SchizophreniaNCT00466323
The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness.
A study testing Family Member Provider Outreach and Enhanced treatment as usual (e-TAU) in people with Schizophrenia and Schizoaffective Disorder, run by US Department of Veterans Affairs at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Major Depression
- What is being tested?
- Family Member Provider Outreach and Enhanced treatment as usual (e-TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- Family Member/Caregiver Inclusion Criteria
- Age 18-80 years
- Decisional capacity to provide informed consent
- Permission from veteran to be contacted
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
Official title: The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness
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.
Read the 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).
- Conditions
- Schizophrenia, Schizoaffective Disorder, Major Depression
- Being tested
- Family Member Provider Outreach, Enhanced treatment as usual (e-TAU)
- Keywords
- Mental Illness, Schizophrenia, Education, Family member treatment, Active psychoses
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Depressive Disorder, Major, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Member Provider OutreachBehavioural
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)Behavioural
Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family Member Provider Outreach |
| 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. Receives: Behavioral: Enhanced treatment as usual (e-TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family-Clinician Contact (Including Contact With FMPO Clinician)
Chart review looking at the any clinician contact with veteran's family members
Measured: 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
Measured: Within 6 months of intervention
Secondary outcomes (2)
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.
Measured: Within 6 months of intervention
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.
Measured: Within 6 month of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startSep 2007
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland, Baltimore County
- Responsible party
- Sponsor
- Investigators
- Lisa B Dixon, MD MPH, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466323
- Sponsor's protocol ID
- IIR 04-255
- Other IDs
- H-28791
- Status last verified
- Aug 2014
- First submitted
- 24 Apr 2007
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18678695Cohen 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.
PubMed 23242515Dixon 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.
PubMed 24177229
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness
- ClinicalTrials.gov ID
- NCT00466323
- Acronym / sponsor ID
- IIR 04-255
- Conditions
- Schizophrenia, Schizoaffective Disorder, Major Depression
- Keywords
- Mental Illness, Schizophrenia, Education, Family member treatment, Active psychoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Maryland, Baltimore County
- Study start
- Sep 2007
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Posted 20 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMPO Condition | Experimental | Behavioral: Family Member Provider OutreachFamily 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) | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
- Individuals who do not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Member Provider OutreachFamily 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. | Behavioural | FMPO Condition |
| 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. | Behavioural | Enhanced treatment as usual (e-TAU) |
Primary outcome
Family-Clinician Contact (Including Contact With FMPO Clinician)
Time frame: 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)
Time frame: Within 6 months of intervention
Chart review looking at the any clinician contact with veteran's family members
2 secondary outcomes
Consumer's Recovery Rating - MHRM Total Score
Time frame: Within 6 months of intervention
Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score
Time frame: Within 6 month of the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18678695Glynn 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 publication: PubMed 23242515Cohen 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 publication: PubMed 24177229Dixon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa B Dixon, MD MPH principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Member Provider Outreach and Enhanced treatment as usual (e-TAU) in people with Schizophrenia and Schizoaffective Disorder, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family-Clinician Contact (Including Contact With FMPO Clinician) (time frame: Within 6 months of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00466323, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.