<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/NCT03840018</url>
  </required_header>
  <id_info>
    <org_study_id>EVB-IBP-2017-01</org_study_id>
    <nct_id>NCT03840018</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Postal Intervention to Improve the Use of PPI</brief_title>
  <official_title>Randomized Trial to Assess the Effectiveness of a Postal Intervention for Reducing the Chronic Use of Highe Doses of Proton Pump Inhibitors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Osakidetza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Osakidetza</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>
      It was a randomised intervention study, with before-and-after outcome measures and a control&#xD;
      group, in patients who had an active long-term prescription for PPIs at high doses for at&#xD;
      least 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention consisted of sending patients an informative letter by post, in which their&#xD;
      doctor invited them to seek an appointment for a medication review. Control group patients&#xD;
      did not receive such a letter, and they were treated as usual (their doctors received a list&#xD;
      of identifiers of patients on high doses).&#xD;
&#xD;
      The main outcome variable was the number of active prescriptions of each PPI dose (high&#xD;
      dose/standard dose/treatment cessation) at 6 months after the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2017</start_date>
  <completion_date type="Actual">April 18, 2018</completion_date>
  <primary_completion_date type="Actual">December 10, 2017</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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Active prescriptions of each proton pump inhibitors dose after the intervention</measure>
    <time_frame>6 months</time_frame>
    <description>Number of active prescriptions of each proton pump inhibitors dose (high dose/standard dose/treatment cessation) at 6 months after the intervention</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">401</enrollment>
  <condition>Drug Overdose</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Sending doctors the lists of patients that meet the inclusion criteria to have their treatment reviewed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Letter by post to patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients were sent a letter explaining the risks of using PPIs at long-term high doses and encouraging them to visit their doctor</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Letter by post to patients</intervention_name>
    <description>Patients received an informative letter by post, in which their doctor invited them to seek an appointment for a medication review</description>
    <arm_group_label>Letter by post to patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients under the care of our organisation who in May 2017 had an active long-term&#xD;
             prescription for PPIs at high doses for at least 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients whose GPs declined to participate&#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>Elena Valverde</last_name>
    <role>Principal Investigator</role>
    <affiliation>Osakidetza</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bidasoa Integrated Health Organization</name>
      <address>
        <city>Hondarribia</city>
        <state>Gipuzkoa</state>
        <zip>20270</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Osakidetza</investigator_affiliation>
    <investigator_full_name>Elena Valverde</investigator_full_name>
    <investigator_title>Primary care pharmacist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug Overdose</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 15, 2020</submitted>
    <returned>October 6, 2020</returned>
  </pending_results>
  <!-- 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/NCT03840018
org study id: EVB-IBP-2017-01
nct id: NCT03840018
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It was a randomised intervention study, with before-and-after outcome measures and a control
      group, in patients who had an active long-term prescription for PPIs at high doses for at
      least 6 months.
The intervention consisted of sending patients an informative letter by post, in which their
      doctor invited them to seek an appointment for a medication review. Control group patients
      did not receive such a letter, and they were treated as usual (their doctors received a list
      of identifiers of patients on high doses).

      The main outcome variable was the number of active prescriptions of each PPI dose (high
      dose/standard dose/treatment cessation) at 6 months after the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Care Provider)
measure: Active prescriptions of each proton pump inhibitors dose after the intervention
time frame: 6 months
description: Number of active prescriptions of each proton pump inhibitors dose (high dose/standard dose/treatment cessation) at 6 months after the intervention
arm group label: Control
arm group type: No Intervention
description: Sending doctors the lists of patients that meet the inclusion criteria to have their treatment reviewed
arm group label: Letter by post to patients
arm group type: Other
description: Patients were sent a letter explaining the risks of using PPIs at long-term high doses and encouraging them to visit their doctor
intervention type: Other
intervention name: Letter by post to patients
description: Patients received an informative letter by post, in which their doctor invited them to seek an appointment for a medication review
arm group label: Letter by post to patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elena Valverde
role: Principal Investigator
affiliation: Osakidetza
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Osakidetza
investigator full name: Elena Valverde
investigator title: Primary care pharmacist
mesh term: Drug Overdose
sharing ipd: No
submitted: September 15, 2020
returned: October 6, 2020