Life Goals Collaborative Care to Improve Health Outcomes in Mental Disorders
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Peripheral Vascular Disease, Schizophrenia, Schizophrenia, Major Depression Disorder (MDD), Psychiatric, Psychiatric, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/21/2016 |
| Start Date: | December 2011 |
| End Date: | May 2015 |
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.
(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.
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.
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.
Inclusion Criteria:
- Diagnosis of serious mental illness (schizophrenia, bipolar disorder, other
psychosis, major depressive disorder, or other recurrent depression or affective
disorder)
- Have at least one of the following risk factors for CVD (cardiovascular disease):
- Body mass index (BMI) >28 or waist circumference of >35 (women) or >40 (men)
inches OR
- Self-reported diagnosis of hypertension ("high blood pressure"), dyslipidemia
("high cholesterol") or diabetes or high blood sugar OR
- Documentation in the medical record of a diagnosis of or treatment for
hypertension (defined as documented diagnosis or blood pressure of >140/90 on 2
occasions or prescription for an antihypertensive medication), dyslipidemia
(documented diagnosis or LDL>160 or prescription for a lipid-lowering
medication) or diabetes mellitus (documented diagnosis or HbA1C >7% or current
prescription for oral hypoglycemic therapy)
Exclusion Criteria:
- Have unresolved substance intoxication or withdrawal, such as appearing to be
intoxicated (e.g., incoherent, slurred speech), or experiencing withdrawal symptoms
from substance abuse at the time of enrollment.
- Are unwilling or unable to provide informed consent or comply with study requirements
at the time of enrollment (e.g., unable to complete forms or attend sessions due to
substantial functional limitations).
- Active suicidal ideation at time of enrollment (focused interventions are more
appropriate for this group)
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