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临床试验/NCT03602456
NCT03602456终止不适用

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

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 378,828 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
378,828
试验地点
2
主要终点
Number of dental care visits

研究概览

简要总结

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.

详细描述

General Background

With the approval of the Centers for Medicare and Medicaid Services (CMS) on January 12, 2018, the Commonwealth of Kentucky is implementing a 5-year § 1115 demonstration project entitled Kentucky HEALTH (for "Helping to Engage and Achieve Long-Term Health"). The project will modify the Medicaid program for eligible beneficiaries, which include the majority of able-bodied adults.

The Commonwealth's Medicaid demonstration waiver seeks to improve health behaviors, health outcomes, and socioeconomic outcomes in the waiver-eligible population through several innovations as described in the § 1115 CMS Medicaid waiver approval letter from January, 2018:

  • The Kentucky HEALTH benefit plan for the expansion population will provide a comprehensive commercial insurance benefit package. Dental services, vision services, and over the counter medications will now be provided via the beneficiary's My Rewards Account.

  • Kentucky HEALTH beneficiaries, with the exception of medically frail individuals, pregnant women, former foster youth, and children, will be required to make sliding scale flat rate monthly premium payments based on family income. As described in the application the plan is:

  • Under 25% FPL - $1.00 per month

  • 25-50% FPL - $4.00 per month

  • 51-100% FPL - $8.00 per month

  • 101-138% FPL - $15.00 per month

  • Beneficiaries will be provided a 60-day grace period to make their required monthly premium payments - individuals who do not elect to pay a required premium payment within sixty calendar days from the due date will face a six-month non-payment penalty.

  • The non-payment penalty varies based on whether the member has income above or below federal poverty:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Waiver-eligible adults currently enrolled in Medicaid

排除标准

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

结局指标

主要结局

Number of dental care visits

时间窗: 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.

Months uninsured in the past year

时间窗: 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.

Number of ED visits for ambulatory care sensitive conditions

时间窗: 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.

Hospitalizations for ambulatory care sensitive conditions

时间窗: 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.

Hemoglobin a1C

时间窗: 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.

Total cholesterol

时间窗: 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.

Family income

时间窗: 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.

Days mental health not good in past month

时间窗: 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.

Current Medicaid enrollment

时间窗: 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.

Number of ED visits

时间窗: 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.

Hospitalizations

时间窗: 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.

Substance use

时间窗: 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.

Hours worked per week

时间窗: 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.

Participation in education or job training (composite)

时间窗: 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.

Type of insurance coverage

时间窗: 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.

Blood pressure

时间窗: 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.

Banking

时间窗: 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.

BMI

时间窗: 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.

Currently employed

时间窗: 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.

Mortality

时间窗: 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.

Days physical health not good in past month

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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