Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-20 @ 7:16 AM
Study NCT ID:
NCT03066492
Status:
COMPLETED
Last Update Posted:
2019-06-25
First Post:
2017-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Hospital Discharge Clinic to Improve Care Coordination and Reduce Rehospitalization in Low Income Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 654}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-21', 'studyFirstSubmitDate': '2017-02-22', 'studyFirstSubmitQcDate': '2017-02-22', 'lastUpdatePostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90-Day Re-hospitalization or Death', 'timeFrame': '90 days', 'description': '90-day re-hospitalization (Emergency Department and/or inpatient admission) or death'}], 'secondaryOutcomes': [{'measure': 'Usual Source of Primary Care', 'timeFrame': '6 months', 'description': 'Patient report of being seen in a usual source of primary medical care 6 months after discharge'}, {'measure': '30-Day Re-hospitalization or Death', 'timeFrame': '30 days', 'description': '90-day re-hospitalization (Emergency Department and/or inpatient admission) or death'}, {'measure': '180-Day Re-hospitalization or Death', 'timeFrame': '180 days', 'description': '180-day re-hospitalization (Emergency Department and/or inpatient admission) or death'}, {'measure': '365-Day Re-hospitalization or Death', 'timeFrame': '365 days', 'description': '365-day re-hospitalization (Emergency Department and/or inpatient admission) or death'}, {'measure': 'Health Advocate Effect', 'timeFrame': '12 months', 'description': 'This evaluation will determine if being offered support of a novel care team member known as a "health advocate" (a form of care navigator who will assist patients to overcome social determinants of readmission) is more likely to prevent hospital readmission than receiving the standard Northwestern Transitional Follow Up Care team intervention alone.'}, {'measure': 'Intervention Cost', 'timeFrame': '12 months', 'description': 'This is an evaluation of the incremental costs to implement and sustain standard Northwestern Transitional Follow Up team care, as well as the enhanced standard + health advocate personnel model'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tertiary Care Center', 'Patient Readmission', 'Health Services Research', 'Hospital Readmissions'], 'conditions': ['Patient Readmission']}, 'referencesModule': {'references': [{'pmid': '31144279', 'type': 'RESULT', 'citation': 'Liss DT, Ackermann RT, Cooper A, Finch EA, Hurt C, Lancki N, Rogers A, Sheth A, Teter C, Schaeffer C. Effects of a Transitional Care Practice for a Vulnerable Population: a Pragmatic, Randomized Comparative Effectiveness Trial. J Gen Intern Med. 2019 Sep;34(9):1758-1765. doi: 10.1007/s11606-019-05078-4. Epub 2019 May 29.'}, {'pmid': '35266127', 'type': 'DERIVED', 'citation': 'Ackermann RT, Liss DT, French DD, Cooper AJ, Aikman C, Schaeffer C. Randomized Trial Evaluating Health System Expenditures with Transitional Care Services for Adults with No Usual Source of Care at Discharge. J Gen Intern Med. 2022 Nov;37(15):3832-3838. doi: 10.1007/s11606-022-07473-w. Epub 2022 Mar 9.'}]}, 'descriptionModule': {'briefSummary': "This randomized controlled trial examines the effects of a transitional care clinic for high-risk patients at an academic medical center who had no trusted medical home. The trial will provide the first reliable evaluation of the Northwestern Transitional Care Clinic / Follow Up Clinic's (NFC) impact on re-admissions, care coordination, and costs. This research will allow us to assess the value of the NFC and similar models of care for providing a more coordinated care approach that results in better treatment outcomes for urban poor populations.\n\nIt is hypothesized that NFC patients will have fewer 90-day re-hospitalizations and are more likely to have a usual source of primary care 6 months after discharge.", 'detailedDescription': "The Northwestern Transitional Care Follow-up Clinic (NFC) was established in 2012 to improve the coordination of care for these patients following inpatient or Emergency Department discharge from Northwestern Memorial Hospital. Since 2012, the NFC has constructed an integrated team care approach, logging about 2000 post-discharge encounters with Medicaid or patients without insurance. The NFC model has evolved over the past 2 years in response to a need to address mental as well as physical health needs and to interface with community resources to address social determinants of health that might otherwise lead to frequent re-admission. By working with clinical partners and public payers like Medicaid and County Care, the NFC has also worked to transition patients to accessible primary care medical homes that will provide behavioral, physical, and preventive care. The current study will provide the first reliable evaluation of the clinic's impact on re-admissions, care coordination, and costs. This research will allow us to assess the value of the NFC and similar models of care for providing a more coordinated care approach that results in better treatment outcomes for urban poor populations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients eligible for Northwestern Transitional Follow Up care post-discharge from Northwestern Memorial Hospital\n* Adults (18 years of age or older)\n* Patients referred by an Northwestern Memorial Hospital care provider for discharge coordination by the Northwestern Transitional Follow Up Clinic\n\nExclusion Criteria:\n\n* Individuals who are not yet adults (infants, children, teenagers)\n* Pregnant Women\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT03066492', 'briefTitle': 'Evaluation of a Hospital Discharge Clinic to Improve Care Coordination and Reduce Rehospitalization in Low Income Adults', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Evaluation of a Novel Hospital Discharge Clinic to Improve Care Coordination and Reduce Rehospitalization Among Low Income Adults', 'orgStudyIdInfo': {'id': 'STU00200259'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Federally Qualified Health Center', 'description': 'Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at a nearby Federally Qualified Health Center.', 'interventionNames': ['Other: Federally Qualified Health Center']}, {'type': 'EXPERIMENTAL', 'label': 'Northwestern Follow Up Care Coordination', 'description': 'Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at the Northwestern Transitional Care Follow Up Clinic.', 'interventionNames': ['Other: Northwestern Follow Up Care Coordination']}], 'interventions': [{'name': 'Northwestern Follow Up Care Coordination', 'type': 'OTHER', 'description': 'Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at the Northwestern Transitional Care Follow Up Clinic.', 'armGroupLabels': ['Northwestern Follow Up Care Coordination']}, {'name': 'Federally Qualified Health Center', 'type': 'OTHER', 'description': 'Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at a nearby Federally Qualified Health Center.', 'armGroupLabels': ['Federally Qualified Health Center']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Ronald T Ackermann, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern Memorial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Associate Dean for Public Health, Director, Institute for Public Health and Medicine, Professor of Medicine', 'investigatorFullName': 'Ronald Ackermann', 'investigatorAffiliation': 'Northwestern University'}}}}