PACT for Individuals With Serious Mental Illness (SMI-PACT)
|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.|
|ClinicalTrials.gov Identifier: NCT01668355|
Recruitment Status : Recruiting
First Posted : August 20, 2012
Last Update Posted : September 11, 2017
|Condition or disease||Intervention/treatment|
|Schizophrenia and Disorders With Psychotic Feature||Other: Patient Aligned Care Team (PACT)|
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.
Using available evidence, the investigators propose to implement and evaluate a specialized PACT model that meets the needs of individuals with SMI ("SMI-PACT").
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||314 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||medical home tailored for people with serious mental illness|
|Masking:||Single (Outcomes Assessor)|
|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 :||September 30, 2018|
|Estimated Study Completion Date :||December 31, 2018|
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
- 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 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668355
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668355
|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, 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 firstname.lastname@example.org|
|Principal Investigator: Alexander Stehle Young, MD MSHS|
|Sub-Investigator: Amy N. Cohen, PhD|
|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|
|Principal Investigator:||Alexander Stehle Young, MD MSHS||VA Greater Los Angeles Healthcare System, West Los Angeles, CA|