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Coordinated HEalthcare for Complex Kids (CHECK)

Primary Purpose

Asthma, Diabetes Mellitus, Sickle Cell Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Care Coordination
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring care coordination, Children, Young adults, Chronic disease

Eligibility Criteria

undefined - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 0-25 years;
  • Documentation of asthma,
  • Diabetes mellitus (type 1 or 2), sickle cell disease,
  • Seizure disorder or
  • Prematurity; 3)
  • Enrolled in Medicaid; and
  • Ride in Cook County, Illinois.

Exclusion criteria:

• None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CHECK Program

    Comparison Group

    Arm Description

    Participants were offered enrollment into CHECK care coordination services.

    Participants were not offered enrollment into CHECK.

    Outcomes

    Primary Outcome Measures

    Annual inpatient healthcare utilization per 1000 patient years
    Number of inpatient hospitalizations/1000 patient years obtained from the Illinois Medicaid paid claims for CHECK participants using the Care Coordination Claims Data (CCCD) provided by the Illinois Department of Healthcare and Family Services (HFS).Claims for the same patient identifier with overlapping service dates were considered one hospitalization. Due to the fact that professional service claims may be submitted independent from facility claims, those claims with the same patient identification number, national provider ID (NPI), and service date were considered the same event to avoid duplication.
    Annual emergency room healthcare utilization per 1000 patient years
    Number of emergency room visits/1000 patient years obtained from the Illinois Medicaid paid claims for CHECK participants using the Care Coordination Claims Data (CCCD) provided by the Illinois Department of Healthcare and Family Services (HFS). The number of inpatient hospitalizations per patient were identified using inpatient facility claims. The number of ED visits per patient were identified from outpatient facility claims or professional claims with revenue codes indicating an ED place of service or Current Procedural Terminology (CPT) codes for emergency services. Due to the fact that professional service claims may be submitted independent from facility claims, those claims with the same patient identification number, national provider ID (NPI), and service date were considered the same event to avoid duplication.
    Annual outpatient visit healthcare utilization per patient per 1000 patient years
    Number of outpatient visits/1000 patient years obtained from the Illinois Medicaid paid claims for CHECK participants using the Care Coordination Claims Data (CCCD) provided by the Illinois Department of Healthcare and Family Services (HFS).Outpatient visits were defined as outpatient facility claims or professional service claims with evaluation and management CPT codes for office visits (excluding observation or outpatient surgery).Due to the fact that professional service claims may be submitted independent from facility claims, those claims with the same patient identification number, national provider ID (NPI), and service date were considered the same event to avoid duplication.

    Secondary Outcome Measures

    Annual inpatient healthcare expenditures per patient
    Annual inpatient healthcare expenditures are reported as expenditures/patient/year (US dollars).For the inpatient visit expenditures, costs associated with any remaining outpatient or professional claims with overlapping dates of service were considered part of the event.
    Annual emergency room healthcare expenditures per patient
    Annual emergency room healthcare expenditures are reported as expenditures/patient/year (US dollars).For the emergency room visit expenditures, costs associated with any remaining outpatient or professional claims with overlapping dates of service were considered part of the event.
    Annual outpatient healthcare expenditures per patient
    Annual outpatient healthcare expenditures are reported as expenditures/patient/year (US dollars). Outpatient visits were defined as outpatient facility claims or professional service claims with evaluation and management CPT codes for office visits (excluding observation or outpatient surgery).
    Annual prescription healthcare expenditures per patient
    Annual prescription healthcare expenditures are reported as expenditures/patient/year (US dollars). Prescription expenditures were obtained from the prescription drug file of the CCCD.
    Annual "other" healthcare expenditures per patient
    Annual "other" healthcare expenditures are reported as expenditures/patient/year (US dollars). Expenditures not attributable to inpatient, ED, outpatient visits, or prescription costs were considered 'other' and include services such as observation, outpatient surgery, dental, mental health, labs, and radiology.
    Annual total healthcare expenditures per patient
    Annual total healthcare expenditures are reported as expenditures/patient/year (US dollars). Expenditures were measured for each patient overall, and by category of service (e.g., inpatient, ED, outpatient visits, prescriptions, and other). Outpatient visits were defined as outpatient facility claims or professional service claims with evaluation and management CPT codes for office visits (excluding observation or outpatient surgery). Prescription expenditures were obtained from the prescription drug file of the CCCD. For the inpatient, ED, and outpatient visit expenditures, costs associated with any remaining outpatient or professional claims with overlapping dates of service were considered part of the event. Total expenditures per patient were defined as the sum of all paid claims for any covered service - (e.g., inpatient, ED, outpatient visits, prescriptions, and other).

    Full Information

    First Posted
    August 9, 2019
    Last Updated
    August 13, 2019
    Sponsor
    University of Illinois at Chicago
    Collaborators
    Centers for Medicare and Medicaid Services
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04057521
    Brief Title
    Coordinated HEalthcare for Complex Kids
    Acronym
    CHECK
    Official Title
    Coordinated HEalthcare for Complex Kids Impact on Medicaid Expenditures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    August 31, 2018 (Actual)
    Study Completion Date
    August 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Illinois at Chicago
    Collaborators
    Centers for Medicare and Medicaid Services

    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 University of Illinois Health and Health Sciences System (UI Health) developed an integrated care management quality improvement model designed to provide comprehensive care coordination for Medicaid insured minority children and young adults with chronic health conditions living in Chicago. This program, called CHECK (Coordinated HEalthcare for Complex Kids), targeted children and young adults with chronic disease.
    Detailed Description
    The University of Illinois Health and Health Sciences System (UI Health) developed an integrated care management quality improvement model designed to provide comprehensive care coordination for Medicaid insured minority children and young adults with chronic health conditions living in Chicago. This program, called CHECK (Coordinated HEalthcare for Complex Kids), was funded by a Centers for Medicare and Medicaid Services Innovation (CMMI) Award. The CHECK model took a broad approach to health promotion by addressing social determinants of health, caregiver wellness and mental health needs; in addition to disease management. The program targeted children and young adults from birth to age 25 with diagnoses of asthma, diabetes, sickle cell disease, seizure disorder or prematurity. All participants were enrolled in either the traditional (fee-for-service) state Medicaid program or a Medicaid Managed Care Organization (MCO) in Illinois. CHECK provided access to care coordination delivered by community health workers; mental health services and health education. CHECK was designed as a demonstration program and participants were enrolled passively over time and received different services depending on their level of risk and need. One primary aim of the CHECK program was to decrease Medicaid expenditures over a three-year period by decreasing unnecessary emergency department visits and hospitalizations. Though CHECK was designed as a care delivery demonstration program, in April, 2016 we had the opportunity to prospectively randomize 6,259 participants who met eligibility criteria for CHECK, for the purpose of program evaluation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Diabetes Mellitus, Sickle Cell Disease, Premature Birth
    Keywords
    care coordination, Children, Young adults, Chronic disease

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    For the purpose of program evaluation; 6,259 participants who met eligibility criteria for CHECK were randomized. These participants had no previous exposure to CHECK and were randomized to either enrollment into the CHECK program or to usual care (comparison group). Purposive randomization to CHECK or usual care by age, disease and risk level was conducted by Mathmatica.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    6259 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CHECK Program
    Arm Type
    Experimental
    Arm Description
    Participants were offered enrollment into CHECK care coordination services.
    Arm Title
    Comparison Group
    Arm Type
    Active Comparator
    Arm Description
    Participants were not offered enrollment into CHECK.
    Intervention Type
    Other
    Intervention Name(s)
    Care Coordination
    Other Intervention Name(s)
    Demonstration project
    Intervention Description
    Comprehensive care coordination.
    Primary Outcome Measure Information:
    Title
    Annual inpatient healthcare utilization per 1000 patient years
    Description
    Number of inpatient hospitalizations/1000 patient years obtained from the Illinois Medicaid paid claims for CHECK participants using the Care Coordination Claims Data (CCCD) provided by the Illinois Department of Healthcare and Family Services (HFS).Claims for the same patient identifier with overlapping service dates were considered one hospitalization. Due to the fact that professional service claims may be submitted independent from facility claims, those claims with the same patient identification number, national provider ID (NPI), and service date were considered the same event to avoid duplication.
    Time Frame
    Three years
    Title
    Annual emergency room healthcare utilization per 1000 patient years
    Description
    Number of emergency room visits/1000 patient years obtained from the Illinois Medicaid paid claims for CHECK participants using the Care Coordination Claims Data (CCCD) provided by the Illinois Department of Healthcare and Family Services (HFS). The number of inpatient hospitalizations per patient were identified using inpatient facility claims. The number of ED visits per patient were identified from outpatient facility claims or professional claims with revenue codes indicating an ED place of service or Current Procedural Terminology (CPT) codes for emergency services. Due to the fact that professional service claims may be submitted independent from facility claims, those claims with the same patient identification number, national provider ID (NPI), and service date were considered the same event to avoid duplication.
    Time Frame
    Three years
    Title
    Annual outpatient visit healthcare utilization per patient per 1000 patient years
    Description
    Number of outpatient visits/1000 patient years obtained from the Illinois Medicaid paid claims for CHECK participants using the Care Coordination Claims Data (CCCD) provided by the Illinois Department of Healthcare and Family Services (HFS).Outpatient visits were defined as outpatient facility claims or professional service claims with evaluation and management CPT codes for office visits (excluding observation or outpatient surgery).Due to the fact that professional service claims may be submitted independent from facility claims, those claims with the same patient identification number, national provider ID (NPI), and service date were considered the same event to avoid duplication.
    Time Frame
    Three years
    Secondary Outcome Measure Information:
    Title
    Annual inpatient healthcare expenditures per patient
    Description
    Annual inpatient healthcare expenditures are reported as expenditures/patient/year (US dollars).For the inpatient visit expenditures, costs associated with any remaining outpatient or professional claims with overlapping dates of service were considered part of the event.
    Time Frame
    Three years
    Title
    Annual emergency room healthcare expenditures per patient
    Description
    Annual emergency room healthcare expenditures are reported as expenditures/patient/year (US dollars).For the emergency room visit expenditures, costs associated with any remaining outpatient or professional claims with overlapping dates of service were considered part of the event.
    Time Frame
    Three years
    Title
    Annual outpatient healthcare expenditures per patient
    Description
    Annual outpatient healthcare expenditures are reported as expenditures/patient/year (US dollars). Outpatient visits were defined as outpatient facility claims or professional service claims with evaluation and management CPT codes for office visits (excluding observation or outpatient surgery).
    Time Frame
    Three years
    Title
    Annual prescription healthcare expenditures per patient
    Description
    Annual prescription healthcare expenditures are reported as expenditures/patient/year (US dollars). Prescription expenditures were obtained from the prescription drug file of the CCCD.
    Time Frame
    Three years
    Title
    Annual "other" healthcare expenditures per patient
    Description
    Annual "other" healthcare expenditures are reported as expenditures/patient/year (US dollars). Expenditures not attributable to inpatient, ED, outpatient visits, or prescription costs were considered 'other' and include services such as observation, outpatient surgery, dental, mental health, labs, and radiology.
    Time Frame
    Three years
    Title
    Annual total healthcare expenditures per patient
    Description
    Annual total healthcare expenditures are reported as expenditures/patient/year (US dollars). Expenditures were measured for each patient overall, and by category of service (e.g., inpatient, ED, outpatient visits, prescriptions, and other). Outpatient visits were defined as outpatient facility claims or professional service claims with evaluation and management CPT codes for office visits (excluding observation or outpatient surgery). Prescription expenditures were obtained from the prescription drug file of the CCCD. For the inpatient, ED, and outpatient visit expenditures, costs associated with any remaining outpatient or professional claims with overlapping dates of service were considered part of the event. Total expenditures per patient were defined as the sum of all paid claims for any covered service - (e.g., inpatient, ED, outpatient visits, prescriptions, and other).
    Time Frame
    Three years

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    26 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 0-25 years; Documentation of asthma, Diabetes mellitus (type 1 or 2), sickle cell disease, Seizure disorder or Prematurity; 3) Enrolled in Medicaid; and Ride in Cook County, Illinois. Exclusion criteria: • None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Benjamin VanVoorhees, MD
    Organizational Affiliation
    University of Illinois at Chicago
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29119824
    Citation
    Glassgow AE, Martin MA, Caskey R, Bansa M, Gerges M, Johnson M, Marko M, Perry-Bell K, Risser HJ, Smith PJ, Van Voorhees B. An innovative health-care delivery model for children with medical complexity. J Child Health Care. 2017 Sep;21(3):263-272. doi: 10.1177/1367493517712063. Epub 2017 Jun 5.
    Results Reference
    background
    PubMed Identifier
    30956250
    Citation
    Bansa M, Glassgow AE, Martin M, Caskey R, Paulson A, Minier M, Roper P, Mitacek R, Wilder J, Van Voorhees B. Development of a Community-Based Medical Neighborhood for Children with Chronic Conditions. Prog Community Health Partnersh. 2019;13(1):83-95. doi: 10.1353/cpr.2019.0011.
    Results Reference
    background
    PubMed Identifier
    31584682
    Citation
    Caskey R, Moran K, Touchette D, Martin M, Munoz G, Kanabar P, Van Voorhees B. Effect of Comprehensive Care Coordination on Medicaid Expenditures Compared With Usual Care Among Children and Youth With Chronic Disease: A Randomized Clinical Trial. JAMA Netw Open. 2019 Oct 2;2(10):e1912604. doi: 10.1001/jamanetworkopen.2019.12604.
    Results Reference
    derived

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