- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00466323
The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness.
6. april 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
238
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
West Los Angeles, California, Forenede Stater, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lisa B Dixon, MD MPH, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2007
Primær færdiggørelse (Faktiske)
1. maj 2011
Studieafslutning (Faktiske)
1. juni 2011
Datoer for studieregistrering
Først indsendt
24. april 2007
Først indsendt, der opfyldte QC-kriterier
25. april 2007
Først opslået (Skøn)
27. april 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. april 2015
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIR 04-255
- H-28791 (Anden identifikator: UMB IRB)
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