Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-06 @ 6:32 PM
Study NCT ID:
NCT03293160
Status:
COMPLETED
Last Update Posted:
2020-05-20
First Post:
2017-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Evaluation of the Michigan State Innovation Model in Washtenaw and Livingston Counties
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2017-09-21', 'studyFirstSubmitQcDate': '2017-09-21', 'lastUpdatePostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emergency department utilization', 'timeFrame': '6 months', 'description': 'Number of emergency department visits per patient'}], 'secondaryOutcomes': [{'measure': 'Health care spending', 'timeFrame': '6 months', 'description': 'Dollars of health care spending incurred by patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Utilization of Emergency Departments']}, 'referencesModule': {'references': [{'pmid': '33694072', 'type': 'DERIVED', 'citation': 'Post B, Lapedis J, Singh K, Valenstein P, Buyuktur AG, Teske K, Ryan AM. Predictive Model-Driven Hotspotting to Decrease Emergency Department Visits: a Randomized Controlled Trial. J Gen Intern Med. 2021 Sep;36(9):2563-2570. doi: 10.1007/s11606-021-06664-1. Epub 2021 Mar 10.'}]}, 'descriptionModule': {'briefSummary': "This study will examine the effects of a care management program on the health and health spending outcomes of patients residing in Michigan's Washtenaw and Livingston Counties.", 'detailedDescription': 'In 2017, the State of Michigan will offer enrollment in care management services to a set of patients in Washtenaw and Livingston Counties who are predicted to be high-frequency users of emergency departments. This is a quality improvement initiative. The Center for Healthcare Research and Transformation (CHRT) will administer this enrollment and collect patient data. The Principal Investigators will conduct a study that uses the data from this quality improvement initiative to compare the outcomes of the treatment and control groups. Specifically, the study will examine whether the care management services had an effect on the number of emergency department visits and the total healthcare spending of the patients in the treatment group.\n\nThe present study therefore is the second of two related projects - the first is the CHRT-administered random assignment and enrollment of patients into care management services. The present study is a secondary analysis of the data produced by the first project.\n\nThis Protocol Registration and Results submission refers to the secondary analysis component wherever applicable, and where not applicable, describes the information relevant to the CHRT project. For example, while the present study does not assign anyone into treatment or control groups, the Sample Description indicates "Probability Sample" to describe the way in which CHRT intends to enroll patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who frequently use the emergency department of hospitals located in Washtenaw or Livingston Counties.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. reside in Washtenaw or Livingston counties or have an unknown address;\n2. Have a probability of being admitted to an emergency department (ED) in Washtenaw or Livingston counties that exceeds a threshold value in a predictive model;\n\nExclusion criteria\n\n1. Patients referred by a community provider\n2. Patient declines to consent'}, 'identificationModule': {'nctId': 'NCT03293160', 'briefTitle': 'An Evaluation of the Michigan State Innovation Model in Washtenaw and Livingston Counties', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'An Evaluation of the Michigan State Innovation Model in Washtenaw and Livingston Counties', 'orgStudyIdInfo': {'id': 'HUM00133309'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment group', 'description': 'The set of patients in the sample who are offered enrollment in care management services.', 'interventionNames': ['Other: Care management services']}, {'label': 'Control group', 'description': 'The set of patients in the sample who are not initially offered enrollment in care management services (will be offered enrollment after six months).'}], 'interventions': [{'name': 'Care management services', 'type': 'OTHER', 'description': "Patients who receive care management services will interact with a care manager who will take an inventory of the patient's needs (including social determinants of health such as housing) and provide guidance about available social supports and clinical resources.", 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Center for Healthcare Research & Transformation', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Marianne Udow-Phillips, MHSA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center for Healthcare Research & Transformation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center for Healthcare Research and Transformation', 'class': 'UNKNOWN'}, {'name': 'Community Foundation of Southeast Michigan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Graduate Student Research Assistant', 'investigatorFullName': 'Brady Post', 'investigatorAffiliation': 'University of Michigan'}}}}