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Evaluating a Collaborative Care Model for the Treatment of Schizophrenia (EQUIP)

Primary Purpose

Schizophrenia Disorders, Chronic Illness, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Chronic Illness Model
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia Disorders focused on measuring Randomized Controlled Trial, Quality of Health Care, Health Services Research, Guidelines, Medical Informatics Computing, Services, Mental Health, Medicine, Evidence-Based, Quality Assurance, Healthcare, Quality Indicators, Health Care, Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Providers (Psychiatrists, Case Managers, Nurses): Working at one of the participating VA Mental Health Clinics Providers: 68 Patients: 375 Patients: At least 18 years old Diagnosis of Schizophrenia, Schizoaffective, or schizophreniform disorder At least 2 treatment visits with a psychiatrist at the clinic during the previous 6 months. Exclusion Criteria: None

Sites / Locations

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

At 15 mo.: Provider attitudes on controlling symptoms & side-effects, & on family involvement Patient clinical outcomes Throughout the study: Patient compliance Provider practice patterns & adherence to VA guidelines Patient utilization

Secondary Outcome Measures

Process assessment throughout the course of the study of barriers and facilitators to the intervention�s implementation

Full Information

First Posted
July 1, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
Collaborators
University of California, Los Angeles, asd
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1. Study Identification

Unique Protocol Identification Number
NCT00119574
Brief Title
Evaluating a Collaborative Care Model for the Treatment of Schizophrenia (EQUIP)
Official Title
Evaluating a Collaborative Care Model for the Treatment of Schizophrenia (EQUIP)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
University of California, Los Angeles, asd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Policy makers and consumers are increasingly concerned about the quality and efficiency of care provided to individuals with severe, chronic illnesses such as schizophrenia. These illnesses are expensive to treat and present significant challenges to organizations that are responsible for providing effective care. Occurring in 1% of the United States population, schizophrenia accounts for 10% of permanently disabled people, and 2.5% of all healthcare expenditures. Clinical practice guidelines have been promulgated. Schizophrenia is treatable and outcomes can be substantially improved with the appropriate use of antipsychotic medication, caregiver education and counseling, vocational rehabilitation, and assertive treatment. However, in the VA and other mental health systems, many patients with schizophrenia receive substandard care. Methods are needed that improve the quality of usual care for this disorder while being feasible to implement at typical clinics. To date, most efforts to improve care for schizophrenia have focused on educating clinicians or changing the financing of care, and have had limited success. We believe a more fundamental approach should be tried. While there are many potential strategies, experience in chronic medical illness and mental health support the efficacy of specific approaches. Collaborative care models are one such approach. They are a blueprint for reorganizing practice, and involve changes in division of labor and responsibility, adoption of new care protocols, and increased attention to patients' needs. Although collaborative care models have been successful in other chronic medical conditions, they have not yet been studied in the treatment of schizophrenia. We have developed a collaborative care model for schizophrenia that builds on work in other disorders, and includes service delivery approaches that are known to be effective in schizophrenia. The model focuses on improving treatment through assertive care management, caregiver education and support, and standardized patient assessment with feedback of information to psychiatrists. This project, "EQUIP" (Enhancing Quality Utilization In Psychosis) is implementing collaborative care and evaluating its effectiveness in schizophrenia.
Detailed Description
Background: Policy makers and consumers are increasingly concerned about the quality and efficiency of care provided to individuals with severe, chronic illnesses such as schizophrenia. These illnesses are expensive to treat and present significant challenges to organizations that are responsible for providing effective care. Occurring in 1% of the United States population, schizophrenia accounts for 10% of permanently disabled people, and 2.5% of all healthcare expenditures. Clinical practice guidelines have been promulgated. Schizophrenia is treatable and outcomes can be substantially improved with the appropriate use of antipsychotic medication, caregiver education and counseling, vocational rehabilitation, and assertive treatment. However, in the VA and other mental health systems, many patients with schizophrenia receive substandard care. Methods are needed that improve the quality of usual care for this disorder while being feasible to implement at typical clinics. To date, most efforts to improve care for schizophrenia have focused on educating clinicians or changing the financing of care, and have had limited success. We believe a more fundamental approach should be tried. While there are many potential strategies, experience in chronic medical illness and mental health support the efficacy of specific approaches. Collaborative care models are one such approach. They are a blueprint for reorganizing practice, and involve changes in division of labor and responsibility, adoption of new care protocols, and increased attention to patients' needs. Although collaborative care models have been successful in other chronic medical conditions, they have not yet been studied in the treatment of schizophrenia. We have developed a collaborative care model for schizophrenia that builds on work in other disorders, and includes service delivery approaches that are known to be effective in schizophrenia. The model focuses on improving treatment through assertive care management, caregiver education and support, and standardized patient assessment with feedback of information to psychiatrists. This project, "EQUIP" (Enhancing Quality Utilization In Psychosis) is implementing collaborative care and evaluating its effectiveness in schizophrenia. Objectives: The objective of this project was to implement the care model at two large VA mental health centers, and evaluate its effect on clinicians, the organization of care, and treatment appropriateness, utilization and outcomes in veterans with schizophrenia. We hypothesized that this care model would increase provider adherence to treatment guidelines and improve the quality of care. We planned to describe implementation of the model, and barriers and facilitators to its implementation. We planned to evaluate the model by comparing treatment under the care model with usual care. Changes in the structure of care were evaluated using qualitative methods. Methods: EQUIP was a controlled trial of the care model. At two VA medical centers, clinicians (n=66) and their patients (n=398) were randomized to an intervention or a control condition. In the intervention group, a chronic care model was implemented for 15 months. Before, during, and after implementation, surveys and semi-structured interviews were conducted with clinicians and managers to assess their clinical practices, competencies, expectations, experiences, and observations concerning the implementation. Data sources included patient interviews, clinician interviews, and data from VistA. The feasibility of more broadly implementing the collaborative care model was assessed utilizing qualitative and quantitative information about the model's strengths and weaknesses, factors that facilitated/impeded implementation, direct costs of implementation and maintenance, and effects on treatment service utilization. Status: Data collection is complete. Data analyses are ongoing. Reports are being written and published. Presentations are being given.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Disorders, Chronic Illness, Schizoaffective Disorder, Weight Gain
Keywords
Randomized Controlled Trial, Quality of Health Care, Health Services Research, Guidelines, Medical Informatics Computing, Services, Mental Health, Medicine, Evidence-Based, Quality Assurance, Healthcare, Quality Indicators, Health Care, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
443 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Collaborative Chronic Illness Model
Primary Outcome Measure Information:
Title
At 15 mo.: Provider attitudes on controlling symptoms & side-effects, & on family involvement Patient clinical outcomes Throughout the study: Patient compliance Provider practice patterns & adherence to VA guidelines Patient utilization
Secondary Outcome Measure Information:
Title
Process assessment throughout the course of the study of barriers and facilitators to the intervention�s implementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Providers (Psychiatrists, Case Managers, Nurses): Working at one of the participating VA Mental Health Clinics Providers: 68 Patients: 375 Patients: At least 18 years old Diagnosis of Schizophrenia, Schizoaffective, or schizophreniform disorder At least 2 treatment visits with a psychiatrist at the clinic during the previous 6 months. Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Stehle Young, MD MSHS
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17412856
Citation
Niv N, Cohen AN, Sullivan G, Young AS. The MIRECC version of the Global Assessment of Functioning scale: reliability and validity. Psychiatr Serv. 2007 Apr;58(4):529-35. doi: 10.1176/ps.2007.58.4.529.
Results Reference
result
PubMed Identifier
17204397
Citation
Niv N, Cohen AN, Mintz J, Ventura J, Young AS. The validity of using patient self-report to assess psychotic symptoms in schizophrenia. Schizophr Res. 2007 Feb;90(1-3):245-50. doi: 10.1016/j.schres.2006.11.011. Epub 2007 Jan 3.
Results Reference
result
PubMed Identifier
17187495
Citation
Glynn SM, Cohen AN, Niv N. New challenges in family interventions for schizophrenia. Expert Rev Neurother. 2007 Jan;7(1):33-43. doi: 10.1586/14737175.7.1.33.
Results Reference
result
PubMed Identifier
16086610
Citation
Erhart SM, Young AS, Marder SR, Mintz J. Clinical utility of magnetic resonance imaging radiographs for suspected organic syndromes in adult psychiatry. J Clin Psychiatry. 2005 Aug;66(8):968-73. doi: 10.4088/jcp.v66n0802.
Results Reference
result
PubMed Identifier
15187072
Citation
Young AS, Mintz J, Cohen AN, Chinman MJ. A network-based system to improve care for schizophrenia: the Medical Informatics Network Tool (MINT). J Am Med Inform Assoc. 2004 Sep-Oct;11(5):358-67. doi: 10.1197/jamia.M1492. Epub 2004 Jun 7.
Results Reference
result
PubMed Identifier
15001724
Citation
Young AS, Mintz J, Cohen AN. Using information systems to improve care for persons with schizophrenia. Psychiatr Serv. 2004 Mar;55(3):253-5. doi: 10.1176/appi.ps.55.3.253. No abstract available.
Results Reference
result

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Evaluating a Collaborative Care Model for the Treatment of Schizophrenia (EQUIP)

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