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Completed

NCT Number: NCT01668355

PACT for Individuals With Serious Mental Illness

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, CA, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Aligned Care Team (PACT)

Other

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.

Other names: SMI-PACT

Primary outcomes

  1. Provision of Appropriate Preventive and Medical Treatments

    Time frame: 15 months

    Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.

  2. Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health

    Time frame: 15 months

    Physical health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.

  3. Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health

    Time frame: 15 months

    Mental health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.

  4. Patient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)

    Time frame: 15 months

    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.

  5. Patient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)

    Time frame: 15 months

    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.

Other outcomes

  1. Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis

    Time frame: 15 months

    Assesses patient psychopathology in the domain of psychosis. Scores range from 0 to 4. Higher scores mean a worse outcome.

  2. Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning

    Time frame: 15 months

    Assesses patient psychopathology in the domain of depression/daily functioning. Scores range from 0 to 4. Higher scores mean a worse outcome.

  3. Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning

    Time frame: 15 months

    Assesses patient psychopathology in the domain of interpersonal functioning. Scores range from 0 to 4. Lower scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: SMI-PACT

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 20, 2012
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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