The Health Outcomes Management and Evaluation (HOME) Study

Diabetes Clinical Trial

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Official title:

Improving Primary Care of Patients With Mental Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228032
• Other study ID #: IRB00027782
• Secondary ID: 2R01MH070437-06A
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2010
• Last updated: February 25, 2016
• Start date: April 2010
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Heart Disease
• High Blood Pressure
• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Other:
• Care team
The ICC will provide care for both the index cardiometabolic conditions and common acute and chronic comorbidities.

Locations

Country	Name	City	State
United States	Cobb County Community Service Board	Marietta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of healthcare services received		1 year	No