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

NCT ID: NCT00119574

Last Updated: 2015-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

443 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2004-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Disorders Chronic Illness Schizoaffective Disorder Weight Gain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Group Type OTHER

Collaborative Chronic Illness Model

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Collaborative Chronic Illness Model

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Los Angeles

OTHER

Sponsor Role collaborator

asd

UNKNOWN

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexander Stehle Young, MD MSHS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

West Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 17412856 (View on PubMed)

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.

Reference Type RESULT
PMID: 17204397 (View on PubMed)

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.

Reference Type RESULT
PMID: 17187495 (View on PubMed)

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.

Reference Type RESULT
PMID: 16086610 (View on PubMed)

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.

Reference Type RESULT
PMID: 15187072 (View on PubMed)

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.

Reference Type RESULT
PMID: 15001724 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.npistat.com/mint-tour

Tour of the Medical Informatics Tool (MINT) which was developed and utilized to support the intervention

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RCD 00-033

Identifier Type: -

Identifier Source: secondary_id

NIMH MH-5423

Identifier Type: -

Identifier Source: secondary_id

NIMH MH-068639

Identifier Type: -

Identifier Source: secondary_id

CPI 99-383

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mobile CBT for Negative Symptoms
NCT03621774 COMPLETED NA