<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/NCT02248857</url>
  </required_header>
  <id_info>
    <org_study_id>STU00097744</org_study_id>
    <nct_id>NCT02248857</nct_id>
  </id_info>
  <brief_title>Promoting the Universal Medication Schedule Via Mobile and EHR Technologies</brief_title>
  <official_title>Promoting the Universal Medication Schedule Via Mobile and EHR Technologies: A Physician-randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</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 test the effectiveness of the Universal Medication Schedule (UMS),&#xD;
      which was designed as a strategy to standardize and simplify medication instructions to&#xD;
      support safe and effective prescription drug use among diabetic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research has shown the UMS (1) improves patients' understanding of how much to take of a&#xD;
      medicine and when, and (2) reduces the number of times per day patients would take a&#xD;
      multi-drug regimen. In this study, UMS tools will be exported into a second electronic health&#xD;
      record platform to demonstrate ease of dissemination. Also, as patients may require&#xD;
      assistance outside of clinic visits to adapt their prescription regimen to the UMS, this&#xD;
      study will test the potential benefit of daily short message service (SMS) text reminders via&#xD;
      cell phone.&#xD;
&#xD;
      We will conduct a three-arm, provider-randomized controlled trial among English and&#xD;
      Spanish-speaking adults taking three or more prescription drugs to evaluate the effectiveness&#xD;
      of the UMS strategy, with and without SMS text reminders, to improve patient understanding,&#xD;
      consolidation, and adherence compared to usual care.We will conduct a three-arm,&#xD;
      provider-randomized trial at two community health centers in Chicago, IL to evaluate the UMS&#xD;
      and UMS+SMS text reminder strategies compared to usual care. English and Spanish-speaking&#xD;
      patients who are prescribed three or more medications will be recruited and assessed by phone&#xD;
      at baseline, three months, and six months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 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>Prescription Understanding</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication Knowledge</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>Predictive probabilities of medication knowledge will be calculated based on patients' ability to identify each medication's purpose and side effects, risks, warnings, and benefits using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Patients will be asked through a structured questionnaire about each of the above via structured, open-ended items. Each medication will be scored as correct/incorrect if the participant knew the purpose and could name at least 1 side effect, risk, or warning of the medication. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence: Pill Count</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>Predictive probabilities of medication adherence will be calculated based on telephone pill counts using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Pills taken/pills prescribed will be calculated for each medication and scored as adherent for that medication if that score is between 80% and 120%. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence: PMAQ</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>Predictive probabilities of medication adherence will be calculated based on a 4-item validated Patient Medication Adherence Questionnaire (PMAQ) using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. The PMAQ assesses adherence behaviors by asking patients to self-report missed/wrong doses in past 4 days, scoring each medication as adherent for that medication if no missed doses were reported. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence: Pharmacy Records</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>Predictive probabilities of primary medication adherence will be calculated based on the proportion of days covered (PDC) with medication obtained from pharmacy records using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. PDC is calculated by summing the number of days' supply obtained by a patient during a given time period and dividing by the number of days for which the patient was prescribed the medication. Each medication is scored as adherent if the patient was covered for that medication more than 80% of the time. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in Blood Pressure</measure>
    <time_frame>6 months before baseline to 1 year after baseline</time_frame>
    <description>An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Systolic blood pressure will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Hemoglobin A1c (hbA1c)</measure>
    <time_frame>6 months before baseline to 1 year after baseline</time_frame>
    <description>An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Hemoglobin A1c (hbA1c) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Low-density Lipoprotein Cholesterol (LDL)</measure>
    <time_frame>6 months before baseline to 1 year after baseline</time_frame>
    <description>An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Low-density lipoprotein cholesterol (LDL) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">452</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Employ the current standard of care. No intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UMS strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.&#xD;
Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.&#xD;
A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UMS strategy + SMS texting reminders</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>UMS Strategy</intervention_name>
    <description>Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.</description>
    <arm_group_label>UMS strategy</arm_group_label>
    <arm_group_label>UMS strategy + SMS texting reminders</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMS Texting Reminders</intervention_name>
    <description>In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.</description>
    <arm_group_label>UMS strategy + SMS texting reminders</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of type II diabetes&#xD;
&#xD;
          -  age 30 or older&#xD;
&#xD;
          -  taking 3 or more prescription medications for chronic conditions&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  self-reported severe, uncorrectable vision&#xD;
&#xD;
          -  hearing impairment&#xD;
&#xD;
          -  cognitive impairment&#xD;
&#xD;
          -  not responsible for administering his/her own medications&#xD;
&#xD;
          -  not able to receive text messages on their cell phone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Wolf, PhD, MPH</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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>December 21, 2017</results_first_submitted>
  <results_first_submitted_qc>December 10, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 25, 2019</results_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Michael S. Wolf</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>UMS</keyword>
  <keyword>medication schedule</keyword>
  <keyword>diabetes</keyword>
  <keyword>drug labeling</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Usual Care</title>
          <description>Employ the current standard of care. No intervention.</description>
        </group>
        <group group_id="P2">
          <title>UMS Strategy</title>
          <description>Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.&#xD;
Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.&#xD;
A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.</description>
        </group>
        <group group_id="P3">
          <title>UMS Strategy + SMS Texting Reminders</title>
          <description>In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.&#xD;
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="157"/>
                <participants group_id="P2" count="168"/>
                <participants group_id="P3" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="157"/>
                <participants group_id="P2" count="168"/>
                <participants group_id="P3" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>3 Month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="157"/>
                <participants group_id="P2" count="168"/>
                <participants group_id="P3" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="134"/>
                <participants group_id="P3" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to reach for 3 month</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="26"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Partially completed, unable to finish</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6 Month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="148">157 baseline - 9 who withdrew = 148</participants>
                <participants group_id="P2" count="165">168 baseline - 3 who withdrew = 165</participants>
                <participants group_id="P3" count="123">127 baseline - 4 who withdrew = 123</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="136"/>
                <participants group_id="P3" count="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Partially completed, unable to finish</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Usual Care</title>
          <description>Employ the current standard of care. No intervention.</description>
        </group>
        <group group_id="B2">
          <title>UMS Strategy</title>
          <description>Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.&#xD;
Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.&#xD;
A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.</description>
        </group>
        <group group_id="B3">
          <title>UMS Strategy + SMS Texting Reminders</title>
          <description>In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.&#xD;
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="157"/>
            <count group_id="B2" value="168"/>
            <count group_id="B3" value="127"/>
            <count group_id="B4" value="452"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="142"/>
                    <measurement group_id="B3" value="95"/>
                    <measurement group_id="B4" value="368"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.5" spread="9.4"/>
                    <measurement group_id="B2" value="56.4" spread="9.3"/>
                    <measurement group_id="B3" value="57.5" spread="9.9"/>
                    <measurement group_id="B4" value="56.7" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="87"/>
                    <measurement group_id="B4" value="295"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="113"/>
                    <measurement group_id="B2" value="127"/>
                    <measurement group_id="B3" value="91"/>
                    <measurement group_id="B4" value="331"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                    <measurement group_id="B2" value="130"/>
                    <measurement group_id="B3" value="96"/>
                    <measurement group_id="B4" value="338"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                    <measurement group_id="B2" value="168"/>
                    <measurement group_id="B3" value="127"/>
                    <measurement group_id="B4" value="452"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Prescription Understanding</title>
        <description>Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
        <time_frame>6 months after baseline</time_frame>
        <population>All participants who completed the 6 month assessment and had complete data for the outcome for at least 1 medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Employ the current standard of care. No intervention.</description>
          </group>
          <group group_id="O2">
            <title>UMS Strategy</title>
            <description>Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.&#xD;
Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.&#xD;
A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.</description>
          </group>
          <group group_id="O3">
            <title>UMS Strategy + SMS Texting Reminders</title>
            <description>In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.&#xD;
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.</description>
          </group>
        </group_list>
        <measure>
          <title>Prescription Understanding</title>
          <description>Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
          <population>All participants who completed the 6 month assessment and had complete data for the outcome for at least 1 medication.</population>
          <units>Probability</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Medications</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="134"/>
                <count group_id="O3" value="104"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Medications</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="559"/>
                <count group_id="O2" value="611"/>
                <count group_id="O3" value="455"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.81" lower_limit="0.77" upper_limit="0.84"/>
                    <measurement group_id="O2" value="0.82" lower_limit="0.79" upper_limit="0.85"/>
                    <measurement group_id="O3" value="0.78" lower_limit="0.74" upper_limit="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medication Knowledge</title>
        <description>Predictive probabilities of medication knowledge will be calculated based on patients' ability to identify each medication's purpose and side effects, risks, warnings, and benefits using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Patients will be asked through a structured questionnaire about each of the above via structured, open-ended items. Each medication will be scored as correct/incorrect if the participant knew the purpose and could name at least 1 side effect, risk, or warning of the medication. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
        <time_frame>6 months after baseline</time_frame>
        <population>All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Employ the current standard of care. No intervention.</description>
          </group>
          <group group_id="O2">
            <title>UMS Strategy</title>
            <description>Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.&#xD;
Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.&#xD;
A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.</description>
          </group>
          <group group_id="O3">
            <title>UMS Strategy + SMS Texting Reminders</title>
            <description>In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.&#xD;
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Knowledge</title>
          <description>Predictive probabilities of medication knowledge will be calculated based on patients' ability to identify each medication's purpose and side effects, risks, warnings, and benefits using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Patients will be asked through a structured questionnaire about each of the above via structured, open-ended items. Each medication will be scored as correct/incorrect if the participant knew the purpose and could name at least 1 side effect, risk, or warning of the medication. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
          <population>All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication</population>
          <units>Probability of medication knowledge</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Medications</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="137"/>
                <count group_id="O3" value="104"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Medications</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="611"/>
                <count group_id="O2" value="654"/>
                <count group_id="O3" value="488"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" lower_limit="0.18" upper_limit="0.25"/>
                    <measurement group_id="O2" value="0.28" lower_limit="0.25" upper_limit="0.32"/>
                    <measurement group_id="O3" value="0.26" lower_limit="0.22" upper_limit="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medication Adherence: Pill Count</title>
        <description>Predictive probabilities of medication adherence will be calculated based on telephone pill counts using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Pills taken/pills prescribed will be calculated for each medication and scored as adherent for that medication if that score is between 80% and 120%. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
        <time_frame>6 months after baseline</time_frame>
        <population>All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Employ the current standard of care. No intervention.</description>
          </group>
          <group group_id="O2">
            <title>UMS Strategy</title>
            <description>Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.&#xD;
Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.&#xD;
A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.</description>
          </group>
          <group group_id="O3">
            <title>UMS Strategy + SMS Texting Reminders</title>
            <description>In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.&#xD;
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Adherence: Pill Count</title>
          <description>Predictive probabilities of medication adherence will be calculated based on telephone pill counts using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Pills taken/pills prescribed will be calculated for each medication and scored as adherent for that medication if that score is between 80% and 120%. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
          <population>All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication</population>
          <units>Probability of adherence</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Medications</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="128"/>
                <count group_id="O3" value="98"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Medications</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="296"/>
                <count group_id="O2" value="366"/>
                <count group_id="O3" value="277"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" lower_limit="0.35" upper_limit="0.47"/>
                    <measurement group_id="O2" value="0.31" lower_limit="0.27" upper_limit="0.36"/>
                    <measurement group_id="O3" value="0.34" lower_limit="0.29" upper_limit="0.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medication Adherence: PMAQ</title>
        <description>Predictive probabilities of medication adherence will be calculated based on a 4-item validated Patient Medication Adherence Questionnaire (PMAQ) using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. The PMAQ assesses adherence behaviors by asking patients to self-report missed/wrong doses in past 4 days, scoring each medication as adherent for that medication if no missed doses were reported. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
        <time_frame>6 months after baseline</time_frame>
        <population>All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Employ the current standard of care. No intervention.</description>
          </group>
          <group group_id="O2">
            <title>UMS Strategy</title>
            <description>Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.&#xD;
Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.&#xD;
A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.</description>
          </group>
          <group group_id="O3">
            <title>UMS Strategy + SMS Texting Reminders</title>
            <description>In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.&#xD;
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Adherence: PMAQ</title>
          <description>Predictive probabilities of medication adherence will be calculated based on a 4-item validated Patient Medication Adherence Questionnaire (PMAQ) using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. The PMAQ assesses adherence behaviors by asking patients to self-report missed/wrong doses in past 4 days, scoring each medication as adherent for that medication if no missed doses were reported. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
          <population>All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication</population>
          <units>Probability of adherence</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Medications</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="137"/>
                <count group_id="O3" value="104"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Medications</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="609"/>
                <count group_id="O2" value="654"/>
                <count group_id="O3" value="487"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" lower_limit="0.68" upper_limit="0.75"/>
                    <measurement group_id="O2" value="0.72" lower_limit="0.69" upper_limit="0.76"/>
                    <measurement group_id="O3" value="0.77" lower_limit="0.73" upper_limit="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medication Adherence: Pharmacy Records</title>
        <description>Predictive probabilities of primary medication adherence will be calculated based on the proportion of days covered (PDC) with medication obtained from pharmacy records using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. PDC is calculated by summing the number of days' supply obtained by a patient during a given time period and dividing by the number of days for which the patient was prescribed the medication. Each medication is scored as adherent if the patient was covered for that medication more than 80% of the time. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
        <time_frame>6 months after baseline</time_frame>
        <population>Participants who filled medications at Walgreens during the study period.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Employ the current standard of care. No intervention.</description>
          </group>
          <group group_id="O2">
            <title>UMS Strategy</title>
            <description>Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.&#xD;
Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.&#xD;
A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.</description>
          </group>
          <group group_id="O3">
            <title>UMS Strategy + SMS Texting Reminders</title>
            <description>In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.&#xD;
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Adherence: Pharmacy Records</title>
          <description>Predictive probabilities of primary medication adherence will be calculated based on the proportion of days covered (PDC) with medication obtained from pharmacy records using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. PDC is calculated by summing the number of days' supply obtained by a patient during a given time period and dividing by the number of days for which the patient was prescribed the medication. Each medication is scored as adherent if the patient was covered for that medication more than 80% of the time. Results are presented as predicted probabilities with 95% Confidence Intervals.</description>
          <population>Participants who filled medications at Walgreens during the study period.</population>
          <units>Probability of adherence</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Medications</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Medications</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="217"/>
                <count group_id="O3" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" lower_limit="0.41" upper_limit="0.57"/>
                    <measurement group_id="O2" value="0.59" lower_limit="0.52" upper_limit="0.65"/>
                    <measurement group_id="O3" value="0.55" lower_limit="0.48" upper_limit="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Changes in Blood Pressure</title>
        <description>An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Systolic blood pressure will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).</description>
        <time_frame>6 months before baseline to 1 year after baseline</time_frame>
        <population>All participants with both a baseline and 6 month systolic blood pressure measurement</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Employ the current standard of care. No intervention.</description>
          </group>
          <group group_id="O2">
            <title>UMS Strategy</title>
            <description>Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.&#xD;
Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.&#xD;
A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.</description>
          </group>
          <group group_id="O3">
            <title>UMS Strategy + SMS Texting Reminders</title>
            <description>In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.&#xD;
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Blood Pressure</title>
          <description>An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Systolic blood pressure will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).</description>
          <population>All participants with both a baseline and 6 month systolic blood pressure measurement</population>
          <units>mmHG</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
                <count group_id="O2" value="115"/>
                <count group_id="O3" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="14.1"/>
                    <measurement group_id="O2" value="0.5" spread="14.0"/>
                    <measurement group_id="O3" value="0.1" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Changes in Hemoglobin A1c (hbA1c)</title>
        <description>An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Hemoglobin A1c (hbA1c) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).</description>
        <time_frame>6 months before baseline to 1 year after baseline</time_frame>
        <population>All participants with both a baseline and 6 month hbA1c measurement</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Employ the current standard of care. No intervention.</description>
          </group>
          <group group_id="O2">
            <title>UMS Strategy</title>
            <description>Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.&#xD;
Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.&#xD;
A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.</description>
          </group>
          <group group_id="O3">
            <title>UMS Strategy + SMS Texting Reminders</title>
            <description>In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.&#xD;
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Hemoglobin A1c (hbA1c)</title>
          <description>An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Hemoglobin A1c (hbA1c) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).</description>
          <population>All participants with both a baseline and 6 month hbA1c measurement</population>
          <units>percent of glycated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="136"/>
                <count group_id="O3" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="1.3"/>
                    <measurement group_id="O2" value="-0.1" spread="1.5"/>
                    <measurement group_id="O3" value="-0.2" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Changes in Low-density Lipoprotein Cholesterol (LDL)</title>
        <description>An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Low-density lipoprotein cholesterol (LDL) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).</description>
        <time_frame>6 months before baseline to 1 year after baseline</time_frame>
        <population>All participants with both a baseline and 6 month LDL measurement</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Employ the current standard of care. No intervention.</description>
          </group>
          <group group_id="O2">
            <title>UMS Strategy</title>
            <description>Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.&#xD;
Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.&#xD;
A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.</description>
          </group>
          <group group_id="O3">
            <title>UMS Strategy + SMS Texting Reminders</title>
            <description>In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.&#xD;
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Low-density Lipoprotein Cholesterol (LDL)</title>
          <description>An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Low-density lipoprotein cholesterol (LDL) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).</description>
          <population>All participants with both a baseline and 6 month LDL measurement</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.1" spread="26.7"/>
                    <measurement group_id="O2" value="-17.1" spread="66.5"/>
                    <measurement group_id="O3" value="-23.4" spread="38.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Usual Care</title>
          <description>Employ the current standard of care. No intervention.</description>
        </group>
        <group group_id="E2">
          <title>UMS Strategy</title>
          <description>Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.&#xD;
Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.&#xD;
A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.</description>
        </group>
        <group group_id="E3">
          <title>UMS Strategy + SMS Texting Reminders</title>
          <description>In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.&#xD;
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.&#xD;
SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Michael Wolf</name_or_title>
      <organization>Northwestern University</organization>
      <phone>(312) 503-5592</phone>
      <email>mswolf@northwestern.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02248857
org study id: STU00097744
nct id: NCT02248857
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study test the effectiveness of the Universal Medication Schedule (UMS),
      which was designed as a strategy to standardize and simplify medication instructions to
      support safe and effective prescription drug use among diabetic.
Research has shown the UMS (1) improves patients' understanding of how much to take of a
      medicine and when, and (2) reduces the number of times per day patients would take a
      multi-drug regimen. In this study, UMS tools will be exported into a second electronic health
      record platform to demonstrate ease of dissemination. Also, as patients may require
      assistance outside of clinic visits to adapt their prescription regimen to the UMS, this
      study will test the potential benefit of daily short message service (SMS) text reminders via
      cell phone.

      We will conduct a three-arm, provider-randomized controlled trial among English and
      Spanish-speaking adults taking three or more prescription drugs to evaluate the effectiveness
      of the UMS strategy, with and without SMS text reminders, to improve patient understanding,
      consolidation, and adherence compared to usual care.We will conduct a three-arm,
      provider-randomized trial at two community health centers in Chicago, IL to evaluate the UMS
      and UMS+SMS text reminder strategies compared to usual care. English and Spanish-speaking
      patients who are prescribed three or more medications will be recruited and assessed by phone
      at baseline, three months, and six months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Prescription Understanding
time frame: 6 months after baseline
description: Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals.
measure: Medication Knowledge
time frame: 6 months after baseline
description: Predictive probabilities of medication knowledge will be calculated based on patients' ability to identify each medication's purpose and side effects, risks, warnings, and benefits using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Patients will be asked through a structured questionnaire about each of the above via structured, open-ended items. Each medication will be scored as correct/incorrect if the participant knew the purpose and could name at least 1 side effect, risk, or warning of the medication. Results are presented as predicted probabilities with 95% Confidence Intervals.
measure: Medication Adherence: Pill Count
time frame: 6 months after baseline
description: Predictive probabilities of medication adherence will be calculated based on telephone pill counts using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Pills taken/pills prescribed will be calculated for each medication and scored as adherent for that medication if that score is between 80% and 120%. Results are presented as predicted probabilities with 95% Confidence Intervals.
measure: Medication Adherence: PMAQ
time frame: 6 months after baseline
description: Predictive probabilities of medication adherence will be calculated based on a 4-item validated Patient Medication Adherence Questionnaire (PMAQ) using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. The PMAQ assesses adherence behaviors by asking patients to self-report missed/wrong doses in past 4 days, scoring each medication as adherent for that medication if no missed doses were reported. Results are presented as predicted probabilities with 95% Confidence Intervals.
measure: Medication Adherence: Pharmacy Records
time frame: 6 months after baseline
description: Predictive probabilities of primary medication adherence will be calculated based on the proportion of days covered (PDC) with medication obtained from pharmacy records using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. PDC is calculated by summing the number of days' supply obtained by a patient during a given time period and dividing by the number of days for which the patient was prescribed the medication. Each medication is scored as adherent if the patient was covered for that medication more than 80% of the time. Results are presented as predicted probabilities with 95% Confidence Intervals.
measure: Changes in Blood Pressure
time frame: 6 months before baseline to 1 year after baseline
description: An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Systolic blood pressure will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).
measure: Changes in Hemoglobin A1c (hbA1c)
time frame: 6 months before baseline to 1 year after baseline
description: An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Hemoglobin A1c (hbA1c) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).
measure: Changes in Low-density Lipoprotein Cholesterol (LDL)
time frame: 6 months before baseline to 1 year after baseline
description: An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Low-density lipoprotein cholesterol (LDL) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).
arm group label: Usual Care
arm group type: No Intervention
description: Employ the current standard of care. No intervention.
arm group label: UMS strategy
arm group type: Experimental
description: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.
Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices.
A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.
arm group label: UMS strategy + SMS texting reminders
arm group type: Experimental
description: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
intervention type: Other
intervention name: UMS Strategy
description: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
arm group label: UMS strategy
arm group label: UMS strategy + SMS texting reminders
intervention type: Other
intervention name: SMS Texting Reminders
description: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
arm group label: UMS strategy + SMS texting reminders
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Wolf, PhD, MPH
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Michael S. Wolf
investigator title: Professor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 