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

Primary Purpose

Diabetes, Hyperlipidemia, Heart Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Care team
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cobb County Community Service Board

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

referral only

Outcomes

Primary Outcome Measures

Quality of healthcare services received

Secondary Outcome Measures

Full Information

First Posted
October 22, 2010
Last Updated
February 25, 2016
Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01228032
Brief Title
The Health Outcomes Management and Evaluation (HOME) Study
Acronym
HOME
Official Title
Improving Primary Care of Patients With Mental Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hyperlipidemia, Heart Disease, High Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
447 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
referral only
Intervention Type
Other
Intervention Name(s)
Care team
Other Intervention Name(s)
randomized control
Intervention Description
The ICC will provide care for both the index cardiometabolic conditions and common acute and chronic comorbidities.
Primary Outcome Measure Information:
Title
Quality of healthcare services received
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin G Druss, MD MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cobb County Community Service Board
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30008
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Health Outcomes Management and Evaluation (HOME) Study

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