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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Major Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Member Provider Outreach
Enhanced treatment as usual (e-TAU)
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Mental Illness, Schizophrenia, Education, Family member treatment, Active psychoses

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FMPO Condition

Enhanced treatment as usual (e-TAU)

Arm 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.

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

Outcomes

Primary Outcome Measures

Family-Clinician Contact (Including Contact With FMPO Clinician)
Chart review looking at the any clinician contact with veteran's family members
Family-Clinician Contact (Not Including Notes From FMPO Clinicians)
Chart review looking at the any clinician contact with veteran's family members

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 24, 2007
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
Collaborators
University of Maryland, Baltimore County
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1. Study Identification

Unique Protocol Identification Number
NCT00466323
Brief Title
The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness.
Official Title
The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
University of Maryland, Baltimore County

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Major Depression
Keywords
Mental Illness, Schizophrenia, Education, Family member treatment, Active psychoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMPO Condition
Arm Type
Experimental
Arm 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.
Arm Title
Enhanced treatment as usual (e-TAU)
Arm Type
Active Comparator
Arm Description
Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
Intervention Type
Behavioral
Intervention Name(s)
Family Member Provider Outreach
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced treatment as usual (e-TAU)
Intervention Description
Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
Primary Outcome Measure Information:
Title
Family-Clinician Contact (Including Contact With FMPO Clinician)
Description
Chart review looking at the any clinician contact with veteran's family members
Time Frame
Within 6 months of intervention
Title
Family-Clinician Contact (Not Including Notes From FMPO Clinicians)
Description
Chart review looking at the any clinician contact with veteran's family members
Time Frame
Within 6 months of intervention
Secondary Outcome Measure Information:
Title
Consumer's Recovery Rating - MHRM Total Score
Description
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.
Time Frame
Within 6 months of intervention
Title
Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score
Description
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.
Time Frame
Within 6 month of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa B Dixon, MD MPH
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18678695
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/ps.2008.59.8.934. No abstract available.
Results Reference
result
PubMed Identifier
23242515
Citation
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.
Results Reference
result
PubMed Identifier
24177229
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.
Results Reference
result

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

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