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Evaluation of the Healthy Michigan Plan Section 1115 Community Engagement Requirement Waiver

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04207905
Recruitment Status : Suspended (On 3/4/20 a federal judge ruled the HMP work requirement unlawful, thereby ending it and suspending implementation of this RCT. This is not an IRB suspension.)
First Posted : December 23, 2019
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
Michigan Department of Health and Human Services
Information provided by (Responsible Party):
John Ayanian, University of Michigan

Brief Summary:

The Centers for Medicare & Medicaid Services (CMS) approved the renewal of the Healthy Michigan Plan (HMP) Section 1115 Demonstration Waiver on December 21, 2018, for the period January 1, 2019-December 31, 2023. This waiver provides approval for the state to require Medicaid expansion beneficiaries ages 19-62 to complete and report 80 hours per month of community engagement as a condition of eligibility, among other waiver provisions, beginning January 1, 2020. Community engagement activities include employment, education, job training, job search activities, participation in substance use disorder (SUD) treatment, or community service.

The State of Michigan will implement a randomized controlled trial (RCT) to evaluate the impact of community engagement requirements on Medicaid enrollment, health insurance coverage, self-reported health status, access to and utilization of health services, earnings, and employment, compared to a control group of HMP enrollees exempted from the community engagement requirement for purposes of the evaluation.


Condition or disease Intervention/treatment
Health Insurance Other: Healthy Michigan Plan (HMP) coverage with work requirements

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Study Type : Observational
Estimated Enrollment : 229000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Healthy Michigan Plan Section 1115 Community Engagement Requirement Waiver
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Group/Cohort Intervention/treatment
Exempt for Evaluation Purposes
Individuals who would have been subject to the Healthy Michigan Plan (HMP) work requirements but have been randomly assigned to a control group that is exempt from reporting for evaluation purposes
Work Requirement
Individuals who are subject to the Healthy Michigan Plan (HMP) work requirements
Other: Healthy Michigan Plan (HMP) coverage with work requirements
For those who are not in the Exempt for Research Purposes group, to be eligible for HMP coverage beginning January 1, 2020, enrollees ages 19-62 must report 80 hours per calendar month of community engagement activities, such as employment, education, job training, job search activities, participation in substance use disorder (SUD) treatment, or community service.




Primary Outcome Measures :
  1. Insurance coverage [ Time Frame: 3 years ]
    Insurance coverage (self-reported uninsurance, employer-sponsored insurance, other types of insurance)

  2. Enrollment in Medicaid [ Time Frame: 4 years ]
    Enrollment in Medicaid (Medicaid eligibility data)

  3. Employment [ Time Frame: 3 years ]
    Employment status (self-reported)

  4. Employment record [ Time Frame: 4 years ]
    Employment status (state unemployment insurance data)

  5. Educational enrollment [ Time Frame: 3 years ]
    Educational enrollment (self-reported)

  6. Job training participation [ Time Frame: 3 years ]
    Job training participation (self-reported)

  7. Number of hours worked [ Time Frame: 3 years ]
    Number of hours worked (self-reported)

  8. Number of hours worked, recorded [ Time Frame: 4 years ]
    Number of hours worked (state unemployment insurance data)

  9. Earnings [ Time Frame: 4 years ]
    Income (state unemployment insurance data)

  10. Income [ Time Frame: 4 years ]
    Income (Medicaid eligibility data)

  11. Health status, overall [ Time Frame: 3 years ]
    Health status, overall (self-reported)

  12. Days poor physical health [ Time Frame: 3 years ]
    Days poor physical health (self-reported)

  13. Days poor mental health [ Time Frame: 3 years ]
    Days poor mental health (self-reported)

  14. Days limited in usual activities due to health [ Time Frame: 3 years ]
    Days limited in usual activities due to health (self-reported)


Secondary Outcome Measures :
  1. Emergency room (ER) visits [ Time Frame: 4 years ]
    Emergency room (ER) visits in past 12 months (Medicaid claims and encounter data)

  2. Hospital admissions in past 12 months [ Time Frame: 4 years ]
    Hospital admissions in past 12 months (Medicaid claims and encounter data)

  3. Financial well-being [ Time Frame: 3 years ]
    Financial well-being (self-reported)

  4. Material hardship [ Time Frame: 3 years ]
    Material hardship (self-reported)

  5. Credit report outcomes [ Time Frame: 4 years ]
    Credit scores, debt past due, medical bills in collections, public records including evictions, bankruptcies, wage garnishments

  6. Enrollment in TANF [ Time Frame: 4 years ]
    Enrollment in Temporary Assistance for Needy Families (TANF enrollment data)

  7. Enrollment in SNAP [ Time Frame: 4 years ]
    Enrollment in Supplemental Nutrition Assistance Program (SNAP enrollment data)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Healthy Michigan Plan enrollees subject to the community engagement requirement are eligible for the study. The RCT design involves the random selection by the State of Michigan or its designee of a control group of HMP enrollees from across the state who are expected to be subject to the community engagement requirement but who are designated as being not subject to this requirement during the evaluation period (January 1, 2020 through December 31, 2023). This control group will be compared to an intervention group of HMP enrollees who will be subject to the community engagement requirement. Individuals who enroll in HMP after randomization occurs will not be eligible for inclusion in the control group.
Criteria

Inclusion Criteria: Enrollees eligible for the HMP community engagement requirement, including:

  • Adult HMP beneficiaries ages 19-62 who are not otherwise exempt.

Exclusion Criteria: Enrollees exempt from the community engagement requirement includiung:

  • Pregnant women
  • Primary caregivers of a family member under six years of age (limited to one caregiver per household)
  • Caretakers of a dependent with a disability who needs full-time care (allowed for one beneficiary per household if there is only one dependent with a disability who meets the criteria specified above in the household)
  • Caretakers of an incapacitated individual even if the incapacitated individual is not a dependent of the caretaker
  • Beneficiaries considered medically frail
  • Beneficiaries currently receiving temporary or permanent long-term disability benefits from a private insurer or from the government
  • Beneficiaries diagnosed with an acute medical condition that would prevent them from complying with the requirements
  • Beneficiaries who have been incarcerated within the last six months
  • Beneficiaries currently receiving unemployment benefits from the state
  • Beneficiaries under 21 years of age who had previously been in foster care placement in Michigan
  • Full-time students.

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): NCT04207905


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Michigan Department of Health and Human Services
Investigators
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Principal Investigator: John Z Ayanian, MD, MPP University of Michigan
Additional Information:
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Responsible Party: John Ayanian, Director, Institute for Healthcare Policy and Innovation, University of Michigan
ClinicalTrials.gov Identifier: NCT04207905    
Other Study ID Numbers: HUM00168117
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Ayanian, University of Michigan:
Medicaid Expansion
Work Requirement
Community Engagement Requirement