<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/NCT04409613</url>
  </required_header>
  <id_info>
    <org_study_id>ENREC-ASU.2019-99</org_study_id>
    <nct_id>NCT04409613</nct_id>
  </id_info>
  <brief_title>Cost-Effectiveness Study on Establishing a Warfarin Counseling Clinic for Egyptian Patients With Mitral Valve Prostheses</brief_title>
  <official_title>Cost-Effectiveness Study on Establishing a Warfarin Counseling Clinic for Egyptian Patients With Mitral Valve Prostheses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The outcome of poor adherence to medications can be life threatening with certain drugs like&#xD;
      warfarin. For each 10% increase in non-adherence to warfarin, there was a 14% increase in the&#xD;
      risk of under-anticoagulation with significantly higher rates of morbidity and mortality.&#xD;
      Furthermore, warfarin therapy is fraught with several inherent problems. These include a wide&#xD;
      variation in dose requirement, delayed onset of anticoagulant effect, prolonged continuation&#xD;
      after cessation of therapy, serious interactions with a wide range of medications and food&#xD;
      items, risk of major hemorrhage related to overdosing, unpredictable control in presence of&#xD;
      co-morbidities such as hepatic and renal impairment.&#xD;
&#xD;
      There is ongoing evidence that better outcomes are achieved when anticoagulation is managed&#xD;
      by a pharmacist with expertise in anticoagulation management rather than usual care by&#xD;
      physicians. Pharmacists can contribute to positive outcomes of therapy by educating and&#xD;
      counseling patients to prepare and motivate them to follow their therapeutic regimens and&#xD;
      monitoring plans, which will result substantially in improving the quality of care, reducing&#xD;
      complications, and lowering hospitalization rates. Thus, beneficial effects of the&#xD;
      pharmacist-managed counseling clinic have been repeatedly reported in terms of&#xD;
      cost-effectiveness, patients' adherence to and knowledge about pharmacotherapy, and the&#xD;
      outcome of treatment.&#xD;
&#xD;
      The objective of this study is to evaluate the cost-effectiveness of establishing a&#xD;
      Medication Counseling Clinic for outpatients with mitral valve prostheses taking warfarin&#xD;
      therapy in an Egyptian Teaching Hospital setting. Availability of this information could be&#xD;
      used to target further quality improvement efforts, which may significantly improve outcomes&#xD;
      for patients and cost containment efforts in an era when cost-effectiveness is at the&#xD;
      forefront of healthcare policy initiatives.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</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>Quality-adjusted life-years (QALYs)</measure>
    <time_frame>1 year</time_frame>
    <description>The outcome of the two strategies will be measured in terms of quality-adjusted life-years (QALYs).This measurement weighs the length of life by the quality of life a patient experiences while in a specific health state. QALYs combine both morbidity and mortality into a single parameter.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Cost Effectiveness</condition>
  <arm_group>
    <arm_group_label>Clinical pharmacist-provided services+standard care group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>that receive clinical pharmacist-provided services at the Warfarin Counseling Clinic plus standard medical care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>that will receive standard medical care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education and counseling</intervention_name>
    <description>All patients or their caregivers will receive twenty minutes educational sessions for the first three visits according to patient ability to understand. At subsequent visits along the study duration, we will briefly review our educational material to refresh the patient's information. This will include: The objectives of treatment, disease progression process, risk factors, common symptoms of bleeding/thrombotic events and how to deal with this. Lifestyle modifications, including smoking cessation, blood pressure and diabetes control. Drug information: drug action, dose, indication, possible side effects, how to deal with the side effects, actions to take when missing the dose, storage conditions and when and how to administer. Possible interactions including drug-drug and drug-food interactions. Target INR and INR monitoring</description>
    <arm_group_label>Clinical pharmacist-provided services+standard care group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients (18-70) years.&#xD;
&#xD;
          2. Post mitral valve surgery patients.&#xD;
&#xD;
          3. Patients with a prescription of warfarin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant patients.&#xD;
&#xD;
          2. Patients with double and aortic valve replacement surgery.&#xD;
&#xD;
          3. Patients with biological prostheses.&#xD;
&#xD;
          4. Patients with congenital blood disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Radwa Ahmed</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Academy of CardioThoracic Surgery, Ain-Shams University</name>
      <address>
        <city>Cairo</city>
        <zip>11211</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>July 20, 2021</last_update_submitted>
  <last_update_submitted_qc>July 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Radwa Ahmed Batran</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04409613
org study id: ENREC-ASU.2019-99
nct id: NCT04409613
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The outcome of poor adherence to medications can be life threatening with certain drugs like
      warfarin. For each 10% increase in non-adherence to warfarin, there was a 14% increase in the
      risk of under-anticoagulation with significantly higher rates of morbidity and mortality.
      Furthermore, warfarin therapy is fraught with several inherent problems. These include a wide
      variation in dose requirement, delayed onset of anticoagulant effect, prolonged continuation
      after cessation of therapy, serious interactions with a wide range of medications and food
      items, risk of major hemorrhage related to overdosing, unpredictable control in presence of
      co-morbidities such as hepatic and renal impairment.

      There is ongoing evidence that better outcomes are achieved when anticoagulation is managed
      by a pharmacist with expertise in anticoagulation management rather than usual care by
      physicians. Pharmacists can contribute to positive outcomes of therapy by educating and
      counseling patients to prepare and motivate them to follow their therapeutic regimens and
      monitoring plans, which will result substantially in improving the quality of care, reducing
      complications, and lowering hospitalization rates. Thus, beneficial effects of the
      pharmacist-managed counseling clinic have been repeatedly reported in terms of
      cost-effectiveness, patients' adherence to and knowledge about pharmacotherapy, and the
      outcome of treatment.

      The objective of this study is to evaluate the cost-effectiveness of establishing a
      Medication Counseling Clinic for outpatients with mitral valve prostheses taking warfarin
      therapy in an Egyptian Teaching Hospital setting. Availability of this information could be
      used to target further quality improvement efforts, which may significantly improve outcomes
      for patients and cost containment efforts in an era when cost-effectiveness is at the
      forefront of healthcare policy initiatives.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Quality-adjusted life-years (QALYs)
time frame: 1 year
description: The outcome of the two strategies will be measured in terms of quality-adjusted life-years (QALYs).This measurement weighs the length of life by the quality of life a patient experiences while in a specific health state. QALYs combine both morbidity and mortality into a single parameter.
arm group label: Clinical pharmacist-provided services+standard care group
arm group type: Active Comparator
description: that receive clinical pharmacist-provided services at the Warfarin Counseling Clinic plus standard medical care
arm group label: Standard care group
arm group type: No Intervention
description: that will receive standard medical care
intervention type: Other
intervention name: Education and counseling
description: All patients or their caregivers will receive twenty minutes educational sessions for the first three visits according to patient ability to understand. At subsequent visits along the study duration, we will briefly review our educational material to refresh the patient's information. This will include: The objectives of treatment, disease progression process, risk factors, common symptoms of bleeding/thrombotic events and how to deal with this. Lifestyle modifications, including smoking cessation, blood pressure and diabetes control. Drug information: drug action, dose, indication, possible side effects, how to deal with the side effects, actions to take when missing the dose, storage conditions and when and how to administer. Possible interactions including drug-drug and drug-food interactions. Target INR and INR monitoring
arm group label: Clinical pharmacist-provided services+standard care group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Radwa Ahmed
role: Principal Investigator
affiliation: Ain Shams University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Radwa Ahmed Batran
investigator title: Doctor
sharing ipd: Undecided