SchizophreniaJCPUKENCT03240380
Joint Crisis Plans or Crisis Cards for People With Severe Mental Disorders to Reduce Coercion in Psychiatric Care.
A study testing joint crisis plan and crisis card in people with Schizophrenia and Bipolar Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This randomized clinical trial compares the influence of joint crisis plans (JCP) or crisis cards to reduce psychiatric coercion for people with severe and often recurring mental illnesses like schizophrenia, bipolar disorder or schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
- What is being tested?
- joint crisis plan and crisis card
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2017to 30 Jun 2019
- 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
- mental capacity to consent the participation in the study
- principal diagnosis according to criteria in ICD-10 main groups F20-F29 or F30-F39
- patient is residing in the care area of the clinic OR currently at least 2nd inpatient hospital stay in this clinic OR currently treated in a psychiatric outpatients department of the participating clinic
- at least one psychiatric hospital stay within the last 24 months in any clinic including the current stay OR patient has a history of coercion (involuntary hospitalization, mechanical restraint, isolation, forced medication) in any clinic including the current stay
Who cannot join
- clinical impression of insufficient cognitive capacity
- insufficient understanding of the German language
- planned transfer to involuntary long-term inpatient care or forensic facilities
- serious somatic or organic brain disorder (dementia e.g.) or more than slight mental retardation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Candelaria I. Mahlke, Dr. phil., +49 (0)40 7410 58933, c.mahlke@uke.de
About this study
Official title: A Randomized Controlled Trial Comparing Joint Crisis Plans With Crisis Cards for People With Bipolar Disorders, Schizophrenia and Other Psychotic Disorders to Reduce Involuntary Admission and Coercive Measures.
This randomized clinical trial compares the influence of joint crisis plans (JCP) or crisis cards to reduce psychiatric coercion for people with severe and often recurring mental illnesses like schizophrenia, bipolar disorder or schizoaffective disorder. Both interventions will be carried out as an integrated part of otherwise standard psychiatric in-patient and out-patient care in psychiatric units specializing in the acute or non-acute treatment of mentioned mental illnesses.
Read the detailed description
Single open-label randomised clinical trial with parallel control groups.
The intervention group "joint crisis plan" benefits from a joint crisis plan in addition to the usual in-patient care. The active control group "crisis card" benefits from the crisis card in addition to the usual in-patient or out-patient care.
OBJECTIVES:
The study aims at evaluating the effectiveness of a joint crisis plan compared with crisis cards regarding the reduction of coercive measure in the following hospital admission.
PROCEDURES:
A weekly screening of all service users regarding eligibility will be carried out. Each eligible person will be approached by a trained staff member of the unit and invited to participate in the study, but not before the patient is capable of consenting to treatment. After informed consent has been obtained, a staff member conducts a baseline assessment using the Global Assessment of Functioning (GAF), the Clinical Global Impression (CGI) and the Brief Psychiatric Rating Scale (BPRS). Then participants will be randomly allocated to either intervention or control group and specific intervention will be carried out. Joint crisis plan: Due to the duration of the process, the facilitated preparations for the negotiation session should start immediately. For those treated as in-patients, intervention should be finish before their release from the hospital. Crisis card: The in-patient and the attending physician fill out a crisis card together when the patient is to be released from the clinic. Out-patient prepare a crisis card together with their clinic physician during a routine visit to the clinic doctor's office. After the 12-month-follow-up-period participants will be assessed again regarding received psychiatric in-patient care and experienced coercive measures in any clinic during this period. Additionally, the patient's case files are examined for documented coercive measures.
HYPOTHESES:
The primary hypothesis to be tested is whether JCPs significantly reduce the average of involuntarily spent days of hospitalization during the 12 month follow-up period, compared with the control group receiving crisis cards.
Secondary hypotheses will be to determine whether compared with the control condition, JCP use will result in improvements regarding other common coercive incidents: involuntary medication, isolation, and physical restraint.
SAMPLE SIZE CALCULATION:
The necessary sample size regarding the primary outcome criterion "days in accommodation" was calculated utilizing routine data of a random sample (N = 20) of in-patients. The following inclusion criteria were used for the population of patients:
- relevant period: 1st of January to 31st of December 2016
- at least one acute psychiatric inpatient hospital stay with admission and discharge in 2016 (UKE: station PEAG)
- minimum length of in-patient treatment 3 days
- documented ICD-10 diagnosis: F2*/F3*
A zero-inflated negative binomial regression was calculated to obtain the estimator for the average number of days in accommodation (15.69) and the estimator for the overdispersion (0.49). The sample size calculation was carried out with a type I error of 5% (two-tailed) and a power of 80%.
The calculation was carried out with PASS 2008 (NCSS, LLC Kaysville, Utah). It led to a sample size of 151 patients per group (a total of 302 patients). Taking withdrawal and follow-up loss of combined approx. 20% into account an initial sample size of 374 patients (187 per group) will be necessary.
STATISTICAL ANALYSIS:
In order to address primary and secondary objectives, an intention-to-treat analysis (ITT) will be calculated as a zero-inflated negative binomial regression. The group variable (JCP vs. crisis card) is included as a fixed effect into the model. Additionally, a per-protocol analysis (PP) will be performed to examine the actual interventional effect.
- Conditions
- Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
- Being tested
- joint crisis plan, crisis card
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
joint crisis planBehavioural
Also called Behandlungsvereinbarungen (German)
Joint crisis plans are consensual written patient-clinic-agreements for future crisis intervention, especially for people with recurring severe mental illnesses. In case of relapse, they provide the hospital with contact information and detailed patient's preferences regarding medical, psychological and psychosocial measures. Thus JCPs aim to implement patient self-determination rights, prevent psychiatric coercion and foster self-management and recovery.
Between the patient and the clinic represented by the attending physician a joint crisis plan is to be negotiated and agreed upon on individual basis as part of inpatient care. If possible this is to be facilitated by peer counselors or another third party. If for an in-patient the process is not completed until the end of the hospital stay it becomes part of regular outpatient aftercare.
crisis cardBehavioural
Also called Krisenpass (German)
Crisis cards are credit card-sized booklets to be kept preferably always at hand. They can contain important information: persons to contact, current medication, basic treatment preferences and hints to advance directives or other existing legal documents. They may be of use in the event of a mental health crisis and help to quickly receive appropriate support.
When the in-patient is to be released from the clinic, the attending physician and the patient together fill out a crisis card. Out-patients get their crisis cards during the next routine visit to their clinic doctor's office.
| Study group | Role | What they receive |
|---|---|---|
| joint crisis plan | Experimental | Subjects benefit from a joint crisis plan and the process of its negotiation in addition to the usual in-patient or out-patient care. Receives: Behavioral: joint crisis plan |
| crisis card | Active comparator | Subjects benefit from a crisis card in addition to the usual in-patient or out-patient care. Receives: Behavioral: crisis card |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative time in days of involuntary psychiatric hospitalization
involuntarily spent psychiatric hospital days during follow-up period
Measured: 12 month
Secondary outcomes (3)
cumulative frequency of forced medication
cumulative occurrences of the coercive measure "forced medication" during the follow-up period
Measured: 12 month
cumulative duration of mechanical restraint
cumulative duration of the coercive measure "mechanical restraint" in minutes during the follow-up period
Measured: 12 month
cumulative duration of isolation
cumulative duration of the coercive measure "isolation" in minutes during the follow-up period
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start1 May 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Health, Germany, Bundesarbeitsgemeinschaft Gemeindepsychiatrischer Verbünde e. V., Aktion Psychisch Kranke e. V., Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Thomas Bock, Prof. Dr., Principal investigator, Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-EppendorfCandelaria I. Mahlke, Dr. phil., Principal investigator, Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240380
- Sponsor's protocol ID
- 0748-111
- Acronym
- JCPUKE
- Status last verified
- Oct 2017
- First submitted
- 2 Aug 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Joint Crisis Plans With Crisis Cards for People With Bipolar Disorders, Schizophrenia and Other Psychotic Disorders to Reduce Involuntary Admission and Coercive Measures.
- ClinicalTrials.gov ID
- NCT03240380
- Acronym / sponsor ID
- JCPUKE / 0748-111
- Conditions
- Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Federal Ministry of Health, Germany, Bundesarbeitsgemeinschaft Gemeindepsychiatrischer Verbünde e. V., Aktion Psychisch Kranke e. V., Charite University, Berlin, Germany
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 7 Aug 2017 (actual)
- 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.
This randomized clinical trial compares the influence of joint crisis plans (JCP) or crisis cards to reduce psychiatric coercion for people with severe and often recurring mental illnesses like schizophrenia, bipolar disorder or schizoaffective disorder. Both interventions will be carried out as an integrated part of otherwise standard psychiatric in-patient and out-patient care in psychiatric units specializing in the acute or non-acute treatment of mentioned mental illnesses.
Detailed description
Single open-label randomised clinical trial with parallel control groups.
The intervention group "joint crisis plan" benefits from a joint crisis plan in addition to the usual in-patient care. The active control group "crisis card" benefits from the crisis card in addition to the usual in-patient or out-patient care.
OBJECTIVES:
The study aims at evaluating the effectiveness of a joint crisis plan compared with crisis cards regarding the reduction of coercive measure in the following hospital admission.
PROCEDURES:
A weekly screening of all service users regarding eligibility will be carried out. Each eligible person will be approached by a trained staff member of the unit and invited to participate in the study, but not before the patient is capable of consenting to treatment. After informed consent has been obtained, a staff member conducts a baseline assessment using the Global Assessment of Functioning (GAF), the Clinical Global Impression (CGI) and the Brief Psychiatric Rating Scale (BPRS). Then participants will be randomly allocated to either intervention or control group and specific intervention will be carried out. Joint crisis plan: Due to the duration of the process, the facilitated preparations for the negotiation session should start immediately. For those treated as in-patients, intervention should be finish before their release from the hospital. Crisis card: The in-patient and the attending physician fill out a crisis card together when the patient is to be released from the clinic. Out-patient prepare a crisis card together with their clinic physician during a routine visit to the clinic doctor's office. After the 12-month-follow-up-period participants will be assessed again regarding received psychiatric in-patient care and experienced coercive measures in any clinic during this period. Additionally, the patient's case files are examined for documented coercive measures.
HYPOTHESES:
The primary hypothesis to be tested is whether JCPs significantly reduce the average of involuntarily spent days of hospitalization during the 12 month follow-up period, compared with the control group receiving crisis cards.
Secondary hypotheses will be to determine whether compared with the control condition, JCP use will result in improvements regarding other common coercive incidents: involuntary medication, isolation, and physical restraint.
SAMPLE SIZE CALCULATION:
The necessary sample size regarding the primary outcome criterion "days in accommodation" was calculated utilizing routine data of a random sample (N = 20) of in-patients. The following inclusion criteria were used for the population of patients:
- relevant period: 1st of January to 31st of December 2016
- at least one acute psychiatric inpatient hospital stay with admission and discharge in 2016 (UKE: station PEAG)
- minimum length of in-patient treatment 3 days
- documented ICD-10 diagnosis: F2*/F3*
A zero-inflated negative binomial regression was calculated to obtain the estimator for the average number of days in accommodation (15.69) and the estimator for the overdispersion (0.49). The sample size calculation was carried out with a type I error of 5% (two-tailed) and a power of 80%.
The calculation was carried out with PASS 2008 (NCSS, LLC Kaysville, Utah). It led to a sample size of 151 patients per group (a total of 302 patients). Taking withdrawal and follow-up loss of combined approx. 20% into account an initial sample size of 374 patients (187 per group) will be necessary.
STATISTICAL ANALYSIS:
In order to address primary and secondary objectives, an intention-to-treat analysis (ITT) will be calculated as a zero-inflated negative binomial regression. The group variable (JCP vs. crisis card) is included as a fixed effect into the model. Additionally, a per-protocol analysis (PP) will be performed to examine the actual interventional effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| joint crisis plan | Experimental | Behavioral: joint crisis planSubjects benefit from a joint crisis plan and the process of its negotiation in addition to the usual in-patient or out-patient care. |
| crisis card | Active comparator | Behavioral: crisis cardSubjects benefit from a crisis card in addition to the usual in-patient or out-patient care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- mental capacity to consent the participation in the study
- principal diagnosis according to criteria in ICD-10 main groups F20-F29 or F30-F39
- patient is residing in the care area of the clinic OR currently at least 2nd inpatient hospital stay in this clinic OR currently treated in a psychiatric outpatients department of the participating clinic
- at least one psychiatric hospital stay within the last 24 months in any clinic including the current stay OR patient has a history of coercion (involuntary hospitalization, mechanical restraint, isolation, forced medication) in any clinic including the current stay
Key exclusion criteria (4 listed)
- clinical impression of insufficient cognitive capacity
- insufficient understanding of the German language
- planned transfer to involuntary long-term inpatient care or forensic facilities
- serious somatic or organic brain disorder (dementia e.g.) or more than slight mental retardation
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 |
|---|---|---|
| joint crisis planAlso: Behandlungsvereinbarungen (German)Joint crisis plans are consensual written patient-clinic-agreements for future crisis intervention, especially for people with recurring severe mental illnesses. In case of relapse, they provide the hospital with contact information and detailed patient's preferences regarding medical, psychological and psychosocial measures. Thus JCPs aim to implement patient self-determination rights, prevent psychiatric coercion and foster self-management and recovery. Between the patient and the clinic represented by the attending physician a joint crisis plan is to be negotiated and agreed upon on individual basis as part of inpatient care. If possible this is to be facilitated by peer counselors or another third party. If for an in-patient the process is not completed until the end of the hospital stay it becomes part of regular outpatient aftercare. | Behavioural | joint crisis plan |
| crisis cardAlso: Krisenpass (German)Crisis cards are credit card-sized booklets to be kept preferably always at hand. They can contain important information: persons to contact, current medication, basic treatment preferences and hints to advance directives or other existing legal documents. They may be of use in the event of a mental health crisis and help to quickly receive appropriate support. When the in-patient is to be released from the clinic, the attending physician and the patient together fill out a crisis card. Out-patients get their crisis cards during the next routine visit to their clinic doctor's office. | Behavioural | crisis card |
Primary outcome
cumulative time in days of involuntary psychiatric hospitalization
Time frame: 12 month
involuntarily spent psychiatric hospital days during follow-up period
3 secondary outcomes
cumulative frequency of forced medication
Time frame: 12 month
cumulative duration of mechanical restraint
Time frame: 12 month
cumulative duration of isolation
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- main site of the overarching projectLink provided by the sponsor.
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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.
Thomas Bock, Prof. Dr. principal investigator
Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf
Candelaria I. Mahlke, Dr. phil. principal investigator
Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing joint crisis plan and crisis card in people with Schizophrenia and Bipolar Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Oct 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Candelaria I. Mahlke, Dr. phil. (+49 (0)40 7410 58933, c.mahlke@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative time in days of involuntary psychiatric hospitalization (time frame: 12 month). 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 26 Oct 2017.