Emergency Services, PsychiatricPhase 1NCT00278811
Emergency Linkage to Outpatient Psychiatric Services
A Phase 1 study testing mobile crisis team in people with Emergency Services, Psychiatric, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to compare two different kinds of follow-up care and their effects on psychiatric service use and psychological well-being. This randomized, controlled trial of subjects discharged from the psychiatric emergency services to outpatient care receive traditional hospital-based outpatient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Services, Psychiatric
- What is being tested?
- mobile crisis team
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Mar 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English and Spanish-speaking adult patients (18-and above) presenting to the psychiatric emergency service who rate a "1" or higher on the Spectrum of Suicidal Behavior of Pfeffer screening scale, and who have outpatient followup organized by Comprehensive Psychiatric Emergency Program staff through hospital outpatient psychiatric services are eligible for inclusion.
Who cannot join
- Subjects less than 18 years old, those rated as not suicidal in the emergency department, subjects with mental retardation/developmental delay, and subjects who have community psychiatric treatment that they elect to continue in lieu of hospital outpatient psychiatric services referral are ineligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
The purpose of this study is to compare two different kinds of follow-up care and their effects on psychiatric service use and psychological well-being. This randomized, controlled trial of subjects discharged from the psychiatric emergency services to outpatient care receive traditional hospital-based outpatient clinic referrals (treatment as usual) or appointments for community-based follow-up by a mobile crisis team.
Read the detailed description
There are subgroups of patients who only seek care in emergency settings. An effective strategy to link that group to ambulatory care involves extending contact with psychiatric emergency services beyond the initial hospital-based visit. The "window of opportunity" to promote successful treatment linkage is brief. This is a study of a novel treatment format that seeks to expand the concept of the emergency contact, the study patients method of entering the mental health system of care, and by doing this, enhance retention in prescribed outpatient care. The effects of the intervention on patient symptoms and mental health service use will be examined.
- Conditions
- Emergency Services, Psychiatric
- Being tested
- mobile crisis team
- Keywords
- Mental Health Services, Suicide, Suicide ideation
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile crisis teamProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects randomized to the experimental treatment will demonstrate significantly increased rates of linkage to first outpatient contact as compared with subjects randomized to control treatment.
Measured: 1 week
Secondary outcomes (2)
Subjects randomized to experimental treatment will demonstrate significantly reduced levels of psychiatric symptoms and significantly increased scores of overall functioning at 3 months after study enrollment,
Measured: 3 months
and will demonstrate significantly higher use of outpatient mental health clinical services, lower use of ED contacts, and lower use of inpatient mental health services versus the control group during the six months after study enrollment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startApr 2003
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Services, PsychiatricStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Glenn Currier, University of Rochester
- Investigators
- Glenn W. Currier, M.D., M.P.H., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278811
- Sponsor's protocol ID
- 09541
- Status last verified
- Oct 2015
- First submitted
- 16 Jan 2006
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Linkage to Outpatient Psychiatric Services
- ClinicalTrials.gov ID
- NCT00278811
- Acronym / sponsor ID
- 09541
- Conditions
- Emergency Services, Psychiatric
- Keywords
- Mental Health Services, Suicide, Suicide ideation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2003
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 18 Jan 2006 (estimated)
- Results
- Not posted in the source record
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 compare two different kinds of follow-up care and their effects on psychiatric service use and psychological well-being. This randomized, controlled trial of subjects discharged from the psychiatric emergency services to outpatient care receive traditional hospital-based outpatient clinic referrals (treatment as usual) or appointments for community-based follow-up by a mobile crisis team.
Detailed description
There are subgroups of patients who only seek care in emergency settings. An effective strategy to link that group to ambulatory care involves extending contact with psychiatric emergency services beyond the initial hospital-based visit. The "window of opportunity" to promote successful treatment linkage is brief. This is a study of a novel treatment format that seeks to expand the concept of the emergency contact, the study patients method of entering the mental health system of care, and by doing this, enhance retention in prescribed outpatient care. The effects of the intervention on patient symptoms and mental health service use will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English and Spanish-speaking adult patients (18-and above) presenting to the psychiatric emergency service who rate a "1" or higher on the Spectrum of Suicidal Behavior of Pfeffer screening scale, and who have outpatient followup organized by Comprehensive Psychiatric Emergency Program staff through hospital outpatient psychiatric services are eligible for inclusion.
Key exclusion criteria (1 listed)
- Subjects less than 18 years old, those rated as not suicidal in the emergency department, subjects with mental retardation/developmental delay, and subjects who have community psychiatric treatment that they elect to continue in lieu of hospital outpatient psychiatric services referral are ineligible.
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 |
|---|---|---|
| mobile crisis team | Procedure or surgery | – |
Primary outcome
Subjects randomized to the experimental treatment will demonstrate significantly increased rates of linkage to first outpatient contact as compared with subjects randomized to control treatment.
Time frame: 1 week
2 secondary outcomes
Subjects randomized to experimental treatment will demonstrate significantly reduced levels of psychiatric symptoms and significantly increased scores of overall functioning at 3 months after study enrollment,
Time frame: 3 months
and will demonstrate significantly higher use of outpatient mental health clinical services, lower use of ED contacts, and lower use of inpatient mental health services versus the control group during the six months after study enrollment.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
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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.
Glenn W. Currier, M.D., M.P.H. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mobile crisis team in people with Emergency Services, Psychiatric, run by University of Rochester at 1 site 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 1 inclusion and 1 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 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subjects randomized to the experimental treatment will demonstrate significantly increased rates of linkage to first outpatient contact as compared with subjects randomized to control treatment. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2015.