Study Stopped
The Healthy Michigan Plan community engagement requirement was implemented on 1/1/2020. On 3/4/2020, a US District Court judge vacated the CMS approval of this policy, thereby suspending implementation of this RCT. This was not an IRB suspension.
Evaluation of the Healthy Michigan Plan Section 1115 Community Engagement Requirement Waiver
1 other identifier
observational
892
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2020
CompletedMarch 8, 2024
March 1, 2024
2 months
December 19, 2019
March 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Insurance coverage
Insurance coverage (self-reported uninsurance, employer-sponsored insurance, other types of insurance)
3 years
Enrollment in Medicaid
Enrollment in Medicaid (Medicaid eligibility data)
4 years
Employment
Employment status (self-reported)
3 years
Employment record
Employment status (state unemployment insurance data)
4 years
Educational enrollment
Educational enrollment (self-reported)
3 years
Job training participation
Job training participation (self-reported)
3 years
Number of hours worked
Number of hours worked (self-reported)
3 years
Number of hours worked, recorded
Number of hours worked (state unemployment insurance data)
4 years
Earnings
Income (state unemployment insurance data)
4 years
Income
Income (Medicaid eligibility data)
4 years
Health status, overall
Health status, overall (self-reported)
3 years
Days poor physical health
Days poor physical health (self-reported)
3 years
Days poor mental health
Days poor mental health (self-reported)
3 years
Days limited in usual activities due to health
Days limited in usual activities due to health (self-reported)
3 years
Secondary Outcomes (7)
Emergency room (ER) visits
4 years
Hospital admissions in past 12 months
4 years
Financial well-being
3 years
Material hardship
3 years
Credit report outcomes
4 years
- +2 more secondary outcomes
Study Arms (2)
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
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Adult HMP beneficiaries ages 19-62 who are not otherwise exempt.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
John Z Ayanian, MD, MPP
University of Michigan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Institute for Healthcare Policy and Innovation
Study Record Dates
First Submitted
December 19, 2019
First Posted
December 23, 2019
Study Start
January 1, 2020
Primary Completion
March 4, 2020
Study Completion
March 4, 2020
Last Updated
March 8, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share