Implementing Effective, Collaborative Care for Schizophrenia (EQUIP-2) (EQUIP-2)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00137280|
Recruitment Status : Completed
First Posted : August 29, 2005
Results First Posted : October 15, 2014
Last Update Posted : February 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Chronic Illness Weight Gain Psychotic Disorder||Behavioral: Collaborative Chronic Illness Care Model||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1067 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||research assessors had minimal contact with staff involved in implementation|
|Primary Purpose:||Health Services Research|
|Official Title:||Implementing Effective, Collaborative Care for Schizophrenia|
|Actual Study Start Date :||June 13, 2007|
|Actual Primary Completion Date :||March 5, 2010|
|Actual Study Completion Date :||May 31, 2011|
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
- The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization [ Time Frame: 1 year ]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 ]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 ]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 ]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.
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): NCT00137280
|United States, California|
|VA Long Beach Healthcare System, Long Beach, CA|
|Long Beach, California, United States, 90822|
|VA Greater Los Angeles Healthcare System, West Los Angeles, CA|
|West Los Angeles, California, United States, 90073|
|United States, Louisiana|
|Overton Brooks VA Medical Center, Shreveport, LA|
|Shreveport, Louisiana, United States, 71101|
|United States, Nevada|
|VA Southern Nevada Healthcare System, North Las Vegas, NV|
|Las Vegas, Nevada, United States, 89106|
|United States, New York|
|James J. Peters VA Medical Center, Bronx, NY|
|Bronx, New York, United States, 10468|
|Northport VA Medical Center, Northport, NY|
|Northport, New York, United States, 11768|
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX|
|Houston, Texas, United States, 77030|
|Central Texas Veterans Health Care System, Temple, TX|
|Temple, Texas, United States, 76504|
|Principal Investigator:||Alexander Stehle Young, MD MSHS||VA Greater Los Angeles Healthcare System, West Los Angeles, CA|