<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/NCT03819036</url>
  </required_header>
  <id_info>
    <org_study_id>APHP180366</org_study_id>
    <secondary_id>2018-A02692-53</secondary_id>
    <nct_id>NCT03819036</nct_id>
  </id_info>
  <brief_title>Qualitative Assessment of Emergency Dental Treatments</brief_title>
  <acronym>URGDENT</acronym>
  <official_title>Qualitative Assessment of Emergency Dental Treatments in the Pitie Salpetriere Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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 objective of the study is to evaluate the efficiency of emergency procedures and patient&#xD;
      satisfaction within the GHPS (Groupe Hospitalier Pitié Salpêtrière) Dental Emergency&#xD;
      Department.&#xD;
&#xD;
      Pain is the main reason of consultation at dental emergency.&#xD;
&#xD;
      The investigators evaluate the pain felt before and after the intervention of the emergency&#xD;
      with questionnaires at the day of the consultation (D0), then with phone interviews at D1, D3&#xD;
      and D7.&#xD;
&#xD;
      The investigators also evaluate the quality of the reception and care provided in the GHPS&#xD;
      service using a satisfaction questionnaire completed by the patients at D0.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      I. Research progress&#xD;
&#xD;
      Two investigators will take turns in the service for the research duration. They will be&#xD;
      responsible for informing patients of the research upon their arrival in the service, for the&#xD;
      data collection and telephone follow-ups.&#xD;
&#xD;
      The course of the research will take place as follows:&#xD;
&#xD;
      Day of consultation (D0):&#xD;
&#xD;
        1. Patient information on the research when he arrives in the service; explanation of its&#xD;
           objectives, its modalities and constraints.&#xD;
&#xD;
        2. Verification of eligibility criteria.&#xD;
&#xD;
        3. Collection of the patient's non-opposition by the dentist during the consultation&#xD;
&#xD;
        4. Consultation according to the usual care. During this procedure, the practitioner&#xD;
           performs a medical history and, according to the patient's answers, completes the&#xD;
           &quot;General Information Questionnaire&quot;. He carries out the emergency care and explains the&#xD;
           postoperative consequences.&#xD;
&#xD;
        5. Patient filling in the satisfaction questionnaire immediately after consultation.&#xD;
&#xD;
           Telephone follow-up (D1, D3, D7):&#xD;
&#xD;
        6. Telephone follow-up by the interviewer and fill in the questionnaire - in case of&#xD;
           non-availability of the patient on day 1, the patient will be recalled on day 2 and the&#xD;
           extrapolated data on the slope of the curve between D1 and D2&#xD;
&#xD;
        7. Telephone follow-up by the interviewer on the day and filling in the questionnaire - if&#xD;
           the patient is not available on day 3, the patient will be recalled on day 4 and the&#xD;
           data extrapolated according to the slope of the curve between D1 and D4; if the patient&#xD;
           is not available at D4, he will be recalled to D5 and the extrapolated data between D1&#xD;
           and D5.&#xD;
&#xD;
        8. Telephone follow-up on the interviewer's day and fill in the questionnaire in case of&#xD;
           non-availability of the patient on day 7, the patient will be recalled to D8 and the&#xD;
           data extrapolated according to the slope of the curve between D3 and D8; if the patient&#xD;
           is still not available on D8, he will be recalled to D9 and the extrapolated data&#xD;
           between D3 and D9.&#xD;
&#xD;
      II.STATISTICAL ASPECTS&#xD;
&#xD;
      II.1. Statistical justification for the sample size&#xD;
&#xD;
      58,921 patients were received in emergency consultation day and night during the year 2017. A&#xD;
      sample of 1% of the population concerned will be constituted.&#xD;
&#xD;
      Patients received in day emergencies (44,191 patients in 2017) will be eligible. On average&#xD;
      121 patients are received daily in emergencies of day, about 600 per week (excluding&#xD;
      weekend).&#xD;
&#xD;
      According to a previous study in the department, 50% of patients in care could not be&#xD;
      included in the study or were lost to follow-up.&#xD;
&#xD;
      This leads to a number of 300 patients per week.&#xD;
&#xD;
      The study will therefore be conduct over 2 weeks, to include 600 patients, ie 1.3% of the&#xD;
      population consulting&#xD;
&#xD;
      II.2. Description of statistical methods&#xD;
&#xD;
      A descriptive analysis of the characteristics of the sample will be performed (age, sex,&#xD;
      reason for consultation, diagnosis, prior appointment test, average score of anxiety and pain&#xD;
      scores on D0, D1, D3, D7, compliance with instructions and making follow-up appointments,),&#xD;
      satisfaction rating, appreciation of the quality of medical care, politeness of staff,&#xD;
      waiting time, assessment of the quality of the care setting, the information received, the&#xD;
      treatment received, and the recommendation of the service to third parties will be made.&#xD;
&#xD;
      An analysis of the evolution of pain and anxiety scores between D0, D1, D3 and D7 will be&#xD;
      performed.&#xD;
&#xD;
      Correlations between the type of treatment and the perceived pain as well as the type of&#xD;
      treatment and the perceived anxiety will be made.&#xD;
&#xD;
      II.3. Method of taking into account missing or invalid data&#xD;
&#xD;
      Patients unreachable during the telephone follow-up period will be contacted the next day;&#xD;
      the pain and anxiety scores will then be extrapolated from the previous data and the new data&#xD;
      collected, by calculating the nearest point on the curve connecting these two data. If they&#xD;
      are new unreachable, the data will be considered missing. Data from patients with missing&#xD;
      data will be analyzed separately.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 18, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single Group Assignment</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain scores evolution 24 hours after treatment</measure>
    <time_frame>Day 1</time_frame>
    <description>The pain is measured by simple digital scale (ENS).&#xD;
The patient notes his pain between 0 and 10.&#xD;
0 being the lowest pain, 10 being the highest pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain scores evolution 3 days ans 7 days after treatment</measure>
    <time_frame>Day 3 and Day 7</time_frame>
    <description>The pain is measured by simple digital scale (ENS).&#xD;
The patient notes his pain between 0 and 10.&#xD;
0 being the lowest pain, 10 being the highest pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety score evaluation bound to the care</measure>
    <time_frame>Day 0, Day 1, Day 3 and Day 7</time_frame>
    <description>Anxiety is measured by simple digital scale (ENS) from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Welcome quality evaluation from hospital staff</measure>
    <time_frame>The day of the emergency care (Day 0).</time_frame>
    <description>The reception, cleanliness quality and waiting time will be measured by ENS scale from 0 to 10.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">583</enrollment>
  <condition>Dental Care</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Questionnaires for patients requiring dental emergencies care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Day 0 : Satisfaction questionnaire immediately after consultation Day 1, Day 3 and Day 7 : Telephone follow-up</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Patient reachable by telephone during the week following his / her care in the service&#xD;
&#xD;
          -  Collection of the non-opposition of the patient for his participation in research&#xD;
&#xD;
          -  Good understanding of the French language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with communication difficulties or difficulties in understanding the French&#xD;
             language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yves BOUCHER, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique Hoptiaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Pitié-Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>March 1, 2021</last_update_submitted>
  <last_update_submitted_qc>March 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dental emergency</keyword>
  <keyword>Toothache</keyword>
  <keyword>Tooth pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <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/NCT03819036
org study id: APHP180366
secondary id: 2018-A02692-53
nct id: NCT03819036
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to evaluate the efficiency of emergency procedures and patient
      satisfaction within the GHPS (Groupe Hospitalier Pitié Salpêtrière) Dental Emergency
      Department.

      Pain is the main reason of consultation at dental emergency.

      The investigators evaluate the pain felt before and after the intervention of the emergency
      with questionnaires at the day of the consultation (D0), then with phone interviews at D1, D3
      and D7.

      The investigators also evaluate the quality of the reception and care provided in the GHPS
      service using a satisfaction questionnaire completed by the patients at D0.
I. Research progress

      Two investigators will take turns in the service for the research duration. They will be
      responsible for informing patients of the research upon their arrival in the service, for the
      data collection and telephone follow-ups.

      The course of the research will take place as follows:

      Day of consultation (D0):

        1. Patient information on the research when he arrives in the service; explanation of its
           objectives, its modalities and constraints.

        2. Verification of eligibility criteria.

        3. Collection of the patient's non-opposition by the dentist during the consultation

        4. Consultation according to the usual care. During this procedure, the practitioner
           performs a medical history and, according to the patient's answers, completes the
           "General Information Questionnaire". He carries out the emergency care and explains the
           postoperative consequences.

        5. Patient filling in the satisfaction questionnaire immediately after consultation.

           Telephone follow-up (D1, D3, D7):

        6. Telephone follow-up by the interviewer and fill in the questionnaire - in case of
           non-availability of the patient on day 1, the patient will be recalled on day 2 and the
           extrapolated data on the slope of the curve between D1 and D2

        7. Telephone follow-up by the interviewer on the day and filling in the questionnaire - if
           the patient is not available on day 3, the patient will be recalled on day 4 and the
           data extrapolated according to the slope of the curve between D1 and D4; if the patient
           is not available at D4, he will be recalled to D5 and the extrapolated data between D1
           and D5.

        8. Telephone follow-up on the interviewer's day and fill in the questionnaire in case of
           non-availability of the patient on day 7, the patient will be recalled to D8 and the
           data extrapolated according to the slope of the curve between D3 and D8; if the patient
           is still not available on D8, he will be recalled to D9 and the extrapolated data
           between D3 and D9.

      II.STATISTICAL ASPECTS

      II.1. Statistical justification for the sample size

      58,921 patients were received in emergency consultation day and night during the year 2017. A
      sample of 1% of the population concerned will be constituted.

      Patients received in day emergencies (44,191 patients in 2017) will be eligible. On average
      121 patients are received daily in emergencies of day, about 600 per week (excluding
      weekend).

      According to a previous study in the department, 50% of patients in care could not be
      included in the study or were lost to follow-up.

      This leads to a number of 300 patients per week.

      The study will therefore be conduct over 2 weeks, to include 600 patients, ie 1.3% of the
      population consulting

      II.2. Description of statistical methods

      A descriptive analysis of the characteristics of the sample will be performed (age, sex,
      reason for consultation, diagnosis, prior appointment test, average score of anxiety and pain
      scores on D0, D1, D3, D7, compliance with instructions and making follow-up appointments,),
      satisfaction rating, appreciation of the quality of medical care, politeness of staff,
      waiting time, assessment of the quality of the care setting, the information received, the
      treatment received, and the recommendation of the service to third parties will be made.

      An analysis of the evolution of pain and anxiety scores between D0, D1, D3 and D7 will be
      performed.

      Correlations between the type of treatment and the perceived pain as well as the type of
      treatment and the perceived anxiety will be made.

      II.3. Method of taking into account missing or invalid data

      Patients unreachable during the telephone follow-up period will be contacted the next day;
      the pain and anxiety scores will then be extrapolated from the previous data and the new data
      collected, by calculating the nearest point on the curve connecting these two data. If they
      are new unreachable, the data will be considered missing. Data from patients with missing
      data will be analyzed separately.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Pain scores evolution 24 hours after treatment
time frame: Day 1
description: The pain is measured by simple digital scale (ENS).
The patient notes his pain between 0 and 10.
0 being the lowest pain, 10 being the highest pain.
measure: Pain scores evolution 3 days ans 7 days after treatment
time frame: Day 3 and Day 7
description: The pain is measured by simple digital scale (ENS).
The patient notes his pain between 0 and 10.
0 being the lowest pain, 10 being the highest pain.
measure: Anxiety score evaluation bound to the care
time frame: Day 0, Day 1, Day 3 and Day 7
description: Anxiety is measured by simple digital scale (ENS) from 0 to 10.
measure: Welcome quality evaluation from hospital staff
time frame: The day of the emergency care (Day 0).
description: The reception, cleanliness quality and waiting time will be measured by ENS scale from 0 to 10.
arm group label: Patients
arm group type: Experimental
description: Questionnaires for patients requiring dental emergencies care
intervention type: Other
intervention name: Questionnaires
description: Day 0 : Satisfaction questionnaire immediately after consultation Day 1, Day 3 and Day 7 : Telephone follow-up
arm group label: Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yves BOUCHER, PU-PH
role: Principal Investigator
affiliation: Assistance Publique Hoptiaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: No