Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-02 @ 5:20 AM
Study NCT ID:
NCT04550169
Status:
COMPLETED
Last Update Posted:
2025-01-10
First Post:
2020-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wisconsin Evaluation of Emergency Department Care Coordination
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': 3405}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2020-09-09', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Emergency Department Visits', 'timeFrame': '6 months'}, {'measure': 'Total Number of Emergency Department Visits', 'timeFrame': '12 months'}, {'measure': 'Total Number of Emergency Department Visits', 'timeFrame': '18 months'}, {'measure': 'Total Number of Emergency Department Visits', 'timeFrame': '24 months'}, {'measure': 'Total Number of Emergency Department Visits for Primary Care Preventable and/or Non-Emergent Conditions', 'timeFrame': '6 months'}, {'measure': 'Total Number of Emergency Department Visits for Primary Care Preventable and/or Non-Emergent Conditions', 'timeFrame': '12 months'}, {'measure': 'Total Number of Emergency Department Visits for Primary Care Preventable and/or Non-Emergent Conditions', 'timeFrame': '18 months'}, {'measure': 'Total Number of Emergency Department Visits for Primary Care Preventable and/or Non-Emergent Conditions', 'timeFrame': '24 months'}, {'measure': 'Cost to Medicaid for all Emergency Department Visits', 'timeFrame': '6 months'}, {'measure': 'Cost to Medicaid for all Emergency Department Visits', 'timeFrame': '12 months'}, {'measure': 'Cost to Medicaid for all Emergency Department Visits', 'timeFrame': '18 months'}, {'measure': 'Cost to Medicaid for all Emergency Department Visits', 'timeFrame': '24 months'}, {'measure': 'Cost to Medicaid for Emergency Department Use for Primary Care Preventable and/or Non-Emergent Conditions', 'timeFrame': '6 months'}, {'measure': 'Cost to Medicaid for Emergency Department Use for Primary Care Preventable and/or Non-Emergent Conditions', 'timeFrame': '12 months'}, {'measure': 'Cost to Medicaid for Emergency Department Use for Primary Care Preventable and/or Non-Emergent Conditions', 'timeFrame': '18 months'}, {'measure': 'Cost to Medicaid for Emergency Department Use for Primary Care Preventable and/or Non-Emergent Conditions', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Total Number of Primary Care Visits', 'timeFrame': '6, 12, 18, and 24 months'}, {'measure': 'Number of Participants Who Used Any Primary Care Visits', 'timeFrame': '6, 12, 18, and 24 months'}, {'measure': 'Number of Participants Who Used Specialty Care Visits', 'timeFrame': '6, 12, 18, and 24 months'}, {'measure': 'Total Number of Specialty Care Visits', 'timeFrame': '6, 12, 18, and 24 months'}, {'measure': 'Number of Participants with Any Hospitalizations', 'timeFrame': '6, 12, 18, and 24 months'}, {'measure': 'Number of Hospitalization Events', 'timeFrame': '6, 12, 18, and 24 months'}, {'measure': 'Number of visits to use behavioral health resources, if applicable for the participant', 'timeFrame': '6, 12, 18, and 24 months'}, {'measure': 'Number of visits to use alcohol and other drug abuse resources if applicable for the participant', 'timeFrame': '6, 12, 18, and 24 months'}, {'measure': 'Total Cost Related to the Use of Behavioral Health Resources if applicable for the participant', 'timeFrame': '6, 12, 18, and 24 months'}, {'measure': 'Total Cost Related to Use of Alcohol and other Drug Abuse Resources if applicable for the participant', 'timeFrame': '6, 12, 18, and 24 months'}, {'measure': 'Total costs of care to Medicaid', 'timeFrame': '6, 12, 18, and 24 months'}, {'measure': 'Number of participants enrolled in Temporary Assistance for Needy Families (TANF)', 'timeFrame': '6, 12, 18, and 24 months'}, {'measure': 'Number of participants enrolled in FoodShare', 'timeFrame': '6, 12, 18, and 24 months', 'description': 'FoodShare is a program that helps people with limited resources buy the food they need for good health.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medicaid', 'CARES (Wisconsin Client Assistance for Re-Employment and Economic Support)'], 'conditions': ['Emergency Department Visit']}, 'descriptionModule': {'briefSummary': 'The State of Wisconsin is now expanding its investment in care coordination models as an effort to reduce inappropriate hospital emergency department (ED) use, improve health outcomes, and reduce Medicaid expenditures. This effort begins with a pilot program to support emergency department care coordination in hospitals and health systems that apply and are selected to participate in the pilot program.\n\nThe Wisconsin Medicaid program seeks to understand whether this program achieves its intended goals and, specifically, whether the Medicaid payment for such care coordination services produces the intended program outcomes. Hospitals will select members that will receive care coordination services. In a quasi-experimental approach, the study team will compare members that do vs. do not receive the services will be used examine the effects of care coordination and referrals on total ED visits, primary-care treatable ED visits, non-emergent ED visits, and health care costs, as well as the specific effects of referring patients to providers who offer low-cost and after-hours care. To assess the importance of targeting, study team will conduct stratified analyses of vulnerable groups such as people with disabilities and individuals with specific clinical needs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion Criteria:\n\n* Adults who are Medicaid enrolled\n* Have had 5+ emergency department visits in the past year\n\nExclusion Criteria:\n\n* Participants who are concurrently eligible for Medicare\n* Children (individuals age \\<18 years).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults who are Medicaid enrolled\n* Have had 5+ emergency department visits in the past year\n\nExclusion Criteria:\n\n* Participants who are concurrently eligible for Medicare\n* Children (individuals age \\<18 years).'}, 'identificationModule': {'nctId': 'NCT04550169', 'briefTitle': 'Wisconsin Evaluation of Emergency Department Care Coordination', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Evaluation of an Intensive Care Coordination Program to Reduce Use of Hospital Emergency Department Services by Wisconsin Medicaid Members', 'orgStudyIdInfo': {'id': '2020-1211'}, 'secondaryIdInfos': [{'id': 'MSN240705', 'type': 'OTHER_GRANT', 'domain': 'DHHS, CENTERS FOR MEDICARE & MEDICAID SE'}, {'id': 'A538500', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/POP HEALTH SCI/POP HEALTH', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version April 2020', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intensive Care Coordination', 'description': 'Intensive Care Coordination along with Standard of Care', 'interventionNames': ['Other: Intensive Care Coordination']}, {'label': 'Control', 'description': 'Standard of Care alone'}], 'interventions': [{'name': 'Intensive Care Coordination', 'type': 'OTHER', 'description': 'Intensive care coordination will include:\n\n* Discharge instructions and contacts for following up on care and treatment\n* Referral information\n* Appointment scheduling\n* Medication instructions\n* Intensive care coordination by a social worker, case manager, nurse, or care coordinator to connect Medical Assistance (MA) recipient to a primary care provider or to a managed care organization\n* Information about other health and social resources, such as transportation and housing\n* Sharing of information (discharge instructions, medication information, and care plan information) with managed care organization in which patients are enrolled, if applicable', 'armGroupLabels': ['Intensive Care Coordination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54911', 'city': 'Appleton', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'ThedaCare', 'geoPoint': {'lat': 44.26193, 'lon': -88.41538}}, {'zip': '53217', 'city': 'Glendale', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Ascension Wisconsin', 'geoPoint': {'lat': 43.13529, 'lon': -87.93564}}, {'zip': '53202', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aurora Health Care', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53226', 'city': 'Wauwatosa', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert Health , Wisconsin', 'geoPoint': {'lat': 43.04946, 'lon': -88.00759}}], 'overallOfficials': [{'name': 'Rebecca Myerson, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}