Plain English Summary
Background and study aims
The high number of compulsory admissions of people with mental disorders to psychiatric inpatient care is a major public health issue in Switzerland and other European countries. New methods are needed to improve this situation. The aim of this study is to assess the usefulness of a programme for patients at high risk of compulsory admission to psychiatric hospitals. The usefulness of the programme will be assessed in terms of a reduced number of psychiatric hospitalisations and days of inpatient care. Furthermore, the study aims to increase patient empowerment and satisfaction and reduce the degree to which the patients see treatment as coercive (perceived coercion).
Who can participate?
Patients aged 18-65 who are admitted to the participating psychiatric hospitals, who have been compulsorily admitted at least once during the past 24 months
What does the study involve?
Participants are randomly allocated to either the intervention or to the control group. The control group are treated according to the standard care procedures. Participants in the intervention group receive a 24-month intervention programme that consists of the following elements. First of all, participants attend one to three instruction sessions before they are discharged from the psychiatric hospital. These sessions are individually adapted to the patient's specific needs and experiences. They address information on relapses in mental disorders, treatment and adequate behaviour to prevent a crisis, as well as individual risk factors for a potential crisis. These risk and protective factors are discussed at the regular monitoring contacts after discharge. During the last instruction session an individualised crisis card is drawn up and handed out to the participants. Crisis cards contain information on the patient, professional or personal contact persons, diagnostic data, treatment, medication, and an individual action plan in case of a relapse. After discharge from the hospital, each participant is contacted every fourth week by telephone. These contacts cover the complete follow-up period (24 months). At each contact, the participant’s present status is assessed along with opportunities to discuss issues or to intervene in case of problems. Participants in both groups undergo an assessment at the start of the study including interviews and questionnaires, and detailed follow-up assessments are scheduled again 12 and 24 months later.
What are the possible benefits and risks of participating?
All participants will also receive psychiatric treatment as usual (regular out- or inpatient mental health care). There are no known risks to participants.
Where is the study run from?
The study takes place at four psychiatric hospitals in the Canton of Zurich, Switzerland:
Integrierte Psychiatrie Winterthur - Zürcher Unterland, Sanatorium Kilchberg AG - Privatklinik für Psychiatrie und Psychotherapie, Klinik für Affektive Erkrankungen und Allgemeinpsychiatrie Zürich Ost der Psychiatrischen Universitätsklinik Zürich and Klinik für Soziale Psychiatrie und Allgemeinpsychiatrie Zürich West der Psychiatrischen Universitätsklinik Zürich (which is the lead centre).
When is the study starting and how long is it expected to run for?
April 2010 to May 2014
Who is funding the study?
Department of Health Canton Zurich (Switzerland)
Who is the main contact?
Dr Barbara Lay
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Preventing compulsory admission to psychiatric inpatient care through psycho-education and crisis focused monitoring: a randomised controlled trial
Acronym
Study hypothesis
1. Number and length of compulsory inpatient episodes in a psychiatric hospital during the follow-up is lower in the intervention group, compared to the control group.
2. Treatment satisfaction and level of empowerment are increased, level of internalised stigma is decreased in the intervention group, compared to the control group.
3. The outcomes are associated with a number of covariates on the patient level (treatment history, diagnosis, social network, treatment adherence in the two-year follow-up).
Ethics approval
Zurich Cantonal Ethics Committee (CEC), Division 3 (Kantonale Ethik-Kommission Zürich (KEK) Abteilung 3), 30/11/2009, Ref E-60/2009
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Patient information can be found at http://www.zinep.ch/pvz/flyer (German)
Condition
Severe mental illness
Intervention
1. A programme of individualised psycho-educational instruction focusing on behaviours prior to and during a illness related crisis
2. The distribution of an individualised crisis card containing essential information and guidelines for preventing an acute crisis or for acting properly prior to or during a relapse
2. A 24-month preventive monitoring of individual risk factors of relapse or inadequate disorder-treatment-related behaviour
Total duration of intervention per subject is 24 months.
The control group receives treatment as usual. For the purpose of evaluation, the control group is contacted by phone every three months only in order to gather information on health care use.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Number and length of compulsory inpatient episodes in a psychiatric hospital during the follow-up (t0 t2). This outcome criterion will be analysed in terms of both "time in hospital" and "health care costs" (measured using the Sociodemographic and Service Receipt Inventory CSSRI-EU: number and length of voluntary and involuntary psychiatric inpatient episodes; frequency and length of stays in forensic facilities, frequency of use of outpatient psychiatric care and of other services during follow-up)
1.1. All major endpoints and outcomes of the study will be compared between the intervention and the control group. The group comparability will be tested by control variables (age, sex, length of illness, severity of illness, social support).
Secondary outcome measures
1. Treatment satisfaction [baseline (t0) end of intervention (t2)], Client Satisfaction Questionnaire CSQ-8
2. Level of empowerment (t0 t2; Empowerment-Scale)
3. Internalised Stigma (t0 t2; Internalised Stigma of Mental Illness Inventory)
Overall trial start date
01/04/2010
Overall trial end date
01/05/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. People with mental disorder in psychiatric inpatient treatment who have been compulsorily admitted to psychiatry at least once during the past 24 months
2. Aged 18-65 years at admission
3. Are residing in the Canton of Zurich
4. Have sufficient language skills to give meaningful information on study instruments
5. Are willing and able to consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400, of which 200 each will be assigned to the intervention group or to the control group
Participant exclusion criteria
1. Patients who cannot be contacted by telephone (no telephone or mobile phone available)
2. Main diagnosis of organic mental disorder International Classfication of Diseases (ICD-10 F0), mental retardation (ICD-10 F7), behavioural syndromes associated with physical factors (ICD-10 F5), developmental or behavioural disorders with onset usually occurring in childhood and adolescence (ICD-10 F8-F9)
Recruitment start date
01/04/2010
Recruitment end date
01/04/2012
Locations
Countries of recruitment
Switzerland
Trial participating centre
Psychiatric University Hospital Zurich
Zurich
8021
Switzerland
Funders
Funder type
Government
Funder name
Department of Health Canton Zurich (Gesundheitsdirektion Kanton Zürich) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22946957
Publication citations
-
Protocol
Lay B, Salize HJ, Dressing H, Rüsch N, Schönenberger T, Bühlmann M, Bleiker M, Lengler S, Korinth L, Rössler W, Preventing compulsory admission to psychiatric inpatient care through psycho-education and crisis focused monitoring., BMC Psychiatry, 2012, 12, 136, doi: 10.1186/1471-244X-12-136.