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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00119574
Other study ID # CPI 99-383
Secondary ID RCD 00-033NIMH M
Status Completed
Phase N/A
First received July 1, 2005
Last updated April 6, 2015
Start date January 2002
Est. completion date December 2004

Study information

Verified date July 2005
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 443
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Collaborative Chronic Illness Model


Locations

Country Name City State
United States VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles California

Sponsors (3)

Lead Sponsor Collaborator
VA Office of Research and Development asd, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

Glynn SM, Cohen AN, Niv N. New challenges in family interventions for schizophrenia. Expert Rev Neurother. 2007 Jan;7(1):33-43. Review. — View 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. Epub 2007 Jan 3. — View 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. — View 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. Epub 2004 Jun 7. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Process assessment throughout the course of the study of barriers and facilitators to the intervention?s implementation No
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