Clinical trial NCT00466323: The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness.
Official title: The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Major Depression
Keywords: Mental Illness
Schizophrenia
Education
Family member treatment
Active psychoses
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Maryland, Baltimore County
First posted: 2007-04-27
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Family-Clinician Contact (Including Contact With FMPO Clinician)
timeFrame: Within 6 months of intervention
measure: Family-Clinician Contact (Not Including Notes From FMPO Clinicians)
timeFrame: Within 6 months of intervention
Secondary outcomes:
measure: Consumer's Recovery Rating - MHRM Total Score
timeFrame: Within 6 months of intervention
measure: Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score
timeFrame: Within 6 month of the intervention
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Lisa B Dixon, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.