<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/NCT03259373</url>
  </required_header>
  <id_info>
    <org_study_id>IMPACT-AFib</org_study_id>
    <nct_id>NCT03259373</nct_id>
  </id_info>
  <brief_title>IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation</brief_title>
  <acronym>IMPACT-AFib</acronym>
  <official_title>IMplementation of a Randomized Controlled Trial (RCT) to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harvard Pilgrim Health Care</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke Clinical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinical Trials Transformation Initiative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Humana Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aetna, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>OptumInsight Life Sciences, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Food and Drug Administration (FDA)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Harvard Pilgrim Health Care</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 purpose of this study is to use a decentralized claims database to determine whether&#xD;
      education on stroke prevention in atrial fibrillation (AF) among AF patients and their&#xD;
      providers can result in increased use of oral anticoagulants (OAC) for stroke prevention&#xD;
      among those AF patients with guideline-based indications for oral anticoagulation&#xD;
      (CHA₂DS₂-VASc score of 2 or greater). Specifically, the investigators will conduct a&#xD;
      prospective, randomized, open-label education intervention trial to evaluate the effect of&#xD;
      the early patient and provider education interventions on the proportion of patients with&#xD;
      evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4&#xD;
      international normalized ratio [INR tests] over the course of the follow-up through the date&#xD;
      on which at least 80% of eligible study participants have at least 12 months of follow-up&#xD;
      time). A total of approximately 80,000 patients will be enrolled within multiple major health&#xD;
      plans across the United States. The randomization will be performed by the central&#xD;
      coordinating center, and the health plans will mail the educational intervention materials to&#xD;
      their members and providers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective, randomized, and open-label education intervention trial. Patients&#xD;
      with AF and a CHA₂DS₂-VASc score of 2 or greater will be randomized in a 1:1 ratio to an&#xD;
      intervention cohort and a control cohort within each participating health plan. The&#xD;
      definition for OAC medication fill will be an OAC medication dispensing or at least 4 INR&#xD;
      tests in the claims data. The claims records of the patients randomized to the intervention&#xD;
      cohort will then be linked to &quot;fresh&quot; (i.e. about 1 month old) pharmacy claims data at the&#xD;
      time of randomization. Patients without evidence of an OAC medication fill during the 12&#xD;
      months prior to randomization will be included in the patient-level and provider-level early&#xD;
      educational intervention. In addition to usual care, these patients and their providers,&#xD;
      where an individual provider may be identified, will receive a one-time mailing at trial&#xD;
      start. Patients randomized to this early intervention with evidence of an OAC medication fill&#xD;
      during the 12 months prior to randomization will be excluded from the trial.&#xD;
&#xD;
      The control cohort will receive usual care over the initial study period. After the date on&#xD;
      which at least 80% of eligible study participants have at least 12 months of follow-up time,&#xD;
      &quot;fresh&quot; pharmacy claims data for the control intervention cohort that was generated and&#xD;
      locked at the time of randomization will be used to assess trial eligibility, and those&#xD;
      patients without evidence of an OAC medication fill during the 12 months prior to&#xD;
      randomization will be included in the primary and secondary analyses as the control arm.&#xD;
      Patients randomized to the control arm with evidence of an OAC medication fill during the 12&#xD;
      months prior to randomization will be excluded from the trial and will not be included in&#xD;
      analyses. The baseline characteristics of the control patients will be examined at the same&#xD;
      time point as the intervention patients, meaning at the time of randomization. The primary&#xD;
      outcome is a comparison of the proportion of patients not on OAC during the 12 months prior&#xD;
      to randomization, who were started on OAC over the course of the follow-up through the date&#xD;
      on which at least 80% of eligible study participants have at least 12 months of follow-up&#xD;
      time in the early versus the delayed intervention arm. A total of approximately 80,000&#xD;
      patients (randomized 1:1) across all participating data partners (Aetna, Harvard Pilgrim,&#xD;
      Humana, and Optum) will be enrolled from participating data partners across the United&#xD;
      States. The follow-up time for the primary outcome will be 12 months from the date at which&#xD;
      at least 80% of eligible study participates are enrolled (date on which early intervention&#xD;
      materials are mailed).&#xD;
&#xD;
      The providers of patients in the control cohort who did not receive OAC medication during the&#xD;
      course of the 12-month study period and meet the inclusion criteria will receive the delayed&#xD;
      intervention: the provider-only education intervention, a one-time mailing administered 12&#xD;
      months after at least 80% of early intervention mailings have occurred (patients will not&#xD;
      receive any educational materials). The investigators intend to assess the primary and&#xD;
      secondary endpoints again 24 months after at least 80% of early intervention mailings have&#xD;
      occurred to assess the durability and longer-term outcomes of the effect of the patient- and&#xD;
      provider-level education intervention, as well as the use of OAC following the delayed&#xD;
      provider-level education intervention. However, as this second assessment is exploratory,&#xD;
      investigators may not conduct these analyses if the results of the primary outcome are&#xD;
      consistently null.&#xD;
&#xD;
      Because the Sentinel Distributed Database will be used for follow-up information, and this&#xD;
      information is refreshed approximately quarterly and this is done on separate timetables for&#xD;
      the different health plans, it is likely that when at least the required follow-up time is&#xD;
      available for at least 80% of people, there will be more than 12 or 24 months of followup for&#xD;
      over 80% of people. All participants' outcomes will be assessed using all possible&#xD;
      person-time; patients will have different duration of follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with evidence of at least one OAC dispensing (prescription fill) (defined as one OAC dispensing or 4 INR (International Normalized Ratio) tests)</measure>
    <time_frame>Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time</time_frame>
    <description>Evaluate the effect of the patient and provider education interventions (versus usual care with delayed provider education intervention) on the proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 INR tests) over the course of the 12 months of follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of hospitalization for ischemic or unknown stroke</measure>
    <time_frame>Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time</time_frame>
    <description>Evaluate the impact of the patient and provider education interventions on rates of ischemic / unknown stroke hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of hospitalization for hemorrhagic stroke</measure>
    <time_frame>Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time</time_frame>
    <description>Evaluate the impact of the patient and provider education interventions on rates of hospitalization for hemorrhagic stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of hospitalization for ischemic or hemorrhagic stroke</measure>
    <time_frame>Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time</time_frame>
    <description>Evaluate the impact of the patient and provider education interventions on rates of hospitalization for ischemic or hemorrhagic stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of hospitalization for ischemic or hemorrhagic stroke or systemic embolism</measure>
    <time_frame>Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time</time_frame>
    <description>Evaluate the impact of the patient and provider education interventions on rates of hospitalization for ischemic or hemorrhagic stroke or systemic embolism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of hospitalization for ischemic or hemorrhagic stroke or systemic embolism or bleeding</measure>
    <time_frame>Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time</time_frame>
    <description>Evaluate the impact of the patient and provider education interventions on rates of hospitalization for ischemic or hemorrhagic stroke or systemic embolism or bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of hospitalization for bleeding</measure>
    <time_frame>Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time</time_frame>
    <description>Evaluate the impact of the patient and provider education interventions on rates of hospitalization for any bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first OAC dispensing</measure>
    <time_frame>Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time</time_frame>
    <description>Evaluate the impact of the patient and provider education interventions on time to first OAC dispensing (prescription fill)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of days covered by OAC dispensing</measure>
    <time_frame>Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time</time_frame>
    <description>Evaluate the impact of the patient and provider education interventions on proportion of days covered by OAC dispensings (prescription fills)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients on oral anticoagulation</measure>
    <time_frame>Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time</time_frame>
    <description>Evaluate the impact of the patient and provider education interventions on proportion of patients on oral anticoagulation at 12 months of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause in-hospital mortality rates</measure>
    <time_frame>Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time</time_frame>
    <description>Evaluate the impact of the patient and provider education interventions on all-cause in-hospital mortality rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization for AF patients</measure>
    <time_frame>Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time</time_frame>
    <description>Evaluate the impact of the patient and provider education interventions on health care utilization for AF patients, which would be reported as counts of number of health care utilization events (outpatient visits, days hospitalized, number of emergency department visits, etc.)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64666</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Educational mailing to (1) AF patients with guideline-based indications for oral anticoagulation (CHA₂DS₂-VASc score of 2 or greater) who appear to not have received OAC treatment at time of randomization and (2) their providers, where an individual provider may be identified</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Educational mailing to providers of AF patients with guideline-based indications for oral anticoagulation (CHA₂DS₂-VASc score of 2 or greater) who appear to not have received OAC treatment in the time following randomization. These patients will have received 'usual care' for the time between randomization and delayed educational mailing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Early Patient-Level and Provider-Level Educational Intervention</intervention_name>
    <description>Letters to patients that (1) explain to the patient that he or she appears to have AF, characterize the risk of stroke, and emphasize that although there may be a medical reason, the patient does not seem to be on an anticoagulant and (2) encourage the patient to discuss this with his or her provider to ask if he or she might benefit from OAC therapy to prevent stroke.&#xD;
Early intervention letters to providers explain this project, the nature of the problem, and identify a list of the provider's patients who have been contacted, as the provider and patient letters will be sent at approximately the same time; describe evidence and guidelines regarding oral anticoagulation.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Delayed Provider-Level Educational Intervention</intervention_name>
    <description>Delayed intervention letters to patients' providers, where they may be identified, that explain this project, the nature of the problem, and identify a list of their patients who are flagged as at risk for stroke and have not been treated with an oral anticoagulant; describe evidence and guidelines regarding oral anticoagulation.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Two or more diagnoses of AF (ICD-9 and/or 10 codes) at least one day apart and with at&#xD;
             least one diagnosis within the last 12 months prior to the last date in the current&#xD;
             approved data used for cohort identification&#xD;
&#xD;
          2. CHA₂DS₂-VASc score of 2 or greater&#xD;
&#xD;
          3. Medical and pharmacy insurance coverage of at least the prior year as identified via&#xD;
             administrative claims databases of one of the participating data partners as of the&#xD;
             date of randomization&#xD;
&#xD;
          4. Age 30 years or greater as of the last date in the current approved data used for&#xD;
             cohort identification&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of OAC medication fill during the 12 months prior to randomization&#xD;
             (determined at randomization for the early intervention cohort and 12 months&#xD;
             post-randomization for the delayed intervention cohort)&#xD;
&#xD;
          2. Conditions other than AF that require anticoagulation, including treatment of deep&#xD;
             venous thrombosis, pulmonary embolism, or ever having had a mechanical prosthetic&#xD;
             heart valve prior to the last date in the current approved data used for cohort&#xD;
             identification&#xD;
&#xD;
          3. Pregnancy within 6 months of the last date in the current approved data used for&#xD;
             cohort identification&#xD;
&#xD;
          4. Any known history of intracranial hemorrhage prior to the last date in the current&#xD;
             approved data used for cohort identification&#xD;
&#xD;
          5. Hospitalization for bleeding within the last 6 months of the last date in the current&#xD;
             approved data used for cohort identification&#xD;
&#xD;
          6. Patients with recent P2Y12 antagonist use (i.e. clopidogrel, prasugrel, ticlopidine,&#xD;
             or ticagrelor within 90 days of the last date in the current approved data used for&#xD;
             cohort identification&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Humana Healthcare Research, Inc.</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harvard Pilgrim Health Care</name>
      <address>
        <city>Quincy</city>
        <state>Massachusetts</state>
        <zip>02169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OptumInsight, Inc</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aetna, Inc.</name>
      <address>
        <city>Blue Bell</city>
        <state>Pennsylvania</state>
        <zip>19422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.sentinelinitiative.org/sites/default/files/Methods/Mini-Sentinel_Methods_CTTI_Developing-Approaches-to-Conducting-Randomized-Trials-Usi.pdf</url>
    <description>White Paper: Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database</description>
  </link>
  <link>
    <url>https://www.sentinelinitiative.org/FDA-catalyst/projects/implementation-randomized-controlled-trial-improve-treatment-oral-anticoagulants-patients</url>
    <description>Sentinel Initiative IMPACT-AFib Project Page</description>
  </link>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>December 4, 2021</last_update_submitted>
  <last_update_submitted_qc>December 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harvard Pilgrim Health Care</investigator_affiliation>
    <investigator_full_name>Richard Platt</investigator_full_name>
    <investigator_title>Professor and Department Chair</investigator_title>
  </responsible_party>
  <keyword>AF</keyword>
  <keyword>AFib</keyword>
  <keyword>OAC</keyword>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Oral anticoagulant</keyword>
  <keyword>Education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03259373/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>January 7, 2022</submitted>
    <returned>March 7, 2022</returned>
    <submitted>April 13, 2022</submitted>
    <returned>January 12, 2023</returned>
    <submitted>February 9, 2023</submitted>
  </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/NCT03259373
org study id: IMPACT-AFib
nct id: NCT03259373
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to use a decentralized claims database to determine whether
      education on stroke prevention in atrial fibrillation (AF) among AF patients and their
      providers can result in increased use of oral anticoagulants (OAC) for stroke prevention
      among those AF patients with guideline-based indications for oral anticoagulation
      (CHA₂DS₂-VASc score of 2 or greater). Specifically, the investigators will conduct a
      prospective, randomized, open-label education intervention trial to evaluate the effect of
      the early patient and provider education interventions on the proportion of patients with
      evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4
      international normalized ratio [INR tests] over the course of the follow-up through the date
      on which at least 80% of eligible study participants have at least 12 months of follow-up
      time). A total of approximately 80,000 patients will be enrolled within multiple major health
      plans across the United States. The randomization will be performed by the central
      coordinating center, and the health plans will mail the educational intervention materials to
      their members and providers.
The study is a prospective, randomized, and open-label education intervention trial. Patients
      with AF and a CHA₂DS₂-VASc score of 2 or greater will be randomized in a 1:1 ratio to an
      intervention cohort and a control cohort within each participating health plan. The
      definition for OAC medication fill will be an OAC medication dispensing or at least 4 INR
      tests in the claims data. The claims records of the patients randomized to the intervention
      cohort will then be linked to "fresh" (i.e. about 1 month old) pharmacy claims data at the
      time of randomization. Patients without evidence of an OAC medication fill during the 12
      months prior to randomization will be included in the patient-level and provider-level early
      educational intervention. In addition to usual care, these patients and their providers,
      where an individual provider may be identified, will receive a one-time mailing at trial
      start. Patients randomized to this early intervention with evidence of an OAC medication fill
      during the 12 months prior to randomization will be excluded from the trial.

      The control cohort will receive usual care over the initial study period. After the date on
      which at least 80% of eligible study participants have at least 12 months of follow-up time,
      "fresh" pharmacy claims data for the control intervention cohort that was generated and
      locked at the time of randomization will be used to assess trial eligibility, and those
      patients without evidence of an OAC medication fill during the 12 months prior to
      randomization will be included in the primary and secondary analyses as the control arm.
      Patients randomized to the control arm with evidence of an OAC medication fill during the 12
      months prior to randomization will be excluded from the trial and will not be included in
      analyses. The baseline characteristics of the control patients will be examined at the same
      time point as the intervention patients, meaning at the time of randomization. The primary
      outcome is a comparison of the proportion of patients not on OAC during the 12 months prior
      to randomization, who were started on OAC over the course of the follow-up through the date
      on which at least 80% of eligible study participants have at least 12 months of follow-up
      time in the early versus the delayed intervention arm. A total of approximately 80,000
      patients (randomized 1:1) across all participating data partners (Aetna, Harvard Pilgrim,
      Humana, and Optum) will be enrolled from participating data partners across the United
      States. The follow-up time for the primary outcome will be 12 months from the date at which
      at least 80% of eligible study participates are enrolled (date on which early intervention
      materials are mailed).

      The providers of patients in the control cohort who did not receive OAC medication during the
      course of the 12-month study period and meet the inclusion criteria will receive the delayed
      intervention: the provider-only education intervention, a one-time mailing administered 12
      months after at least 80% of early intervention mailings have occurred (patients will not
      receive any educational materials). The investigators intend to assess the primary and
      secondary endpoints again 24 months after at least 80% of early intervention mailings have
      occurred to assess the durability and longer-term outcomes of the effect of the patient- and
      provider-level education intervention, as well as the use of OAC following the delayed
      provider-level education intervention. However, as this second assessment is exploratory,
      investigators may not conduct these analyses if the results of the primary outcome are
      consistently null.

      Because the Sentinel Distributed Database will be used for follow-up information, and this
      information is refreshed approximately quarterly and this is done on separate timetables for
      the different health plans, it is likely that when at least the required follow-up time is
      available for at least 80% of people, there will be more than 12 or 24 months of followup for
      over 80% of people. All participants' outcomes will be assessed using all possible
      person-time; patients will have different duration of follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Proportion of patients with evidence of at least one OAC dispensing (prescription fill) (defined as one OAC dispensing or 4 INR (International Normalized Ratio) tests)
time frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time
description: Evaluate the effect of the patient and provider education interventions (versus usual care with delayed provider education intervention) on the proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 INR tests) over the course of the 12 months of follow-up.
measure: Rates of hospitalization for ischemic or unknown stroke
time frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time
description: Evaluate the impact of the patient and provider education interventions on rates of ischemic / unknown stroke hospitalization
measure: Rates of hospitalization for hemorrhagic stroke
time frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time
description: Evaluate the impact of the patient and provider education interventions on rates of hospitalization for hemorrhagic stroke
measure: Rates of hospitalization for ischemic or hemorrhagic stroke
time frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time
description: Evaluate the impact of the patient and provider education interventions on rates of hospitalization for ischemic or hemorrhagic stroke
measure: Rates of hospitalization for ischemic or hemorrhagic stroke or systemic embolism
time frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time
description: Evaluate the impact of the patient and provider education interventions on rates of hospitalization for ischemic or hemorrhagic stroke or systemic embolism
measure: Rates of hospitalization for ischemic or hemorrhagic stroke or systemic embolism or bleeding
time frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time
description: Evaluate the impact of the patient and provider education interventions on rates of hospitalization for ischemic or hemorrhagic stroke or systemic embolism or bleeding
measure: Rates of hospitalization for bleeding
time frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time
description: Evaluate the impact of the patient and provider education interventions on rates of hospitalization for any bleeding
measure: Time to first OAC dispensing
time frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time
description: Evaluate the impact of the patient and provider education interventions on time to first OAC dispensing (prescription fill)
measure: Proportion of days covered by OAC dispensing
time frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time
description: Evaluate the impact of the patient and provider education interventions on proportion of days covered by OAC dispensings (prescription fills)
measure: Proportion of patients on oral anticoagulation
time frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time
description: Evaluate the impact of the patient and provider education interventions on proportion of patients on oral anticoagulation at 12 months of follow-up
measure: All-cause in-hospital mortality rates
time frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time
description: Evaluate the impact of the patient and provider education interventions on all-cause in-hospital mortality rates
measure: Health care utilization for AF patients
time frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time
description: Evaluate the impact of the patient and provider education interventions on health care utilization for AF patients, which would be reported as counts of number of health care utilization events (outpatient visits, days hospitalized, number of emergency department visits, etc.)
arm group label: Intervention
arm group type: Experimental
description: Educational mailing to (1) AF patients with guideline-based indications for oral anticoagulation (CHA₂DS₂-VASc score of 2 or greater) who appear to not have received OAC treatment at time of randomization and (2) their providers, where an individual provider may be identified
arm group label: Control
arm group type: Experimental
description: Educational mailing to providers of AF patients with guideline-based indications for oral anticoagulation (CHA₂DS₂-VASc score of 2 or greater) who appear to not have received OAC treatment in the time following randomization. These patients will have received 'usual care' for the time between randomization and delayed educational mailing.
intervention type: Behavioral
intervention name: Early Patient-Level and Provider-Level Educational Intervention
description: Letters to patients that (1) explain to the patient that he or she appears to have AF, characterize the risk of stroke, and emphasize that although there may be a medical reason, the patient does not seem to be on an anticoagulant and (2) encourage the patient to discuss this with his or her provider to ask if he or she might benefit from OAC therapy to prevent stroke.
Early intervention letters to providers explain this project, the nature of the problem, and identify a list of the provider's patients who have been contacted, as the provider and patient letters will be sent at approximately the same time; describe evidence and guidelines regarding oral anticoagulation.
arm group label: Intervention
intervention type: Behavioral
intervention name: Delayed Provider-Level Educational Intervention
description: Delayed intervention letters to patients' providers, where they may be identified, that explain this project, the nature of the problem, and identify a list of their patients who are flagged as at risk for stroke and have not been treated with an oral anticoagulant; describe evidence and guidelines regarding oral anticoagulation.
arm group label: Control
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://www.sentinelinitiative.org/sites/default/files/Methods/Mini-Sentinel_Methods_CTTI_Developing-Approaches-to-Conducting-Randomized-Trials-Usi.pdf
description: White Paper: Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database
url: https://www.sentinelinitiative.org/FDA-catalyst/projects/implementation-randomized-controlled-trial-improve-treatment-oral-anticoagulants-patients
description: Sentinel Initiative IMPACT-AFib Project Page
responsible party type: Principal Investigator
investigator affiliation: Harvard Pilgrim Health Care
investigator full name: Richard Platt
investigator title: Professor and Department Chair
mesh term: Atrial Fibrillation
sharing ipd: No
provided document: 
submitted: January 7, 2022
returned: March 7, 2022
submitted: April 13, 2022
returned: January 12, 2023
submitted: February 9, 2023