<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/NCT02215408</url>
  </required_header>
  <id_info>
    <org_study_id>201309828</org_study_id>
    <nct_id>NCT02215408</nct_id>
  </id_info>
  <brief_title>MEDication Focused Outpatient Care for Underutilization of Secondary Prevention</brief_title>
  <acronym>MEDFOCUS</acronym>
  <official_title>MEDication Focused Outpatient Care for Underutilization of Secondary Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korey Kennelty</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>Yes</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 study tested whether a pharmacist-run cardiovascular risk service (CVRS) at the&#xD;
      University of Iowa can increase use of national standards of care in clinics&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project conducted a multicenter, cluster-randomized study utilizing a centralized CVRS&#xD;
      for medical offices with large geographic, racial and ethnic diversity to determine the&#xD;
      extent to which the CVRS model will be implemented. Twenty primary care offices were&#xD;
      randomized to either the CVRS arm or a usual care arm, and 18 continued in the study. Each&#xD;
      clinic enrolled 20-30 patients per office for a total of 402 subjects, of which 186&#xD;
      represented racial minorities.&#xD;
&#xD;
      Subjects in the intervention arm clinic had regular contact by phone, email or text with a&#xD;
      CVRS clinical pharmacist housed at the University of Iowa. The pharmacist communicated with&#xD;
      the subject, with the site clinical pharmacist and, as needed, with the site provider to&#xD;
      optimize both the subject's pharmaceutical regimen and lifestyle behaviors. The CVRS&#xD;
      intervention lasted for 12 months.&#xD;
&#xD;
      A complex algorithm was used to calculate the degree to which the subject's care and medical&#xD;
      regimen follows national guidelines for reducing the risk of developing cardiovascular risk.&#xD;
&#xD;
      Post-intervention telephone interviews are being conducted with 20 intervention subjects in&#xD;
      order to assess their experience with the intervention and barriers and facilitators to the&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2015</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The mean percent of applicable Guideline Advantage standards of care that are met at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Of the 53 specific standards of care listed in the Guideline Advantage criteria, the mean percent of those standards applicable to each subject that are met at the 12 month time point</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The average cost per subject, measured in dollars and cents, of implementing the intervention</measure>
    <time_frame>12 months</time_frame>
    <description>The cost per subject will include costs for visits to the primary care physician, the cost of prescribed drugs, and the cost for the time spent by study pharmacists communicating with the patient, creating a care plan, and communicating with the patient's primary care provider.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percent of intervention group patients who rate the intervention as helpful (versus not helpful)</measure>
    <time_frame>24 months</time_frame>
    <description>Of the subset of 20 intervention group patients who are interviewed about the study intervention, the percent who state that the intervention was helpful (versus not helpful).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">402</enrollment>
  <condition>Diabetes</condition>
  <condition>Hyperlipidemia</condition>
  <condition>Hypertension</condition>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient received usual care from the provider in the local clinic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CVRS Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CVRS pharmacist followed the patient for 12 months in order to decrease the patient's risk of developing cardiovascular disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CVRS Intervention</intervention_name>
    <description>A clinical pharmacist working in the University of Iowa CVRS followed each patient for 12 months, working on lifestyle modification and recommending medication changes to the patient's clinical pharmacist in the local clinic.</description>
    <arm_group_label>CVRS Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speakers age 55 or greater&#xD;
&#xD;
          -  Must have a medical history of at least one of the following:&#xD;
&#xD;
          -  Coronary artery disease&#xD;
&#xD;
          -  Myocardial infarction&#xD;
&#xD;
          -  Stroke&#xD;
&#xD;
          -  Transient Ischemic Attack&#xD;
&#xD;
          -  Atrial Fibrillation&#xD;
&#xD;
          -  Systolic heart failure&#xD;
&#xD;
          -  Peripheral vascular disease/claudication&#xD;
&#xD;
          -  Carotid artery disease&#xD;
&#xD;
          -  Diabetes with either: Low density lipoprotein (LDL) 100 or greater AND/OR systolic&#xD;
             blood pressure 140 or higher or diastolic blood pressure 90 or higher&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Signs of acute angina, stroke, heart failure or renal failure&#xD;
&#xD;
          -  Systolic blood pressure 200 or greater or diastolic blood pressure 115 or greater&#xD;
&#xD;
          -  Significant hepatic disease, including: Cirrhosis, Hepatitis B or C infection, Alanine&#xD;
             Aminotransferase (ALT) or Aspartate Aminotransferase (AST) 3 times control or higher,&#xD;
             or total bilirubin 2.0 mg/dl or higher&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barry L. Carter, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christopher Coffey, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Idaho State University</name>
      <address>
        <city>Pocatello</city>
        <state>Idaho</state>
        <zip>83209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwestern University</name>
      <address>
        <city>Downers Grove</city>
        <state>Illinois</state>
        <zip>60515</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Health System</name>
      <address>
        <city>Davenport</city>
        <state>Iowa</state>
        <zip>52803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siouxland Medical Education Foundation</name>
      <address>
        <city>Sioux City</city>
        <state>Iowa</state>
        <zip>51104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Iowa Medical Education Foundation</name>
      <address>
        <city>Waterloo</city>
        <state>Iowa</state>
        <zip>50702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY-University of Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27559</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Tech University Health Science Center</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Hospital System</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112-5820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wheaton Franciscan Medical Group</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Milwaukee Health Services,Inc.</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Carter BL, Coffey CS, Chrischilles EA, Ardery G, Ecklund D, Gryzlak B, Vander Weg MW, James PA, Christensen AJ, Parker CP, Gums T, Finkelstein RJ, Uribe L, Polgreen LA; MEDication Focused Outpatient Care for Underutilization of Secondary Prevention Trial Investigators. A Cluster-Randomized Trial of a Centralized Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence. Pharmacotherapy. 2015 Jul;35(7):653-62. doi: 10.1002/phar.1603. Epub 2015 Jun 25.</citation>
    <PMID>26111939</PMID>
  </reference>
  <reference>
    <citation>Carter BL, Ardery G. Avoiding Pitfalls With Implementation of Randomized Controlled Multicenter Trials: Strategies to Achieve Milestones. J Am Heart Assoc. 2016 Dec 19;5(12):e004432. doi: 10.1161/JAHA.116.004432. No abstract available.</citation>
    <PMID>27993832</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>July 22, 2021</last_update_submitted>
  <last_update_submitted_qc>July 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Korey Kennelty</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Hyperlipidemia</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Hyperlipidemias</mesh_term>
    <mesh_term>Hyperlipoproteinemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data (IPD) datasets will be created without direct or indirect identifiers and reviewed to make sure that elements cannot be used to potentially identify individual subjects. We will create datasets in transport format and package them along with a copy of the protocol, data dictionaries, and a manual that shows the user how to import the data into their own system. Datasets will include baseline data, interim visit data, ancillary data, procedural based data and outcome data, along with laboratory measurements.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Within 12 months of study completion.</ipd_time_frame>
    <ipd_access_criteria>Requests for data will be evaluated by both the Principal Investigator and the study statistician. Investigators requesting access to the data will be asked to complete a data sharing agreement that provides for: 1) a commitment to using the data only for research purposes and not to attempt to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT02215408/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02215408
org study id: 201309828
nct id: NCT02215408
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study tested whether a pharmacist-run cardiovascular risk service (CVRS) at the
      University of Iowa can increase use of national standards of care in clinics
This project conducted a multicenter, cluster-randomized study utilizing a centralized CVRS
      for medical offices with large geographic, racial and ethnic diversity to determine the
      extent to which the CVRS model will be implemented. Twenty primary care offices were
      randomized to either the CVRS arm or a usual care arm, and 18 continued in the study. Each
      clinic enrolled 20-30 patients per office for a total of 402 subjects, of which 186
      represented racial minorities.

      Subjects in the intervention arm clinic had regular contact by phone, email or text with a
      CVRS clinical pharmacist housed at the University of Iowa. The pharmacist communicated with
      the subject, with the site clinical pharmacist and, as needed, with the site provider to
      optimize both the subject's pharmaceutical regimen and lifestyle behaviors. The CVRS
      intervention lasted for 12 months.

      A complex algorithm was used to calculate the degree to which the subject's care and medical
      regimen follows national guidelines for reducing the risk of developing cardiovascular risk.

      Post-intervention telephone interviews are being conducted with 20 intervention subjects in
      order to assess their experience with the intervention and barriers and facilitators to the
      intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The mean percent of applicable Guideline Advantage standards of care that are met at 12 months
time frame: 12 months
description: Of the 53 specific standards of care listed in the Guideline Advantage criteria, the mean percent of those standards applicable to each subject that are met at the 12 month time point
measure: The average cost per subject, measured in dollars and cents, of implementing the intervention
time frame: 12 months
description: The cost per subject will include costs for visits to the primary care physician, the cost of prescribed drugs, and the cost for the time spent by study pharmacists communicating with the patient, creating a care plan, and communicating with the patient's primary care provider.
measure: The percent of intervention group patients who rate the intervention as helpful (versus not helpful)
time frame: 24 months
description: Of the subset of 20 intervention group patients who are interviewed about the study intervention, the percent who state that the intervention was helpful (versus not helpful).
arm group label: Control
arm group type: No Intervention
description: Patient received usual care from the provider in the local clinic.
arm group label: CVRS Intervention
arm group type: Experimental
description: CVRS pharmacist followed the patient for 12 months in order to decrease the patient's risk of developing cardiovascular disease.
intervention type: Behavioral
intervention name: CVRS Intervention
description: A clinical pharmacist working in the University of Iowa CVRS followed each patient for 12 months, working on lifestyle modification and recommending medication changes to the patient's clinical pharmacist in the local clinic.
arm group label: CVRS Intervention
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Barry L. Carter, PharmD
role: Principal Investigator
affiliation: University of Iowa
last name: Christopher Coffey, PhD
role: Principal Investigator
affiliation: University of Iowa
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Carter BL, Coffey CS, Chrischilles EA, Ardery G, Ecklund D, Gryzlak B, Vander Weg MW, James PA, Christensen AJ, Parker CP, Gums T, Finkelstein RJ, Uribe L, Polgreen LA; MEDication Focused Outpatient Care for Underutilization of Secondary Prevention Trial Investigators. A Cluster-Randomized Trial of a Centralized Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence. Pharmacotherapy. 2015 Jul;35(7):653-62. doi: 10.1002/phar.1603. Epub 2015 Jun 25.
PMID: 26111939
citation: Carter BL, Ardery G. Avoiding Pitfalls With Implementation of Randomized Controlled Multicenter Trials: Strategies to Achieve Milestones. J Am Heart Assoc. 2016 Dec 19;5(12):e004432. doi: 10.1161/JAHA.116.004432. No abstract available.
PMID: 27993832
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Korey Kennelty
investigator title: Assistant Professor
mesh term: Hypertension
mesh term: Cardiovascular Diseases
mesh term: Hyperlipidemias
mesh term: Hyperlipoproteinemias
sharing ipd: Yes
ipd description: Individual participant data (IPD) datasets will be created without direct or indirect identifiers and reviewed to make sure that elements cannot be used to potentially identify individual subjects. We will create datasets in transport format and package them along with a copy of the protocol, data dictionaries, and a manual that shows the user how to import the data into their own system. Datasets will include baseline data, interim visit data, ancillary data, procedural based data and outcome data, along with laboratory measurements.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Within 12 months of study completion.
ipd access criteria: Requests for data will be evaluated by both the Principal Investigator and the study statistician. Investigators requesting access to the data will be asked to complete a data sharing agreement that provides for: 1) a commitment to using the data only for research purposes and not to attempt to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.
provided document: 