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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466323
• Other study ID #: IIR 04-255
• Secondary ID: H-28791
• Status: Completed
• Phase: N/A
• First received: April 24, 2007
• Last updated: April 6, 2015
• Start date: September 2007
• Est. completion date: June 2011

Study information

• Verified date: August 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depression
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Family Member Provider Outreach
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.
• 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.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Maryland, Baltimore County

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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/appi.ps.59.8.934. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No