<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/NCT03257579</url>
  </required_header>
  <id_info>
    <org_study_id>2979</org_study_id>
    <nct_id>NCT03257579</nct_id>
  </id_info>
  <brief_title>Myocardial Infarction Prescription Duration Adherence Study</brief_title>
  <acronym>MIPAD</acronym>
  <official_title>Length of Initial Prescription at Hospital Discharge and Long-term Medication Adherence for Elderly Patients Post-Myocardial Infarction: An Interventional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hamilton Health Sciences Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Population Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute for Clinical Evaluative Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hamilton Health Sciences Corporation</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>
      Quasi-experimental, controlled interrupted time series design, evaluating the impact of the&#xD;
      intervention at Hamilton Health Sciences (HHS) where standardized prescriptions and education&#xD;
      will be provided and St Joseph's Hospital (SJH) and Niagara Health Services (NHS) where&#xD;
      education alone will be provided, with remaining Ontario cardiac sites as a concurrent&#xD;
      control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overarching goal of this study is to reduce the morbidity and mortality of post-MI&#xD;
      patients through improved long-term cardiac medication adherence.&#xD;
&#xD;
      The specific objectives include: 1. Assess the impact on long-term cardiac medication&#xD;
      adherence following the implementation of a standardized increase in discharge prescription&#xD;
      length to 90-days with 3 repeats in post-MI patients as compared to education alone and usual&#xD;
      care; 2. Assess the cost implications of the intervention as compared to usual care; 3.&#xD;
      Compare clinical outcomes between longer (&gt;60 days) versus shorter prescription durations; 4.&#xD;
      Collect baseline information to inform a multi-centre interventional study (i.e., simple&#xD;
      monthly proportions of 1-year adherence by hospitals in Ontario).&#xD;
&#xD;
      Intervention:1. Policy Change implementing a standardized discharge prescription form&#xD;
      available on all wards where MI patients are managed at HHS that includes a 90-day supply&#xD;
      with 3 repeats for all cardiac medications, and education alone provided at SJH and NHS 2.&#xD;
      Educational materials will be disseminated to all involved health care providers (e.g.,&#xD;
      physicians, residents, nurses) at the start of the intervention period to ensure the new&#xD;
      discharge prescriptions are understood and used. Furthermore, extensive outreach to community&#xD;
      pharmacies in LHIN IV will be undertaken with help from Ontario Pharmacists' Association&#xD;
      (OPA) and Ontario Pharmacy Evidence Network (OPEN).&#xD;
&#xD;
      3. Education (e.g., emails, mail-outs, site visits) will recur every 3-4 months during the&#xD;
      intervention period. Furthermore, monthly monitoring will ensure standardized prescription&#xD;
      forms and point of care reminders are implemented at all intervention sites.&#xD;
&#xD;
      The intervention group will be exposed to this intervention post-MI and include all eligible&#xD;
      patients at HHS/SJH/NHS in the 6-months post-intervention implementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Patients with High Adherence</measure>
    <time_frame>One year</time_frame>
    <description>Increased proportion of patients with high adherence (proportion of days covered (PDC) &gt;80%) for the combined four cardiac medications classes at one year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in adherence of medication classes</measure>
    <time_frame>One year</time_frame>
    <description>Difference in proportion with high adherence (mean PDC &gt;80%) to the individual cardiac medication classes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in combined and individual medications as measured by Proportion of Days Covered (PDC)</measure>
    <time_frame>One year</time_frame>
    <description>Difference in mean of Proportion of Days Covered (PDC &gt;80%) of the combined cardiac medications as compared to PDC of individual cardiac medications classes as collected by Ontario Drug Benefits usage and reported to the Institute of Clinical Evaluative Sciences (ICES).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge Prescription Length</measure>
    <time_frame>One year</time_frame>
    <description>Difference in discharge prescription length (&lt;90 days and ≥90 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes as measured by number of participants who experience death, myocardial infarction, coronary revascularization, and hospital readmission</measure>
    <time_frame>One year</time_frame>
    <description>Difference in proportion of participants experiencing death, myocardial infarction, coronary revascularization and hospital readmission at one year at each interventional site compared to control sites, as reported by Cardiac Care Network and analyzed by ICES.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost implications</measure>
    <time_frame>One year</time_frame>
    <description>Cost implications of interventions of each arm</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20896</enrollment>
  <condition>Medication Adherence</condition>
  <arm_group>
    <arm_group_label>90 Day Supply</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: At Hamilton Health Sciences a policy change implementing a standardized discharge prescription form of a 90-day supply with 3 repeats for all cardiac medications available on all wards where MI patients are managed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education Alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At St. Joseph's Hospital and Niagara Health System education regarding the benefits of lengthening prescriptions to a 90 day supply with 3 repeats for all cardiac medications will be implemented.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Remaining Ontario cardiac sites will receive usual care and act as concurrent control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>90 Day Supply</intervention_name>
    <description>Policy Change implementing a 90 day standardized discharge prescription form with 3 repeats for all cardiac medications available on all wards where MI patients are managed at Hamilton Health Sciences sites</description>
    <arm_group_label>90 Day Supply</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Education Alone provided at St. Joseph's Hospital and Niagara Health System</description>
    <arm_group_label>Education Alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Use of Ontario Drug Benefits (ODB-Age &gt;65 years, social assistance, and disability);&#xD;
&#xD;
          -  Cardiac catheterization during an index admission with an MI;&#xD;
&#xD;
          -  Evidence of obstructive coronary artery disease;&#xD;
&#xD;
          -  Discharged alive&#xD;
&#xD;
          -  Ontario Residents (Ontario, Canada)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Jon-David Schwalm, MD,FRCPC,MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>905-577-1423</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myocardial Infarction</keyword>
  <keyword>Adherence</keyword>
  <keyword>Medication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <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/NCT03257579
org study id: 2979
nct id: NCT03257579
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Quasi-experimental, controlled interrupted time series design, evaluating the impact of the
      intervention at Hamilton Health Sciences (HHS) where standardized prescriptions and education
      will be provided and St Joseph's Hospital (SJH) and Niagara Health Services (NHS) where
      education alone will be provided, with remaining Ontario cardiac sites as a concurrent
      control group.
The overarching goal of this study is to reduce the morbidity and mortality of post-MI
      patients through improved long-term cardiac medication adherence.

      The specific objectives include: 1. Assess the impact on long-term cardiac medication
      adherence following the implementation of a standardized increase in discharge prescription
      length to 90-days with 3 repeats in post-MI patients as compared to education alone and usual
      care; 2. Assess the cost implications of the intervention as compared to usual care; 3.
      Compare clinical outcomes between longer (>60 days) versus shorter prescription durations; 4.
      Collect baseline information to inform a multi-centre interventional study (i.e., simple
      monthly proportions of 1-year adherence by hospitals in Ontario).

      Intervention:1. Policy Change implementing a standardized discharge prescription form
      available on all wards where MI patients are managed at HHS that includes a 90-day supply
      with 3 repeats for all cardiac medications, and education alone provided at SJH and NHS 2.
      Educational materials will be disseminated to all involved health care providers (e.g.,
      physicians, residents, nurses) at the start of the intervention period to ensure the new
      discharge prescriptions are understood and used. Furthermore, extensive outreach to community
      pharmacies in LHIN IV will be undertaken with help from Ontario Pharmacists' Association
      (OPA) and Ontario Pharmacy Evidence Network (OPEN).

      3. Education (e.g., emails, mail-outs, site visits) will recur every 3-4 months during the
      intervention period. Furthermore, monthly monitoring will ensure standardized prescription
      forms and point of care reminders are implemented at all intervention sites.

      The intervention group will be exposed to this intervention post-MI and include all eligible
      patients at HHS/SJH/NHS in the 6-months post-intervention implementation.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Proportion of Patients with High Adherence
time frame: One year
description: Increased proportion of patients with high adherence (proportion of days covered (PDC) >80%) for the combined four cardiac medications classes at one year
measure: Difference in adherence of medication classes
time frame: One year
description: Difference in proportion with high adherence (mean PDC >80%) to the individual cardiac medication classes
measure: Difference in combined and individual medications as measured by Proportion of Days Covered (PDC)
time frame: One year
description: Difference in mean of Proportion of Days Covered (PDC >80%) of the combined cardiac medications as compared to PDC of individual cardiac medications classes as collected by Ontario Drug Benefits usage and reported to the Institute of Clinical Evaluative Sciences (ICES).
measure: Discharge Prescription Length
time frame: One year
description: Difference in discharge prescription length (<90 days and ≥90 days)
measure: Clinical outcomes as measured by number of participants who experience death, myocardial infarction, coronary revascularization, and hospital readmission
time frame: One year
description: Difference in proportion of participants experiencing death, myocardial infarction, coronary revascularization and hospital readmission at one year at each interventional site compared to control sites, as reported by Cardiac Care Network and analyzed by ICES.
measure: Cost implications
time frame: One year
description: Cost implications of interventions of each arm
arm group label: 90 Day Supply
arm group type: Experimental
description: Intervention: At Hamilton Health Sciences a policy change implementing a standardized discharge prescription form of a 90-day supply with 3 repeats for all cardiac medications available on all wards where MI patients are managed.
arm group label: Education Alone
arm group type: Experimental
description: At St. Joseph's Hospital and Niagara Health System education regarding the benefits of lengthening prescriptions to a 90 day supply with 3 repeats for all cardiac medications will be implemented.
arm group label: Control
arm group type: No Intervention
description: Remaining Ontario cardiac sites will receive usual care and act as concurrent control group.
intervention type: Other
intervention name: 90 Day Supply
description: Policy Change implementing a 90 day standardized discharge prescription form with 3 repeats for all cardiac medications available on all wards where MI patients are managed at Hamilton Health Sciences sites
arm group label: 90 Day Supply
intervention type: Behavioral
intervention name: Education
description: Education Alone provided at St. Joseph's Hospital and Niagara Health System
arm group label: Education Alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jon-David Schwalm, MD,FRCPC,MSc
role: Principal Investigator
affiliation: 905-577-1423
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No