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Intensive Management of At-risk Patients

Primary Purpose

Chronic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intensive management
Control
Sponsored by
CareMore Health, San Bernardino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease focused on measuring high need high cost, population health, care management, quality improvement, ambulatory care, primary care, readmission prevention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: At-risk patients, meaning Gold, Silver, or Bronze tier, as identified by our member 360 platform:

  • Gold tier - 6+ emergency department (ED) visits last year, annual spend >$100,000, 8 or more hierarchical condition category (HCC) diagnoses, readmission <30 days prior, or ambulatory care-sensitive condition (ACSC) hospitalization <30 days prior
  • Silver tier - 4+ ED visits last year, annual spend >$75,000, 6 or more HCC diagnoses, readmission <90 days prior, substance abuse HCC diagnosis, behavioral health admit <90 days, 15+ chronic medications prescribed in the last 90 days (and not qualifying for Gold tier)
  • Bronze tier - 3+ ED visits last year, annual spend >$50,000, 5 or more HCC diagnoses, 3+ hospitalizations last year, end-stage liver disease, end-stage renal disease, Medicare and Medicaid dual-enrolled, disease-management program patients with ACSC admission or ED visit in the last year, 10+ chronic medications in the last 90 days, 6+ health risk-assessment score, 12+ Edmonton Frail Scale score (and not qualifying for Gold or Silver tiers)

Exclusion Criteria:

  • enrolled in hospice
  • enrolled in Institutional Special Needs Plan
  • primary patient of study investigator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    Usual care group

    Intensive management utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring.

    Outcomes

    Primary Outcome Measures

    inpatient bed days
    number of total participants' days of care in an inpatient setting
    inpatient admissions
    total number of participants' inpatient admissions

    Secondary Outcome Measures

    ED visits
    participants' total emergency department visits
    30-day readmissions
    participants' total inpatient readmissions within 30 days
    180-day readmissions
    participants' total inpatient readmissions within 180 days
    ACSC admits
    participants' inpatient admissions for ambulatory care sensitive conditions
    inpatient plus SNF bed days
    number of total days of participants' care in an inpatient or skilled nursing facility setting
    cost
    participants' total medical expenditures
    delta MLR
    average change in each participant's medical loss ratio
    average percent post-acute contact within 1 week
    average percent of participants contacted within 1 week of emergency department visit, hospital or skilled-nursing facility discharge
    average percent of high-priority tasks completed within 1 week
    average percent of participant care tasks designated as high-priority that are completed within 1 week of being assigned
    average percent of Gold patients contacted weekly
    average percent of participants in Gold tier contacted every week
    average percent of participants contacted monthly
    average percent of participants contacted every 4 weeks
    average change in percent of high-priority HEDIS gaps
    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
    average change in staff satisfaction score
    average difference in sum of Likert scale responses to staff satisfaction survey
    average change in participant satisfaction score
    average difference in sum of Likert scale responses to participant satisfaction survey

    Full Information

    First Posted
    June 21, 2020
    Last Updated
    June 30, 2020
    Sponsor
    CareMore Health, San Bernardino
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04456725
    Brief Title
    Intensive Management of At-risk Patients
    Official Title
    Intensive Management of At-risk Patients: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    CareMore Health, San Bernardino

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Disease
    Keywords
    high need high cost, population health, care management, quality improvement, ambulatory care, primary care, readmission prevention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Participants will not be informed that their care is different than usual care.
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Usual care group
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Intensive management utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intensive management
    Intervention 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control
    Intervention Description
    Usual care
    Primary Outcome Measure Information:
    Title
    inpatient bed days
    Description
    number of total participants' days of care in an inpatient setting
    Time Frame
    6 months
    Title
    inpatient admissions
    Description
    total number of participants' inpatient admissions
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    ED visits
    Description
    participants' total emergency department visits
    Time Frame
    6 months
    Title
    30-day readmissions
    Description
    participants' total inpatient readmissions within 30 days
    Time Frame
    30 days
    Title
    180-day readmissions
    Description
    participants' total inpatient readmissions within 180 days
    Time Frame
    180 days
    Title
    ACSC admits
    Description
    participants' inpatient admissions for ambulatory care sensitive conditions
    Time Frame
    6 months
    Title
    inpatient plus SNF bed days
    Description
    number of total days of participants' care in an inpatient or skilled nursing facility setting
    Time Frame
    6 months
    Title
    cost
    Description
    participants' total medical expenditures
    Time Frame
    6 months
    Title
    delta MLR
    Description
    average change in each participant's medical loss ratio
    Time Frame
    6 months
    Title
    average percent post-acute contact within 1 week
    Description
    average percent of participants contacted within 1 week of emergency department visit, hospital or skilled-nursing facility discharge
    Time Frame
    1 week
    Title
    average percent of high-priority tasks completed within 1 week
    Description
    average percent of participant care tasks designated as high-priority that are completed within 1 week of being assigned
    Time Frame
    1 week
    Title
    average percent of Gold patients contacted weekly
    Description
    average percent of participants in Gold tier contacted every week
    Time Frame
    1 week
    Title
    average percent of participants contacted monthly
    Description
    average percent of participants contacted every 4 weeks
    Time Frame
    1 month
    Title
    average change in percent of high-priority HEDIS gaps
    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
    Time Frame
    6 months
    Title
    average change in staff satisfaction score
    Description
    average difference in sum of Likert scale responses to staff satisfaction survey
    Time Frame
    6 months
    Title
    average change in participant satisfaction score
    Description
    average difference in sum of Likert scale responses to participant satisfaction survey
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    average change in RAF
    Description
    average change in each participant's Risk Adjustment Factor
    Time Frame
    6 months
    Title
    average number of high-priority tasks completed per week
    Description
    average number of participant care tasks designated high-priority completed per week
    Time Frame
    1 week
    Title
    average time on high-priority tasks per week
    Description
    average amount of time in minutes per week spent by staff in attempting to complete high-priority participant care tasks
    Time Frame
    1 week
    Title
    number of in-person visits
    Description
    total number of in-person care visits by participants
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: At-risk patients, meaning Gold, Silver, or Bronze tier, as identified by our member 360 platform: Gold tier - 6+ emergency department (ED) visits last year, annual spend >$100,000, 8 or more hierarchical condition category (HCC) diagnoses, readmission <30 days prior, or ambulatory care-sensitive condition (ACSC) hospitalization <30 days prior Silver tier - 4+ ED visits last year, annual spend >$75,000, 6 or more HCC diagnoses, readmission <90 days prior, substance abuse HCC diagnosis, behavioral health admit <90 days, 15+ chronic medications prescribed in the last 90 days (and not qualifying for Gold tier) Bronze tier - 3+ ED visits last year, annual spend >$50,000, 5 or more HCC diagnoses, 3+ hospitalizations last year, end-stage liver disease, end-stage renal disease, Medicare and Medicaid dual-enrolled, disease-management program patients with ACSC admission or ED visit in the last year, 10+ chronic medications in the last 90 days, 6+ health risk-assessment score, 12+ Edmonton Frail Scale score (and not qualifying for Gold or Silver tiers) Exclusion Criteria: enrolled in hospice enrolled in Institutional Special Needs Plan primary patient of study investigator
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paul J Bixenstine, MD
    Phone
    909-296-8800
    Email
    paul.bixenstine@caremore.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul Bixenstine, MD
    Organizational Affiliation
    CareMore Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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