<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/NCT04415515</url>
  </required_header>
  <id_info>
    <org_study_id>UHC100023A</org_study_id>
    <secondary_id>DP006128</secondary_id>
    <nct_id>NCT04415515</nct_id>
  </id_info>
  <brief_title>Standard Care Coordination Expansion Pilot</brief_title>
  <official_title>Standard Care Coordination Expansion Pilot - A Quality Improvement Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UnitedHealthcare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UnitedHealthcare</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 Standard Care Coordination (SCC) solution integrates aspects of case management &amp; care&#xD;
      coordination &amp; was designed by UnitedHealth Group for high-cost, complex, at-risk consumers&#xD;
      to facilitate health care access and decisions that can have a dramatic impact on the quality&#xD;
      and affordability of the consumer's health care. Currently members only receive the SCC if&#xD;
      they are: 1) identified as high risk for readmission upon discharge from the hospital, 2) are&#xD;
      self-referred, or 3) are directly referred to the program by their physician. The current&#xD;
      quality improvement study was designed as a randomized controlled trial to determine if the&#xD;
      expansion of the SCC program to commercially insured members identified via a proprietary&#xD;
      administrative algorithms as being at high risk would significantly impact rates of acute&#xD;
      inpatient admissions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Cost</measure>
    <time_frame>24 months</time_frame>
    <description>Defined as total plan cost (medical and pharmacy) per member</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute Inpatient Admission Rate</measure>
    <time_frame>24 months</time_frame>
    <description>Defined as acute inpatient admissions per 1,000 qualified members</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emergency Room Visit Rate</measure>
    <time_frame>24 months</time_frame>
    <description>Defined as the number of emergency room visits per 1,000 qualified members</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diabetes-Related Complications</measure>
    <time_frame>24 months</time_frame>
    <description>Defined as the Diabetes Complications Severity Index (DCSI) composite score. The composite DCSI score ranges between 0 to 13 (sum of scores from 7 diabetes complication categories [cardiovascular disease, cerebrovascular disease/stroke, peripheral vascular disease, nephropathy, retinopathy, neuropathy, and metabolic complications such as ketoacidosis, hyperosmolar, or other coma] which are each scored from 0 to 2 [0=no complication, 1=non-severe complication, 2=severe complication], except for neuropathy which is scored from 0 to 1)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk of Acute Inpatient Admission</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as time to first acute inpatient admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-Cause 30-Day Readmission Risk</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as first acute inpatient readmission for all-causes within 30 days of index acute inpatient discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outpatient Emergency Room Visit Rate</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as emergency room visits per 1,000 qualified members per year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of Emergency Room Visit</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as time to first emergency room visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Care Physician Visit Rate</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as primary care physician visits per qualified member</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specialist Physician Visit Rate</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as specialist physician visits per qualified member</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular Disease</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as percentage of members with cardiovascular disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes-related complications (DCSI)</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amputations</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as lower extremity amputations per 1,000 qualified members</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic Kidney Disease</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as attenuated decline of eGFR, for members with baseline eGFR below 60mL/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic Control</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as number of members with A1c below 7%, below 8%, and/or above 9%, per 100 qualified members with diabetes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to Diabetes-Related Medications</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as number of members with medication possession ratio (MPR) values of 80% or higher, per 100 qualified members with diabetes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to Diabetes-Related Processes of Care</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as rates of microalbuminuria screening, retinal/eye exams, A1c test frequency, LDL test frequency, Statin use, ACE/ARB use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Plan and Member Cost</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as total (plan+member) cost per member</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Complications Count</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as the Diabetes Complications Severity Index (DCSI) count. The DCSI count ranges from 0 to 7 (count of the 7 diabetes complication categories [cardiovascular disease, cerebrovascular disease/stroke, peripheral vascular disease, nephropathy, retinopathy, neuropathy, and metabolic complications such as ketoacidosis, hyperosmolar, or other coma]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any Acute Inpatient Admission</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as the number of members with any Acute Inpatient Admission per 1,000 qualified members</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any Emergency Room Visit</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as the number of members with any emergency room visit per 1,000 qualified members</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebrovascular disease/stroke</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as percentage of members with Cerebrovascular disease/stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral vascular disease</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as percentage of members with Peripheral vascular disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nephropathy</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as percentage of members with Nephropathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinopathy</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as percentage of members with Retinopathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathy</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as percentage of members with Neuropathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic complications such as ketoacidosis, hyperosmolar, or other coma</measure>
    <time_frame>12, 18, 24, 36, 48 months</time_frame>
    <description>Defined as percentage of members with metabolic complications</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">592023</enrollment>
  <condition>Superutilizers, Health Care Utilization</condition>
  <arm_group>
    <arm_group_label>Treatment 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RN Standard care coordination and disease management + RN Case Management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RN Standard care coordination and disease management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RN Standard care coordination and disease management + Community Health Worker Case Management</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>RN case management</intervention_name>
    <description>A Registered Nurse (RN) case manager makes phone contact with the member to review medications, health risks, care gaps/barriers, &amp; to develop a case management plan that focuses on improving medication adherence &amp; reconciliation, condition-based measures &amp; outcomes, addressing psycho-social needs, &amp; intensive post-admission care transition. RNs may refer the member to social workers,specialist providers, &amp; support programs (including to more intense case management where the primary care physician is notified that RNs may contact them to support treatment &amp; coordinate services).</description>
    <arm_group_label>Treatment 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community Health Worker Case Management</intervention_name>
    <description>In selected UHC markets for defined time periods, members randomized to the treatment arm also received an enhanced version of the SCC that included in-home case management support from non-clinical Community Health Workers (CHW).</description>
    <arm_group_label>Treatment 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>RN Standard care coordination and disease management</intervention_name>
    <description>RN Standard care coordination and disease management</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Treatment 1</arm_group_label>
    <arm_group_label>Treatment 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  UnitedHealthcare commercial Fully Insured members; all states; 18+ years old; actively&#xD;
             enrolled in the health plan as of randomization identified via proprietary&#xD;
             administrative algorithm as being at high risk for persistent super utilizer status.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  : pregnant women, individuals prescribed medications for infertility, members with&#xD;
             evidence of dementing disorders, members indicated as &quot;do not contact &quot; for program&#xD;
             outreach, and Members in the following products and plans:&#xD;
&#xD;
               -  legacy UHC ASO groups (populations for which UHC provides administrative services&#xD;
                  only),&#xD;
&#xD;
               -  legacy Oxford health plan members (all members receive the SCC program),&#xD;
&#xD;
               -  legacy PacifiCare members,&#xD;
&#xD;
               -  legacy River Valley/NHP members, and&#xD;
&#xD;
               -  Public Sector clients&#xD;
&#xD;
               -  the PHS 2.0 intervention (a small population within Fully Insured)&#xD;
&#xD;
               -  assignment to a clinically activated Accountable Care Organization (ACO)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony V Pirrello, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>UnitedHealthcare</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eileen Birmingham</last_name>
    <phone>800-842-3225</phone>
  </overall_contact>
  <location>
    <facility>
      <name>UnitedHealthcare</name>
      <address>
        <city>Minnetonka</city>
        <state>Minnesota</state>
        <zip>55343</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eileen Birmingham</last_name>
      <phone>800-842-3225</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>November 16, 2022</last_update_submitted>
  <last_update_submitted_qc>November 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UnitedHealthcare</investigator_affiliation>
    <investigator_full_name>Anthony Pirrello</investigator_full_name>
    <investigator_title>Director UHC E&amp;I Healthcare Econ</investigator_title>
  </responsible_party>
  <keyword>Care coordination, case management, superutilizers, health care utilization</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04415515
org study id: UHC100023A
secondary id: DP006128
nct id: NCT04415515
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Standard Care Coordination (SCC) solution integrates aspects of case management & care
      coordination & was designed by UnitedHealth Group for high-cost, complex, at-risk consumers
      to facilitate health care access and decisions that can have a dramatic impact on the quality
      and affordability of the consumer's health care. Currently members only receive the SCC if
      they are: 1) identified as high risk for readmission upon discharge from the hospital, 2) are
      self-referred, or 3) are directly referred to the program by their physician. The current
      quality improvement study was designed as a randomized controlled trial to determine if the
      expansion of the SCC program to commercially insured members identified via a proprietary
      administrative algorithms as being at high risk would significantly impact rates of acute
      inpatient admissions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Total Cost
time frame: 24 months
description: Defined as total plan cost (medical and pharmacy) per member
measure: Acute Inpatient Admission Rate
time frame: 24 months
description: Defined as acute inpatient admissions per 1,000 qualified members
measure: Emergency Room Visit Rate
time frame: 24 months
description: Defined as the number of emergency room visits per 1,000 qualified members
measure: Diabetes-Related Complications
time frame: 24 months
description: Defined as the Diabetes Complications Severity Index (DCSI) composite score. The composite DCSI score ranges between 0 to 13 (sum of scores from 7 diabetes complication categories [cardiovascular disease, cerebrovascular disease/stroke, peripheral vascular disease, nephropathy, retinopathy, neuropathy, and metabolic complications such as ketoacidosis, hyperosmolar, or other coma] which are each scored from 0 to 2 [0=no complication, 1=non-severe complication, 2=severe complication], except for neuropathy which is scored from 0 to 1)
measure: Risk of Acute Inpatient Admission
time frame: 12, 18, 24, 36, 48 months
description: Defined as time to first acute inpatient admission
measure: All-Cause 30-Day Readmission Risk
time frame: 12, 18, 24, 36, 48 months
description: Defined as first acute inpatient readmission for all-causes within 30 days of index acute inpatient discharge
measure: Outpatient Emergency Room Visit Rate
time frame: 12, 18, 24, 36, 48 months
description: Defined as emergency room visits per 1,000 qualified members per year
measure: Risk of Emergency Room Visit
time frame: 12, 18, 24, 36, 48 months
description: Defined as time to first emergency room visit
measure: Primary Care Physician Visit Rate
time frame: 12, 18, 24, 36, 48 months
description: Defined as primary care physician visits per qualified member
measure: Specialist Physician Visit Rate
time frame: 12, 18, 24, 36, 48 months
description: Defined as specialist physician visits per qualified member
measure: Cardiovascular Disease
time frame: 12, 18, 24, 36, 48 months
description: Defined as percentage of members with cardiovascular disease
measure: Diabetes-related complications (DCSI)
time frame: 12, 18, 24, 36, 48 months
measure: Amputations
time frame: 12, 18, 24, 36, 48 months
description: Defined as lower extremity amputations per 1,000 qualified members
measure: Chronic Kidney Disease
time frame: 12, 18, 24, 36, 48 months
description: Defined as attenuated decline of eGFR, for members with baseline eGFR below 60mL/min
measure: Glycemic Control
time frame: 12, 18, 24, 36, 48 months
description: Defined as number of members with A1c below 7%, below 8%, and/or above 9%, per 100 qualified members with diabetes
measure: Adherence to Diabetes-Related Medications
time frame: 12, 18, 24, 36, 48 months
description: Defined as number of members with medication possession ratio (MPR) values of 80% or higher, per 100 qualified members with diabetes
measure: Adherence to Diabetes-Related Processes of Care
time frame: 12, 18, 24, 36, 48 months
description: Defined as rates of microalbuminuria screening, retinal/eye exams, A1c test frequency, LDL test frequency, Statin use, ACE/ARB use
measure: Total Plan and Member Cost
time frame: 12, 18, 24, 36, 48 months
description: Defined as total (plan+member) cost per member
measure: Diabetes Complications Count
time frame: 12, 18, 24, 36, 48 months
description: Defined as the Diabetes Complications Severity Index (DCSI) count. The DCSI count ranges from 0 to 7 (count of the 7 diabetes complication categories [cardiovascular disease, cerebrovascular disease/stroke, peripheral vascular disease, nephropathy, retinopathy, neuropathy, and metabolic complications such as ketoacidosis, hyperosmolar, or other coma]).
measure: Any Acute Inpatient Admission
time frame: 12, 18, 24, 36, 48 months
description: Defined as the number of members with any Acute Inpatient Admission per 1,000 qualified members
measure: Any Emergency Room Visit
time frame: 12, 18, 24, 36, 48 months
description: Defined as the number of members with any emergency room visit per 1,000 qualified members
measure: Cerebrovascular disease/stroke
time frame: 12, 18, 24, 36, 48 months
description: Defined as percentage of members with Cerebrovascular disease/stroke
measure: Peripheral vascular disease
time frame: 12, 18, 24, 36, 48 months
description: Defined as percentage of members with Peripheral vascular disease
measure: Nephropathy
time frame: 12, 18, 24, 36, 48 months
description: Defined as percentage of members with Nephropathy
measure: Retinopathy
time frame: 12, 18, 24, 36, 48 months
description: Defined as percentage of members with Retinopathy
measure: Neuropathy
time frame: 12, 18, 24, 36, 48 months
description: Defined as percentage of members with Neuropathy
measure: Metabolic complications such as ketoacidosis, hyperosmolar, or other coma
time frame: 12, 18, 24, 36, 48 months
description: Defined as percentage of members with metabolic complications
arm group label: Treatment 1
arm group type: Experimental
description: RN Standard care coordination and disease management + RN Case Management
arm group label: Control
arm group type: Experimental
description: RN Standard care coordination and disease management
arm group label: Treatment 2
arm group type: Experimental
description: RN Standard care coordination and disease management + Community Health Worker Case Management
intervention type: Behavioral
intervention name: RN case management
description: A Registered Nurse (RN) case manager makes phone contact with the member to review medications, health risks, care gaps/barriers, & to develop a case management plan that focuses on improving medication adherence & reconciliation, condition-based measures & outcomes, addressing psycho-social needs, & intensive post-admission care transition. RNs may refer the member to social workers,specialist providers, & support programs (including to more intense case management where the primary care physician is notified that RNs may contact them to support treatment & coordinate services).
arm group label: Treatment 1
intervention type: Behavioral
intervention name: Community Health Worker Case Management
description: In selected UHC markets for defined time periods, members randomized to the treatment arm also received an enhanced version of the SCC that included in-home case management support from non-clinical Community Health Workers (CHW).
arm group label: Treatment 2
intervention type: Behavioral
intervention name: RN Standard care coordination and disease management
description: RN Standard care coordination and disease management
arm group label: Control
arm group label: Treatment 1
arm group label: Treatment 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anthony V Pirrello, MS
role: Principal Investigator
affiliation: UnitedHealthcare
last name: Eileen Birmingham
phone: 800-842-3225
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: UnitedHealthcare
investigator full name: Anthony Pirrello
investigator title: Director UHC E&I Healthcare Econ
sharing ipd: No