The Health Outcomes Management and Evaluation (HOME) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Benjamin Druss, Emory University
ClinicalTrials.gov Identifier:
NCT01228032
First received: October 22, 2010
Last updated: May 19, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228032

Locations
United States, Georgia
Cobb County Community Service Board
Marietta, Georgia, United States, 30008
Sponsors and Collaborators
Emory University
Investigators
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: IRB0027782, 2R01MH070437-06A1
Study First Received: October 22, 2010
Last Updated: May 19, 2014
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 August 20, 2014