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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01668355
First received: August 7, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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 is being 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 require 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 at two VA healthcare centers, and evaluates its effect on veterans with SMI.


Condition Intervention
Schizophrenia and Disorders With Psychotic Feature
Other: Patient Aligned Care Team (PACT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PACT to Improve Health Care in People With Serious Mental Illness (SMI-PACT)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Composite Prevention Score [ Time Frame: 15-months ] [ Designated as safety issue: No ]
    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:
  • Composite Diabetes Mellitus Score [ Time Frame: 15-months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Assess acceptability of the SMI-PACT model, and barriers and facilitators to its implementation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Investigate the relationships between organizational context, intervention factors, and patient and provider outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Identify factors related to successful patient outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • VA Decision Support System National Database Extracts (DSS NDEs) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Using DSS NDE data and using microcosting methods we will determine healthcare costs

  • Assessment of Chronic Illness Care (ACIC) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    assesses three factors that potentially affect rate of adoption: complexity, relative advantage, and observability; 20-items

  • Maslach Burnout Inventory (MBI) [ Time Frame: 15-months ] [ Designated as safety issue: No ]
    Measure 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 1000
Study Start Date: October 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SMI-PACT
Patient Aligned Care Team (PACT) 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

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 who get the majority of their care in specialty settings, such as people with SMI. Research can inform efforts to apply the PACT model in specialty settings. For example, while people with SMI do poorly with usual primary care arrangements, there is now 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, we 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 at two medical centers 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 beyond primary care. 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 with serious mental illness. Findings regarding PACT in specialty mental health may also inform efforts to improve care in other specialty healthcare settings.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patient subjects and all staff subjects will be currently enrolled in care at one of the 4 sites for this study (which are yet to be named).
  • All patient subjects will be veterans.

Patient subjects:

  • We will enroll a random sample of 1000 patients who have diagnoses of schizophrenia
  • schizoaffective disorder
  • bipolar disorder
  • or recurrent major depression with psychosis (500 intervention, 500 control).

Staff subjects:

  • We 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 enhanced supports to make effective use of PC.
  • This will be assessed at baseline by each patient's clinician, using the Milestones of Recovery Scale (MORS)69 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668355

Contacts
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

Locations
United States, California
VA Greater Los Angeles Health Care System Not yet recruiting
West Los Angeles, California, United States, 90073
Contact: Alexander S Young, MD MSHS    310-268-3416    Alexander.Young@va.gov   
Contact: Dawn L Glover, MA    (310) 478-3711 ext 48338    Dawn.Glover@va.gov   
Principal Investigator: Alexander S. Young, MD MSHS         
Sub-Investigator: Amy N. Cohen, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Alexander S. Young, MD MSHS VA Greater Los Angeles Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01668355     History of Changes
Other Study ID Numbers: SDP 12-177
Study First Received: August 7, 2012
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Delivery of Healthcare
Health Services Research
Integrated Healthcare Systems
Healthcare Quality, Access, and Evaluation

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 16, 2014