The Health Outcomes Management and Evaluation (HOME) Study

This study is currently recruiting participants.
Verified November 2013 by Emory University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Benjamin Druss, Emory University
ClinicalTrials.gov Identifier:
NCT01228032
First received: October 22, 2010
Last updated: November 18, 2013
Last verified: November 2013

October 22, 2010
November 18, 2013
April 2010
September 2014   (final data collection date for primary outcome measure)
Quality of healthcare services received [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01228032 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Health Outcomes Management and Evaluation (HOME) Study
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes
  • Hyperlipidemia
  • Heart Disease
  • High Blood Pressure
Other: Care team
The ICC will provide care for both the index cardiometabolic conditions and common acute and chronic comorbidities.
Other Name: randomized control
  • Experimental: Intervention
    Intervention: Other: Care team
  • No Intervention: Control
    referral only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
January 2015
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Robin Hill 404/576-0601 rlhill@emory.edu
Contact: Silke A von Esenwein, PHD 404/712-8525 svonese@emory.edu
United States
 
NCT01228032
IRB0027782, 2R01MH070437-06A1
Yes
Benjamin Druss, Emory University
Emory University
National Institute of Mental Health (NIMH)
Principal Investigator: Benjamin G Druss, MD MPH Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP