<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/NCT02258503</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0211</org_study_id>
    <nct_id>NCT02258503</nct_id>
  </id_info>
  <brief_title>Impact of the Use of the Scale ALGOPLUS® on the Prescriptions of Analgesics in Emergency Department on Patients of 75 Years Old or More</brief_title>
  <acronym>DOLEVA75</acronym>
  <official_title>Impact of the Use of the Scale ALGOPLUS® on the Prescriptions of Analgesics in Emergency Department on Patients of 75 Years Old or More</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      The pain of the elderly is even often unrecognized or trivialized and ignored in spite of its&#xD;
      big frequency: the chronic pain affects 50 % of the elderly living at home, 49 to 83 % of&#xD;
      those living in institution and 80 % of this population at the end of life.&#xD;
&#xD;
      So in the elderly, the noxious character of the pain is more pregnant than at the young&#xD;
      adult. The echo on the acts of the everyday life is fast, the activities decrease, coming to&#xD;
      deteriorate the isolation and the dependence: the echo on the psychic state is frequent and&#xD;
      the pain is a part of the cause of a confusional state. Finally, the presence of a pain&#xD;
      distorts considerably the quality of life and can modify the state general as the desire of&#xD;
      life.&#xD;
&#xD;
      The evaluation of the pain appeals to the same strategy as to the younger subject but with&#xD;
      some specificities, related more to the pathologies associated with the ageing than with the&#xD;
      real age. For that purpose, the investigators have first of all scale of self-assessment as&#xD;
      the numerical scale which is adapted to estimate the acute and chronic pains but this scale&#xD;
      presents a bias because, certain patients do not express spontaneously their pain and this&#xD;
      one must be attentively looked for in case of modification of behavior.&#xD;
&#xD;
      So scales of hetero-evaluation were elaborated to solve the difficulties of detection and to&#xD;
      care the pain of the elderly. One of these is the scale Algoplus® (5 items which allow within&#xD;
      one minute a good quality evaluation whatever is the place of care) whose objective is the&#xD;
      observation of the behavioral changes caused by the acute pain in elderly having&#xD;
      communication disorders.&#xD;
&#xD;
      Due to the demographic evolution, emergency departments are more and more frequently a place&#xD;
      of consultation of the elderly. Indeed, the elderly represent approximately 10 to 20 % of all&#xD;
      the passages in emergency department and 50 % of the patients hospitalized during the passage&#xD;
      in the reception of Emergency department are elderly. Elderly care is difficult for a certain&#xD;
      number of reasons (vulnerability, accumulation of pathologies and treatments). So, in this&#xD;
      context, the evaluation of the presence of pain and its care are difficult in particular at&#xD;
      the elderly with communication disorders.&#xD;
&#xD;
      In a preliminary study in the emergency department of the Hospital of Clermont-Ferrand, on&#xD;
      700 patients of more than 75 years old admitted in April 2012, 32 % had a prescription of&#xD;
      analgesic while 13 % only had a real quotation of the pain.&#xD;
&#xD;
      The aim of the investigators study is to analyze if the systematic introduction of the scale&#xD;
      Algoplus® in the evaluation of elderly during its entrance to emergency department could&#xD;
      modify the prescription of analgesic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      First period of the study :&#xD;
&#xD;
      Evaluation of the pain of elderly patient admitted in the emergency department by numerical&#xD;
      scale and then taken care according to the usual practice of the emergency department.&#xD;
&#xD;
      A Clinical Research Associate will collect the quotation of pain by numerical scale and the&#xD;
      analgesics treatments prescribed and their posology and route of administration.&#xD;
&#xD;
      This data collection must be realized for 100 elderly patients of 75 or more years old&#xD;
      admitted the Emergency department during one month.&#xD;
&#xD;
      Training period :&#xD;
&#xD;
      Training of the emergency physicians in the use of the Algoplus® scale.&#xD;
&#xD;
      Second period of the study :&#xD;
&#xD;
      Evaluation of the pain of elderly patient admitted in the emergency department by numerical&#xD;
      scale and by Algoplus® scale then taken care according to the usual practice of the emergency&#xD;
      department.&#xD;
&#xD;
      A Clinical Research Associate will collect the quotation of pain by numerical scale and by&#xD;
      Algoplus® scale and the analgesics treatments prescribed and their posology and route of&#xD;
      administration.&#xD;
&#xD;
      This data collection must be realized for 100 elderly patients of 75 or more years old&#xD;
      admitted the Emergency department during one month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Collection of the rate of prescription of analgesic treatments</measure>
    <time_frame>at day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Collection of the score of quotation of pain by numerical scale (score from 0 to 10)</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collection of prescription of analgesic</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collection of the prescription of analgesic by class according to the scale of the WHO</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collection of the score of the scale Algoplus®</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>numerical scale</arm_group_label>
    <description>Evaluation of the pain of elderly patient admitted in the emergency department by numerical scale and then taken care according to the usual practice of the emergency department.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>algoplus scale</arm_group_label>
    <description>Evaluation of the pain of elderly patient admitted in the emergency department by numerical scale and by Algoplus® scale then taken care according to the usual practice of the emergency department.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pain in elderly patients</intervention_name>
    <arm_group_label>algoplus scale</arm_group_label>
    <arm_group_label>numerical scale</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        elderly patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted in emergency department for any pathologies,&#xD;
&#xD;
          -  Patients of 75 or more years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients of less than 75 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gisèle PICKERING</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>04 73 75 11 95</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>04 73 75 11 95</phone>
      <email>placarin@chu-clermontferrand.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>October 6, 2014</last_update_submitted>
  <last_update_submitted_qc>October 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Numerical scale</keyword>
  <keyword>Pain in elderly patients admitted in emergency department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</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/NCT02258503
org study id: CHU-0211
nct id: NCT02258503
lead sponsor: 
collaborator: 
The pain of the elderly is even often unrecognized or trivialized and ignored in spite of its
      big frequency: the chronic pain affects 50 % of the elderly living at home, 49 to 83 % of
      those living in institution and 80 % of this population at the end of life.

      So in the elderly, the noxious character of the pain is more pregnant than at the young
      adult. The echo on the acts of the everyday life is fast, the activities decrease, coming to
      deteriorate the isolation and the dependence: the echo on the psychic state is frequent and
      the pain is a part of the cause of a confusional state. Finally, the presence of a pain
      distorts considerably the quality of life and can modify the state general as the desire of
      life.

      The evaluation of the pain appeals to the same strategy as to the younger subject but with
      some specificities, related more to the pathologies associated with the ageing than with the
      real age. For that purpose, the investigators have first of all scale of self-assessment as
      the numerical scale which is adapted to estimate the acute and chronic pains but this scale
      presents a bias because, certain patients do not express spontaneously their pain and this
      one must be attentively looked for in case of modification of behavior.

      So scales of hetero-evaluation were elaborated to solve the difficulties of detection and to
      care the pain of the elderly. One of these is the scale Algoplus® (5 items which allow within
      one minute a good quality evaluation whatever is the place of care) whose objective is the
      observation of the behavioral changes caused by the acute pain in elderly having
      communication disorders.

      Due to the demographic evolution, emergency departments are more and more frequently a place
      of consultation of the elderly. Indeed, the elderly represent approximately 10 to 20 % of all
      the passages in emergency department and 50 % of the patients hospitalized during the passage
      in the reception of Emergency department are elderly. Elderly care is difficult for a certain
      number of reasons (vulnerability, accumulation of pathologies and treatments). So, in this
      context, the evaluation of the presence of pain and its care are difficult in particular at
      the elderly with communication disorders.

      In a preliminary study in the emergency department of the Hospital of Clermont-Ferrand, on
      700 patients of more than 75 years old admitted in April 2012, 32 % had a prescription of
      analgesic while 13 % only had a real quotation of the pain.

      The aim of the investigators study is to analyze if the systematic introduction of the scale
      Algoplus® in the evaluation of elderly during its entrance to emergency department could
      modify the prescription of analgesic.
First period of the study :

      Evaluation of the pain of elderly patient admitted in the emergency department by numerical
      scale and then taken care according to the usual practice of the emergency department.

      A Clinical Research Associate will collect the quotation of pain by numerical scale and the
      analgesics treatments prescribed and their posology and route of administration.

      This data collection must be realized for 100 elderly patients of 75 or more years old
      admitted the Emergency department during one month.

      Training period :

      Training of the emergency physicians in the use of the Algoplus® scale.

      Second period of the study :

      Evaluation of the pain of elderly patient admitted in the emergency department by numerical
      scale and by Algoplus® scale then taken care according to the usual practice of the emergency
      department.

      A Clinical Research Associate will collect the quotation of pain by numerical scale and by
      Algoplus® scale and the analgesics treatments prescribed and their posology and route of
      administration.

      This data collection must be realized for 100 elderly patients of 75 or more years old
      admitted the Emergency department during one month.
time perspective: Cross-Sectional
measure: Collection of the rate of prescription of analgesic treatments
time frame: at day 1
measure: Collection of the score of quotation of pain by numerical scale (score from 0 to 10)
time frame: at day 1
measure: Collection of prescription of analgesic
time frame: at day 1
measure: Collection of the prescription of analgesic by class according to the scale of the WHO
time frame: at day 1
measure: Collection of the score of the scale Algoplus®
time frame: at day 1
arm group label: numerical scale
description: Evaluation of the pain of elderly patient admitted in the emergency department by numerical scale and then taken care according to the usual practice of the emergency department.
arm group label: algoplus scale
description: Evaluation of the pain of elderly patient admitted in the emergency department by numerical scale and by Algoplus® scale then taken care according to the usual practice of the emergency department.
intervention type: Other
intervention name: pain in elderly patients
arm group label: algoplus scale
arm group label: numerical scale
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Gisèle PICKERING
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Patrick LACARIN
phone: 04 73 75 11 95
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Emergencies