Health InsuranceNCT04207905
Evaluation of the Healthy Michigan Plan Section 1115 Community Engagement Requirement Waiver
An observational study of Health Insurance, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 62 years
- Conditions the study is for
- Health Insurance
- What is being tested?
- Healthy Michigan Plan (HMP) coverage with work requirements
- How many people
- 892 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 4 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 62 years
- All sexes
- No healthy volunteers
- Adult
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.
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Goals of the Demonstration
As stated by the Michigan Department of Health and Human Services (MDHHS), the overarching goals of the Healthy Michigan Plan (HMP) demonstration are to increase access to quality health care, encourage the utilization of high-value services, promote beneficiary adoption of healthy behaviors, and implement evidence-based practice initiatives.
The main objectives of MDHHS for HMP include:
- Improving access to healthcare for uninsured or underinsured low-income Michigan residents;
- Improving the quality of healthcare services delivered;
- Reducing uncompensated care;
- Strengthening beneficiary engagement and personal responsibility;
- Encouraging individuals to seek preventive care, adopt healthy behaviors, and make responsible decisions about their healthcare;
- Supporting coordinated strategies to address social determinants of health in order to promote positive health outcomes, greater independence, and improved quality of life;
- Helping uninsured or underinsured individuals manage their health care issues;
- Encouraging quality, continuity, and appropriate medical care.
The evaluation for this demonstration is focused on examining:
- The impact of the community engagement requirement on enrollees' employment, earnings and financial well-being; enrollment in other public support programs; health outcomes; and health insurance status (HMP, commercial health insurance, or uninsurance);
- The extent to which new eligibility and coverage policies impact:
- Hospital uncompensated care
- Insurance coverage in the state
- Overall HMP enrollment and characteristics of HMP enrollees
- Enrollees' health care utilization
- Medicaid health service expenditures
- The impact HMP has had on enrollees' health outcomes, employment status, and financial well-being;
- The experiences of HMP enrollees who are disenrolled regarding insurance coverage status, access to care, and re-enrollment; and
- Medicaid program sustainability, including Medicaid expenditures.
The RCT design involves the random selection 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.
The random selection of the control group (22,917 HMP enrollees, representing 10% of the individuals identified as subject to the work requirements as of November 2019) was performed in December 2019. This sample size for the control group will enable longitudinal analysis of key outcomes (e.g., employment, insurance coverage, self-reported health status, health services utilization, income, and credit outcomes) over the demonstration period, with sufficient statistical power to assess differences in these outcomes.
Data sources will include beneficiary surveys; state administrative data, including Medicaid enrollment files, Medicaid administrative claims, specialty behavioral health administrative claims, Michigan Care Improvement Registry immunization history, health risk assessment tables, cost-share tables, and other Medicaid tables; state workforce data, including state unemployment insurance program data; and public use data, including American Community Survey, Current Population Survey, Medicaid enrollment data from Medicaid Budget and Expenditure System (MBES), Medicaid and Medicare cost reports, Credit data, Behavioral Risk Factor Surveillance System, Healthcare Cost \& Utilization Project (HCUP) inpatient discharge data, and program administrative cost data.
- Conditions
- Health Insurance
- Being tested
- Healthy Michigan Plan (HMP) coverage with work requirements
- Keywords
- Medicaid Expansion, Work Requirement, Community Engagement Requirement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Michigan Plan (HMP) coverage with work requirementsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Healthy Michigan Plan (HMP) coverage with work requirements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insurance coverage
Insurance coverage (self-reported uninsurance, employer-sponsored insurance, other types of insurance)
Measured: 3 years
Enrollment in Medicaid
Enrollment in Medicaid (Medicaid eligibility data)
Measured: 4 years
Employment
Employment status (self-reported)
Measured: 3 years
Employment record
Employment status (state unemployment insurance data)
Measured: 4 years
Educational enrollment
Educational enrollment (self-reported)
Measured: 3 years
Job training participation
Job training participation (self-reported)
Measured: 3 years
Number of hours worked
Number of hours worked (self-reported)
Measured: 3 years
Number of hours worked, recorded
Number of hours worked (state unemployment insurance data)
Measured: 4 years
Earnings
Income (state unemployment insurance data)
Measured: 4 years
Income
Income (Medicaid eligibility data)
Measured: 4 years
Health status, overall
Health status, overall (self-reported)
Measured: 3 years
Days poor physical health
Days poor physical health (self-reported)
Measured: 3 years
Days poor mental health
Days poor mental health (self-reported)
Measured: 3 years
Days limited in usual activities due to health
Days limited in usual activities due to health (self-reported)
Measured: 3 years
Secondary outcomes (7)
Emergency room (ER) visits
Emergency room (ER) visits in past 12 months (Medicaid claims and encounter data)
Measured: 4 years
Hospital admissions in past 12 months
Hospital admissions in past 12 months (Medicaid claims and encounter data)
Measured: 4 years
Financial well-being
Financial well-being (self-reported)
Measured: 3 years
Material hardship
Material hardship (self-reported)
Measured: 3 years
Credit report outcomes
Credit scores, debt past due, medical bills in collections, public records including evictions, bankruptcies, wage garnishments
Measured: 4 years
Enrollment in TANF
Enrollment in Temporary Assistance for Needy Families (TANF enrollment data)
Measured: 4 years
Enrollment in SNAP
Enrollment in Supplemental Nutrition Assistance Program (SNAP enrollment data)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 Jan 2020
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health InsuranceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 892 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Responsible party
- Principal investigator, John Ayanian, University of Michigan
- Investigators
- John Z Ayanian, MD, MPP, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207905
- Sponsor's protocol ID
- HUM00168117
- Status last verified
- Mar 2024
- First submitted
- 19 Dec 2019
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Healthy Michigan Plan Section 1115 Community Engagement Requirement Waiver
- ClinicalTrials.gov ID
- NCT04207905
- Acronym / sponsor ID
- HUM00168117
- Conditions
- Health Insurance
- Keywords
- Medicaid Expansion, Work Requirement, Community Engagement Requirement
- Study type
- Observational
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 892 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Goals of the Demonstration
As stated by the Michigan Department of Health and Human Services (MDHHS), the overarching goals of the Healthy Michigan Plan (HMP) demonstration are to increase access to quality health care, encourage the utilization of high-value services, promote beneficiary adoption of healthy behaviors, and implement evidence-based practice initiatives.
The main objectives of MDHHS for HMP include:
- Improving access to healthcare for uninsured or underinsured low-income Michigan residents;
- Improving the quality of healthcare services delivered;
- Reducing uncompensated care;
- Strengthening beneficiary engagement and personal responsibility;
- Encouraging individuals to seek preventive care, adopt healthy behaviors, and make responsible decisions about their healthcare;
- Supporting coordinated strategies to address social determinants of health in order to promote positive health outcomes, greater independence, and improved quality of life;
- Helping uninsured or underinsured individuals manage their health care issues;
- Encouraging quality, continuity, and appropriate medical care.
The evaluation for this demonstration is focused on examining:
- The impact of the community engagement requirement on enrollees' employment, earnings and financial well-being; enrollment in other public support programs; health outcomes; and health insurance status (HMP, commercial health insurance, or uninsurance);
- The extent to which new eligibility and coverage policies impact:
- Hospital uncompensated care
- Insurance coverage in the state
- Overall HMP enrollment and characteristics of HMP enrollees
- Enrollees' health care utilization
- Medicaid health service expenditures
- The impact HMP has had on enrollees' health outcomes, employment status, and financial well-being;
- The experiences of HMP enrollees who are disenrolled regarding insurance coverage status, access to care, and re-enrollment; and
- Medicaid program sustainability, including Medicaid expenditures.
The RCT design involves the random selection 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.
The random selection of the control group (22,917 HMP enrollees, representing 10% of the individuals identified as subject to the work requirements as of November 2019) was performed in December 2019. This sample size for the control group will enable longitudinal analysis of key outcomes (e.g., employment, insurance coverage, self-reported health status, health services utilization, income, and credit outcomes) over the demonstration period, with sufficient statistical power to assess differences in these outcomes.
Data sources will include beneficiary surveys; state administrative data, including Medicaid enrollment files, Medicaid administrative claims, specialty behavioral health administrative claims, Michigan Care Improvement Registry immunization history, health risk assessment tables, cost-share tables, and other Medicaid tables; state workforce data, including state unemployment insurance program data; and public use data, including American Community Survey, Current Population Survey, Medicaid enrollment data from Medicaid Budget and Expenditure System (MBES), Medicaid and Medicare cost reports, Credit data, Behavioral Risk Factor Surveillance System, Healthcare Cost \& Utilization Project (HCUP) inpatient discharge data, and program administrative cost data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Healthy Michigan Plan (HMP) coverage with work requirementsIndividuals who are subject to the Healthy Michigan Plan (HMP) work requirements |
Who may qualify
- Ages
- 19 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Michigan Plan (HMP) coverage with work requirementsFor 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. | Other | Work Requirement |
Primary outcome
Insurance coverage
Time frame: 3 years
Insurance coverage (self-reported uninsurance, employer-sponsored insurance, other types of insurance)
Enrollment in Medicaid
Time frame: 4 years
Enrollment in Medicaid (Medicaid eligibility data)
Employment
Time frame: 3 years
Employment status (self-reported)
Employment record
Time frame: 4 years
Employment status (state unemployment insurance data)
Educational enrollment
Time frame: 3 years
Educational enrollment (self-reported)
Job training participation
Time frame: 3 years
Job training participation (self-reported)
Number of hours worked
Time frame: 3 years
Number of hours worked (self-reported)
Number of hours worked, recorded
Time frame: 4 years
Number of hours worked (state unemployment insurance data)
Earnings
Time frame: 4 years
Income (state unemployment insurance data)
Income
Time frame: 4 years
Income (Medicaid eligibility data)
Health status, overall
Time frame: 3 years
Health status, overall (self-reported)
Days poor physical health
Time frame: 3 years
Days poor physical health (self-reported)
Days poor mental health
Time frame: 3 years
Days poor mental health (self-reported)
Days limited in usual activities due to health
Time frame: 3 years
Days limited in usual activities due to health (self-reported)
7 secondary outcomes
Emergency room (ER) visits
Time frame: 4 years
Hospital admissions in past 12 months
Time frame: 4 years
Financial well-being
Time frame: 3 years
Material hardship
Time frame: 3 years
Credit report outcomes
Time frame: 4 years
Enrollment in TANF
Time frame: 4 years
Enrollment in SNAP
Time frame: 4 years
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Healthy Michigan Plan evaluation webpage of the University of Michigan Institute for Healthcare Policy \& InnovationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Z Ayanian, MD, MPP principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Insurance, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insurance coverage (time frame: 3 years). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.