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NCT03602456 · ClinicalTrials.gov registry record
Evaluation of the Health and Economic Consequences of Kentucky's Section 1115 Demonstration Waiver
A clinical trial, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- 378,828
- Enrollment target
NCT03602456: Clinical Trial study, sponsored by University of Pennsylvania.
NCT03602456 is a clinical trial that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 378,828 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03602456 was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- 378,828 participants
- Enrollment target
Study 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 ne
Primary Outcome
Administrative data for randomized individuals. It will be measured by comparing changes in outcome between the treatment and control.
Interventions
- OTHER Kentucky HEALTH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 378,828 participants |
| Start Date | 2018-04-01 |
| Est. Completion | 2019-12-16 |
Why NCT03602456 stopped before completion
NCT03602456 is an observational study that tracks outcomes without assigning an intervention. Its 378,828 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Kentucky HEALTH is the first listed.
NCT03602456 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03602456 about?
NCT03602456 is a clinical study titled "Evaluation of the Health and Economic Consequences of Kentucky's Section 1115 Demonstration Waiver". 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, ...
What is the current status of trial NCT03602456?
This trial is currently terminated. The enrollment target is 378,828 participants. The study started on 2018-04-01. Estimated completion is 2019-12-16.
What interventions are being tested in trial NCT03602456?
The interventions under investigation include: Kentucky HEALTH (OTHER).
Who is sponsoring clinical trial NCT03602456?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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