Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

PACT for Individuals With Serious Mental Illness (SMI-PACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01668355
Recruitment Status : Completed
First Posted : August 20, 2012
Results First Posted : February 28, 2020
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Spectrum & Other Psychotic Disorders Other: Patient Aligned Care Team (PACT) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: medical home tailored for people with serious mental illness
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PACT to Improve Health Care in People With Serious Mental Illness (SMI-PACT)
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SMI-PACT
Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness
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.
Other Name: SMI-PACT

No Intervention: Usual Care
Usual Primary Care



Primary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668355


Locations
Layout table for location information
United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
United States, Nevada
VA Southern Nevada Healthcare System, North Las Vegas, NV
Las Vegas, Nevada, United States, 89106
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Alexander S Young, MD MSHS VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Publications of Results:
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01668355    
Other Study ID Numbers: SDP 12-177
First Posted: August 20, 2012    Key Record Dates
Results First Posted: February 28, 2020
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders