single investigator.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Viet-Thi Tran, MD
role: Principal Investigator
affiliation: Paris Diderot University
facility: 
country: France
citation: Macfarlane J, Holmes W, Gard P, Thornhill D, Macfarlane R, Hubbard R. Reducing antibiotic use for acute bronchitis in primary care: blinded, randomised controlled trial of patient information leaflet. BMJ. 2002 Jan 12;324(7329):91-4. doi: 10.1136/bmj.324.7329.91.
PMID: 11786454
responsible party type: Principal Investigator
investigator affiliation: University Paris 7 - Denis Diderot
investigator full name: TRAN Viet thi
investigator title: assistant professor
mesh term: Pharyngitis
mesh term: Enteritis
mesh term: Gastroenteritis