<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/NCT01669473</url>
  </required_header>
  <id_info>
    <org_study_id>1U19HS021093-01</org_study_id>
    <nct_id>NCT01669473</nct_id>
  </id_info>
  <brief_title>A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use</brief_title>
  <official_title>A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to evaluate a low-literacy strategy in a primary health care setting for&#xD;
      promoting safe and effective prescription medication use among English and Spanish-speaking&#xD;
      patients with diabetes.&#xD;
&#xD;
      The investigators hypothesize that in comparison with patients receiving standard care, the&#xD;
      patients that received the Electronic Health Record (EHR) strategy will 1) demonstrate better&#xD;
      understanding of how to safely dose out their medication regimen; 2) have fewer discrepancies&#xD;
      in their medication lists; 3) take their medication regimen more efficiently; 4) have greater&#xD;
      adherence to their medication regimen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The strategy takes advantage of health information technology to assist patients with&#xD;
      Medication Therapy Management (MTM) tasks, intervening with a set of low-literacy MTM printed&#xD;
      tools triggered by the Electronic Health Record (EHR) in a primary health care clinic.&#xD;
      Patients at the University of Illinois at Chicago (UIC) Medicine Clinic who are randomized to&#xD;
      the intervention arm will be given three printed tools, one when they check in to the clinic&#xD;
      and the other two when they check out. The Electronic Health Record (EHR) triggers the&#xD;
      printing of these tools, and the receptionist hands them to the patient. Patients receive&#xD;
      either English or Spanish language materials depending on the preference determined in the&#xD;
      screening process and stored in their EHR.&#xD;
&#xD;
      Specific Aims&#xD;
&#xD;
        1. Refine and Field Test an EHR strategy for generating and distributing low literacy&#xD;
           prescription information for English and Spanish-speaking patients&#xD;
&#xD;
        2. Assess the process of the EHR intervention and its fidelity for providing prescription&#xD;
           information for patients at the point of prescribing and dispensing medications.&#xD;
&#xD;
        3. Evaluate the effectiveness of the EHR strategy to improve medication understanding,&#xD;
           reconciliation, regimen consolidation, and adherence compared to standard care.&#xD;
&#xD;
      In addition, we will be powered to also investigate our strategy's impact on intermediary&#xD;
      clinical outcomes including systolic blood pressure, HbA1c, and LDL cholesterol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Medication adherence</measure>
    <time_frame>One month after patients receive intervention materials</time_frame>
    <description>We will determine to what extent presenting low-literacy information about prescription medicines to patients with diabetes affects their adherence to a medication regimen compared to patients under standard care.&#xD;
Adherence for each prescription medication will be measured through multiple methodologies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes-systolic blood pressure, HbA1, and LDL cholesterol.</measure>
    <time_frame>Baseline interview and after 6 months</time_frame>
    <description>We will investigate our strategy's impact on intermediary clinical outcomes including systolic blood pressure for patients with hypertension, HbA1 for patients with diabetes, and LDL cholesterol for patients with hyperlipidemia, through chart extraction at pre and post-intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">541</enrollment>
  <condition>Diabetes Mellitus Type I</condition>
  <condition>Diabetes Mellitus Type II</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EHR Based Strategy to promote Safe and Appropriate Drug Use&#xD;
Patients randomized to the intervention arm will be given (3) print tools to assist in safe and appropriate medication use. These include a Medreview, Medsheet,and Medlist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive regular standard care at the Clinic. They will not receive any print tools.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EHR Based Strategy to promote Safe and Appropriate Drug Use</intervention_name>
    <description>The printed tools presented in the intervention include:&#xD;
Medication Review: a consolidated list of the medications a patient is currently taking.&#xD;
Medication Sheet: a medication information sheet, including simplified prescription instructions, for each medication that a patient is newly prescribed.&#xD;
Medication List: a table that lists all medications taken by the patient and provides an orientation on how to best organize and simplify their medication regimen</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-years old or older;&#xD;
&#xD;
          -  have a diagnosis of diabetes mellitus either by ICD-billing codes or indicative&#xD;
             medications;&#xD;
&#xD;
          -  are prescribed at least (3) chronic condition medications according to the EHR&#xD;
             medication list;&#xD;
&#xD;
          -  are English or Spanish-speaking;&#xD;
&#xD;
          -  have no imminent intention to move or change clinics within the next year;&#xD;
&#xD;
          -  score 4 or higher on the six-question screener based on the Mini-Mental Status Exam;&#xD;
&#xD;
          -  are primarily responsible for administering their own medications;&#xD;
&#xD;
          -  prescribed a new chronic condition medication (including refills, and change in&#xD;
             titrations) during their clinic visit and day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under age of 18 years-old;&#xD;
&#xD;
          -  does not speak English or Spanish;&#xD;
&#xD;
          -  dependent on assistance for medication administration;&#xD;
&#xD;
          -  scored less than 4 on the six-question screener;&#xD;
&#xD;
          -  not prescribed a new medication or changed medication at clinical appointment;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce Lambert, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60654</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>September 20, 2016</last_update_submitted>
  <last_update_submitted_qc>September 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Bruce Lambert</investigator_full_name>
    <investigator_title>Director, Center for Communication and Health</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <!-- 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/NCT01669473
org study id: 1U19HS021093-01
nct id: NCT01669473
lead sponsor: 
collaborator: 
has dmc: Yes
This study seeks to evaluate a low-literacy strategy in a primary health care setting for
      promoting safe and effective prescription medication use among English and Spanish-speaking
      patients with diabetes.

      The investigators hypothesize that in comparison with patients receiving standard care, the
      patients that received the Electronic Health Record (EHR) strategy will 1) demonstrate better
      understanding of how to safely dose out their medication regimen; 2) have fewer discrepancies
      in their medication lists; 3) take their medication regimen more efficiently; 4) have greater
      adherence to their medication regimen.
The strategy takes advantage of health information technology to assist patients with
      Medication Therapy Management (MTM) tasks, intervening with a set of low-literacy MTM printed
      tools triggered by the Electronic Health Record (EHR) in a primary health care clinic.
      Patients at the University of Illinois at Chicago (UIC) Medicine Clinic who are randomized to
      the intervention arm will be given three printed tools, one when they check in to the clinic
      and the other two when they check out. The Electronic Health Record (EHR) triggers the
      printing of these tools, and the receptionist hands them to the patient. Patients receive
      either English or Spanish language materials depending on the preference determined in the
      screening process and stored in their EHR.

      Specific Aims

        1. Refine and Field Test an EHR strategy for generating and distributing low literacy
           prescription information for English and Spanish-speaking patients

        2. Assess the process of the EHR intervention and its fidelity for providing prescription
           information for patients at the point of prescribing and dispensing medications.

        3. Evaluate the effectiveness of the EHR strategy to improve medication understanding,
           reconciliation, regimen consolidation, and adherence compared to standard care.

      In addition, we will be powered to also investigate our strategy's impact on intermediary
      clinical outcomes including systolic blood pressure, HbA1c, and LDL cholesterol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Medication adherence
time frame: One month after patients receive intervention materials
description: We will determine to what extent presenting low-literacy information about prescription medicines to patients with diabetes affects their adherence to a medication regimen compared to patients under standard care.
Adherence for each prescription medication will be measured through multiple methodologies.
measure: Clinical outcomes-systolic blood pressure, HbA1, and LDL cholesterol.
time frame: Baseline interview and after 6 months
description: We will investigate our strategy's impact on intermediary clinical outcomes including systolic blood pressure for patients with hypertension, HbA1 for patients with diabetes, and LDL cholesterol for patients with hyperlipidemia, through chart extraction at pre and post-intervention.
arm group label: Intervention Arm
arm group type: Experimental
description: EHR Based Strategy to promote Safe and Appropriate Drug Use
Patients randomized to the intervention arm will be given (3) print tools to assist in safe and appropriate medication use. These include a Medreview, Medsheet,and Medlist.
arm group label: Standard Care Arm
arm group type: No Intervention
description: The control group will receive regular standard care at the Clinic. They will not receive any print tools.
intervention type: Other
intervention name: EHR Based Strategy to promote Safe and Appropriate Drug Use
description: The printed tools presented in the intervention include:
Medication Review: a consolidated list of the medications a patient is currently taking.
Medication Sheet: a medication information sheet, including simplified prescription instructions, for each medication that a patient is newly prescribed.
Medication List: a table that lists all medications taken by the patient and provides an orientation on how to best organize and simplify their medication regimen
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Bruce Lambert, PhD
role: Principal Investigator
affiliation: Northwestern University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Bruce Lambert
investigator title: Director, Center for Communication and Health
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Diabetes Mellitus, Type 1