The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FMPO Condition 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: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Family-Clinician Contact (Including Contact With FMPO Clinician) [Within 6 months of intervention]
Chart review looking at the any clinician contact with veteran's family members
- Family-Clinician Contact (Not Including Notes From FMPO Clinicians) [Within 6 months of intervention]
Chart review looking at the any clinician contact with veteran's family members
Secondary Outcome Measures
- Consumer's Recovery Rating - MHRM Total Score [Within 6 months of intervention]
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 [Within 6 month of the intervention]
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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | United States | 90073 |
| 2 | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- US Department of Veterans Affairs
- University of Maryland, Baltimore County
Investigators
- Principal Investigator: Lisa B Dixon, MD MPH, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIR 04-255
- H-28791
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals. |
| Arm/Group Title | FMPO Condition | Enhanced Treatment as Usual (e-TAU) |
|---|---|---|
| Arm/Group 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. 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. In this condition, the consumer is given a list of family services available including the family intervention team. 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. |
| Period Title: Overall Study | ||
| STARTED | 117 | 115 |
| COMPLETED | 89 | 92 |
| NOT COMPLETED | 28 | 23 |
Baseline Characteristics
| Arm/Group Title | FMPO Condition | Enhanced Treatment as Usual (e-TAU) | Total |
|---|---|---|---|
| Arm/Group 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. 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. In this condition, the consumer is given a list of family services available including the family intervention team. 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. | Total of all reporting groups |
| Overall Participants | 117 | 115 | 232 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
51.8
(9.4)
|
51.2
(8.7)
|
51.5
(9.0)
|
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
114
97.4%
|
109
94.8%
|
223
96.1%
|
| >=65 years |
3
2.6%
|
6
5.2%
|
9
3.9%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
20
17.1%
|
17
14.8%
|
37
15.9%
|
| Male |
97
82.9%
|
98
85.2%
|
195
84.1%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
117
100%
|
115
100%
|
232
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals. |
| Arm/Group Title | FMPO Condition | Enhanced Treatment as Usual (e-TAU) |
|---|---|---|
| Arm/Group 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. 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. In this condition, the consumer is given a list of family services available including the family intervention team. 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. |
| Measure Participants | 111 | 115 |
| Pre Test (Baseline) |
.4
(2.0)
|
.3
(.9)
|
| Post Test (Within 6 months of the intervention) |
1.6
(2.3)
|
.3
(1.0)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals. |
| Arm/Group Title | FMPO Condition | Enhanced Treatment as Usual (e-TAU) |
|---|---|---|
| Arm/Group 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. 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. In this condition, the consumer is given a list of family services available including the family intervention team. 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. |
| Measure Participants | 111 | 115 |
| Pre Test (Baseline) |
75.6
(17.3)
|
77.0
(19.1)
|
| Post Test (Within 6 months of the intervention) |
80.2
(18.7)
|
79.9
(20.4)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals. |
| Arm/Group Title | FMPO Condition | Enhanced Treatment as Usual (e-TAU) |
|---|---|---|
| Arm/Group 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. 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. In this condition, the consumer is given a list of family services available including the family intervention team. 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. |
| Measure Participants | 111 | 115 |
| Pre Test (Baseline) |
10.6
(2.5)
|
11.4
(2.5)
|
| Post Test (Within 6 months of the intervention) |
11.4
(2.6)
|
11.3
(2.3)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals. |
| Arm/Group Title | FMPO Condition | Enhanced Treatment as Usual (e-TAU) |
|---|---|---|
| Arm/Group 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. 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. In this condition, the consumer is given a list of family services available including the family intervention team. 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. |
| Measure Participants | 111 | 115 |
| Pre Test (Baseline) |
.4
(2.0)
|
.3
(.9)
|
| Post Test (Within 6 months of the intervention) |
.5
(2.0)
|
.3
(1.0)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | FMPO Condition | Enhanced Treatment as Usual (e-TAU) | ||
| Arm/Group 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. 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. In this condition, the consumer is given a list of family services available including the family intervention team. 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. | ||
All Cause Mortality |
||||
| FMPO Condition | Enhanced Treatment as Usual (e-TAU) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| FMPO Condition | Enhanced Treatment as Usual (e-TAU) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/117 (1.7%) | 1/115 (0.9%) | ||
| Psychiatric disorders | ||||
| Hospitalization | 2/117 (1.7%) | 2 | 1/115 (0.9%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| FMPO Condition | Enhanced Treatment as Usual (e-TAU) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/117 (0%) | 0/115 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Amy Drapalski, Ph.D. |
|---|---|
| Organization | VA VISN 5 Mental Illness Research, Education and Clinical Center |
| Phone | 410-637-1855 |
| amy.drapalski@va.gov |
- IIR 04-255
- H-28791