Clinical trial NCT01668355: PACT for Individuals With Serious Mental Illness
Official title: PACT to Improve Health Care in People With Serious Mental Illness (SMI-PACT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia Spectrum & Other Psychotic Disorders
Keywords: Delivery of Healthcare
Health Services Research
Integrated Healthcare Systems
Healthcare Quality, Access, and Evaluation
Primary Care
Quality Improvement
Psychotic Disorders
Medical Home
Psychiatry
Patient Care Management
Nursing Care Management
Treatment Costs
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-08-20
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: medical home tailored for people with serious mental illness
Primary purpose: TREATMENT

Brief summary: People with serious mental illness have difficulty making good use of primary care, and die, on average, years earlier than others in the population. The greatest contributors to this premature mortality are medical illnesses, especially cardiovascular disease and cancer. The Patient Centered Medical Home is a model for reorganizing primary care practice so that healthcare is more effective, efficient, and user-friendly. It has been implemented across VA as the, "Patient Aligned Care Team" (PACT). It is unclear, however, how this PACT model applies to people whose predominant illness is treated by specialists. This is the case for people with serious mental illness (SMI), many of whom receive ongoing treatment at mental health clinics. To achieve optimal health outcomes in the population with SMI, it may be necessary to adapt the PACT model so that it includes approaches that have proven to improve healthcare in this population. This project implements an adapted "SMI-PACT" model, and evaluates its effect on Veterans with SMI.

Detailed description: 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 whose predominant illness is treated in specialty settings, such as people with SMI. Research can inform efforts to apply the PACT model. For example, while people with SMI do poorly with usual primary care arrangements, there is 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, the investigators 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 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 for patients with serious mental illness. 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.

Eligibility criteria: Inclusion Criteria:

Patient subjects:

* currently enrolled at one of the 3 participating VA healthcare centers
* Veteran
* diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, chronic severe PTSD, or recurrent major depression with psychosis
* Milestone of Recovery Scale (MORS) score is 6 or above (indicates recovery status is coping rehabilitating or better)

Staff subjects:

* employed at one of the 3 participating VA healthcare centers
* member of PACT, member of SMI PACT, member of primary care mental health integration, provider at mental health clinic, administrator overseeing mental health, or administrator overseeing primary care

Exclusion Criteria:

* none

Primary outcomes:
measure: Provision of Appropriate Preventive and Medical Treatments
timeFrame: 15 months
measure: Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health
timeFrame: 15 months
measure: Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health
timeFrame: 15 months
measure: Patient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)
timeFrame: 15 months
measure: Patient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
measure: Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis
timeFrame: 15 months
measure: Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning
timeFrame: 15 months
measure: Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning
timeFrame: 15 months
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: Las Vegas
country: United States
facility: VA Southern Nevada Healthcare System, North Las Vegas, NV
state: Nevada
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Alexander S Young, MD MSHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young AS, Cohen AN, Chang ET, Flynn AWP, Hamilton AB, Oberman R, Vinzon M. A clustered controlled trial of the implementation and effectiveness of a medical home to improve health care of people with serious mental illness: study protocol. BMC Health Serv Res. 2018 Jun 7;18(1):428. doi: 10.1186/s12913-018-3237-0.
citation: Young AS, Chang ET, Cohen AN, Oberman R, Chang DT, Hamilton AB, Lindamer LA, Sanford J, Whelan F. The Effectiveness of a Specialized Primary Care Medical Home for Patients with Serious Mental Illness. J Gen Intern Med. 2022 Oct;37(13):3258-3265. doi: 10.1007/s11606-021-07270-x. Epub 2022 Apr 5.