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

Study Description

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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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	314 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
Estimated Primary Completion Date :	November 30, 2018
Estimated Study Completion Date :	December 31, 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: SMI-PACT; Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs for individuals with serious mental illness	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
No Intervention: Usual Care; Primary Care

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. medical and mental health treatment utilization [ Time Frame: 12-months ]
   Using administrative and survey data, assess medical and mental health treatment utilization
3. 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
4. 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
5. Identify factors related to successful patient outcomes [ Time Frame: 2 years ]
   Using qualitative data, study factors related to successful patient outcomes
6. 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
7. 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
8. 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
9. Rogers' Adoption Questionnaire [ Time Frame: 12-months ]
   Assesses three factors that potentially affect rate of adoption: complexity, relative advantage, and observability; 20-items
10. Maslach Burnout Inventory (MBI) [ Time Frame: 12-months ]
    Measures aspects of workplace stress and has three subscales: emotional exhaustion, depersonalization, and personal accomplishments
11. 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)
12. 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
13. 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
14. 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.
15. 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.
16. 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).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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 340 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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Alexander S Young, MD MSHS	(310) 268-3416	Alexander.Young@va.gov
Contact: Amy N Cohen, PhD MA	(310) 478-3711 ext 40770	Amy.Cohen@va.gov

Locations

United States, California
VA Long Beach Healthcare System, Long Beach, CA	Withdrawn
Long Beach, California, United States, 90822
VA San Diego Healthcare System, San Diego, CA	Active, not recruiting
San Diego, California, United States, 92161
VA Greater Los Angeles Healthcare System, West Los Angeles, CA	Recruiting
West Los Angeles, California, United States, 90073
Contact: Alexander S Young, MD MSHS (310) 268-3416 Alexander.Young@va.gov
Contact: Rebecca S Oberman, MPH (310) 478-3711 ext 38165 rebecca.shoai@va.gov
Principal Investigator: Alexander Stehle Young, MD MSHS
Principal Investigator: Amy N. Cohen, PhD MA
Sub-Investigator: Evelyn T. Chang, MD MSHS
Sub-Investigator: Larissa J. Mooney, MD
United States, Nevada
VA Southern Nevada Healthcare System, North Las Vegas, NV	Active, not recruiting
Las Vegas, Nevada, United States, 89106

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator:	Alexander Stehle Young, MD MSHS	VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Principal Investigator:	Amy N. Cohen, PhD MA	VA Greater Los Angeles Healthcare System, West Los Angeles, CA

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT01668355 History of Changes
Other Study ID Numbers:	SDP 12-177
First Posted:	August 20, 2012
Last Update Posted:	February 12, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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:

Schizophrenia; Mental Disorders; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders