<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/NCT03293966</url>
  </required_header>
  <id_info>
    <org_study_id>PRIMACIE</org_study_id>
    <nct_id>NCT03293966</nct_id>
  </id_info>
  <brief_title>A Coordination Card of Care Relative to the Medicinal Treatments Got Out of it From Hospitalization</brief_title>
  <official_title>Therapeutic CARE of the Bronchial Cancer Not in Small Cell: Security of the Dispensation of Medicine by the Implementation of a Card of Coordination of Care Relative to the Medicinal Treatments Got Out of it From Hospitalization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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 continuity of the medicinal care between the city and the hospital stays a major&#xD;
      organizational stake and of safety of patients' therapeutic care.This takeover is more&#xD;
      complex when it concerns pathology needed lots of hospitalization and included the&#xD;
      intervention of multiple healthcare practionners. This is clearly the case of cancer&#xD;
      coverage.&#xD;
&#xD;
      The optimization of the therapeutic suppor in town is based on pharmaceutical advice&#xD;
      strengthening but also on the pharmaceutical analysis to check the entire treatments'&#xD;
      prescription and eventual medicinal interactions which ensue from it.That's why it's&#xD;
      important to have a medicinal conciliation that takes into account all the medecine taken or&#xD;
      have to be taken by the patient.&#xD;
&#xD;
      A specific support was developped by nurses , doctors and pharmacist ; it's a care&#xD;
      coordination card that can be put easely in a pocket by the patient.&#xD;
&#xD;
      The aim of the study is that this card can be also used as a communication tools by sharing&#xD;
      the prescription done at the release of hospital by using an IT link (flea datamatrix) for&#xD;
      the patients Via the use of an IT link (flea datamatrix) for the patients whose pathology is&#xD;
      complex in term of extra hospital coverage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this strudy is to evaluate with community pharmacists the impact of a new&#xD;
      information system on the prevalence of dispensing difficulties reported by pharmacies when&#xD;
      hospitalized patients leave the city. This information system will be based on the care&#xD;
      coordination card implemented by a secure computer link allowing the use of information on&#xD;
      treatments prescribed at the end of hospitalization. Patient management is not changed by&#xD;
      this protocol. Only the information of the pharmacist, which is the object of the study, is&#xD;
      increased.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">February 28, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Composite criteria including all the dysfunctions noticed at the release of the hospital prescription intended to be dispensed in town.</measure>
    <time_frame>7days+/- 2 days</time_frame>
  </primary_outcome>
  <enrollment type="Actual">47</enrollment>
  <condition>Treatment Related Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients admitted to thoracic pneumology and oncology treated with anticancer drugs&#xD;
        will receive a medication conciliation.&#xD;
&#xD;
        Patients integrating the study will be patients who have benefited from the entire process&#xD;
        of medication conciliation (entry and exit) and returning home.&#xD;
&#xD;
        The included patients must have attended the same pharmacy for at least 3 months (according&#xD;
        to the patient declaration).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patient admitted in onco-thoracic service&#xD;
&#xD;
          -  Handled by an anticancer agent&#xD;
&#xD;
          -  Having frequented the same city pharmacy for at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hospitalization above 21 days&#xD;
&#xD;
          -  refusing participation&#xD;
&#xD;
          -  palliative care&#xD;
&#xD;
          -  misunderstanding of french language&#xD;
&#xD;
          -  frequenting several pharmacy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>May 30, 2018</last_update_submitted>
  <last_update_submitted_qc>May 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms, Second Primary</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/NCT03293966
org study id: PRIMACIE
nct id: NCT03293966
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The continuity of the medicinal care between the city and the hospital stays a major
      organizational stake and of safety of patients' therapeutic care.This takeover is more
      complex when it concerns pathology needed lots of hospitalization and included the
      intervention of multiple healthcare practionners. This is clearly the case of cancer
      coverage.

      The optimization of the therapeutic suppor in town is based on pharmaceutical advice
      strengthening but also on the pharmaceutical analysis to check the entire treatments'
      prescription and eventual medicinal interactions which ensue from it.That's why it's
      important to have a medicinal conciliation that takes into account all the medecine taken or
      have to be taken by the patient.

      A specific support was developped by nurses , doctors and pharmacist ; it's a care
      coordination card that can be put easely in a pocket by the patient.

      The aim of the study is that this card can be also used as a communication tools by sharing
      the prescription done at the release of hospital by using an IT link (flea datamatrix) for
      the patients Via the use of an IT link (flea datamatrix) for the patients whose pathology is
      complex in term of extra hospital coverage.
The aim of this strudy is to evaluate with community pharmacists the impact of a new
      information system on the prevalence of dispensing difficulties reported by pharmacies when
      hospitalized patients leave the city. This information system will be based on the care
      coordination card implemented by a secure computer link allowing the use of information on
      treatments prescribed at the end of hospitalization. Patient management is not changed by
      this protocol. Only the information of the pharmacist, which is the object of the study, is
      increased.
observational model: Cohort
time perspective: Prospective
measure: Composite criteria including all the dysfunctions noticed at the release of the hospital prescription intended to be dispensed in town.
time frame: 7days+/- 2 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Neoplasms, Second Primary