- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00466323
The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness.
6. april 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Intervensjonell
Registrering (Faktiske)
238
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
West Los Angeles, California, Forente stater, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Family-Clinician Contact (Including Contact With FMPO Clinician)
Tidsramme: Within 6 months of intervention
|
Chart review looking at the any clinician contact with veteran's family members
|
Within 6 months of intervention
|
Family-Clinician Contact (Not Including Notes From FMPO Clinicians)
Tidsramme: Within 6 months of intervention
|
Chart review looking at the any clinician contact with veteran's family members
|
Within 6 months of intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Consumer's Recovery Rating - MHRM Total Score
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Lisa B Dixon, MD MPH, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2007
Primær fullføring (Faktiske)
1. mai 2011
Studiet fullført (Faktiske)
1. juni 2011
Datoer for studieregistrering
Først innsendt
24. april 2007
Først innsendt som oppfylte QC-kriteriene
25. april 2007
Først lagt ut (Anslag)
27. april 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. april 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. april 2015
Sist bekreftet
1. august 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IIR 04-255
- H-28791 (Annen identifikator: UMB IRB)
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