Life Goals Collaborative Care to Improve Health Outcomes in Mental Disorders
Condition: Bipolar Disorder; Schizophrenia; Major Depressive Disorder; Schizoaffective Disorder; Cardiovascular Disease Risk
MeSH terms: Cardiovascular Diseases; Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      Persons with serious mental illness (SMI) are at increased risk of cardiovascular disease
      (CVD). The goals of this study are to test a treatment, Life Goals Collaborative Care to help
      promote health behavior change and improve mental health and physical health-related quality
      of life, as well as to get feedback from patients and providers on what is needed to help
      better coordinate the physical and mental health care of these patients.
    

Detailed description: 
      Background: VA patients with serious mental illnesses (SMI- e.g., schizophrenia, bipolar
      disorder) die an average of 13-18 years earlier compared to the general U.S. population,
      mostly from cardiovascular disease (CVD). Increased risk of CVD and related risk factors in
      persons with SMI is attributed to patient, provider, and system-level barriers including
      unhealthy behaviors exacerbated by mental health-related symptoms and barriers to access and
      continuity of care between physical and mental health services.

      Objectives: The primary aim of this randomized controlled effectiveness trial (RCT) is to
      determine whether VA patients with SMI receiving Life Goals Collaborative Care (LGCC), a
      program that combines customized behavioral change strategies with chronic care management
      for SMI will experience, within 12 months: a) improved medical outcomes (e.g., reduced CVD
      risk factors, improved physical health-related quality of life), b) improved mental health
      outcomes, including reduced psychiatric symptoms or improved mental health-related quality of
      life or c) improved health behaviors, compared to VA patients with SMI receiving enhanced
      treatment as usual (i.e., dissemination of health behavior change materials in addition to
      standard VA medical and psychiatric care). Secondary aims that will inform further
      implementation of LGCC will be to assess utilization and cost differences of LGCC versus
      treatment as usual, determine the patient factors associated with LGCC treatment response,
      and identify the organizational factors associated with LGCC implementation.

      Methods: LGCC is a groundbreaking psychosocial and behavior change intervention that is based
      on the Chronic Care Model (CCM) and consists of 1) 10 self-management sessions that cover
      personal goal-setting and mental health symptom management reinforced through healthy
      lifestyles; 2) medical care management that includes identification of patient medical risk
      factors, monitoring of patient symptoms and medical needs via a registry over time; and 3)
      support for provider guidelines and community linkages. The investigators will enroll
      individuals diagnosed with SMI and a CVD risk factor who are receiving care within the VA Ann
      Arbor Healthcare System mental health clinic, and who will be randomized to receive LGCC or
      enhanced treatment as usual. Key outcomes include changes in CVD risk factors (e.g., blood
      pressure, BMI), psychiatric symptoms, health-related quality of life, health behaviors (e.g.,
      physical activity), and inpatient and outpatient use assessed at 6 and 12 months.

      Impact: This study addresses VA HSR&D research priorities related to mental health and care
      of complex, chronic conditions, and is consistent with the priorities of the VHA's Office of
      Mental Health Services (Patient Care Services), 10NC, and the National Center for Health
      Promotion and Disease Prevention. Serious mental illness (SMI) is associated with significant
      disability, decreased quality of life, and a decreased life span. The VA is undergoing two
      major quality improvement initiatives: the Patient-Aligned Care Team (PACT), which involves
      enhanced access and continuity of care based on Chronic Care Model (CCM) principles, and
      dissemination of behavioral medicine programs. However, to date these programs have not been
      fully adapted to address gaps in quality or outcomes of care for Veterans with SMI. Findings
      from this RCT will inform ongoing VA transformational initiatives around systems redesign and
      behavioral medicine programs for Veterans with SMI and determine whether a customized
      CCM-behavioral medicine strategy is most effective in improving outcomes for this vulnerable
      group.
    

Intervention name(s): Life Goals Collaborative Care
Intervention type(s): Behavioral
Intervention description(s): LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: chronic mental disorders; cardiovascular disease; behavior change