<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/NCT03827031</url>
  </required_header>
  <id_info>
    <org_study_id>NIMAO/2017-02/JMK-01</org_study_id>
    <nct_id>NCT03827031</nct_id>
  </id_info>
  <brief_title>Impact of Mulstidisciplinary Medication Assessment Review in Surgery Departments</brief_title>
  <acronym>CHIROPMEV</acronym>
  <official_title>Implementation and Impact of Multidisciplinary Medication Review in Surgery Departments on Medication Management of Elderly Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</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 presence of a clinical pharmacist (for their pharmacological expertise) and a general&#xD;
      practitioner (for their somatic expertise) in surgery departments would contribute to improve&#xD;
      the management of medications in elderly patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 18, 2022</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in iatrogenic drug risk in intervention groups versus control group</measure>
    <time_frame>3 months after hospitalization</time_frame>
    <description>Proportion of patients transitioning from intermediate or high to low risk according to Trivalle score (a score between 0-10. A score 0-1 constitutes a low ADE risk (12%), score 2-5 represents an average risk (32%), and a score 6-10 represents a high risk (53%)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of proposed medication modifications made by the clinical pharmacist accepted by the clinical doctor during the Multidisciplinary Medication Review in the experimental groups</measure>
    <time_frame>Hospital discharge (maximum 30 days)</time_frame>
    <description>Number of modifications accepted/number of modifications proposed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of potentially inappropriate medications per patient in each group</measure>
    <time_frame>Hospital discharge (maximum 30 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of proposed medication modifications made by the collaborative team accepted and/or made permanent</measure>
    <time_frame>3 months after hospital discharge</time_frame>
    <description>Number of modifications accepted/number of modifications proposed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of potentially inappropriate medications per patient in each group</measure>
    <time_frame>3 months after hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time required for Multidisciplinary Medication Review in the interventional groups (B1 and B2)</measure>
    <time_frame>Hospital discharge (maximum 30 days)</time_frame>
    <description>Hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time required for ransmitting multidisciplinary correspondence documents in B2 group</measure>
    <time_frame>Hospital discharge (maximum 30 days)</time_frame>
    <description>Hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of multidisciplinary correspondence documents sent to the community acotors in B2 group</measure>
    <time_frame>Hospital discharge (maximum 30 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of mode of diffusion of multidisciplinary correspondence documents in the B2 group</measure>
    <time_frame>Hospital discharge (maximum 30 days)</time_frame>
    <description>email, fax or letter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of reason for non-transmission of multidisciplinary correspondence documents in the B2 group</measure>
    <time_frame>Hospital discharge (maximum 30 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients for whom a follow-up review of proposed medication changes has been performed by the pharmacist in the B2 group</measure>
    <time_frame>2 months post discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of multidisciplinary correspondence documents transmitted by community pharmacist in group B2</measure>
    <time_frame>2 months post hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with at least one rehospitalization in each group</measure>
    <time_frame>3 months after hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate in each group</measure>
    <time_frame>3 months after hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare team satisfaction in interventional groups (B1, B2)</measure>
    <time_frame>3 months after hospital discharge</time_frame>
    <description>Custom-built 7-part questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction in all groups (A, B1, B2)</measure>
    <time_frame>3 months after hospital discharge</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">297</enrollment>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>B1 interventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>B2 interventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mutlidisciplinary medication Review (MMR)</intervention_name>
    <description>The clinical pharmacist performs medication reconciliation and pharmaceutical analysis. The physician performs a clinical examination and analysis of the medical record. Both participate in a collaborative interview. The hospital physician calls the community pharamcist to discuss proposed changes on the order and to establish a new prescription. At the end of the stay, the clinical pharmacist will conduct an exit interview with the patient. Three months after discharge, the patient's community pharmacist will be contacted to assess whether the changes proposed in the MMR were accepted</description>
    <arm_group_label>B1 interventional group</arm_group_label>
    <arm_group_label>B2 interventional group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mutlidisciplinary medication Review (MMR) with community pharmacist follow-up</intervention_name>
    <description>Multidisciplinary medication review (MMR) The clinical pharmacist performs medication reconciliation and pharmaceutical analysis. The physician performs a clinical examination and analysis of the medical record. Both participate in a collaborative interview. The hospital physician calls the community physician to discuss proposed changes on the order and to establish a new prescription. At the end of the stay, the clinical pharmacist will conduct an exit interview with the patient.&#xD;
Community follow-up A summary of the follow-up report stating the therapeutic modifications (called below multidisciplinary correspondence documents) will be sent to the community pharmacist and physician. Within 2 months of discharge, the pharmacist performs a follow-up of medication changes accepted and not accepted by the community physician.&#xD;
Three months after discharge, the patient's community pharmacist will be contacted to assess whether the changes proposed in the MMR were accepted.</description>
    <arm_group_label>B2 interventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient (or their representative) has given his consent and signed the consent&#xD;
             form.&#xD;
&#xD;
          -  The patient is affiliated to a health insurance programme.&#xD;
&#xD;
          -  The patient is at least 65 years old (≥) treated by at least (≥) five medications for&#xD;
             at least (≥) 6 months&#xD;
&#xD;
          -  The patient is available for a follow-up of 3 months.&#xD;
&#xD;
          -  The patient is hospitalized in the surgery department.&#xD;
&#xD;
          -  Patient with a Trivalle score greater than or equal to 2 (≥).&#xD;
&#xD;
          -  Patient living in a nursing home or going back home after hospitalization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is participating in another category I interventional study.&#xD;
&#xD;
          -  The subject is in an exclusion period determined by another study.&#xD;
&#xD;
          -  The subject is under safeguard of justice.&#xD;
&#xD;
          -  It is not possible to give the patient (or his/her trusted-person) informed&#xD;
             information.&#xD;
&#xD;
          -  Palliative care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Marie Kinowski</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nîmes University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jean-Marie Kinowski</last_name>
    <phone>+33(0)4.66.68.31.04</phone>
    <email>jean.marie.kinowski@chu-nimes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pierrick BEDOUCH</last_name>
      <phone>04 76 76 54 97</phone>
      <email>PBedouch@chu-grenoble.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maxime Villiet</last_name>
      <phone>04 67 33 85 62</phone>
      <email>m-villiet@chu-montpellier.fr</email>
    </contact>
    <investigator>
      <last_name>Maxime Villiet</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>François Canovas</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hubert Blain</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nimes University Hospital</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anissa Megzari</last_name>
      <phone>+33 (0)4.66.68.42.36</phone>
      <email>drc@chu-nimes.fr</email>
    </contact>
    <investigator>
      <last_name>Géraldine LEGUELINEL-BLACHE, PharmaD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Marie KINOWSKI, PharmaD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hélène RICHARD, PharmaD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chloe CHOUKROUN, PharmaD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julien Jouglen</last_name>
      <phone>05 67 77 10 55</phone>
      <email>jouglen.j@chu-toulouse.fr</email>
    </contact>
    <investigator>
      <last_name>Julien Jouglen</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre Mansat</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fatemeh Nourhashemi</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 22, 2018</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Safety</keyword>
  <keyword>Clinical Pharmacy</keyword>
  <keyword>General Practice</keyword>
  <keyword>Surgery</keyword>
  <keyword>Geriatrics</keyword>
  <keyword>Medication Review</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</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/NCT03827031
org study id: NIMAO/2017-02/JMK-01
nct id: NCT03827031
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The presence of a clinical pharmacist (for their pharmacological expertise) and a general
      practitioner (for their somatic expertise) in surgery departments would contribute to improve
      the management of medications in elderly patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in iatrogenic drug risk in intervention groups versus control group
time frame: 3 months after hospitalization
description: Proportion of patients transitioning from intermediate or high to low risk according to Trivalle score (a score between 0-10. A score 0-1 constitutes a low ADE risk (12%), score 2-5 represents an average risk (32%), and a score 6-10 represents a high risk (53%)
measure: Proportion of proposed medication modifications made by the clinical pharmacist accepted by the clinical doctor during the Multidisciplinary Medication Review in the experimental groups
time frame: Hospital discharge (maximum 30 days)
description: Number of modifications accepted/number of modifications proposed
measure: Number of potentially inappropriate medications per patient in each group
time frame: Hospital discharge (maximum 30 days)
measure: Proportion of proposed medication modifications made by the collaborative team accepted and/or made permanent
time frame: 3 months after hospital discharge
description: Number of modifications accepted/number of modifications proposed
measure: Number of potentially inappropriate medications per patient in each group
time frame: 3 months after hospital discharge
measure: Time required for Multidisciplinary Medication Review in the interventional groups (B1 and B2)
time frame: Hospital discharge (maximum 30 days)
description: Hours
measure: Time required for ransmitting multidisciplinary correspondence documents in B2 group
time frame: Hospital discharge (maximum 30 days)
description: Hours
measure: Number of multidisciplinary correspondence documents sent to the community acotors in B2 group
time frame: Hospital discharge (maximum 30 days)
measure: Description of mode of diffusion of multidisciplinary correspondence documents in the B2 group
time frame: Hospital discharge (maximum 30 days)
description: email, fax or letter
measure: Description of reason for non-transmission of multidisciplinary correspondence documents in the B2 group
time frame: Hospital discharge (maximum 30 days)
measure: Rate of patients for whom a follow-up review of proposed medication changes has been performed by the pharmacist in the B2 group
time frame: 2 months post discharge
measure: Number of multidisciplinary correspondence documents transmitted by community pharmacist in group B2
time frame: 2 months post hospital discharge
measure: Rate of patients with at least one rehospitalization in each group
time frame: 3 months after hospital discharge
measure: Mortality rate in each group
time frame: 3 months after hospital discharge
measure: Healthcare team satisfaction in interventional groups (B1, B2)
time frame: 3 months after hospital discharge
description: Custom-built 7-part questionnaire
measure: patient satisfaction in all groups (A, B1, B2)
time frame: 3 months after hospital discharge
description: questionnaire
arm group label: Control group
arm group type: No Intervention
arm group label: B1 interventional group
arm group type: Experimental
arm group label: B2 interventional group
arm group type: Experimental
intervention type: Other
intervention name: Mutlidisciplinary medication Review (MMR)
description: The clinical pharmacist performs medication reconciliation and pharmaceutical analysis. The physician performs a clinical examination and analysis of the medical record. Both participate in a collaborative interview. The hospital physician calls the community pharamcist to discuss proposed changes on the order and to establish a new prescription. At the end of the stay, the clinical pharmacist will conduct an exit interview with the patient. Three months after discharge, the patient's community pharmacist will be contacted to assess whether the changes proposed in the MMR were accepted
arm group label: B1 interventional group
arm group label: B2 interventional group
intervention type: Other
intervention name: Mutlidisciplinary medication Review (MMR) with community pharmacist follow-up
description: Multidisciplinary medication review (MMR) The clinical pharmacist performs medication reconciliation and pharmaceutical analysis. The physician performs a clinical examination and analysis of the medical record. Both participate in a collaborative interview. The hospital physician calls the community physician to discuss proposed changes on the order and to establish a new prescription. At the end of the stay, the clinical pharmacist will conduct an exit interview with the patient.
Community follow-up A summary of the follow-up report stating the therapeutic modifications (called below multidisciplinary correspondence documents) will be sent to the community pharmacist and physician. Within 2 months of discharge, the pharmacist performs a follow-up of medication changes accepted and not accepted by the community physician.
Three months after discharge, the patient's community pharmacist will be contacted to assess whether the changes proposed in the MMR were accepted.
arm group label: B2 interventional group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Marie Kinowski
role: Principal Investigator
affiliation: Nîmes University Hospital
last name: Jean-Marie Kinowski
phone: +33(0)4.66.68.31.04
email: jean.marie.kinowski@chu-nimes.fr
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Chronic Disease