Condition category
Mental and Behavioural Disorders
Date applied
11/08/2010
Date assigned
15/09/2010
Last edited
26/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.cedar-net.eu

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 measures

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

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

http://cordis.europa.eu/fp7/health/

Funders

Funder type

Government

Funder name

European Union (EU) (Belgium) - Seventh Framework Programme (FP7) for Improving Clinical Decision Making (HEALTH-2007-3.1-4) (ref: 223290)

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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

Editorial Notes