Implementing Effective, Collaborative Care for Schizophrenia (EQUIP-2)
| Tracking Information | |||||
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| First Received Date ICMJE | August 25, 2005 | ||||
| Last Updated Date | April 18, 2013 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Evaluate the effect of care model implementation on provider competencies, treatment appropriateness, patient outcomes and service utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
At 9 months, evaluate the effect of care model implementation on provider competencies, treatment appropriateness, patient outcomes and service utilization | ||||
| Change History | Complete list of historical versions of study NCT00137280 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Evaluate processes of and variations in care model implementation and effectiveness to strengthen the intervention and to assess acceptability, how strategies affect implementation and the impact of individual components on treatment appropriateness | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Implementing Effective, Collaborative Care for Schizophrenia (EQUIP-2) | ||||
| Official Title ICMJE | Implementing Effective, Collaborative Care for Schizophrenia | ||||
| Brief Summary | This project evaluates the 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 more 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. |
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| Detailed Description | Objectives: EQUIP-2 is a clinic-level controlled trial. From the four participating 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 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, clozapine, and peer support. All 4 VISNs chose the same two targets, SE and wellness. The support for 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 quality improvement addressing any barriers to utilization of these services. To inform future wellness implementation, in-depth, semi-structured interviews have been 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 (n=106) with special attention to those patients who completed at least half of the wellness program (n=53). Non-participants consist of patients who were referred to the wellness program but did not attend (n=57). Clinicians were interviewed specifically regarding wellness implementation. Findings / Results: The research enrolled 801 veterans with schizophrenia and 171 mental health clinicians and administrators across 8 sites in 4 VISNs. EQUIP significantly improved use of evidence-based services and outcomes for Veterans. Regarding Supported Employment (SE), individuals at intervention sites were 2.2 times more likely to utilize SE services during the study as compared to individuals at control sites. Formative evaluation indicated an overall increase in SE capacity at intervention sites, via reorganization of resources. One site with high fidelity to the SE model increased the number of Veterans who returned to competitive employment. Regarding weight management, overweight individuals at implementation sites were 2.3 times more likely to use weight services during the study compared to control sites. Controlling for pre-baseline and baseline weight, at control sites patients' final weight was 13.4 pounds heavier than at intervention sites. Sites had varying levels of attendance at the groups, although any attendance is a considerable improvement in care for wellness at these sites. Identifying barriers and facilitators (objective 5) is ongoing. Status: The intervention and data collection are complete. Staff worked with sites to sustain gains. Dr. Young is working with VA OI&T to develop and implement routine kiosk self-assessment as part of the VA electronic health record. Data are being analyzed, and methods and results disseminated. Impact: Schizophrenia is a common, disabling illness that has a very high cost to society. In fiscal year 2000, the VA provided care to over 102,000 people with schizophrenia, and 16% of the VA's health care budget was spent on care for people with psychotic disorders. This project evaluates implementation of a care model to improve treatment for schizophrenia within the context of diverse VA practices and priorities. It is possible to use technology to elicit information regarding patient preferences and needs, and to establish evidence-based quality improvement that uses this information to implement recovery-oriented care. The project created a platform that clinical and research interventions can build upon to improve care, and informs a national strategy for implementing evidence-based care in specialty mental health settings, including practices for weight management and return to competitive employment. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: 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. |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1067 | ||||
| Completion Date | May 2011 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Patients:
Exclusion Criteria: None |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00137280 | ||||
| Other Study ID Numbers ICMJE | MNT 03-213, P30MH082760 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | UCLA-RAND NIMH Partnered Research Center for Quality Care | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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