Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-29 @ 1:17 PM
Study NCT ID:
NCT01797068
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2013-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Navigation for Medicaid Frequent ED Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062526', 'term': 'Patient Navigation'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D018802', 'term': 'Patient-Centered Care'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2020-03-26', 'studyFirstSubmitDate': '2013-02-20', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of ED visits', 'timeFrame': 'One Year', 'description': 'Additional outcomes include number of hospitalizations, number of outpatient visits, and outpatient imaging utilization.'}], 'secondaryOutcomes': [{'measure': 'Number of hospitalizations', 'timeFrame': 'One Year'}, {'measure': 'Number of outpatient visits', 'timeFrame': 'One Year'}, {'measure': 'Costs by analyzing global use with Medicaid claims data', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HEALTHCARE UTILIZATION', 'ED UTILIZATION', 'PRIMARY CARE UTILIZATION', 'PATIENT NAVIGATION', 'UNDERSERVED POPULATIONS', 'HEALTH DISPARITIES'], 'conditions': ['Chronic Illness']}, 'descriptionModule': {'briefSummary': 'A large proportion of frequent ED users have Medicaid insurance. The purpose of this study is to evaluate the effectiveness of patient navigation for reducing Emergency Department (ED) visits and hospitalizations and improving patient-centered outcomes (e.g., self-reported health status, quality of life, access/barriers to care) among Medicaid patients who are high utilizers of the ED, as well as to identify best practices for engaging and providing healthcare services to underserved patients using patient navigation. This study will address needs that have been identified within the New Haven community and the local healthcare system, contribute to knowledge and literature surrounding the use of patient navigation to improve care for underserved patients and improve health system efficiency, and inform the design and development of programs that address these needs both locally and in other communities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '62 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 4-18 ED visits per year\n* Frequent ED users\n* age 18 to 62\n* Medicaid insurance only\n* Those living in the greater New Haven area (i.e. having a zip code that matches that)\n\nExclusion Criteria:\n\n* the current visit for primary psychiatric or substance abuse\n* more than 50% of all ED visits in the past year for primary psychiatric or substance abuse.'}, 'identificationModule': {'nctId': 'NCT01797068', 'briefTitle': 'Patient Navigation for Medicaid Frequent ED Users', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Patient Navigation to Improve Care and Reduce Costs for High Utilizers of the Emergency Department', 'orgStudyIdInfo': {'id': '1007007154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient Navigator', 'description': 'Patients in the experimental group will be offered patient navigation and timely access to comprehensive care and services through Project Access-New Haven (PA-NH).', 'interventionNames': ['Behavioral: Patient Navigator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Patients in the active comparator group will experience the usual intake process in the ED setting.', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'Patient Navigator', 'type': 'BEHAVIORAL', 'description': 'Patients in the intervention group will be offered patient navigation and timely access to comprehensive care and services through Project Access-New Haven (PA-NH), a local non-profit organization that coordinates the provision of donated medical care and services to underserved patients through a network of participating hospitals and volunteer physicians.', 'armGroupLabels': ['Patient Navigator']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Patients in the standard of care group will experience the usual intake process in the ED setting.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}