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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMI-PACT | Experimental | Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness |
|
| Usual Care | No Intervention | Usual Primary Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Provision of Appropriate Preventive and Medical Treatments | Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c. | 15 months |
| 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 |
| 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 |
| 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 |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning |
Inclusion Criteria:
Patient subjects:
Staff subjects:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander S Young, MD MSHS | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | United States | ||
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29880047 | Result | 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. | |
| 35380346 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | SMI-PACT | Patient Aligned Care Team (PACT) medical home to address the physical healthcare needs for individuals with serious mental illness (SMI). An integrated healthcare model designed to coordinate and address physical health needs of people with serious mental illness. |
| FG001 | Usual Care | Usual Primary Care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SMI-PACT | Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs for individuals with serious mental illness (SMI). An integrated healthcare model to coordinate and address physical health needs. |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Provision of Appropriate Preventive and Medical Treatments | Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c. | These are the number of subjects for whom data was available for this measure during the relevant time frame. | Posted | Count of Participants | Participants | 15 months |
|
2 years, 5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SMI-PACT | Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs for individuals with serious mental illness (SMI). An integrated healthcare model to coordinate and address physical health needs. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Young | VA | 310-794-7219 | alexander.young@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2017 | Jan 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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medical home tailored for people with serious mental illness
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|
Assesses patient psychopathology in the domain of depression/daily functioning. Scores range from 0 to 4. Higher scores mean a worse outcome. |
| 15 months |
| 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 |
| West Los Angeles |
| California |
| 90073 |
| United States |
| VA Southern Nevada Healthcare System, North Las Vegas, NV | Las Vegas | Nevada | 89106 | United States |
| 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. |
Usual Primary Care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Usual Primary Care |
|
|
| 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. | These are the number of subjects for whom data was available for this measure during the relevant time frame. | Posted | Mean | Standard Deviation | score on a scale | 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. | These are the number of subjects for whom data was available for this measure during the relevant time frame. | Posted | Mean | Standard Deviation | score on a scale | 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. | These are the number of subjects for whom data was available for this measure during the relevant time frame. | Posted | Mean | Standard Deviation | score on a scale | 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. | These are the number of subjects for whom data was available for this measure during the relevant time frame. | Posted | Mean | Standard Deviation | score on a scale | 15 months |
|
|
|
| Other Pre-specified | 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. | These are the number of subjects for whom data was available for this measure during the relevant time frame. | Posted | Mean | Standard Deviation | score on a scale | 15 months |
|
|
|
| Other Pre-specified | 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. | These are the number of subjects for whom data was available for this measure during the relevant time frame. | Posted | Mean | Standard Deviation | score on a scale | 15 months |
|
|
|
| Other Pre-specified | 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. | These are the number of subjects for whom data was available for this measure during the relevant time frame. | Posted | Mean | Standard Deviation | score on a scale | 15 months |
|
|
|
| 3 |
| 164 |
| 0 |
| 164 |
| 0 |
| 164 |
| EG001 | Usual Care | Usual Primary Care | 1 | 167 | 0 | 167 | 0 | 167 |
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