The Health Outcomes Management and Evaluation (HOME) Study (HOME)
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|ClinicalTrials.gov Identifier: NCT01228032|
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : February 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Hyperlipidemia Heart Disease High Blood Pressure||Other: Care team||Phase 3|
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.
The 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||447 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Primary Care of Patients With Mental Disorders|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||December 2015|
Other: Care team
The ICC will provide care for both the index cardiometabolic conditions and common acute and chronic comorbidities.
Other Name: randomized control
No Intervention: Control
- Quality of healthcare services received [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228032
|United States, Georgia|
|Cobb County Community Service Board|
|Marietta, Georgia, United States, 30008|
|Principal Investigator:||Benjamin G Druss, MD MPH||Emory University|