The Health Outcomes Management and Evaluation (HOME) Study
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Hyperlipidemia Heart Disease High Blood Pressure |
Other: Care team |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Improving Primary Care of Patients With Mental Disorders |
- Quality of healthcare services received [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Intervention |
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
referral only
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient at Cobb County CSB
- one or more of the following conditions: hyperlipidemia, high blood pressure, heart failure, diabetes
- able to give consent
Exclusion Criteria:
- unable to give consent
- does not have a cardiometabolic condition
Contacts and Locations| Contact: Robin Hill | 404/576-0601 | rlhill@emory.edu |
| Contact: Silke A von Esenwein, PHD | 404/712-8525 | svonese@emory.edu |
| United States, Georgia | |
| Cobb County Community Service Board | Recruiting |
| Marietta, Georgia, United States, 30008 | |
| Contact: Bryan Stephens, MBA bgstephens@cobbcsb.com | |
| Principal Investigator: | Benjamin G Druss, MD MPH | Emory University |
More Information
No publications provided
| Responsible Party: | Benjamin Druss, Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT01228032 History of Changes |
| Other Study ID Numbers: | 2R01MH070437-06A1, 2R01MH070437-06A1 |
| Study First Received: | October 22, 2010 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Heart Diseases Hyperlipidemias Hypertension Cardiovascular Diseases |
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013