<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/NCT02192255</url>
  </required_header>
  <id_info>
    <org_study_id>10-018</org_study_id>
    <nct_id>NCT02192255</nct_id>
  </id_info>
  <brief_title>SUPREME-DM (Diabetes Mellitis) Treatment Study</brief_title>
  <official_title>An Intervention to Feedback 'Early' Non-Adherence Data to ImproveCardiovascular Disease Risk Factor Outcomes in Patients With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthPartners Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>HealthPartners Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multisite pragmatic clinical trial was designed to assess the effectiveness of a single&#xD;
      scripted telephone call to diabetes patients who (a) were currently above recommended&#xD;
      clinical goals for glucose, blood pressure, or lipids, and (b) had recently been prescribed a&#xD;
      new medication for that specific clinical domain. The goals of the intervention were to&#xD;
      improve primary adherence and persistence to the newly prescribed medication and to improve&#xD;
      control of glucose, blood pressure, and lipids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized trial tested the hypothesis that a telephone contact with a patient recently&#xD;
      prescribed a new medication for uncontrolled glycated hemoglobin (A1c), blood pressure, or&#xD;
      low-density lipoprotein cholesterol would improve (a) primary medication adherence, (b)&#xD;
      medication persistence, (c) medication possession ratio, and (d) A1c, blood pressure or&#xD;
      low-density lipoprotein cholesterol control. This study was part of the larger Agency for&#xD;
      Healthcare Research and Quality funded SUPREME-DM study. The clinical trial reported here was&#xD;
      coordinated and led by HealthPartners Institute for Education and Research, while data&#xD;
      collection was coordinated through Kaiser Permanente Northwest and analysis was conducted at&#xD;
      Kaiser Permanente Colorado. The clinical intervention sites for this study included Kaiser&#xD;
      Permanente Northern California, Group Health Cooperative, Marshfield Clinic, and Geisinger&#xD;
      Clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>60 day Medication Adherence</measure>
    <time_frame>60 days</time_frame>
    <description>In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who were recently prescribed a new class of medication for elevated glycated hemoglobin (A1c) &gt;= 8%, blood pressure &gt;= 140/90 mm Hg, or low-density lipoprotein cholesterol &gt;=100 mg/dL, to receive (a) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or (b) usual care. Hierarchical linear and logistic regression models were used to assess impact on (a) first medication fill within 60 days of prescription,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>120 day medication adherence</measure>
    <time_frame>120 days</time_frame>
    <description>In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who were recently prescribed a new class of medication for elevated glycated hemoglobin (A1c) &gt;= 8%, Blood pressure &gt;= 140/90 mm Hg, or low-density lipoprotein cholesterol &gt;=100 mg/dL, to receive (a) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or (b) usual care. Hierarchical linear and logistic regression models were used to assess impact on (b) &gt;=2 medication fills within 180 days of prescription,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite Control Level of Blood pressure, A1c and/or LDL</measure>
    <time_frame>180 days</time_frame>
    <description>In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who were recently prescribed a new class of medication for elevated glycated hemoglobin (A1c) &gt;= 8%, Blood pressure &gt;= 140/90 mm Hg, or low-density lipoprotein cholesterol &gt;=100 mg/dL, to receive (a) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or (b) usual care. Hierarchical linear and logistic regression models were used to assess impact on (c) clinically significant improvement in a composite measure of A1c, Blood pressure, or low-density lipoprotein cholesterol</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2378</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Intervention phone call</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention arm consisted of one protocol-structured telephone call from an interventionist who was a nurse health manager (1 site), diabetes educator or diabetes educator trainee (1 site), or pharmacist (2 sites). Interventionists followed the same structured telephone interview protocol to ascertain whether the subject had started taking the new prescription. Those taking the new medication as prescribed received positive reinforcement. Those who either had not filled the prescription or were not taking the medication as directed, were asked about reasons for nonadherence and assisted in identifying and resolving barriers. The median call lasted &lt; than 5 minutes, and up to 3 call attempts were made. Most intervention calls occurred within 2 to 6 weeks after the prescription date.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm - usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Those in the control arm received usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention Phone Call</intervention_name>
    <description>The intervention arm consisted of one protocol-structured telephone call from an interventionist who was a nurse health manager (1 site), diabetes educator or diabetes educator trainee (1 site), or pharmacist (2 sites). Interventionists followed the same structured telephone interview protocol to ascertain whether the subject had started taking the new prescription. Those taking the new medication as prescribed received positive reinforcement. Those who either had not filled the prescription or were not taking the medication as directed, were asked about reasons for nonadherence and assisted in identifying and resolving barriers. The median call lasted &lt; than 5 minutes, and up to 3 call attempts were made. Most intervention calls occurred within 2 to 6 weeks after the prescription date.</description>
    <arm_group_label>Intervention phone call</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At each clinical intervention site, study subjects were selected if they:&#xD;
&#xD;
               -  were age 18-75 years&#xD;
&#xD;
               -  met study criteria for diabetes mellitus before study enrollment&#xD;
&#xD;
               -  received clinical care at a designated clinic or medical center involved in this&#xD;
                  study for at least 15 months before enrollment&#xD;
&#xD;
               -  were prescribed a new class of medication (not filled in the past 180 days) for&#xD;
                  A1c, BP, or LDL that was uncontrolled at the time of medication prescription&#xD;
                  (A1c&gt;=8%, systolic BP&gt;= 140 mm Hg, or LDL &gt;=100 mg/dL).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Study subjects were excluded if they were younger than 18 years of age&#xD;
&#xD;
          -  Older than 75 years of age&#xD;
&#xD;
          -  Did not have evidence of diabetes mellitus prior to study enrollment&#xD;
&#xD;
          -  Were not receiving care at a clinic site involved in this study for at least 15 months&#xD;
             before enrollment&#xD;
&#xD;
          -  Did not have prescribed a new class of medication for uncontrolled A1c, BP or LDL.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick J. O'Connor, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>HealthPartners Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HealthPartners Institute for Education and Research</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes type 2</keyword>
  <keyword>primary care</keyword>
  <keyword>chronic disease care improvement</keyword>
  <keyword>adherence, randomized trial</keyword>
  <keyword>BP control</keyword>
  <keyword>lipid control</keyword>
  <keyword>glucose control</keyword>
  <keyword>natural language processing.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT02192255
org study id: 10-018
nct id: NCT02192255
lead sponsor: 
collaborator: 
has dmc: No
This multisite pragmatic clinical trial was designed to assess the effectiveness of a single
      scripted telephone call to diabetes patients who (a) were currently above recommended
      clinical goals for glucose, blood pressure, or lipids, and (b) had recently been prescribed a
      new medication for that specific clinical domain. The goals of the intervention were to
      improve primary adherence and persistence to the newly prescribed medication and to improve
      control of glucose, blood pressure, and lipids.
This randomized trial tested the hypothesis that a telephone contact with a patient recently
      prescribed a new medication for uncontrolled glycated hemoglobin (A1c), blood pressure, or
      low-density lipoprotein cholesterol would improve (a) primary medication adherence, (b)
      medication persistence, (c) medication possession ratio, and (d) A1c, blood pressure or
      low-density lipoprotein cholesterol control. This study was part of the larger Agency for
      Healthcare Research and Quality funded SUPREME-DM study. The clinical trial reported here was
      coordinated and led by HealthPartners Institute for Education and Research, while data
      collection was coordinated through Kaiser Permanente Northwest and analysis was conducted at
      Kaiser Permanente Colorado. The clinical intervention sites for this study included Kaiser
      Permanente Northern California, Group Health Cooperative, Marshfield Clinic, and Geisinger
      Clinic.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: 60 day Medication Adherence
time frame: 60 days
description: In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who were recently prescribed a new class of medication for elevated glycated hemoglobin (A1c) >= 8%, blood pressure >= 140/90 mm Hg, or low-density lipoprotein cholesterol >=100 mg/dL, to receive (a) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or (b) usual care. Hierarchical linear and logistic regression models were used to assess impact on (a) first medication fill within 60 days of prescription,
measure: 120 day medication adherence
time frame: 120 days
description: In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who were recently prescribed a new class of medication for elevated glycated hemoglobin (A1c) >= 8%, Blood pressure >= 140/90 mm Hg, or low-density lipoprotein cholesterol >=100 mg/dL, to receive (a) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or (b) usual care. Hierarchical linear and logistic regression models were used to assess impact on (b) >=2 medication fills within 180 days of prescription,
measure: Composite Control Level of Blood pressure, A1c and/or LDL
time frame: 180 days
description: In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who were recently prescribed a new class of medication for elevated glycated hemoglobin (A1c) >= 8%, Blood pressure >= 140/90 mm Hg, or low-density lipoprotein cholesterol >=100 mg/dL, to receive (a) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or (b) usual care. Hierarchical linear and logistic regression models were used to assess impact on (c) clinically significant improvement in a composite measure of A1c, Blood pressure, or low-density lipoprotein cholesterol
arm group label: Intervention phone call
arm group type: Experimental
description: The intervention arm consisted of one protocol-structured telephone call from an interventionist who was a nurse health manager (1 site), diabetes educator or diabetes educator trainee (1 site), or pharmacist (2 sites). Interventionists followed the same structured telephone interview protocol to ascertain whether the subject had started taking the new prescription. Those taking the new medication as prescribed received positive reinforcement. Those who either had not filled the prescription or were not taking the medication as directed, were asked about reasons for nonadherence and assisted in identifying and resolving barriers. The median call lasted < than 5 minutes, and up to 3 call attempts were made. Most intervention calls occurred within 2 to 6 weeks after the prescription date.
arm group label: Control arm - usual care
arm group type: No Intervention
description: Those in the control arm received usual care.
intervention type: Behavioral
intervention name: Intervention Phone Call
description: The intervention arm consisted of one protocol-structured telephone call from an interventionist who was a nurse health manager (1 site), diabetes educator or diabetes educator trainee (1 site), or pharmacist (2 sites). Interventionists followed the same structured telephone interview protocol to ascertain whether the subject had started taking the new prescription. Those taking the new medication as prescribed received positive reinforcement. Those who either had not filled the prescription or were not taking the medication as directed, were asked about reasons for nonadherence and assisted in identifying and resolving barriers. The median call lasted < than 5 minutes, and up to 3 call attempts were made. Most intervention calls occurred within 2 to 6 weeks after the prescription date.
arm group label: Intervention phone call
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Patrick J. O'Connor, MD, MPH
role: Principal Investigator
affiliation: HealthPartners Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus