- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00466323
The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness.
6 aprile 2015 aggiornato da: US Department of Veterans Affairs
The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness
The purpose of this study is to learn how to help veterans play a stronger role in shaping their mental health care.
Specifically we want to see if we can help veterans improve their mental health treatment by helping them decide if they want to involve family in their mental health treatment, and if so, how.
The study will compare a "family member provider" program to an "enhanced treatment as usual approach" in achieving these goals.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
Previous research demonstrates that when families are active participants in the clinical care of persons with SMI, veterans experience improved outcomes, including treatment retention, vocational services participation, and empowerment.
Numerous controlled trials show that when family involvement achieves the level of intensity and family psychoeducation (FPE), relapse rates are cut in half, and treatment adherence, clinical symptoms, and patient functioning are improved.
However, despite these demonstrated benefits, rates of family involvement in the VA are unacceptably low.
Even minimal family-clinician contact occurs for only one third of VA SMI patients, a lower rate than in non-VA systems of care.
Therefore, it is not surprising that FPE, an intensive form of family-clinician contact, is almost never offered in the VA.
In fact, a national VA survey conducted within the last three years indicated that 0% of VAs offer FPE programs conforming to EBP guidelines.
Our previous experience further suggests that these deficits in care are due to combinations of provider, patient, and family factors, and that the VA presents specific challenges to implementing existing model programs, including FPE.
We therefore believe it is necessary to approach the challenge of increasing family involvement in a step-wise fashion, first by engaging families in the processes of care, before trying to enlist them in more intensive programs such as FPE.
Further, family engagement would likely be most effective if it builds on a foundation that empowers consumers to make informed choices regarding the involvement of relatives in care.
Our group has developed and piloted a new, family-engagement approach that is gradual, patient-centered, recovery-based, and can address various barriers to improving care.
It is manualized and thus replicable.
The proposed study will implement and further evaluate this intervention, the brief Family Member Provider Outreach (FMPO).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
238
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
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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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 70 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Age 18-70 years
- Diagnosis of a psychotic disorder in keeping with criteria established by the Serious Mental Illness Treatment Research and Evaluation Center (SMITREC){{646}} (schizophrenic disorders (295.0-295.9), affective psychoses (296.1, 296.4-296.8) and other psychotic diagnoses (297.0-298.9)) or diagnosis of Major Depression with psychotic features (296.xx)
- Decisional capacity to provide informed consent
- At least two outpatient visits within last six months
- At least monthly face-to-face contact for one hour or more with a patient-identified family member or caregiver
- Assessment by the treating therapist or psychiatrist that the patient is clinically stable enough to participate in the program.
Family Member/Caregiver Inclusion Criteria
- Age 18-80 years
- Decisional capacity to provide informed consent
- Permission from veteran to be contacted
Exclusion Criteria:
- Patients whose families have attended the FPE group within the last six months
- Patients whose families have had at least monthly clinician contact in the last six months
- Patients who are currently homeless
- Patients who participated in the FMPO pilot.
Family Member/Caregiver Exclusion Criteria:
- Individuals who do not meet the inclusion criteria
- Individuals who participated in the FMPO pilot.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: FMPO Condition
Family Member Provider Outreach is a brief recovery oriented model.
THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.
|
Family Member Provider Outreach is a brief recovery oriented model.
THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.
|
Comparatore attivo: Enhanced treatment as usual (e-TAU)
Enhanced treatment as usual.
In this condition, the consumer is given a list of family services available including the family intervention team.
|
Enhanced treatment as usual.
In this condition, the consumer is given a list of family services available including the family intervention team.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Family-Clinician Contact (Including Contact With FMPO Clinician)
Lasso di tempo: Within 6 months of intervention
|
Chart review looking at the any clinician contact with veteran's family members
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Within 6 months of intervention
|
Family-Clinician Contact (Not Including Notes From FMPO Clinicians)
Lasso di tempo: Within 6 months of intervention
|
Chart review looking at the any clinician contact with veteran's family members
|
Within 6 months of intervention
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Consumer's Recovery Rating - MHRM Total Score
Lasso di tempo: Within 6 months of intervention
|
We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales.The MHRM scales range from 0-120, with a higher score indicating better recovery.
|
Within 6 months of intervention
|
Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score
Lasso di tempo: Within 6 month of the intervention
|
We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales.
This sub score is Overcoming Stuckness.The MHRM sub scales range from 0-16, with a higher score indicating better recovery.
|
Within 6 month of the intervention
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Lisa B Dixon, MD MPH, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Glynn SM, Dixon LB, Cohen A, Murray-Swank A. The Family Member Provider Outreach program. Psychiatr Serv. 2008 Aug;59(8):934. doi: 10.1176/ps.2008.59.8.934. No abstract available.
- Cohen AN, Drapalski AL, Glynn SM, Medoff D, Fang LJ, Dixon LB. Preferences for family involvement in care among consumers with serious mental illness. Psychiatr Serv. 2013 Mar 1;64(3):257-63. doi: 10.1176/appi.ps.201200176.
- Dixon LB, Glynn SM, Cohen AN, Drapalski AL, Medoff D, Fang LJ, Potts W, Gioia D. Outcomes of a brief program, REORDER, to promote consumer recovery and family involvement in care. Psychiatr Serv. 2014 Jan 1;65(1):116-20. doi: 10.1176/appi.ps.201300074.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2007
Completamento primario (Effettivo)
1 maggio 2011
Completamento dello studio (Effettivo)
1 giugno 2011
Date di iscrizione allo studio
Primo inviato
24 aprile 2007
Primo inviato che soddisfa i criteri di controllo qualità
25 aprile 2007
Primo Inserito (Stima)
27 aprile 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
24 aprile 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 aprile 2015
Ultimo verificato
1 agosto 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IIR 04-255
- H-28791 (Altro identificatore: UMB IRB)
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 .