Life Goals Collaborative Care to Improve Health Outcomes in Mental Disorders
Major Depressive Disorder
Cardiovascular Disease Risk
Behavioral: Life Goals Collaborative Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||Life Goals Collaborative Care to Improve Health Outcomes in Mental Disorders|
- overall health-related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]Change in VR-12 physical and mental health scores from baseline to 12 months
- improved mental health-related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]Change in SF-12 mental health scores from baseline to 12 months
- improved health behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- change in cardiovascular risk factors [ Time Frame: 12 months ] [ Designated as safety issue: No ]change in systolic and diastolic blood pressure (mm/Hg) and body mass index (BMI) from baseline to 12 months
|Study Start Date:||December 2011|
|Study Completion Date:||May 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
No Intervention: Arm 1
Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
Behavioral: Life Goals Collaborative Care
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.
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. We will enroll 376 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487668
|United States, Michigan|
|VA Ann Arbor Healthcare System, Ann Arbor, MI|
|Ann Arbor, Michigan, United States, 48105|
|Principal Investigator:||Amy M. Kilbourne, PhD MPH||VA Ann Arbor Healthcare System, Ann Arbor, MI|