Trial Outcomes & Findings for The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness. (NCT NCT00466323)
NCT ID: NCT00466323
Last Updated: 2015-04-24
Results Overview
Chart review looking at the any clinician contact with veteran's family members
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
238 participants
Primary outcome timeframe
Within 6 months of intervention
Results posted on
2015-04-24
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
115
|
|
Overall Study
COMPLETED
|
89
|
92
|
|
Overall Study
NOT COMPLETED
|
28
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness.
Baseline characteristics by cohort
| Measure |
FMPO Condition
n=117 Participants
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 (e-TAU)
n=115 Participants
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
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 9.4 • n=99 Participants
|
51.2 years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
51.5 years
STANDARD_DEVIATION 9.0 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
114 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
223 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
195 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
117 participants
n=99 Participants
|
115 participants
n=107 Participants
|
232 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 6 months of interventionPopulation: 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.
Chart review looking at the any clinician contact with veteran's family members
Outcome measures
| Measure |
FMPO Condition
n=111 Participants
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 (e-TAU)
n=115 Participants
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.
|
|---|---|---|
|
Family-Clinician Contact (Including Contact With FMPO Clinician)
Pre Test (Baseline)
|
.4 Number of Interactions
Standard Deviation 2.0
|
.3 Number of Interactions
Standard Deviation .9
|
|
Family-Clinician Contact (Including Contact With FMPO Clinician)
Post Test (Within 6 months of the intervention)
|
1.6 Number of Interactions
Standard Deviation 2.3
|
.3 Number of Interactions
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: Within 6 months of interventionPopulation: 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.
Chart review looking at the any clinician contact with veteran's family members
Outcome measures
| Measure |
FMPO Condition
n=111 Participants
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 (e-TAU)
n=115 Participants
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.
|
|---|---|---|
|
Family-Clinician Contact (Not Including Notes From FMPO Clinicians)
Pre Test (Baseline)
|
.4 Number of Interactions
Standard Deviation 2.0
|
.3 Number of Interactions
Standard Deviation .9
|
|
Family-Clinician Contact (Not Including Notes From FMPO Clinicians)
Post Test (Within 6 months of the intervention)
|
.5 Number of Interactions
Standard Deviation 2.0
|
.3 Number of Interactions
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Within 6 months of interventionPopulation: 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.
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.
Outcome measures
| Measure |
FMPO Condition
n=111 Participants
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 (e-TAU)
n=115 Participants
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.
|
|---|---|---|
|
Consumer's Recovery Rating - MHRM Total Score
Pre Test (Baseline)
|
75.6 Units on a Scale
Standard Deviation 17.3
|
77.0 Units on a Scale
Standard Deviation 19.1
|
|
Consumer's Recovery Rating - MHRM Total Score
Post Test (Within 6 months of the intervention)
|
80.2 Units on a Scale
Standard Deviation 18.7
|
79.9 Units on a Scale
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: Within 6 month of the interventionPopulation: 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.
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.
Outcome measures
| Measure |
FMPO Condition
n=111 Participants
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 (e-TAU)
n=115 Participants
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.
|
|---|---|---|
|
Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score
Pre Test (Baseline)
|
10.6 units on a scale
Standard Deviation 2.5
|
11.4 units on a scale
Standard Deviation 2.5
|
|
Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score
Post Test (Within 6 months of the intervention)
|
11.4 units on a scale
Standard Deviation 2.6
|
11.3 units on a scale
Standard Deviation 2.3
|
Adverse Events
FMPO Condition
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Treatment as Usual (e-TAU)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FMPO Condition
n=117 participants at risk
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 (e-TAU)
n=115 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
1.7%
2/117 • Number of events 2
|
0.87%
1/115 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Amy Drapalski, Ph.D.
VA VISN 5 Mental Illness Research, Education and Clinical Center
Phone: 410-637-1855
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place