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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Schizophrenia, Schizoaffective Disorder, Major Depression

Intervention / Treatment
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* Behavioral: Family Member Provider Outreach
* Behavioral: Enhanced treatment as usual (e-TAU)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMPO Condition<br>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. | Behavioral: Family Member Provider Outreach<br>* 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.<br>|
| Active Comparator: Enhanced treatment as usual (e-TAU)<br>Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team. | Behavioral: Enhanced treatment as usual (e-TAU)<br>* Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Family-Clinician Contact (Including Contact With FMPO Clinician) | 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) | Chart review looking at the any clinician contact with veteran's family members | Within 6 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumer's Recovery Rating - MHRM Total Score | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental Illness, Schizophrenia, Education, Family member treatment, Active psychoses