- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00119574
Evaluating a Collaborative Care Model for the Treatment of Schizophrenia (EQUIP)
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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California
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West Los Angeles, California, Stati Uniti, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: Braccio 1
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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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
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Misure di risultato secondarie
Misura del risultato |
|---|
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Process assessment throughout the course of the study of barriers and facilitators to the intervention�s implementation
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Alexander Stehle Young, MD MSHS, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CPI 99-383
- RCD 00-033
- NIMH MH-5423
- NIMH MH-068639
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .