Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Implementing Effective, Collaborative Care for Schizophrenia (EQUIP-2)

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00137280
First received: August 25, 2005
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

This project evaluates the implementation and effectiveness of a care model to improve treatment for schizophrenia within the context of diverse VA practices and priorities. The project provides information to VA clinicians and managers about Veterans with schizophrenia or schizoaffective disorder who are overweight and/or who would like to return to competitive work. The project facilitates reorganization of care practices in order to get veterans needed and desired services around wellness and work. The project creates a platform that other clinical and research interventions can build upon to improve care, and is designed to inform a national strategy for implementing evidence-based care in schizophrenia.


Condition Intervention
Schizophrenia
Chronic Illness
Weight Gain
Psychotic Disorder
Behavioral: Collaborative Chronic Illness Care Model

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Implementing Effective, Collaborative Care for Schizophrenia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The number of participants with one or more weight service appointments in the one year during implementation (implementation sites versus control sites) for those participants who were overweight at the baseline interview (e.g., eligible for weight services). This only includes participants who were overweight at the baseline interview (e.g., eligible for weight services).

  • The Effect of Care Model Implementation on Treatment Appropriateness: Patient Weight Outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Analysis of Covariance (ANCOVA) was used to examine weight gained during treatment in implementation versus control groups. The dependent variable was final weight. Baseline weight, weight 6 months prior to baseline, and baseline psychotic and negative symptom subscales were included as covariates. The inclusion of weight 6 months prior to baseline served to control for subjects' weight gain/loss trajectories prior to entering the study. The two-way interactions of group by covariates were also included in the model.

  • The Effect of Care Model Implementation on Treatment Appropriateness: Supported Employment Utilization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The number of participants with one or more Supported Employment appointments in the one year during implementation (implementation sites versus control sites) for those participants who endorsed a desire to return to work at the baseline interview (e.g., eligible for Supported Employment services). This only includes participants who endorsed a desire to return to work at the baseline interview (e.g., eligible for Supported Employment services).

  • The Effect of Care Model Implementation on Treatment Appropriateness: Patient Employment Outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Chi-square analysis was used to examine competitive employment gained during treatment in implementation versus control groups. The dependent variable was competitive employment. Individuals included were only those who expressed interest in returning to work at both the baseline and follow-up interview time-points.


Enrollment: 1067
Study Start Date: June 2007
Study Completion Date: May 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Collaborative Chronic Illness Care Model
Collaborative Chronic Illness Care Model: A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
Behavioral: Collaborative Chronic Illness Care Model
A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
No Intervention: Usual Care
Usual Care

Detailed Description:

Objectives:

EQUIP-2 is a clinic-level controlled trial. From the four participating Veterans Integrated Services Networks (VISNs), eight specialty mental health programs were enrolled and assigned to care as usual or to receive an intervention supporting evidence-based quality improvement and use of a chronic illness care model. Participants are VISN 3 (James J. Peters VA; Northport VA); VISN 16 (Houston VA; Shreveport VA); VISN 17 (Waco VA; Temple VA); and VISN 22 (Long Beach VA; Greater Los Angeles VA). The objectives of this VA Quality Enhancement Research Initiative (QUERI) Service Directed Project are 1) assist in identifying and making available recovery-oriented services to veterans with schizophrenia; 2) implement information systems that efficiently and accurately identify patient status and who would be appropriate for these services; 3) implement a care model to support recovery-oriented care delivery; 4) evaluate, in a controlled trial, the effect of implementation on treatment delivery and patient outcomes; and 5) identify facilitators and barriers to wellness program participation in an effort to strengthen the weight management services available to patients with schizophrenia. The project studies intervention feasibility, acceptability, and impact on outcomes; performs qualitative analyses examining processes and variation in care model implementation and impact. Research includes a controlled trial of the impact of implementation, relative to usual care, on treatment quality. Participants include clinic staff and patients with schizophrenia. Data sources include interviews with participants, focus groups with a sub-set of patients, implementation documentation, the project informatics system, and VistA.

Methods:

The care model targets two clinical domains selected by the VISNs from the following: Supported Employment (SE), caregiver support, wellness programs, or clozapine. All 4 VISNs chose the same two targets: SE and wellness. The care model includes: 1) at each visit, routine collection of patient outcomes data and provision of decision support using a self-assessment kiosk; 2) provision of "psychiatric vital signs" to patients and clinicians at the time of the clinical encounter via report that prints from the kiosk; 3) education and activation of both clinicians and patients around the clinical targets; 4) regular reports identifying patients appropriate for services associated with these targets; and 5) facilitation of problem-solving and evidence-based quality improvement addressing any barriers to utilization of these services.

To inform future wellness implementation, in-depth, semi-structured interviews are conducted with patients who participated in wellness groups ("participants"), and with patients who were referred (because they were overweight or obese) but did not participate ("non-participants"). Participants consist of all enrolled patients who attended the wellness program with special attention to those patients who completed at least half of the wellness program. Non-participants consist of patients who were referred to the wellness program but did not attend. Clinicians were interviewed specifically regarding wellness implementation.

  Eligibility

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

Inclusion Criteria:

Clinicians and Managers:

  • Psychiatrists, Case Managers, Nurses, Supported Employment workers Nutritionists, Local Recovery Coordinators, and Quality Improvement experts working at one of the participating VA Medical Centers

Patients:

  • At least 18 years old
  • Diagnosis of Schizophrenia, Schizoaffective, or schizophreniform disorder
  • At least 1 treatment visit with a clinician at the clinic during the 6 months prior to enrollment and then at least 1 treatment visit with a clinician at the clinic during the 5 months of enrollment.

Exclusion Criteria:

None

  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: NCT00137280

Locations
United States, California
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
VA Greater Los Angeles Health Care System
West Los Angeles, California, United States, 90073
United States, Louisiana
VA Medical Center
Shreveport, Louisiana, United States, 71101
United States, New York
James J Peters VA Medical Center
Bronx, New York, United States, 10468
VA Medical Center, Northport
Northport, New York, United States, 11768
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Central Texas Veterans Health Care System
Temple, Texas, United States, 76504
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Alexander S. Young, MD MSHS VA Greater Los Angeles Health Care System
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00137280     History of Changes
Other Study ID Numbers: MNT 03-213, P30MH082760
Study First Received: August 25, 2005
Results First Received: October 3, 2014
Last Updated: October 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Randomized Controlled Trial
Quality of Health Care
Health Services Research
Guidelines
Medical Informatics Computing
Services, Mental Health
Medicine, Evidenced-Based
Quality Assurance, Healthcare
Quality Indicators, Health Care
Veterans
Unemployment
Obesity
Quality Improvement

Additional relevant MeSH terms:
Chronic Disease
Mental Disorders
Psychotic Disorders
Schizophrenia
Weight Gain
Body Weight
Body Weight Changes
Disease Attributes
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014