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

This study is currently recruiting participants.
Verified September 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT01668355
First Posted: August 20, 2012
Last Update Posted: September 11, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
August 7, 2012
August 20, 2012
September 11, 2017
September 1, 2015
September 30, 2018   (Final data collection date for primary outcome measure)
Composite Prevention Score [ Time Frame: 12-months ]
Preventive score is calculated based on the Office of Quality and Performance Technical Manual and uses the following data: pneumococcal immunization age 65 and older, ever received; Influenza vaccination 50-64 years of age; Influenza vaccination 65+ years of age; % of women age 50-69 screened for breast cancer; % of women age 21-64 screened for cervical cancer in the past three years; % of patients receiving appropriate colorectal cancer screening; % of patients screened for obesity
Composite Prevention Score [ Time Frame: 15-months ]
Preventive score is calculated based on the Office of Quality and Performance Technical Manual and uses the following data: pneumococcal immunization age 65 and older, ever received; Influenza vaccination 50-64 years of age; Influenza vaccination 65+ years of age; % of women age 50-69 screened for breast cancer; % of women age 21-64 screened for cervical cancer in the past three years; % of patients receiving appropriate colorectal cancer screening; % of patients screened for obesity
Complete list of historical versions of study NCT01668355 on ClinicalTrials.gov Archive Site
  • Composite Diabetes Mellitus Score [ Time Frame: 12-months ]
    Diabetes Mellitus score is calculated based on the Office of Quality and Performance Technical Manual and uses the following data: LDL-C < 100 mg/Dl; HbA1c Annual; HbA1c >9 or not done (poor control) in past year; Retinal Exam, timely by disease; LDL Measured; BP < 140/90; Nephropathy screening test or evidence of nephropathy
  • medical and mental health treatment utilization [ Time Frame: 12-months ]
    Using administrative and survey data, assess medical and mental health treatment utilization
  • Assess acceptability of the SMI-PACT model, and barriers and facilitators to its implementation [ Time Frame: 2 years ]
    acceptability of the SMI-PACT model, and barriers and facilitators to its implementation
  • Investigate the relationships among organizational context, intervention factors, and patient and provider outcomes [ Time Frame: 2 years ]
    Using qualitative data, study relationships among organizational context, intervention factors, and patient and provider outcomes
  • Identify factors related to successful patient outcomes [ Time Frame: 2 years ]
    Using qualitative data, study factors related to successful patient outcomes
  • VA Decision Support System National Database Extracts (DSS NDEs) [ Time Frame: 12 months ]
    Using VA Decision Support System National Database Extract data and microcosting methods to determine healthcare costs
  • Assessment of Chronic Illness Care (ACIC) [ Time Frame: 12 months ]
    Assesses organizational impacts of intervention vs. usual care and strengths and weaknesses in care for chronic illnesses. 28-items
  • Patient Assessment of Chronic Illness Care (PACIC) [ Time Frame: 12 months ]
    Assesses the extent to which patients with chronic illness receive care that aligns with the Chronic Care Model; 20-items; gathered from patients
  • Rogers' Adoption Questionnaire [ Time Frame: 12-months ]
    Assesses three factors that potentially affect rate of adoption: complexity, relative advantage, and observability; 20-items
  • Maslach Burnout Inventory (MBI) [ Time Frame: 12-months ]
    Measures aspects of workplace stress and has three subscales: emotional exhaustion, depersonalization, and personal accomplishments
  • Behavior and Symptom Identification Scale - Revised (BASIS-R) [ Time Frame: 12-months ]
    measures psychopathology, and provides covariates for analyses. The investigators will use the following scales: psychosis (4 items), depression/daily functioning (6 items), interpersonal functioning (5 items), and alcohol/drug use (4 items)
  • Ambulatory Care Experiences Survey (ACES; Short Form) [ Time Frame: 12-months ]
    Evaluates patients' experiences with a specific physician and that physician's practice. The ACES uses the Institute of Medicine definition of primary care as its underlying conceptual model for measurement, but was designed to evaluate any sustained clinician-patient relationship, irrespective of clinical specialty. It is sensitive to changes in patients' experiences of care over time
  • Interpersonal Support Evaluation List (ISEL) [ Time Frame: 12-months ]
    30-item instrument that assesses perceptions of social support, including: belonging, appraisal help, tangible support, and self-esteem support
  • Medication Possession Ratio (MPR) [ Time Frame: 12-months ]
    assesses the extent to which dispensed medications provide coverage for a given interval. It has been shown to be a valid measure of adherence in people with serious mental illness.
  • Ethnographic field notes [ Time Frame: 12-months ]
    Ethnographic field notes will be taken by the Evaluation Lead throughout implementation to capture aspects of the inner setting and otherwise unmeasured aspects of usual care.
  • Semi-structured qualitative interviews [ Time Frame: 12-months ]
    Baseline assessment will include an examination of usual practices, and knowledge, attitudes, and behaviors regarding medical care of patients with SMI. Staff at intervention sites will be asked about their expectations for SMI-PACT, and anticipated barriers and facilitators to implementation. The mid-study and final follow-up will interviews will assess: (1) usual care versus SMI-PACT; (2) barriers and facilitators to implementation of SMI-PACT (intervention staff); (3) provider perceptions of acceptability of SMI-PACT (intervention staff).
  • Composite Diabetes Mellitus Score [ Time Frame: 15-months ]
    Diabetes Mellitus score is calculated based on the Office of Quality and Performance Technical Manual and uses the following data: LDL-C < 100 mg/Dl; HbA1c Annual; HbA1c >9 or not done (poor control) in past year; Retinal Exam, timely by disease; LDL Measured; BP < 140/90; Nephropathy screening test or evidence of nephropathy
  • medical and mental health treatment utilization and cost [ Time Frame: 15-months ]
  • Assess acceptability of the SMI-PACT model, and barriers and facilitators to its implementation [ Time Frame: 2 years ]
  • Investigate the relationships between organizational context, intervention factors, and patient and provider outcomes [ Time Frame: 2 years ]
  • Identify factors related to successful patient outcomes [ Time Frame: 2 years ]
  • VA Decision Support System National Database Extracts (DSS NDEs) [ Time Frame: 15 months ]
    Using DSS NDE data and using microcosting methods we will determine healthcare costs
  • Assessment of Chronic Illness Care (ACIC) [ Time Frame: 15 months ]
    organizational impacts of SMI-PACT vs usual care; strengths and weaknesses in care for chronic illnesses; 28-items
  • Patient Assessment of Chronic Illness Care (PACIC) [ Time Frame: 15 months ]
    Assesses the extent to which patients with chronic illness receive care that aligns with the Chronic Care Model; 20-items; gathered from patients
  • Rogers' Adoption Questionnaire [ Time Frame: 15-months ]
    Assesses three factors that potentially affect rate of adoption: complexity, relative advantage, and observability; 20-items
  • Maslach Burnout Inventory (MBI) [ Time Frame: 15-months ]
    Measures aspects of workplace stress and has three subscales: emotional exhaustion, depersonalization, and personal accomplishments
  • Behavior and Symptom Identification Scale - Revised (BASIS-R) [ Time Frame: 15-months ]
    measures psychopathology, and provides covariates for analyses. We will use the following scales: psychosis (4 items), depression/daily functioning (6 items), interpersonal functioning (5 items), and alcohol/drug use (4 items)
  • Ambulatory Care Experiences Survey (ACES; Short Form) [ Time Frame: 15-months ]
    Evaluates patients' experiences with a specific physician and that physician's practice. The ACES uses the Institute of Medicine definition of primary care as its underlying conceptual model for measurement, but was designed to evaluate any sustained clinician-patient relationship, irrespective of clinical specialty. It is sensitive to changes in patients� experiences of care over time
  • Interpersonal Support Evaluation List (ISEL) [ Time Frame: 15-months ]
    30-item instrument that assesses perceptions of social support, including: belonging, appraisal help, tangible support, and self-esteem support
  • Medication Possession Ratio (MPR) [ Time Frame: 15-months ]
    MPR assesses the extent to which dispensed medications provide coverage for a given interval. It has been shown to be a valid measure of adherence in people with SMI
  • Ethnographic field notes [ Time Frame: 15-months ]
    Will be taken by the Evaluation Lead throughout implementation to capture aspects of the inner setting and otherwise unmeasured aspects of usual care.
  • Semi-structured qualitative interviews [ Time Frame: 15-months ]
    Baseline assessment will include an examination of usual practices, and knowledge, attitudes, and behaviors regarding medical care of patients with SMI. Staff at intervention sites will be asked about their expectations for SMI-PACT, and anticipated barriers and facilitators to implementation. The mid-study and final follow-up will interviews will assess: (1) usual care versus SMI-PACT; (2) barriers and facilitators to implementation of SMI-PACT (intervention staff); (3) provider perceptions of acceptability of SMI-PACT (intervention staff).
Not Provided
Not Provided
 
PACT for Individuals With Serious Mental Illness
PACT to Improve Health Care in People With Serious Mental Illness (SMI-PACT)
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.

Interventional
Not Provided
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
Schizophrenia and Disorders With Psychotic Feature
Other: Patient Aligned Care Team (PACT)
A integrated healthcare model to coordinate and address physical health needs. The PACT model to be implemented here will be specially designed for individuals with serious mental illness.
Other Name: SMI-PACT
  • Experimental: SMI-PACT
    Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs for individuals with serious mental illness
    Intervention: Other: Patient Aligned Care Team (PACT)
  • No Intervention: Usual Care
    Primary Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
314
December 31, 2018
September 30, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patient subjects and all staff subjects are currently enrolled in care at one of the 3 sites for this study.
  • All patient subjects will be Veterans.

Patient subjects:

  • The investigators will enroll a random sample of 314 patients who have diagnoses of schizophrenia
  • schizoaffective disorder
  • bipolar disorder
  • chronic PTSD
  • or recurrent major depression with psychosis

Staff subjects:

  • The investigators will enroll approximately 15 staff per site.
  • At each site this will include:

    • 3 members of PACT
    • 4 members of SMI-PACT (intervention site) or mental health integration (control site)
    • 4 providers from the mental health clinic
    • 2 administrators who oversee the mental health clinic (e.g., psychiatry, psychology, nursing, social work, clerks)
    • and 2 administrators who oversee primary care.

Exclusion Criteria:

  • Patients will not be excluded based on comorbid mental or medical diagnoses.
  • However, there is a subset of individuals at mental health clinics who are psychiatrically stable and advanced enough in their recovery that they do not require high intensity mental health supports to make effective use of PACT.
  • This will be assessed at baseline by each patient's clinician, using the Milestones of Recovery Scale (MORS)scale.
  • This scale rates an individual's ability to self-manage their care.
  • Patients who rate at "early recovery" or "advanced recovery" on this scale will remain with standard PACT, and are not eligible for SMI-PACT.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Alexander S Young, MD MSHS (310) 268-3416 Alexander.Young@va.gov
Contact: Amy N Cohen, PhD (310) 478-3711 ext 40770 Amy.Cohen@va.gov
United States
 
 
NCT01668355
SDP 12-177
Yes
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
Plan to Share IPD: Undecided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Alexander Stehle Young, MD MSHS VA Greater Los Angeles Healthcare System, West Los Angeles, CA
VA Office of Research and Development
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP