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PACT to Improve Health Care in People With Serious Mental Illness


N/A
18 Years
N/A
Not Enrolling
Both
Schizophrenia and Disorders With Psychotic Feature

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Trial Information

PACT to Improve Health Care in People With Serious Mental Illness


Background/Rationale:

People with serious mental illness (SMI) die, on average, many years prematurely, with rates
of premature mortality 2 to 3 times greater than the general population. Over 60% of
premature deaths in this population are due to "natural causes," especially poorly treated
cardiovascular, respiratory, and infectious diseases. Although the VA is a centrally
organized, comprehensive healthcare system, veterans with SMI still have difficulty
navigating the system, and are at substantially elevated risk for premature death. Too
often, they do not attend scheduled appointments or fail to engage in primary care
treatment, and consequently do not get valuable preventive and primary care services.

Primary care in VA has undergone significant transformation under the Patent Aligned Care
Team (PACT) model, which is based on the Patient Centered Medical Home (PCMH) concept. PACT
has the goal of improving the quality, efficiency, and patient-centeredness of primary care.
But it remains unclear how PACT will impact the large populations of veterans who get the
majority of their care in specialty settings, such as people with SMI. Research can inform
efforts to apply the PACT model in specialty settings. For example, while people with SMI
do poorly with usual primary care arrangements, there is now substantial evidence that
integrated care and medical care management approaches can improve medical treatment and
outcomes, and reduce treatment costs, in people with SMI.

Objective:

Using available evidence, we propose to implement and evaluate a specialized PACT model that
meets the needs of individuals with SMI ("SMI-PACT").

Methods:

This project will partner with leadership at two medical centers to implement SMI-PACT, with
the goal of improving healthcare and outcomes among people with SMI, while reducing
unnecessary use of emergency and hospital services. Evidence-based quality improvement
strategies will be used to reorganize processes of care. In a site-level controlled trial,
this project will evaluate the effect, relative to usual care, of SMI-PACT implementation on
(a) provision of appropriate preventive and medical treatments; (b) patient health-related
quality of life and satisfaction with care; and (c) medical and mental health treatment
utilization and costs. The project includes a mixed methods formative evaluation of usual
care and SMI-PACT implementation to strengthen the intervention, and assess barriers and
facilitators to its implementation. Mixed methods will also be used to investigate the
relationships between organizational context, intervention factors, and patient and provider
outcomes; and identify patient factors related to successful patient outcomes.

Significance:

This project's approach to SMI-PACT is consistent with the VA PACT model, and with efforts
in VA to improve care for veterans with psychiatric disorders. This will be one of the
first projects to systematically implement and evaluate the PCMH and PACT concepts beyond
primary care. Should SMI-PACT be demonstrated to be feasible and effective, the model could
be used more broadly to improve the quality and efficiency of care for veterans with serious
mental illness. Findings regarding PACT in specialty mental health may also inform efforts
to improve care in other specialty healthcare settings.


Inclusion Criteria:



- All patient subjects and all staff subjects will be currently enrolled in care at one
of the 4 sites for this study (which are yet to be named).

- All patient subjects will be veterans.

Patient subjects:

- We will enroll a random sample of 1000 patients who have diagnoses of schizophrenia

- schizoaffective disorder

- bipolar disorder

- or recurrent major depression with psychosis (500 intervention, 500 control).

Staff subjects:

- We will enroll approximately 15 staff per site.

- At each site this will include:

- 3 members of PACT

- 4 members of SMI-PACT (intervention site) or mental health integration (control
site)

- 4 providers from the mental health clinic

- 2 administrators who oversee the mental health clinic (e.g., psychiatry,
psychology, nursing, social work, clerks)

- and 2 administrators who oversee primary care.

Exclusion Criteria:

- Patients will not be excluded based on comorbid mental or medical diagnoses.

- However, there is a subset of individuals at mental health clinics who are
psychiatrically stable and advanced enough in their recovery that they do not require
enhanced supports to make effective use of PC.

- This will be assessed at baseline by each patient's clinician, using the Milestones
of Recovery Scale (MORS)69 scale.

- This scale rates an individual's ability to self-manage their care.

- Patients who rate at "early recovery" or "advanced recovery" on this scale will
remain with standard PACT, and are not eligible for SMI-PACT.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Composite Prevention Score

Outcome Description:

Preventive score is calculated based on the Office of Quality and Performance Technical Manual and uses the following data: pneumococcal immunization age 65 and older, ever received; Influenza vaccination 50-64 years of age; Influenza vaccination 65+ years of age; % of women age 50-69 screened for breast cancer; % of women age 21-64 screened for cervical cancer in the past three years; % of patients receiving appropriate colorectal cancer screening; % of patients screened for obesity

Outcome Time Frame:

15-months

Safety Issue:

No

Principal Investigator

Alexander S. Young, MD MSHS

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Greater Los Angeles Health Care System

Authority:

United States: Federal Government

Study ID:

SDP 12-177

NCT ID:

NCT01668355

Start Date:

April 2014

Completion Date:

June 2017

Related Keywords:

  • Schizophrenia and Disorders With Psychotic Feature
  • Delivery of Healthcare
  • Health Services Research
  • Integrated Healthcare Systems
  • Healthcare Quality, Access, and Evaluation
  • Mental Disorders
  • Psychotic Disorders
  • Schizophrenia
  • Schizophrenia and Disorders with Psychotic Features

Name

Location

VA Greater Los Angeles Health Care System West Los Angeles, California  90073