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Evaluation of the Health and Economic Consequences of Kentucky's Section 1115 Demonstration Waiver

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ClinicalTrials.gov Identifier: NCT03602456
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : April 15, 2019
Sponsor:
Collaborators:
Columbia University
NORC at the University of Chicago
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

Kentucky HEALTH is an 1115 Medicaid waiver that was approved by the Centers for Medicare and Medicaid Services (CMS) in January 2018. This 5-year demonstration waiver aims to modify the traditional Medicaid program to improve health behaviors, health outcomes, and socioeconomic outcomes in the waiver-eligible population through several innovations. In brief, these include introducing Community Engagement requirements, monthly premiums, MyRewards accounts for dental and vision services, and annual recertification to continue receiving benefits. These innovations will be coupled with various levels of penalization if beneficiaries fail to complete including suspension and 6-month lockouts from the Medicaid program.

The Commonwealth of Kentucky has chosen to implement this program in a randomized fashion, where 10% of the target population will be randomly assigned to continue receiving traditional Medicaid while 90% will receive Kentucky HEALTH and be subject to the components and requirements discussed above. Randomization will be conducted by the state, through their separate contract with a non-profit research firm (National Opinion Research Center, NORC). The NORC will also engage in primary data collection to support the analysis of the project. Our team will serve as the independent evaluation team of this randomized intervention conducted by the Commonwealth of Kentucky. The analysis will measure the impact of KY HEALTH compared to traditional Medicaid.

Due to ongoing legal challenges, the implementation date of Kentucky HEALTH has been delayed. Initially, the waiver was expected to be implemented on July 1, 2018. This was ultimately pushed to a staggered launch of April 2019 for MyRewards, May 2019 for premiums, and July 2019 for community engagement. Most recently on March 27, 2019, the DC District Court Judge concluded that the approvals did not address how the requests would align with Medicaid's core objectives. Kentucky HEALTH is delayed until further notice, but data collection is ongoing and the time frames for the outcome measures reflect the last planned implementation date of April 1, 2019.


Condition or disease Intervention/treatment
Health Insurance Other: Kentucky HEALTH

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 378828 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Health and Economic Consequences of Kentucky's Section 1115 Demonstration Waiver
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicaid

Group/Cohort Intervention/treatment
Kentucky HEALTH
This group will consist of 90% of eligible beneficiaries who will receive Kentucky HEALTH benefits throughout the 5-year demonstration waiver.
Other: Kentucky HEALTH
KY HEALTH is the modified Medicaid program including key components such as community engagement requirements, premiums and lockouts, redetermination lockouts, and the My Rewards incentive program.

Traditional Medicaid (control)
This group will consist of 10% of eligible beneficiaries who will continue receiving traditional Medicaid benefits as in place before July 1, 2018 throughout the 5-year demonstration waiver.



Primary Outcome Measures :
  1. Current Medicaid enrollment [ Time Frame: The data will be provided by Kentucky between July 1, 2018 to June 30, 2023. The evaluation team will receive data six months in arrears (i.e. will receive data on 1/1/19 that will run through 6/30/18). ]
    Administrative data for randomized individuals. It will be measured by comparing changes in outcome between the treatment and control.

  2. Months uninsured in the past year [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  3. Type of insurance coverage [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  4. Number of ED visits [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  5. Number of ED visits for ambulatory care sensitive conditions [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  6. Hospitalizations [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  7. Hospitalizations for ambulatory care sensitive conditions [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  8. Number of dental care visits [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  9. Substance use [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  10. Blood pressure [ Time Frame: Biometrics were collected at the intended baseline (July 2018) and will be collected two years post-implementation (April 2021), and possibly 5 years post-implementation (April 2023). ]
    Biometric assessment, subgroup of beneficiaries with baseline hypertension by self-report on KHES baseline survey. It will be measured by comparing changes in outcome between the treatment and control.

  11. Hemoglobin a1C [ Time Frame: Biometrics were collected at the intended baseline (July 2018) and will be collected two years post-implementation (April 2021), and possibly 5 years post-implementation (April 2023). ]
    Biometric assessment, subgroup of beneficiaries with baseline diabetes by self-report on KHES baseline survey. It will be measured by comparing changes in outcome between the treatment and control.

  12. BMI [ Time Frame: Biometrics were collected at the intended baseline (July 2018) and will be collected two years post-implementation (April 2021), and possibly 5 years post-implementation (April 2023). ]
    Biometric assessment, subgroup of beneficiaries with baseline diabetes or hypertension by self-report on KHES baseline survey. It will be measured by comparing changes in outcome between the treatment and control.

  13. Total cholesterol [ Time Frame: Biometrics were collected at the intended baseline (July 2018) and will be collected two years post-implementation (April 2021), and possibly 5 years post-implementation (April 2023). ]
    Biometric assessment, subgroup of beneficiaries with baseline diabetes or hypertension by self-report on KHES baseline survey. It will be measured by comparing changes in outcome between the treatment and control.

  14. Family income [ Time Frame: The data will be provided by Kentucky between July 1, 2018 to June 30, 2023. The evaluation team will receive data six months in arrears (i.e. will receive data on 1/1/19 that will run through 6/30/18). ]
    Administrative data for randomized individuals. It will be measured by comparing changes in outcome between the treatment and control.

  15. Currently employed [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  16. Hours worked per week [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  17. Banking [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  18. Participation in education or job training (composite) [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  19. Mortality [ Time Frame: The data will be provided by Kentucky between July 1, 2018 to June 30, 2023. The evaluation team will receive data six months in arrears (i.e. will receive data on 1/1/19 that will run through 6/30/18). ]
    Administrative data for randomized individuals (vitals). It will be measured by comparing changes in outcome between the treatment and control.

  20. Days physical health not good in past month [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  21. Days mental health not good in past month [ Time Frame: Survey data was collected at the intended baseline (July 2018). It will be collected in September 2019 and every subsequent April (2020, 2021, 2022, 2023). ]
    KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population includes all waiver-eligible adults who are currently enrolled in Medicaid in the Commonwealth of Kentucky (i.e. the majority of able-bodied adults that make up the expansion population).
Criteria

Inclusion Criteria:

  • Waiver-eligible adults currently enrolled in Medicaid

Exclusion Criteria:

  • Medically frail
  • Pregnant
  • Former foster youth (up to age 26)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602456


Contacts
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Contact: Erica Dixon, PhD 215-573-9987 Erica.Dixon@pennmedicine.upenn.edu

Sponsors and Collaborators
University of Pennsylvania
Columbia University
NORC at the University of Chicago
Investigators
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Principal Investigator: Kevin Volpp, MD, PhD University of Pennsylvania
Principal Investigator: Atheendar Venkataramani, MD, PhD University of Pennsylvania
Principal Investigator: Kristen Underhill, JD, DPhil Columbia University

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03602456     History of Changes
Other Study ID Numbers: 828923
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No