SchizophreniaNCT01133587
Patient Guided Psychiatric Admissions
A study testing admissions contract in people with Schizophrenia and Bipolar Disorder, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
To meet the requirement for increased patient involvement, several Community Mental Health Centres (CMHC) have initiated a service called "patient-guided admissions". The investigators will compare a group with "patient guided admission/self-referral to inpatient beds" with a group having treatment as usual. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- admissions contract
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteNorway
- Study dates
- May 2010to Dec 2013
- Phase
- Interventional
- 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
- schizophrenia or bipolar disorder
- long term care
- established relationship with the ward
Who cannot join
- extensive substance use problems
- self-destructive behavior
- not able to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Guided Psychiatric Admissions (Self-referral to Inpatient Beds)
To meet the requirement for increased patient involvement, several Community Mental Health Centres (CMHC) have initiated a service called "patient-guided admissions". The investigators will compare a group with "patient guided admission/self-referral to inpatient beds" with a group having treatment as usual.
It is expected that patients in the intervention group will experience more increased feeling of coping (patient activation) after 4 months and 12 months as a result of participating in "patient-guided admissions" than patients getting treatment as usual. In addition the total number of inpatient days either in the CMHC, psychiatric hospital or community rehabilitation centre is expected to be clearly lower in the intervention group than in the 'treatment-as-usual' group during one year after intake. Also the number of involuntary admissions either as inpatient or outpatient will be significant lower in the intervention group than the 'treatment-as-usual' group.The number of admissions in CMHC and psychiatric hospital, as well as the number of outpatient consultations in primary care, CMHC and psychiatric hospitals, will be lower in the intervention group than in the 'treatment-as-usual' group. Patients in the intervention group will experience improved mental health, increased feeling of coping (patient activation) and increased experience of recovery after 4 months and 12 months as a result of participating in "patient-guided admissions".
Read the detailed description
Participants will be patients with psychosis or bipolar disorders. Patients in the intervention group will have a contract on "self-referral to inpatient beds" for one year. They can call the CMHC directly and ask for a bed for until 5 nights.
The patients in the 'treatment-as-usual' group will follow common procedures by either contacting their general practitioner, emergency department or duty doctor, and they will be offered a "self-referral to inpatient bed" contract after a year if they satisfy the inclusion criteria.
Regardless of the participation in the intervention group, the patients can also be ordinary admitted during the project period by a doctor via regular procedures in both hospital and CMHC if there is a need for this. All admissions will appear in the register data.
- Conditions
- Schizophrenia, Bipolar Disorder
- Being tested
- wait list control, admissions contract
- Keywords
- Schizophrenia, bipolar disorder, Long term care, patient admission
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wait list controlOther
Patient-guided admissions contract regarding "patient-guided admissions" starting a year after.
admissions contractBehavioural
contract regarding "patient-guided admissions" starting immediately
| Study group | Role | What they receive |
|---|---|---|
| admissions contract | Experimental | contract regarding "patient-guided admissions" Receives: Behavioral: admissions contract |
| wait list control | Active comparator | 1 year on waiting list Receives: Other: wait list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient activation/coping
Patient Activation Measure (PAM 13)
Measured: 4 months
Patient activation/coping
Patient Activation Measure (PAM 13)
Measured: 12 months
Secondary outcomes (6)
Number of admissions
Number of admissions in CMHC, psychiatric hospital of community rehabilitation centre
Measured: 12 months
Total number of inpatient days
Total number of inpatient days in CMHC, psychiatric hospital or community rehabilitation centre
Measured: 12 months
Number of outpatient consultations
Number of outpatient consultations in primary care, in CMHC and psychiatric hospital
Measured: 12 months
Number of involuntary admissions
Number of involuntary admissions either as inpatient or outpatient
Measured: 12 months
Symptoms/functioning and recovery
Behavior and symptom identification scale (BASIS 32) and Recovery Assessment Scale (RAS 24)
Measured: 4 months
Symptoms/functioning and recovery
Behavior and symptom identification scale (BASIS 32) and Recovery Assessment Scale (RAS 24)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lasse Eriksen, PhD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133587
- Sponsor's protocol ID
- 2009/1704
- Other IDs
- 2009/1704
- Status last verified
- Mar 2017
- First submitted
- 19 May 2010
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moljord IE, Helland-Hansen KA, Salvesen O, Olso TM, Gudde CB, Rise MB, Steinsbekk A, Eriksen L. Short time effect of a self-referral to inpatient treatment for patients with severe mental disorders: a randomized controlled trial. BMC Health Serv Res. 2016 Sep 22;16(1):513. doi: 10.1186/s12913-016-1712-z.
PubMed 27659102Moljord IEO, Lara-Cabrera ML, Salvesen O, Rise MB, Bjorgen D, Antonsen DO, Olso TM, Evensen GH, Gudde CB, Linaker OM, Steinsbekk A, Eriksen L. Twelve months effect of self-referral to inpatient treatment on patient activation, recovery, symptoms and functioning: A randomized controlled study. Patient Educ Couns. 2017 Jun;100(6):1144-1152. doi: 10.1016/j.pec.2017.01.008. Epub 2017 Jan 11.
PubMed 28096034Sigrunarson V, Moljord IE, Steinsbekk A, Eriksen L, Morken G. A randomized controlled trial comparing self-referral to inpatient treatment and treatment as usual in patients with severe mental disorders. Nord J Psychiatry. 2017 Feb;71(2):120-125. doi: 10.1080/08039488.2016.1240231. Epub 2016 Oct 14.
PubMed 27739334
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Guided Psychiatric Admissions (Self-referral to Inpatient Beds)
- ClinicalTrials.gov ID
- NCT01133587
- Acronym / sponsor ID
- 2009/1704
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- Schizophrenia, bipolar disorder, Long term care, patient admission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 May 2010 (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.
To meet the requirement for increased patient involvement, several Community Mental Health Centres (CMHC) have initiated a service called "patient-guided admissions". The investigators will compare a group with "patient guided admission/self-referral to inpatient beds" with a group having treatment as usual.
It is expected that patients in the intervention group will experience more increased feeling of coping (patient activation) after 4 months and 12 months as a result of participating in "patient-guided admissions" than patients getting treatment as usual. In addition the total number of inpatient days either in the CMHC, psychiatric hospital or community rehabilitation centre is expected to be clearly lower in the intervention group than in the 'treatment-as-usual' group during one year after intake. Also the number of involuntary admissions either as inpatient or outpatient will be significant lower in the intervention group than the 'treatment-as-usual' group.The number of admissions in CMHC and psychiatric hospital, as well as the number of outpatient consultations in primary care, CMHC and psychiatric hospitals, will be lower in the intervention group than in the 'treatment-as-usual' group. Patients in the intervention group will experience improved mental health, increased feeling of coping (patient activation) and increased experience of recovery after 4 months and 12 months as a result of participating in "patient-guided admissions".
Detailed description
Participants will be patients with psychosis or bipolar disorders. Patients in the intervention group will have a contract on "self-referral to inpatient beds" for one year. They can call the CMHC directly and ask for a bed for until 5 nights.
The patients in the 'treatment-as-usual' group will follow common procedures by either contacting their general practitioner, emergency department or duty doctor, and they will be offered a "self-referral to inpatient bed" contract after a year if they satisfy the inclusion criteria.
Regardless of the participation in the intervention group, the patients can also be ordinary admitted during the project period by a doctor via regular procedures in both hospital and CMHC if there is a need for this. All admissions will appear in the register data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| admissions contract | Experimental | Behavioral: admissions contractcontract regarding "patient-guided admissions" |
| wait list control | Active comparator | Other: wait list control1 year on waiting list |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- schizophrenia or bipolar disorder
- long term care
- established relationship with the ward
Key exclusion criteria (3 listed)
- extensive substance use problems
- self-destructive behavior
- not able to consent
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 |
|---|---|---|
| wait list controlPatient-guided admissions contract regarding "patient-guided admissions" starting a year after. | Other | wait list control |
| admissions contractcontract regarding "patient-guided admissions" starting immediately | Behavioural | admissions contract |
Primary outcome
Patient activation/coping
Time frame: 4 months
Patient Activation Measure (PAM 13)
Patient activation/coping
Time frame: 12 months
Patient Activation Measure (PAM 13)
6 secondary outcomes
Number of admissions
Time frame: 12 months
Total number of inpatient days
Time frame: 12 months
Number of outpatient consultations
Time frame: 12 months
Number of involuntary admissions
Time frame: 12 months
Symptoms/functioning and recovery
Time frame: 4 months
Symptoms/functioning and recovery
Time frame: 12 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 4 Apr 2017.
- Results publication: PubMed 27659102Moljord IE, Helland-Hansen KA, Salvesen O, Olso TM, Gudde CB, Rise MB, Steinsbekk A, Eriksen L. Short time effect of a self-referral to inpatient treatment for patients with severe mental disorders: a randomized controlled trial. BMC Health Serv Res. 2016 Sep 22;16(1):513. doi: 10.1186/s12913-016-1712-z.
- Results publication: PubMed 28096034Moljord IEO, Lara-Cabrera ML, Salvesen O, Rise MB, Bjorgen D, Antonsen DO, Olso TM, Evensen GH, Gudde CB, Linaker OM, Steinsbekk A, Eriksen L. Twelve months effect of self-referral to inpatient treatment on patient activation, recovery, symptoms and functioning: A randomized controlled study. Patient Educ Couns. 2017 Jun;100(6):1144-1152. doi: 10.1016/j.pec.2017.01.008. Epub 2017 Jan 11.
- Results publication: PubMed 27739334Sigrunarson V, Moljord IE, Steinsbekk A, Eriksen L, Morken G. A randomized controlled trial comparing self-referral to inpatient treatment and treatment as usual in patients with severe mental disorders. Nord J Psychiatry. 2017 Feb;71(2):120-125. doi: 10.1080/08039488.2016.1240231. Epub 2016 Oct 14.
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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.
Lasse Eriksen, PhD principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing admissions contract in people with Schizophrenia and Bipolar Disorder, run by St. Olavs Hospital at 1 site in Norway.
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 3 inclusion and 3 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 4 Apr 2017. 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 Norway. 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?
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?
Patient activation/coping (time frame: 4 months). 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 NCT01133587, 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 4 Apr 2017.