Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT04207905
Status:
TERMINATED
Last Update Posted:
2024-03-08
First Post:
2019-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Healthy Michigan Plan Section 1115 Community Engagement Requirement Waiver
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 892}, 'patientRegistry': False}, 'statusModule': {'whyStopped': '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.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2019-12-19', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insurance coverage', 'timeFrame': '3 years', 'description': 'Insurance coverage (self-reported uninsurance, employer-sponsored insurance, other types of insurance)'}, {'measure': 'Enrollment in Medicaid', 'timeFrame': '4 years', 'description': 'Enrollment in Medicaid (Medicaid eligibility data)'}, {'measure': 'Employment', 'timeFrame': '3 years', 'description': 'Employment status (self-reported)'}, {'measure': 'Employment record', 'timeFrame': '4 years', 'description': 'Employment status (state unemployment insurance data)'}, {'measure': 'Educational enrollment', 'timeFrame': '3 years', 'description': 'Educational enrollment (self-reported)'}, {'measure': 'Job training participation', 'timeFrame': '3 years', 'description': 'Job training participation (self-reported)'}, {'measure': 'Number of hours worked', 'timeFrame': '3 years', 'description': 'Number of hours worked (self-reported)'}, {'measure': 'Number of hours worked, recorded', 'timeFrame': '4 years', 'description': 'Number of hours worked (state unemployment insurance data)'}, {'measure': 'Earnings', 'timeFrame': '4 years', 'description': 'Income (state unemployment insurance data)'}, {'measure': 'Income', 'timeFrame': '4 years', 'description': 'Income (Medicaid eligibility data)'}, {'measure': 'Health status, overall', 'timeFrame': '3 years', 'description': 'Health status, overall (self-reported)'}, {'measure': 'Days poor physical health', 'timeFrame': '3 years', 'description': 'Days poor physical health (self-reported)'}, {'measure': 'Days poor mental health', 'timeFrame': '3 years', 'description': 'Days poor mental health (self-reported)'}, {'measure': 'Days limited in usual activities due to health', 'timeFrame': '3 years', 'description': 'Days limited in usual activities due to health (self-reported)'}], 'secondaryOutcomes': [{'measure': 'Emergency room (ER) visits', 'timeFrame': '4 years', 'description': 'Emergency room (ER) visits in past 12 months (Medicaid claims and encounter data)'}, {'measure': 'Hospital admissions in past 12 months', 'timeFrame': '4 years', 'description': 'Hospital admissions in past 12 months (Medicaid claims and encounter data)'}, {'measure': 'Financial well-being', 'timeFrame': '3 years', 'description': 'Financial well-being (self-reported)'}, {'measure': 'Material hardship', 'timeFrame': '3 years', 'description': 'Material hardship (self-reported)'}, {'measure': 'Credit report outcomes', 'timeFrame': '4 years', 'description': 'Credit scores, debt past due, medical bills in collections, public records including evictions, bankruptcies, wage garnishments'}, {'measure': 'Enrollment in TANF', 'timeFrame': '4 years', 'description': 'Enrollment in Temporary Assistance for Needy Families (TANF enrollment data)'}, {'measure': 'Enrollment in SNAP', 'timeFrame': '4 years', 'description': 'Enrollment in Supplemental Nutrition Assistance Program (SNAP enrollment data)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medicaid Expansion', 'Work Requirement', 'Community Engagement Requirement'], 'conditions': ['Health Insurance']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://ihpi.umich.edu/signature-programs/healthy-michigan-plan-evaluation', 'label': 'Healthy Michigan Plan evaluation webpage of the University of Michigan Institute for Healthcare Policy \\& Innovation'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': "Goals of the Demonstration\n\nAs 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.\n\nThe main objectives of MDHHS for HMP include:\n\n* Improving access to healthcare for uninsured or underinsured low-income Michigan residents;\n* Improving the quality of healthcare services delivered;\n* Reducing uncompensated care;\n* Strengthening beneficiary engagement and personal responsibility;\n* Encouraging individuals to seek preventive care, adopt healthy behaviors, and make responsible decisions about their healthcare;\n* Supporting coordinated strategies to address social determinants of health in order to promote positive health outcomes, greater independence, and improved quality of life;\n* Helping uninsured or underinsured individuals manage their health care issues;\n* Encouraging quality, continuity, and appropriate medical care.\n\nThe evaluation for this demonstration is focused on examining:\n\n* 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);\n* The extent to which new eligibility and coverage policies impact:\n\n * Hospital uncompensated care\n * Insurance coverage in the state\n * Overall HMP enrollment and characteristics of HMP enrollees\n * Enrollees' health care utilization\n * Medicaid health service expenditures\n* The impact HMP has had on enrollees' health outcomes, employment status, and financial well-being;\n* The experiences of HMP enrollees who are disenrolled regarding insurance coverage status, access to care, and re-enrollment; and\n* Medicaid program sustainability, including Medicaid expenditures.\n\nThe 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.\n\nThe 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.\n\nData 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '62 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Enrollees eligible for the HMP community engagement requirement, including:\n\n* Adult HMP beneficiaries ages 19-62 who are not otherwise exempt.\n\nExclusion Criteria: Enrollees exempt from the community engagement requirement includiung:\n\n* Pregnant women\n* Primary caregivers of a family member under six years of age (limited to one caregiver per household)\n* 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)\n* Caretakers of an incapacitated individual even if the incapacitated individual is not a dependent of the caretaker\n* Beneficiaries considered medically frail\n* Beneficiaries currently receiving temporary or permanent long-term disability benefits from a private insurer or from the government\n* Beneficiaries diagnosed with an acute medical condition that would prevent them from complying with the requirements\n* Beneficiaries who have been incarcerated within the last six months\n* Beneficiaries currently receiving unemployment benefits from the state\n* Beneficiaries under 21 years of age who had previously been in foster care placement in Michigan\n* Full-time students.'}, 'identificationModule': {'nctId': 'NCT04207905', 'briefTitle': 'Evaluation of the Healthy Michigan Plan Section 1115 Community Engagement Requirement Waiver', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Evaluation of the Healthy Michigan Plan Section 1115 Community Engagement Requirement Waiver', 'orgStudyIdInfo': {'id': 'HUM00168117'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exempt for Evaluation Purposes', 'description': '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'}, {'label': 'Work Requirement', 'description': 'Individuals who are subject to the Healthy Michigan Plan (HMP) work requirements', 'interventionNames': ['Other: Healthy Michigan Plan (HMP) coverage with work requirements']}], 'interventions': [{'name': 'Healthy Michigan Plan (HMP) coverage with work requirements', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Work Requirement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'John Z Ayanian, MD, MPP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Michigan Department of Health and Human Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Institute for Healthcare Policy and Innovation', 'investigatorFullName': 'John Ayanian', 'investigatorAffiliation': 'University of Michigan'}}}}