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

NCT03602456 | Terminated

• 1 other identifier: 828923
• Study Type: observational
• Target: 378,828
• Locations: 1 country
• Sites: 2

Brief Summary

Kentucky HEALTH was an 1115 Medicaid waiver that was approved by the Centers for Medicare and Medicaid Services (CMS) in January 2018. In what was initially planned to be a 5-year demonstration, KY HEALTH aimed 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 included introducing Community Engagement requirements (i.e. work requirements), monthly premiums, MyRewards accounts for dental and vision services, and annual recertification. If beneficiaries failed to complete these requirements, some penalties included suspension and 6-month lockouts from the Medicaid program. The Commonwealth of Kentucky had chosen to implement this program in a randomized fashion, where 10% of the target population was randomly assigned to continue receiving traditional Medicaid while 90% would receive Kentucky HEALTH benefits and be subject to the requirements discussed above. Randomization was conducted by the state, through their separate contract with a non-profit research firm (National Opinion Research Center, NORC). The NORC also engaged in primary data collection to support the analysis of the project. The University of Pennsylvania team served as the non-partisan, independent evaluators of this randomized intervention conducted by the Commonwealth of Kentucky. The analysis would measure the impact of KY HEALTH compared to traditional Medicaid. Due to ongoing legal challenges and a change in administrations, the implementation of Kentucky HEALTH was delayed and eventually cancelled. 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. At that point, data collection was ongoing although Kentucky HEALTH was delayed until further notice. Kentucky's 2019 gubernatorial election took place on November 5th and resulted in the election of a new governor. On December 16, 2019, a termination request was sent to CMS as a notification of the new administration's intention to cancel Kentucky HEALTH. On December 18, 2019, a clarification letter was sent to CMS to notify them that the termination did not apply to the SUD program and NEMT portion (among others) of the waiver. While the Penn team will continue conducting a separate evaluation of the ongoing SUD program, the randomized controlled trial and data collection described in this study will end with the terminated components of the waiver. As a result of the legal challenges, the implementation of Kentucky HEALTH was delayed before being cancelled altogether. The study start and end dates above reflect the beginning of data collection and the termination letter that was sent to CMS, respectively. A total of 9,396 surveys (KHES), 127 beneficiary semi-structured interviews, and 40 provider interviews were conducted.

Conditions

Health Insurance

Outcome Measures

Primary Outcomes (21)

• Current Medicaid enrollment

  Administrative data for randomized individuals. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Months uninsured in the past year

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Type of insurance coverage

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Number of ED visits

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Number of ED visits for ambulatory care sensitive conditions

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Hospitalizations

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Hospitalizations for ambulatory care sensitive conditions

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Number of dental care visits

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Substance use

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Blood pressure

  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.

  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).

• Hemoglobin a1C

  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.

  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).

• BMI

  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.

  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).

• Total cholesterol

  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.

  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).

• Family income

  Administrative data for randomized individuals. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Currently employed

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Hours worked per week

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Banking

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Participation in education or job training (composite)

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Mortality

  Administrative data for randomized individuals (vitals). It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Days physical health not good in past month

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

• Days mental health not good in past month

  KHES self-report. It will be measured by comparing changes in outcome between the treatment and control.

  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).

Study Arms (2)

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

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.

Interventions

Kentucky HEALTH OTHER

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.

Kentucky HEALTH

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• Waiver-eligible adults currently enrolled in Medicaid

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Columbia University: collaborator
• NORC at the University of Chicago: collaborator

Study Sites (2)

Kentucky Cabinet for Health and Familty Services

Frankfort, Kentucky, 40621, United States

Location

NORC at the University of Chicago

Bethesda, Maryland, 20814, United States

Location

Related Publications (1)

• Linn KA, Underhill K, Dixon EL, Bair EF, Ferrell WJ, Montgomery ME, Volpp KG, Venkataramani AS. The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements. Contemp Clin Trials. 2020 Nov;98:106173. doi: 10.1016/j.cct.2020.106173. Epub 2020 Oct 7.

  PMID: 33038505 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

NORC collected bio measures such as height, weight, hip-waist ratio, and blood pressure among participants. NORC also collected 1,434 blood spots to measure blood sugar (HbA1c), total cholesterol (CHO), and HDL cholesterol. The blood spots were analyzed by and kept at the Department of Laboratory Medicine at the University of Washington (UW). Due to degradation, CHO and HDL were contaminated and no longer of use to the evaluation. These samples will be destroyed no later than at the end of the contract (June 2025).

Study Officials

• Kevin Volpp, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Atheendar Venkataramani, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Kristen Underhill, JD, DPhil

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 26, 2018
• Study Start: April 1, 2018
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

US (2)