<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/NCT04456725</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT04456725</nct_id>
  </id_info>
  <brief_title>Intensive Management of At-risk Patients</brief_title>
  <official_title>Intensive Management of At-risk Patients: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CareMore Health, San Bernardino</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CareMore Health, San Bernardino</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 is to assess if intensive management of at-risk participants,&#xD;
      utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action&#xD;
      planning and careful outcomes monitoring, will lead to better patient outcomes than usual&#xD;
      care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At-risk participants will be randomized 1:1 to either usual care or intensive management&#xD;
      utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action&#xD;
      planning and careful outcomes monitoring for 6 months. Participants in the intervention group&#xD;
      will be assigned to a partnership of one nurse practitioner and one medical assistant who&#xD;
      will manage them with the support of the study team. Staff will focus on contacting all&#xD;
      patients within one week of any emergency department visit or hospital discharge, contacting&#xD;
      all highest-risk participants weekly and all participants monthly, and completing&#xD;
      high-priority tasks for participant care within one week. The primary outcomes of this&#xD;
      quality improvement study are inpatient bed days and number of inpatient admissions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>
    <masking_description>Participants will not be informed that their care is different than usual care.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>inpatient bed days</measure>
    <time_frame>6 months</time_frame>
    <description>number of total participants' days of care in an inpatient setting</description>
  </primary_outcome>
  <primary_outcome>
    <measure>inpatient admissions</measure>
    <time_frame>6 months</time_frame>
    <description>total number of participants' inpatient admissions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ED visits</measure>
    <time_frame>6 months</time_frame>
    <description>participants' total emergency department visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day readmissions</measure>
    <time_frame>30 days</time_frame>
    <description>participants' total inpatient readmissions within 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>180-day readmissions</measure>
    <time_frame>180 days</time_frame>
    <description>participants' total inpatient readmissions within 180 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACSC admits</measure>
    <time_frame>6 months</time_frame>
    <description>participants' inpatient admissions for ambulatory care sensitive conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inpatient plus SNF bed days</measure>
    <time_frame>6 months</time_frame>
    <description>number of total days of participants' care in an inpatient or skilled nursing facility setting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cost</measure>
    <time_frame>6 months</time_frame>
    <description>participants' total medical expenditures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>delta MLR</measure>
    <time_frame>6 months</time_frame>
    <description>average change in each participant's medical loss ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average percent post-acute contact within 1 week</measure>
    <time_frame>1 week</time_frame>
    <description>average percent of participants contacted within 1 week of emergency department visit, hospital or skilled-nursing facility discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average percent of high-priority tasks completed within 1 week</measure>
    <time_frame>1 week</time_frame>
    <description>average percent of participant care tasks designated as high-priority that are completed within 1 week of being assigned</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average percent of Gold patients contacted weekly</measure>
    <time_frame>1 week</time_frame>
    <description>average percent of participants in Gold tier contacted every week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average percent of participants contacted monthly</measure>
    <time_frame>1 month</time_frame>
    <description>average percent of participants contacted every 4 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average change in percent of high-priority HEDIS gaps</measure>
    <time_frame>6 months</time_frame>
    <description>average change in percent of open Healthcare Effectiveness Data and Information Set (HEDIS) measures that are high-priority, meaning statin use in diabetics and cardiovascular disease; medication adherence for oral diabetes, hypertension and statin; diabetes A1c control; and blood pressure control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average change in staff satisfaction score</measure>
    <time_frame>6 months</time_frame>
    <description>average difference in sum of Likert scale responses to staff satisfaction survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average change in participant satisfaction score</measure>
    <time_frame>6 months</time_frame>
    <description>average difference in sum of Likert scale responses to participant satisfaction survey</description>
  </secondary_outcome>
  <other_outcome>
    <measure>average change in RAF</measure>
    <time_frame>6 months</time_frame>
    <description>average change in each participant's Risk Adjustment Factor</description>
  </other_outcome>
  <other_outcome>
    <measure>average number of high-priority tasks completed per week</measure>
    <time_frame>1 week</time_frame>
    <description>average number of participant care tasks designated high-priority completed per week</description>
  </other_outcome>
  <other_outcome>
    <measure>average time on high-priority tasks per week</measure>
    <time_frame>1 week</time_frame>
    <description>average amount of time in minutes per week spent by staff in attempting to complete high-priority participant care tasks</description>
  </other_outcome>
  <other_outcome>
    <measure>number of in-person visits</measure>
    <time_frame>6 months</time_frame>
    <description>total number of in-person care visits by participants</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intensive management utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive management</intervention_name>
    <description>The intervention group will be assigned to a partnership of one nurse practitioner and one medical assistant who will manage them intensively, with the support of the study team.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Usual care</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: At-risk patients, meaning Gold, Silver, or Bronze tier, as identified&#xD;
        by our member 360 platform:&#xD;
&#xD;
          -  Gold tier - 6+ emergency department (ED) visits last year, annual spend &gt;$100,000, 8&#xD;
             or more hierarchical condition category (HCC) diagnoses, readmission &lt;30 days prior,&#xD;
             or ambulatory care-sensitive condition (ACSC) hospitalization &lt;30 days prior&#xD;
&#xD;
          -  Silver tier - 4+ ED visits last year, annual spend &gt;$75,000, 6 or more HCC diagnoses,&#xD;
             readmission &lt;90 days prior, substance abuse HCC diagnosis, behavioral health admit &lt;90&#xD;
             days, 15+ chronic medications prescribed in the last 90 days (and not qualifying for&#xD;
             Gold tier)&#xD;
&#xD;
          -  Bronze tier - 3+ ED visits last year, annual spend &gt;$50,000, 5 or more HCC diagnoses,&#xD;
             3+ hospitalizations last year, end-stage liver disease, end-stage renal disease,&#xD;
             Medicare and Medicaid dual-enrolled, disease-management program patients with ACSC&#xD;
             admission or ED visit in the last year, 10+ chronic medications in the last 90 days,&#xD;
             6+ health risk-assessment score, 12+ Edmonton Frail Scale score (and not qualifying&#xD;
             for Gold or Silver tiers)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  enrolled in hospice&#xD;
&#xD;
          -  enrolled in Institutional Special Needs Plan&#xD;
&#xD;
          -  primary patient of study investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Bixenstine, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CareMore Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paul J Bixenstine, MD</last_name>
    <phone>909-296-8800</phone>
    <email>paul.bixenstine@caremore.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>CareMore Health, San Bernardino</investigator_affiliation>
    <investigator_full_name>Paul Bixenstine</investigator_full_name>
    <investigator_title>Primary Care Physician</investigator_title>
  </responsible_party>
  <keyword>high need high cost</keyword>
  <keyword>population health</keyword>
  <keyword>care management</keyword>
  <keyword>quality improvement</keyword>
  <keyword>ambulatory care</keyword>
  <keyword>primary care</keyword>
  <keyword>readmission prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <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/NCT04456725
org study id: 001
nct id: NCT04456725
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess if intensive management of at-risk participants,
      utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action
      planning and careful outcomes monitoring, will lead to better patient outcomes than usual
      care.
At-risk participants will be randomized 1:1 to either usual care or intensive management
      utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action
      planning and careful outcomes monitoring for 6 months. Participants in the intervention group
      will be assigned to a partnership of one nurse practitioner and one medical assistant who
      will manage them with the support of the study team. Staff will focus on contacting all
      patients within one week of any emergency department visit or hospital discharge, contacting
      all highest-risk participants weekly and all participants monthly, and completing
      high-priority tasks for participant care within one week. The primary outcomes of this
      quality improvement study are inpatient bed days and number of inpatient admissions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Participants will not be informed that their care is different than usual care.
measure: inpatient bed days
time frame: 6 months
description: number of total participants' days of care in an inpatient setting
measure: inpatient admissions
time frame: 6 months
description: total number of participants' inpatient admissions
measure: ED visits
time frame: 6 months
description: participants' total emergency department visits
measure: 30-day readmissions
time frame: 30 days
description: participants' total inpatient readmissions within 30 days
measure: 180-day readmissions
time frame: 180 days
description: participants' total inpatient readmissions within 180 days
measure: ACSC admits
time frame: 6 months
description: participants' inpatient admissions for ambulatory care sensitive conditions
measure: inpatient plus SNF bed days
time frame: 6 months
description: number of total days of participants' care in an inpatient or skilled nursing facility setting
measure: cost
time frame: 6 months
description: participants' total medical expenditures
measure: delta MLR
time frame: 6 months
description: average change in each participant's medical loss ratio
measure: average percent post-acute contact within 1 week
time frame: 1 week
description: average percent of participants contacted within 1 week of emergency department visit, hospital or skilled-nursing facility discharge
measure: average percent of high-priority tasks completed within 1 week
time frame: 1 week
description: average percent of participant care tasks designated as high-priority that are completed within 1 week of being assigned
measure: average percent of Gold patients contacted weekly
time frame: 1 week
description: average percent of participants in Gold tier contacted every week
measure: average percent of participants contacted monthly
time frame: 1 month
description: average percent of participants contacted every 4 weeks
measure: average change in percent of high-priority HEDIS gaps
time frame: 6 months
description: average change in percent of open Healthcare Effectiveness Data and Information Set (HEDIS) measures that are high-priority, meaning statin use in diabetics and cardiovascular disease; medication adherence for oral diabetes, hypertension and statin; diabetes A1c control; and blood pressure control
measure: average change in staff satisfaction score
time frame: 6 months
description: average difference in sum of Likert scale responses to staff satisfaction survey
measure: average change in participant satisfaction score
time frame: 6 months
description: average difference in sum of Likert scale responses to participant satisfaction survey
measure: average change in RAF
time frame: 6 months
description: average change in each participant's Risk Adjustment Factor
measure: average number of high-priority tasks completed per week
time frame: 1 week
description: average number of participant care tasks designated high-priority completed per week
measure: average time on high-priority tasks per week
time frame: 1 week
description: average amount of time in minutes per week spent by staff in attempting to complete high-priority participant care tasks
measure: number of in-person visits
time frame: 6 months
description: total number of in-person care visits by participants
arm group label: Control
arm group type: Active Comparator
description: Usual care group
arm group label: Intervention
arm group type: Experimental
description: Intensive management utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring.
intervention type: Behavioral
intervention name: Intensive management
description: The intervention group will be assigned to a partnership of one nurse practitioner and one medical assistant who will manage them intensively, with the support of the study team.
arm group label: Intervention
intervention type: Behavioral
intervention name: Control
description: Usual care
arm group label: Control
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paul Bixenstine, MD
role: Principal Investigator
affiliation: CareMore Health
last name: Paul J Bixenstine, MD
phone: 909-296-8800
email: paul.bixenstine@caremore.com
responsible party type: Principal Investigator
investigator affiliation: CareMore Health, San Bernardino
investigator full name: Paul Bixenstine
investigator title: Primary Care Physician
mesh term: Chronic Disease
sharing ipd: No