<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/NCT03029052</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01628-43</org_study_id>
    <nct_id>NCT03029052</nct_id>
  </id_info>
  <brief_title>Medication Reconciliation at Discharge: Impact on Patient's Care</brief_title>
  <acronym>CONCIVILLE</acronym>
  <official_title>A Comparative Pilot Study in an Infectious Disease Department Assessing the Impact of Medication Reconciliation at Discharge Associated With a Patient's Counseling Session, Both Provided by a Pharmacist, on Patient's Care After Discharge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Investigation Clinique et Technologique 805</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre d'Investigation Clinique et Technologique 805</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of&#xD;
      patients. This risk may be linked with discontinuity of care between hospital physicians and&#xD;
      Primary Care Physician (PCP). The investigators aim to assess in this study the impact of&#xD;
      medication reconciliation at discharge associated with a patient's counseling session, both&#xD;
      provided by a pharmacist, on patient's care after discharge. To demonstrate the interest of&#xD;
      medication reconciliation at discharge we expect a reduction by 15% of the number of&#xD;
      prescription changes not maintained by the PCP after discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of&#xD;
      patients and may lead to further hospitalization. This risk may be linked with discontinuity&#xD;
      of care between hospital physicians and Primary Care Physician (PCP) and from discrepancies&#xD;
      between patient's current medications and drugs prescribed at discharge.&#xD;
&#xD;
      Preventing adverse drug events (ADEs) remains a patient safety priority not only in hospitals&#xD;
      but also across the continuum of care for patients. Implementing medication reconciliation at&#xD;
      all transitions in care is an effective strategy for preventing discrepancies and ADEs.&#xD;
      Medication reconciliation prevents and corrects medication errors by promoting transmissions&#xD;
      of complete and accurate information about medicines.&#xD;
&#xD;
      Furthermore, ADEs may be the result of a failure to understand and manage post-discharge care&#xD;
      needs and can lead to hospital readmission.&#xD;
&#xD;
      We assume that medication reconciliation at discharge, secondarily transmitted to the PCP&#xD;
      with a discharge counseling session between the patient and a clinical pharmacist could have&#xD;
      a positive impact on the maintenance of therapeutic optimization decided by in-hospital&#xD;
      practitioners.&#xD;
&#xD;
      In order to evaluate this assumption, we will conduct a randomized controlled study on 120&#xD;
      patients (as a reduction by 15% of the number of prescription changes not maintained by the&#xD;
      PCP after discharge is expected).&#xD;
&#xD;
      The follow-up will last 1 month after discharge from hospital. The first prescription from&#xD;
      the PCP will be collected and analyzed. In addition, patients and PCPs will be contacted by&#xD;
      the pharmacist to answer specific questionnaires.&#xD;
&#xD;
      The primary objective of the study is to assess the impact of medication reconciliation at&#xD;
      discharge associated with a patient's counseling session, both provided by a pharmacist, on&#xD;
      patient's care after discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Actual">July 2, 2019</completion_date>
  <primary_completion_date type="Actual">July 2, 2019</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>
    <intervention_model_description>Monocenter, randomized, controlled, pilot study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of in-hospital prescription changes not maintained by the Primary Care Physician (PCP) one month after discharge.</measure>
    <time_frame>1 month</time_frame>
    <description>The number of in-hospital prescription changes will be evaluated only on discharge prescription transmitted to the patient (after prescription analysis by a clinical pharmacist in the &quot;reconciliation&quot; group)&#xD;
Compared to the list of all current medications at admission, in-hospital prescription changes include the following:&#xD;
Adding a new drug&#xD;
Discontinuing a drug&#xD;
Drug switch&#xD;
Modifying a dose&#xD;
Among these hospital prescription changes, some will not be maintained by the PCP one month after discharge.&#xD;
In-hospital prescription changes not maintained by the PCP will be evaluated on the first prescription of the PCP following discharge.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Medication Reconciliation</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Medical and pharmaceutical management (at admission, during hospitalization and at discharge) will follow standard healthcare procedures of the department.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reconciliation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard healthcare procedures and pharmacist's involvement</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reconciliation</intervention_name>
    <description>In addition to standard healthcare procedures, the pharmacist will analyze discharge prescriptions and proceed to medication reconciliation. A patient's counseling session will also be provided by the pharmacist. A reconciliation mail will be addressed to the PCP.</description>
    <arm_group_label>Reconciliation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 years old&#xD;
&#xD;
          -  hospitalized in infectious disease department&#xD;
&#xD;
          -  with a chronic disease and a current medical prescription including at least three&#xD;
             drugs&#xD;
&#xD;
          -  discharged home or nursing home&#xD;
&#xD;
          -  not opposed to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  foreigners, patients under legal guardianship&#xD;
&#xD;
          -  advanced dementia (MMS&lt;20) or phone tracking impossible&#xD;
&#xD;
          -  primary care physician opposed to answer questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederique BOUCHAND, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Benjamin DAVIDO, MD</last_name>
    <role>Study Director</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Raymond poincaré</name>
      <address>
        <city>Garches</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre d'Investigation Clinique et Technologique 805</investigator_affiliation>
    <investigator_full_name>Frederique Bouchand</investigator_full_name>
    <investigator_title>PharmD</investigator_title>
  </responsible_party>
  <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/NCT03029052
org study id: 2016-A01628-43
nct id: NCT03029052
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of
      patients. This risk may be linked with discontinuity of care between hospital physicians and
      Primary Care Physician (PCP). The investigators aim to assess in this study the impact of
      medication reconciliation at discharge associated with a patient's counseling session, both
      provided by a pharmacist, on patient's care after discharge. To demonstrate the interest of
      medication reconciliation at discharge we expect a reduction by 15% of the number of
      prescription changes not maintained by the PCP after discharge.
Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of
      patients and may lead to further hospitalization. This risk may be linked with discontinuity
      of care between hospital physicians and Primary Care Physician (PCP) and from discrepancies
      between patient's current medications and drugs prescribed at discharge.

      Preventing adverse drug events (ADEs) remains a patient safety priority not only in hospitals
      but also across the continuum of care for patients. Implementing medication reconciliation at
      all transitions in care is an effective strategy for preventing discrepancies and ADEs.
      Medication reconciliation prevents and corrects medication errors by promoting transmissions
      of complete and accurate information about medicines.

      Furthermore, ADEs may be the result of a failure to understand and manage post-discharge care
      needs and can lead to hospital readmission.

      We assume that medication reconciliation at discharge, secondarily transmitted to the PCP
      with a discharge counseling session between the patient and a clinical pharmacist could have
      a positive impact on the maintenance of therapeutic optimization decided by in-hospital
      practitioners.

      In order to evaluate this assumption, we will conduct a randomized controlled study on 120
      patients (as a reduction by 15% of the number of prescription changes not maintained by the
      PCP after discharge is expected).

      The follow-up will last 1 month after discharge from hospital. The first prescription from
      the PCP will be collected and analyzed. In addition, patients and PCPs will be contacted by
      the pharmacist to answer specific questionnaires.

      The primary objective of the study is to assess the impact of medication reconciliation at
      discharge associated with a patient's counseling session, both provided by a pharmacist, on
      patient's care after discharge.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Monocenter, randomized, controlled, pilot study.
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of in-hospital prescription changes not maintained by the Primary Care Physician (PCP) one month after discharge.
time frame: 1 month
description: The number of in-hospital prescription changes will be evaluated only on discharge prescription transmitted to the patient (after prescription analysis by a clinical pharmacist in the "reconciliation" group)
Compared to the list of all current medications at admission, in-hospital prescription changes include the following:
Adding a new drug
Discontinuing a drug
Drug switch
Modifying a dose
Among these hospital prescription changes, some will not be maintained by the PCP one month after discharge.
In-hospital prescription changes not maintained by the PCP will be evaluated on the first prescription of the PCP following discharge.
arm group label: Control group
arm group type: No Intervention
description: Medical and pharmaceutical management (at admission, during hospitalization and at discharge) will follow standard healthcare procedures of the department.
arm group label: Reconciliation group
arm group type: Experimental
description: Standard healthcare procedures and pharmacist's involvement
intervention type: Behavioral
intervention name: Reconciliation
description: In addition to standard healthcare procedures, the pharmacist will analyze discharge prescriptions and proceed to medication reconciliation. A patient's counseling session will also be provided by the pharmacist. A reconciliation mail will be addressed to the PCP.
arm group label: Reconciliation group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Frederique BOUCHAND, PharmD
role: Principal Investigator
affiliation: APHP
last name: Benjamin DAVIDO, MD
role: Study Director
affiliation: APHP
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Centre d'Investigation Clinique et Technologique 805
investigator full name: Frederique Bouchand
investigator title: PharmD
sharing ipd: No