The Health Outcomes Management and Evaluation (HOME) Study (HOME)

February 25, 2016 updated by: Benjamin Druss, Emory University

Improving Primary Care of Patients With Mental Disorders

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

447

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Marietta, Georgia, United States, 30008
        • Cobb County Community Service Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Other: Care team
The ICC will provide care for both the index cardiometabolic conditions and common acute and chronic comorbidities.
Other Names:
  • randomized control
No Intervention: Control
referral only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of healthcare services received
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Benjamin G Druss, MD MPH, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 22, 2010

First Submitted That Met QC Criteria

October 22, 2010

First Posted (Estimate)

October 25, 2010

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00027782
  • 2R01MH070437-06A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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