PACT for Individuals With Serious Mental Illness

Schizophrenia Spectrum & Other Psychotic Disorders Clinical Trial

— SMI-PACT  

Official title:

PACT to Improve Health Care in People With Serious Mental Illness (SMI-PACT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668355
• Other study ID #: SDP 12-177
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: February 6, 2019

Study information

• Verified date: February 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: February 6, 2019
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia Spectrum & Other Psychotic Disorders

Intervention

Other:
• Patient Aligned Care Team (PACT)
An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.

Locations

Country	Name	City	State
United States	VA Southern Nevada Healthcare System, North Las Vegas, NV	Las Vegas	Nevada
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis	Assesses patient psychopathology in the domain of psychosis. Scores range from 0 to 4. Higher scores mean a worse outcome.	15 months
Other	Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning	Assesses patient psychopathology in the domain of depression/daily functioning. Scores range from 0 to 4. Higher scores mean a worse outcome.	15 months
Other	Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning	Assesses patient psychopathology in the domain of interpersonal functioning. Scores range from 0 to 4. Lower scores mean a worse outcome.	15 months
Primary	Provision of Appropriate Preventive and Medical Treatments	Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.	15 months
Primary	Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health	Physical health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.	15 months
Primary	Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health	Mental health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.	15 months
Primary	Patient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)	Evaluates patients' experiences and satisfaction with a physician's practice. The ACES uses the Institute of Medicine definition of primary care as its underlying conceptual model for measurement. The ACES range is 0 to 100. Higher scores mean a better outcome.	15 months
Primary	Patient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)	Assesses the patient's experience and satisfaction with receipt of chronic care. This measure aligns with the Chronic Care Model. The ACIC/PACIC ranges from from 1 to 5. Higher scores mean a better outcome.	15 months