Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-24 @ 8:21 PM
Study NCT ID:
NCT01228032
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2010-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Health Outcomes Management and Evaluation (HOME) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 447}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-25', 'studyFirstSubmitDate': '2010-10-22', 'studyFirstSubmitQcDate': '2010-10-22', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of healthcare services received', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes', 'Hyperlipidemia', 'Heart Disease', 'High Blood Pressure']}, 'descriptionModule': {'briefSummary': 'There is an urgent need to develop practical, sustainable approaches to improving medical care for persons treated in community mental health settings. This study will test a novel approach for improving mental health consumers based on a partnership model between a Community Mental Health Center and a Community Health Center. When this study is completed, it will provide a model for a medical home for persons with severe mental illness that is clinically robust, and organizationally and financially sustainable', 'detailedDescription': "Findings of excess cardiometabolic morbidity and mortality in persons with severe mental illness (SMI) have led to a growing interest by Community Mental Health Centers (CMHCs) in improving the medical care of the populations they treat. However, these organizations face a number of financial and organizational barriers to implementing and sustaining such programs. In previous and ongoing work, the study team has documented the promise of team-based models in improving health and health care in this population. This study will test a novel approach for improving mental health consumers based on a partnership model between a CMHC and a Community Health Center (CHC). This partnership will capitalize on collocation of services, the primary care expertise of the CHC, and favorable reimbursement conditions, to develop a program that is both clinically robust and financially and organizationally sustainable A total of 300 CMHC clients with a severe mental illness and one or more active cardiometabolic problem (diabetes, hypertension, hyperlipidemia) will be randomized to either onsite Integrated Community Care (ICC) (n=150) or to a referral to the partner community health center (CHC) (n=150) for their medical problems. For those in the ICC, the CHC will establish a satellite clinic at the CMHC staffed by a physician assistant and care manager. The ICC will provide care for both the index cardiometabolic conditions and common acute and chronic comorbidities.\n\nThe study will use standardized, validated instruments to assess the impact of integrated community care on quality and outcomes of cardiometabolic and general medical care. A budget impact analysis will be used to assess the program's financial and organizational sustainability. When this study is completed, it will provide a model for CMHCs to provide a medical home for the populations they serve."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient at Cobb County CSB\n* one or more of the following conditions: hyperlipidemia, high blood pressure, heart failure, diabetes\n* able to give consent\n\nExclusion Criteria:\n\n* unable to give consent\n* does not have a cardiometabolic condition'}, 'identificationModule': {'nctId': 'NCT01228032', 'acronym': 'HOME', 'briefTitle': 'The Health Outcomes Management and Evaluation (HOME) Study', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Improving Primary Care of Patients With Mental Disorders', 'orgStudyIdInfo': {'id': 'IRB00027782'}, 'secondaryIdInfos': [{'id': '2R01MH070437-06A1', 'link': 'https://reporter.nih.gov/quickSearch/2R01MH070437-06A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Other: Care team']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'referral only'}], 'interventions': [{'name': 'Care team', 'type': 'OTHER', 'otherNames': ['randomized control'], 'description': 'The ICC will provide care for both the index cardiometabolic conditions and common acute and chronic comorbidities.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30008', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Cobb County Community Service Board', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}], 'overallOfficials': [{'name': 'Benjamin G Druss, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Benjamin Druss', 'investigatorAffiliation': 'Emory University'}}}}