Joint Crisis Plans or Crisis Cards for People With Severe Mental Disorders to Reduce Coercion in Psychiatric Care.

NCT03240380 | Unknown

• 1 other identifier: 0748-111
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• cumulative time in days of involuntary psychiatric hospitalization

  involuntarily spent psychiatric hospital days during follow-up period

  12 month

Secondary Outcomes (3)

• cumulative frequency of forced medication

  12 month

• cumulative duration of mechanical restraint

  12 month

• cumulative duration of isolation

  12 month

Study Arms (2)

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.

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.

Behavioral: crisis card

Interventions

joint crisis plan BEHAVIORAL

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.

Also known as: Behandlungsvereinbarungen (German)

joint crisis plan

crisis card BEHAVIORAL

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.

Also known as: Krisenpass (German)

crisis card

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Federal Ministry of Health, Germany: collaborator
• Bundesarbeitsgemeinschaft Gemeindepsychiatrischer Verbünde e. V.: collaborator
• Aktion Psychisch Kranke e. V.: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related Links

• main site of the overarching project

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Thomas Bock, Prof. Dr.

  Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Candelaria I. Mahlke, Dr. phil.

  Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candelaria I. Mahlke, Dr. phil.

CONTACT

+49 (0)40 7410 58933; c.mahlke@uke.de

René Uhlig, M.Sc. psych.

CONTACT

+49 (0)40 7410 58933; re.uhlig@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: May 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

DE (1)