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

This study has been completed.
Sponsor:
Collaborator:
University of Maryland, Baltimore County
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00466323
First received: April 24, 2007
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Major Depression
Behavioral: Family Member Provider Outreach
Behavioral: Enhanced treatment as usual (e-TAU)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Family-Clinician Contact [ Time Frame: Within 6 months of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Consumer's recovery rating [ Time Frame: Within 6 months of intervention ] [ Designated as safety issue: No ]

Enrollment: 238
Study Start Date: September 2007
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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
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.
Active Comparator: Arm 2
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)
Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466323

Locations
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore County
Investigators
Principal Investigator: Lisa B Dixon, MD Department of Veterans Affairs
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00466323     History of Changes
Other Study ID Numbers: IIR 04-255, H-28791
Study First Received: April 24, 2007
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Mental Illness
Schizophrenia
Education
Family member treatment
Active psychoses

Additional relevant MeSH terms:
Mental Disorders
Depression
Depressive Disorder
Psychotic Disorders
Schizophrenia
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 22, 2014