N/A N=232 Randomized Single-blind Treatment

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

Schizophrenia · Schizoaffective Disorder · Major Depression

Bottom Line

View on ClinicalTrials.gov: NCT00466323 ↗

Enrolled (actual)

232

Serious AEs

1.3%

Results posted

Oct 2014

Primary outcome: Primary: Family-Clinician Contact (Including Contact With FMPO Clinician) — .4; .3; 1.6; .3 Number of Interactions

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Family Member Provider Outreach (Behavioral); Enhanced treatment as usual (e-TAU) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Family-Clinician Contact (Including Contact With FMPO Clinician)	.4; .3; 1.6; .3	—
PRIMARY Family-Clinician Contact (Not Including Notes From FMPO Clinicians)	.4; .3; .5; .3	—
SECONDARY Consumer's Recovery Rating - MHRM Total Score	75.6; 77.0; 80.2; 79.9	—
SECONDARY Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score	10.6; 11.4; 11.4; 11.3	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00466323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.