<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/NCT02246959</url>
  </required_header>
  <id_info>
    <org_study_id>1R01HL118195-01A1</org_study_id>
    <nct_id>NCT02246959</nct_id>
  </id_info>
  <brief_title>Process Versus Outcomes Incentives for Lipid Management</brief_title>
  <official_title>Comparative Effectiveness of Process and Outcomes Incentives for Lipid Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rutgers University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Carnegie Mellon University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lancaster General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and&#xD;
      cost-effectiveness of improving cholesterol levels among participants who are at high risk of&#xD;
      CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial&#xD;
      incentives. Participants will use electronic pill bottles that continuously monitor statin&#xD;
      adherence. The primary outcome will be change in LDL cholesterol over 12 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</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>
    <intervention_model_description>In a 4-arm, randomized controlled trial, we propose to evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in LDL cholesterol from baseline to 12 months</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Statin Adherence</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">764</enrollment>
  <condition>Diabetes</condition>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Arm 1 will be the Control arm, in which participants receive electronic pill bottles for their statin medication but are not enrolled in the sweepstakes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Process Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm 2 will be a Process incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Outcome Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm 3 will be an Outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group may receive incentives if they lower their LDL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Process Plus Outcome Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm 4 will be a process plus outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication and receive additional incentives for lowering their LDL cholesterol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Process Incentive</intervention_name>
    <description>Daily sweepstake conditional on daily medication adherence</description>
    <arm_group_label>Process Arm</arm_group_label>
    <arm_group_label>Process Plus Outcome Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Outcome Incentive</intervention_name>
    <description>Incentives conditional on LDL cholesterol reduction</description>
    <arm_group_label>Outcome Arm</arm_group_label>
    <arm_group_label>Process Plus Outcome Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals at high risk of a cardiac event, specifically one of the following:&#xD;
&#xD;
          -  Individuals with clinical ASCVD (defined as diagnosis with myocardial infarction,&#xD;
             stroke, or peripheral vascular disease) with an LDL greater than or equal to 100 mg/dl&#xD;
             ;&#xD;
&#xD;
          -  Individuals with Diabetes (between the ages of 40-75) with an LDL greater than or&#xD;
             equal to 100 mg/dl;&#xD;
&#xD;
          -  Individuals without clinical ASCVD or diabetes with LDLC with an LDL greater than or&#xD;
             equal to 100 mg/dl and estimated 10-year ASCVD risk 7.5%;&#xD;
&#xD;
          -  Individuals without clinical ASCVD or diabetes with LDL cholesterol 190 mg/dl&#xD;
&#xD;
          -  A prescription filled for a statin medication within the last 12 months (derived from&#xD;
             pharmacy records);&#xD;
&#xD;
          -  Low medication adherence on self-report completed during enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years old&#xD;
&#xD;
          -  A contraindication to further statin use or have suffered statin side effects, such as&#xD;
             myopathy&#xD;
&#xD;
          -  Will not or cannot give consent&#xD;
&#xD;
          -  A history of active or progressive liver disease&#xD;
&#xD;
          -  Participating in another clinical trial with related aims&#xD;
&#xD;
          -  Co-morbidities likely to lead to death within a short period (e.g. metastatic cancer)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Volpp, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Reese, MD, MSCE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Iwan Barankay, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT02246959
org study id: 1R01HL118195-01A1
nct id: NCT02246959
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and
      cost-effectiveness of improving cholesterol levels among participants who are at high risk of
      CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial
      incentives. Participants will use electronic pill bottles that continuously monitor statin
      adherence. The primary outcome will be change in LDL cholesterol over 12 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In a 4-arm, randomized controlled trial, we propose to evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence.
primary purpose: Prevention
masking: None (Open Label)
measure: Change in LDL cholesterol from baseline to 12 months
time frame: 12 months
measure: Statin Adherence
time frame: 18 months
arm group label: Control Arm
arm group type: No Intervention
description: Arm 1 will be the Control arm, in which participants receive electronic pill bottles for their statin medication but are not enrolled in the sweepstakes.
arm group label: Process Arm
arm group type: Experimental
description: Arm 2 will be a Process incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication.
arm group label: Outcome Arm
arm group type: Experimental
description: Arm 3 will be an Outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group may receive incentives if they lower their LDL.
arm group label: Process Plus Outcome Arm
arm group type: Experimental
description: Arm 4 will be a process plus outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication and receive additional incentives for lowering their LDL cholesterol.
intervention type: Behavioral
intervention name: Process Incentive
description: Daily sweepstake conditional on daily medication adherence
arm group label: Process Arm
arm group label: Process Plus Outcome Arm
intervention type: Behavioral
intervention name: Outcome Incentive
description: Incentives conditional on LDL cholesterol reduction
arm group label: Outcome Arm
arm group label: Process Plus Outcome Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Kevin Volpp, MD, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Peter Reese, MD, MSCE
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Iwan Barankay, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases