The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness.

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Major Depression; Schizophrenia; Schizoaffective Disorder

Treatments: Behavioral: Family Member Provider Outreach; Behavioral: Enhanced treatment as usual (e-TAU)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00466323

IIR 04-255

H-28791 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 238 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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238 participants in 2 patient groups

FMPO Condition

Experimental group

Description:

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.

Treatment:

Behavioral: Family Member Provider Outreach

Enhanced treatment as usual (e-TAU)

Active Comparator group

Description:

Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.

Treatment:

Behavioral: Enhanced treatment as usual (e-TAU)