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| ID | Type | Description | Link |
|---|---|---|---|
| H-28791 | Other Identifier | UMB IRB |
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| Name | Class |
|---|---|
| University of Maryland, Baltimore County | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMPO Condition | Experimental | 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. |
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| Enhanced treatment as usual (e-TAU) | Active Comparator | Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family Member Provider Outreach | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Family Member/Caregiver Inclusion Criteria
Exclusion Criteria:
Family Member/Caregiver Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa B Dixon, MD MPH | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18678695 | Result | 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. | |
| 23242515 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Enhanced treatment as usual (e-TAU) | Behavioral | Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team. |
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| 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 |
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| 24177229 | Result | 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. |
| FG001 | 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. 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Family-Clinician Contact (Including Contact With FMPO Clinician) | Chart review looking at the any clinician contact with veteran's family members | 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. | Posted | Mean | Standard Deviation | Number of Interactions | Within 6 months of intervention |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a Scale | Within 6 months of intervention |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Within 6 month of the intervention |
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| Primary | Family-Clinician Contact (Not Including Notes From FMPO Clinicians) | Chart review looking at the any clinician contact with veteran's family members | 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. | Posted | Mean | Standard Deviation | Number of Interactions | Within 6 months of intervention |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. | 2 | 117 | 0 | 117 | ||
| EG001 | 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. 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. | 1 | 115 | 0 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Hospitalization | Non-systematic Assessment | Psychiatric hospitalization |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Drapalski, Ph.D. | VA VISN 5 Mental Illness Research, Education and Clinical Center | 410-637-1855 | amy.drapalski@va.gov |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D003865 | Depressive Disorder, Major |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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