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

Primary Purpose

Schizophrenia Spectrum & Other Psychotic Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Aligned Care Team (PACT)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia Spectrum & Other Psychotic Disorders focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CA
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • VA Southern Nevada Healthcare System, North Las Vegas, NV

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SMI-PACT

Usual Care

Arm Description

Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness

Usual Primary Care

Outcomes

Primary Outcome Measures

Provision of Appropriate Preventive and Medical Treatments
Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2012
Last Updated
February 13, 2020
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01668355
Brief Title
PACT for Individuals With Serious Mental Illness
Acronym
SMI-PACT
Official Title
PACT to Improve Health Care in People With Serious Mental Illness (SMI-PACT)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
February 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
medical home tailored for people with serious mental illness
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMI-PACT
Arm Type
Experimental
Arm Description
Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Primary Care
Intervention Type
Other
Intervention Name(s)
Patient Aligned Care Team (PACT)
Other Intervention Name(s)
SMI-PACT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Provision of Appropriate Preventive and Medical Treatments
Description
Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.
Time Frame
15 months
Title
Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health
Description
Physical health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.
Time Frame
15 months
Title
Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health
Description
Mental health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.
Time Frame
15 months
Title
Patient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)
Description
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.
Time Frame
15 months
Title
Patient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)
Description
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.
Time Frame
15 months
Other Pre-specified Outcome Measures:
Title
Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis
Description
Assesses patient psychopathology in the domain of psychosis. Scores range from 0 to 4. Higher scores mean a worse outcome.
Time Frame
15 months
Title
Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning
Description
Assesses patient psychopathology in the domain of depression/daily functioning. Scores range from 0 to 4. Higher scores mean a worse outcome.
Time Frame
15 months
Title
Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning
Description
Assesses patient psychopathology in the domain of interpersonal functioning. Scores range from 0 to 4. Lower scores mean a worse outcome.
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander S Young, MD MSHS
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
VA Southern Nevada Healthcare System, North Las Vegas, NV
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29880047
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.
Results Reference
result
PubMed Identifier
35380346
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.
Results Reference
derived

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PACT for Individuals With Serious Mental Illness

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