NCT04207905

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
892

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

December 19, 2019

Last Update Submit

March 6, 2024

Conditions

Keywords

Medicaid ExpansionWork RequirementCommunity Engagement Requirement

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

Other: Healthy Michigan Plan (HMP) coverage with 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.

Work Requirement

Eligibility Criteria

Age19 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

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

Location

Related Links

Study Officials

  • John Z Ayanian, MD, MPP

    University of Michigan

    PRINCIPAL INVESTIGATOR

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

Locations