<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/NCT03295799</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00052090</org_study_id>
    <nct_id>NCT03295799</nct_id>
  </id_info>
  <brief_title>Patient-Centred Care for Warfarin Management: A Pilot Study to Transition Care to High Risk Patients</brief_title>
  <official_title>Patient-Centred Care for Warfarin Management: A Pilot Study to Transition Care to High Risk Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</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>
      Warfarin remains the only oral anticoagulant effective in preventing stroke and valve thrombi&#xD;
      for patients having mechanical heart valves (MHVs). Within Edmonton, Alberta, our&#xD;
      pharmacist-directed and staffed Anticoagulation Clinic (AC) is referred all MHVs implanted,&#xD;
      and now has ~450 active patients. The AC mandate is to work with patients to ensure they have&#xD;
      a thorough understanding of their warfarin therapy and the factors that may impact its&#xD;
      control. In European countries patients are often taught to manage their own warfarin therapy&#xD;
      (=Patient Self-Management [PSM]) and achieve good warfarin control and outcomes. Despite&#xD;
      advocating for a patient-centred approach for healthcare delivery in Alberta, no established&#xD;
      programs (or funding models) exist to teach and provide ongoing support for PSM in North&#xD;
      America. The patient population (namely MHVs) served at our AC offers a unique opportunity to&#xD;
      implement PSM given they are already aware of their therapy and only require some extra&#xD;
      training and support to assume their own management. While it is anticipated that an increase&#xD;
      in pharmacist AC resources would be necessary to teach patients to self-manage, the&#xD;
      establishment of a PSM program has the potential to free up AC resources in the long-term,&#xD;
      allowing more patients to be managed with reducing waiting times for the AC. With&#xD;
      infrastructure in place, the AC could serve as a centre of excellence for PSM, accepting&#xD;
      referrals for this level of care from across the province. Given the patient-centred approach&#xD;
      to care delivery in Alberta, it remains prudent to assess patient acceptability to the PSM&#xD;
      approach to anticoagulation care delivery. As such, the primary objective of this randomized&#xD;
      pilot study is to assess the effect of PSM compared to AC care on quality of life. Our&#xD;
      results will inform a larger scale future trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      50 patients will receive a cover letter outlining their random selection for this study,&#xD;
      along with the patient information sheet and consent form (with a return addressed, postage&#xD;
      paid envelope). Patients will be encouraged to contact the AC and speak with the Principal&#xD;
      Investigator (TB) regarding the research study, and all questions will be addressed. We will&#xD;
      continue this mailing process until a total of 50 patients have consented to study. PSM&#xD;
      within the context of this study may use either POC technology or standard venipuncture with&#xD;
      the patient accessing the laboratory for results. After receipt of consent, patients will be&#xD;
      required to pass a foundational exam (outlining the basics of anticoagulation therapy, most&#xD;
      of which should be simple review for the patients managed within our AC).4,10 Upon&#xD;
      successfully passing this multiple choice exam, patients will be randomized to AC care (with&#xD;
      no changes implemented) or to PSM.&#xD;
&#xD;
      PSM Phase I: Preparatory Phase of Patient Training (~6weeks) During the initial preparatory&#xD;
      phase lasting 6 weeks + 2 weeks, the AC will create a patient specific warfarin dosing&#xD;
      nomogram, discuss the same with the patient and ensure clear understanding, while working&#xD;
      through various scenarios with the patient (Appendix 1). The AC will ensure the patient has&#xD;
      an established system to both retrieve INR results (via POC technology or standard&#xD;
      venipuncture) as well as to document the INR results, warfarin dosing, any pertinent&#xD;
      assessment factors, and next date to test the INR. The AC will empower the patient to be&#xD;
      proactive with coming up with warfarin dose changes during this preparatory phase.&#xD;
&#xD;
      PSM Phase II: Patient Practical Training:&#xD;
&#xD;
      The AC will enrol the patient into the PSM practical training phase (lasting 3 months + 1&#xD;
      month). At this time, the patient will retrieve their result and establish a future warfarin&#xD;
      dose and follow-up plan. This information will be transmitted to a single AC team member.&#xD;
      Contact with anotherdiscussed with an AC team member and the ultimate dosing decision will be&#xD;
      tracked to ascertain concordance of the patient's original plan to what was implemented&#xD;
      during the follow-up visit with the to perform standard AC teamcare and management will&#xD;
      occur, thereby enabling comparison of the patient's plan and the AC plan. During this phase,&#xD;
      the AC plan will be implemented. At the end of this phase, patients must pass a multiple&#xD;
      choice exam that provides practical cases targeting warfarin dose adjustment with next&#xD;
      scheduled follow-up visit, and will then be positioned into the PSM arm of the study.&#xD;
&#xD;
      Patient Self-Management During the PSM phase (6 months +/- 1 month), contact will occur with&#xD;
      the AC monthly to retrieve INR results and warfarin dose adjustments (information from the&#xD;
      patient-based charting system). Key points of contact between the patient and the AC will be&#xD;
      required, such as: INR results either &gt; 5.0 or 0.5 INR units below the lower limit of their&#xD;
      desired target INR range, initiation of interacting medications, illness, etc. Patients not&#xD;
      demonstrating the ability to self-manage their own warfarin therapy will be encouraged to&#xD;
      cross-over to AC care. At the end of 6 months, patient choice of AC care or PSM will be&#xD;
      identified.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2017</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in quality of life score (using the validated instruments DASS and Sawicki scale) between PSM and AC care.</measure>
    <time_frame>6 months</time_frame>
    <description>Duke Anticoagulation Satisfaction Scale (DASS) and Sawicki Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients completing PSM</measure>
    <time_frame>9 months</time_frame>
    <description>Beginning from consent and capturing stage at which patients withdrew (if applicable) namely the preparatory and practical training phases or PSM as well as those electing to continue PSM after study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the time in therapeutic INR range between those randomized to AC care versus PSM.</measure>
    <time_frame>6 months</time_frame>
    <description>Time in range will be calculated using the Rosendaal method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of ER and hospitalization for anticoagulant and non-anticoagulant reasons between AC care and PSM.</measure>
    <time_frame>6 months</time_frame>
    <description>presentations to hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The amount of time spent by the AC team for the AC group relative to the PSM group.</measure>
    <time_frame>9 months</time_frame>
    <description>the number of minutes taken for each arm, as a measure of resource use within the AC team.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amongst the PSM group, to determine if strategies for self-managing warfarin therapy have made patients do so for other chronic diseases.</measure>
    <time_frame>6 months</time_frame>
    <description>a descriptive measure of translation of proactive management</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants in AC care vs PSM that are dead at 5 years.</measure>
    <time_frame>5 years following study completion</time_frame>
    <description>mortality measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of encounters in the PSM group that put forward warfarin dosing that is concordant with that of the AC and to provide descriptions of warfarin dose changes.</measure>
    <time_frame>3 months</time_frame>
    <description>assessed prior to entering the PSM phase</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Patient Self-Management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will go through a preparatory phase (creation of warfarin dosing chart, process for documentation and retrieval of labs), a practical training phase (formulate warfarin management plan with support) and then perform patient-self management of their own warfarin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anticoagulation Clinic Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will not have their care altered, and will continue to be managed by our Anticoagulation Clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient Self-Management</intervention_name>
    <description>Patient will manage their own warfarin therapy.</description>
    <arm_group_label>Patient Self-Management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mechanical heart valve as the indication for warfarin&#xD;
&#xD;
          -  &gt; 16 years of age&#xD;
&#xD;
          -  Warfarin therapy managed by the AC for at least the preceding 6 months&#xD;
&#xD;
          -  Anticipated duration of warfarin therapy to be lifelong&#xD;
&#xD;
          -  Previously adherent with medication&#xD;
&#xD;
          -  Competence judged by demonstrated ability to use drug-adjustment nomograms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Severe psychiatric disease&#xD;
&#xD;
               -  Significant language barrier&#xD;
&#xD;
               -  Clinician's judgment that the patient would be a poor candidate for study (with&#xD;
                  reason specified)&#xD;
&#xD;
               -  Known or anticipated procedure/surgery/intervention in the next year&#xD;
&#xD;
               -  Active participation in another study&#xD;
&#xD;
               -  Lack of access to the internet / email&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tammy Bungard, BSP, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2J3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03295799
org study id: Pro00052090
nct id: NCT03295799
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Warfarin remains the only oral anticoagulant effective in preventing stroke and valve thrombi
      for patients having mechanical heart valves (MHVs). Within Edmonton, Alberta, our
      pharmacist-directed and staffed Anticoagulation Clinic (AC) is referred all MHVs implanted,
      and now has ~450 active patients. The AC mandate is to work with patients to ensure they have
      a thorough understanding of their warfarin therapy and the factors that may impact its
      control. In European countries patients are often taught to manage their own warfarin therapy
      (=Patient Self-Management [PSM]) and achieve good warfarin control and outcomes. Despite
      advocating for a patient-centred approach for healthcare delivery in Alberta, no established
      programs (or funding models) exist to teach and provide ongoing support for PSM in North
      America. The patient population (namely MHVs) served at our AC offers a unique opportunity to
      implement PSM given they are already aware of their therapy and only require some extra
      training and support to assume their own management. While it is anticipated that an increase
      in pharmacist AC resources would be necessary to teach patients to self-manage, the
      establishment of a PSM program has the potential to free up AC resources in the long-term,
      allowing more patients to be managed with reducing waiting times for the AC. With
      infrastructure in place, the AC could serve as a centre of excellence for PSM, accepting
      referrals for this level of care from across the province. Given the patient-centred approach
      to care delivery in Alberta, it remains prudent to assess patient acceptability to the PSM
      approach to anticoagulation care delivery. As such, the primary objective of this randomized
      pilot study is to assess the effect of PSM compared to AC care on quality of life. Our
      results will inform a larger scale future trial.
50 patients will receive a cover letter outlining their random selection for this study,
      along with the patient information sheet and consent form (with a return addressed, postage
      paid envelope). Patients will be encouraged to contact the AC and speak with the Principal
      Investigator (TB) regarding the research study, and all questions will be addressed. We will
      continue this mailing process until a total of 50 patients have consented to study. PSM
      within the context of this study may use either POC technology or standard venipuncture with
      the patient accessing the laboratory for results. After receipt of consent, patients will be
      required to pass a foundational exam (outlining the basics of anticoagulation therapy, most
      of which should be simple review for the patients managed within our AC).4,10 Upon
      successfully passing this multiple choice exam, patients will be randomized to AC care (with
      no changes implemented) or to PSM.

      PSM Phase I: Preparatory Phase of Patient Training (~6weeks) During the initial preparatory
      phase lasting 6 weeks + 2 weeks, the AC will create a patient specific warfarin dosing
      nomogram, discuss the same with the patient and ensure clear understanding, while working
      through various scenarios with the patient (Appendix 1). The AC will ensure the patient has
      an established system to both retrieve INR results (via POC technology or standard
      venipuncture) as well as to document the INR results, warfarin dosing, any pertinent
      assessment factors, and next date to test the INR. The AC will empower the patient to be
      proactive with coming up with warfarin dose changes during this preparatory phase.

      PSM Phase II: Patient Practical Training:

      The AC will enrol the patient into the PSM practical training phase (lasting 3 months + 1
      month). At this time, the patient will retrieve their result and establish a future warfarin
      dose and follow-up plan. This information will be transmitted to a single AC team member.
      Contact with anotherdiscussed with an AC team member and the ultimate dosing decision will be
      tracked to ascertain concordance of the patient's original plan to what was implemented
      during the follow-up visit with the to perform standard AC teamcare and management will
      occur, thereby enabling comparison of the patient's plan and the AC plan. During this phase,
      the AC plan will be implemented. At the end of this phase, patients must pass a multiple
      choice exam that provides practical cases targeting warfarin dose adjustment with next
      scheduled follow-up visit, and will then be positioned into the PSM arm of the study.

      Patient Self-Management During the PSM phase (6 months +/- 1 month), contact will occur with
      the AC monthly to retrieve INR results and warfarin dose adjustments (information from the
      patient-based charting system). Key points of contact between the patient and the AC will be
      required, such as: INR results either > 5.0 or 0.5 INR units below the lower limit of their
      desired target INR range, initiation of interacting medications, illness, etc. Patients not
      demonstrating the ability to self-manage their own warfarin therapy will be encouraged to
      cross-over to AC care. At the end of 6 months, patient choice of AC care or PSM will be
      identified.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: The change in quality of life score (using the validated instruments DASS and Sawicki scale) between PSM and AC care.
time frame: 6 months
description: Duke Anticoagulation Satisfaction Scale (DASS) and Sawicki Scale
measure: The proportion of patients completing PSM
time frame: 9 months
description: Beginning from consent and capturing stage at which patients withdrew (if applicable) namely the preparatory and practical training phases or PSM as well as those electing to continue PSM after study
measure: Difference in the time in therapeutic INR range between those randomized to AC care versus PSM.
time frame: 6 months
description: Time in range will be calculated using the Rosendaal method.
measure: The rate of ER and hospitalization for anticoagulant and non-anticoagulant reasons between AC care and PSM.
time frame: 6 months
description: presentations to hospital
measure: The amount of time spent by the AC team for the AC group relative to the PSM group.
time frame: 9 months
description: the number of minutes taken for each arm, as a measure of resource use within the AC team.
measure: Amongst the PSM group, to determine if strategies for self-managing warfarin therapy have made patients do so for other chronic diseases.
time frame: 6 months
description: a descriptive measure of translation of proactive management
measure: Number of participants in AC care vs PSM that are dead at 5 years.
time frame: 5 years following study completion
description: mortality measure
measure: Number of encounters in the PSM group that put forward warfarin dosing that is concordant with that of the AC and to provide descriptions of warfarin dose changes.
time frame: 3 months
description: assessed prior to entering the PSM phase
arm group label: Patient Self-Management
arm group type: Experimental
description: Patients will go through a preparatory phase (creation of warfarin dosing chart, process for documentation and retrieval of labs), a practical training phase (formulate warfarin management plan with support) and then perform patient-self management of their own warfarin.
arm group label: Anticoagulation Clinic Care
arm group type: No Intervention
description: Patients will not have their care altered, and will continue to be managed by our Anticoagulation Clinic.
intervention type: Other
intervention name: Patient Self-Management
description: Patient will manage their own warfarin therapy.
arm group label: Patient Self-Management
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: No
last name: Tammy Bungard, BSP, PharmD
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No