Contact information
Type
Scientific
Primary contact
Dr Bernd Puschner
ORCID ID
Contact details
Ulm University
Department of Psychiatry II
Ludwig-Heilmeyer-Str. 2
Günzburg
89312
Germany
+49 (0)8221 962 866
bernd.puschner@bkh-guenzburg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
223290
Study information
Scientific title
Clinical decision making and outcome in routine care for people with severe mental illness: a multicentre observational longitudinal study
Acronym
CEDAR
Study hypothesis
The main objective of this project is to develop a methodology to assess the scope and quality of clinical decisions in the care of people with severe mental illness (SMI) from both the patient and clinician perspective, and to specify how and to what degree clinical decision making (CDM) in routine care affects patient behaviour and short- and long-term treatment outcome.
The main study hypotheses are:
1. The quality of CDM is positively related to treatment outcome in the routine care of people with SMI
2. The quality of CDM can be adequately described by taking into account decision making styles, satisfaction with decision making, and type of decision making ("paternalistic" versus "shared" versus "informed")
3. Actual CDM in routine care depends on the context, i.e. varies for different kinds of decisions and is susceptible to change over time
4. The relation between quality of CDM and outcome is affected by a number of covariates
Ethics approval
Ulm University Ethics Commission, 15/12/2008, ref: 241/08
Study design
Multicentre observational longitudinal panel study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Can be found at http://www.cedar-net.eu
Condition
Severe mental illness
Intervention
Before the start of recruitment, specific instruments were developed to measure CDM style, key elements of CDM in routine care, as well as CDM involvement and satisfaction from patient and therapist perspectives. Together with established instruments to assess outcome, these are being put to use in the longitudinal study in order to examine the study hypothesis. Total duration of observation per subject is 12 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Needs (Camberwell Assessment of Need Short Appraisal Schedule [CANSAS]), measured at timepoints t0 - t6
Secondary outcome measures
1. Quality of life (Manchester Short Assessment of Quality of Life [MANSA]), measured at timepoints t0 - t6
2. Service use (Client Sociodemographic and Service Receipt Inventory - European version [CSSRI]), measured at timepoints t0 and t6
3. Symptomatic impairment (Health of the Nation Outcome Scales [HoNOS] and Outcome Questionnaire [OQ-45]), measured at timepoints t0 and t6
Overall trial start date
01/11/2009
Overall trial end date
31/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult, aged 18 - 60 years at intake, either sex
2. Main diagnoses mental disorder of any kind established by case notes or staff communication using Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (SCID) criteria
3. Presence of severe mental illness based upon validated criteria including symptom severity (Threshold Assessment Grid [TAG] greater than or equal to 5) and illness duration (greater than or equal to 2 years)
4. Expected contact with mental health services (excluding inpatient services) during the time of study participation
5. Sufficient command of the host country's language
6. Capable of giving informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
560
Participant exclusion criteria
1. Main diagnosis of mental retardation, dementia, substance use or organic brain disorder
2. Cognitive impairment severe enough to make it impossible to give meaningful information on study instruments
3. Treatment by forensic psychiatric services
Recruitment start date
01/11/2009
Recruitment end date
31/10/2011
Locations
Countries of recruitment
Denmark, Germany, Hungary, Italy, Switzerland, United Kingdom
Trial participating centre
Ulm University
Günzburg
89312
Germany
Sponsor information
Organisation
European Commission (Belgium)
Sponsor details
Research Directorate General
Directorate F2 - Public Health
CDMA 2/30
Brussels
1049
Belgium
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Seventh Framework Programme (HEALTH-2007-3.1-4) (ref: 223290)
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
National government
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
2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21062508
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23379280
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25734210
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25471821
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25242154
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28114913
Publication citations
-
Protocol
Puschner B, Steffen S, Slade M, Kaliniecka H, Maj M, Fiorillo A, Munk-Jørgensen P, Larsen JI, Egerházi A, Nemes Z, Rössler W, Kawohl W, Becker T, Clinical decision making and outcome in routine care for people with severe mental illness (CEDAR): study protocol., BMC Psychiatry, 2010, 10, 90, doi: 10.1186/1471-244X-10-90.
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Results
Puschner B, Neumann P, Jordan H, Slade M, Fiorillo A, Giacco D, Egerházi A, Ivánka T, Bording MK, Sørensen HØ, Bär A, Kawohl W, Loos S, , Development and psychometric properties of a five-language multiperspective instrument to assess clinical decision making style in the treatment of people with severe mental illness (CDMS)., BMC Psychiatry, 2013, 13, 48, doi: 10.1186/1471-244X-13-48.
-
Results
Konrad J, Loos S, Neumann P, Zentner N, Mayer B, Slade M, Jordan H, De Rosa C, Del Vecchio V, Égerházi A, Nagy M, Bording MK, Sørensen HØ, Kawohl W, Rössler W, Puschner B; CEDAR Study Group, Content and implementation of clinical decisions in the routine care of people with severe mental illness, Puschner B, Arnold K, Ay E, Becker T, Konrad J, Neumann P, Loos S, Zentner N, Slade M, Clarke E, Jordan H, Maj M, Fiorillo A, Giacco D, Luciano M, De Rosa C, Sampogna G, Del Vecchio V, Cozzolino P, Del Vecchio HG, Salzano A, Égerházi A, Ivánka T, Nagy M, Berecz R, Glaub T, Süveges Á, Kovacs A, Magyar E, Munk-Jørgensen P, Bording MK, Sørensen HØ, Larsen JI, Kawohl W, Bär A, Rössler W, Krömer S, Mutschler J, Obermann C, 2015, 24, 1, 15-19.
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Results
Clarke E, Puschner B, Jordan H, Williams P, Konrad J, Kawohl W, Bär A, Rössler W, Del Vecchio V, Sampogna G, Nagy M, Süveges A, Krogsgaard Bording M, Slade M., Empowerment and satisfaction in a multinational study of routine clinical practice, Acta Psychiatr Scand, 2015, 131, 5, 369-378, doi: 10.1111/acps.12365.
-
Results
Courses of helping alliance in the treatment of people with severe mental illness in Europe: a latent class analytic approach, Loos S, Arnold K, Slade M, Jordan H, Del Vecchio V, Sampogna G, Süveges Á, Nagy M, Krogsgaard Bording M, Østermark Sørensen H, Rössler W, Kawohl W, Puschner B; CEDAR study group, 2015, 50, 3, 363-370, doi: 10.1007/s00127-014-0963-4.