AsthmaCHECKNCT04057521
Coordinated HEalthcare for Complex Kids
A study testing Care Coordination in people with Asthma and Diabetes Mellitus, run by University of Illinois at Chicago.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 26 years
- Conditions the study is for
- Asthma, Diabetes Mellitus, Sickle Cell Disease
- What is being tested?
- Care Coordination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,259 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- None
About this study
Official title: Coordinated HEalthcare for Complex Kids Impact on Medicaid Expenditures
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.
Read the 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.
- Conditions
- Asthma, Diabetes Mellitus, Sickle Cell Disease, Premature Birth
- Being tested
- Care Coordination
- Keywords
- care coordination, Children, Young adults, Chronic disease
- Medical subject headings
- Asthma, Diabetes Mellitus, Anemia, Sickle Cell, Premature Birth, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care CoordinationOther
Also called Demonstration project
Comprehensive care coordination.
| Study group | Role | What they receive |
|---|---|---|
| CHECK Program | Experimental | Participants were offered enrollment into CHECK care coordination services. Receives: Other: Care Coordination |
| Comparison Group | Active comparator | Participants were not offered enrollment into CHECK. Receives: Other: Care Coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three years
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.
Measured: Three years
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.
Measured: Three years
Secondary outcomes (6)
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.
Measured: Three years
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.
Measured: Three years
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).
Measured: Three years
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.
Measured: Three years
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.
Measured: Three years
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).
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Apr 2016
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 6,259 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Responsible party
- Principal investigator, Benjamin Van Voorhees, MD, MPH, University of Illinois at Chicago
- Investigators
- Benjamin VanVoorhees, MD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057521
- Sponsor's protocol ID
- 2014-0738
- Acronym
- CHECK
- Status last verified
- Aug 2019
- First submitted
- 9 Aug 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29119824Bansa 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.
PubMed 30956250Caskey 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.
PubMed 31584682
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinated HEalthcare for Complex Kids Impact on Medicaid Expenditures
- ClinicalTrials.gov ID
- NCT04057521
- Acronym / sponsor ID
- CHECK / 2014-0738
- Conditions
- Asthma, Diabetes Mellitus, Sickle Cell Disease, Premature Birth
- Keywords
- care coordination, Children, Young adults, Chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,259 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CHECK Program | Experimental | Other: Care CoordinationParticipants were offered enrollment into CHECK care coordination services. |
| Comparison Group | Active comparator | Other: Care CoordinationParticipants were not offered enrollment into CHECK. |
Who may qualify
- Ages
- Up to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 0-25 years;
- Documentation of asthma,
- Diabetes mellitus (type 1 or 2), sickle cell disease,
- Seizure disorder or
- Prematurity; 3)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care CoordinationAlso: Demonstration projectComprehensive care coordination. | Other | CHECK Program, Comparison Group |
Primary outcome
Annual inpatient healthcare utilization per 1000 patient years
Time frame: Three 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
Time frame: Three 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
Time frame: Three 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.
6 secondary outcomes
Annual inpatient healthcare expenditures per patient
Time frame: Three years
Annual emergency room healthcare expenditures per patient
Time frame: Three years
Annual outpatient healthcare expenditures per patient
Time frame: Three years
Annual prescription healthcare expenditures per patient
Time frame: Three years
Annual "other" healthcare expenditures per patient
Time frame: Three years
Annual total healthcare expenditures per patient
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Background: PubMed 29119824Glassgow 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.
- Background: PubMed 30956250Bansa 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.
- Derived from this study: PubMed 31584682Caskey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin VanVoorhees, MD principal investigator
University of Illinois at Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Care Coordination in people with Asthma and Diabetes Mellitus, run by University of Illinois at Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual inpatient healthcare utilization per 1000 patient years (time frame: Three years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04057521, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.